306/2012 Sb.
The DECREE
of 12 June. September 2012
on the conditions for the prevention of the emergence and spread of infectious diseases and the
hygiene requirements for the operation of medical facilities and institutions
social care
The Ministry of health provides under section 108, paragraph. 1 of law No.
258/2000 Coll., on the protection of public health and amendment to certain
related laws, as amended by Act No. 274/2001 Coll., Act No.
320/2002 Coll., Act No. 274/2003 Coll., Act No. 392/2005 Coll., Act No.
222/2006 Coll., Act No. 110/2007 Coll. and Act No. 151/2011 Coll. (hereinafter the
"the Act") for the implementation of section 16. 2 (a). (b)) § 17 paragraph. 1 (a). 5,
§ 18 paragraph. 1, section 20 (a). and, section, paragraph 45). 3, section 62, paragraph. 1, section 62, paragraph. 4
(a). and (b)),) and section 70 paragraph. 1 and section 72, paragraph. 1 (a). and) of the Act:
§ 1
The method and scope of the reporting of infectious diseases, with the exception of hospital
diseases
(To section 62 (1) of the Act)
(1) Infectious diseases are classified for the need for information on the
and) a possible case of infectious diseases with clinical symptomatologií
indicative of the disease; This is not a confirmed or probable case
(b)) probable case of infectious diseases with clear clinical
symptomatologií or clinical case in epidemiological context, with
a confirmed case of infectious diseases, where necessary, laboratory
the criteria for a probable case
(c)) confirmed case of infectious diseases meeting the clinical and
laboratory criteria.
(2) Report
and) newly discovered disease, including suspect or relapses
tuberculosis or other mykobakterióz, on the death of tuberculosis in persons
neevidovaných in the Group of active tuberculosis or other mykobakteriózy
(hereinafter referred to as "tuberculosis or other mykobakterióza reportable") and
about the discovery of tuberculosis or other persons in the mykobakteriózy neevidovaných
a group of active tuberculosis that have died from other causes, serving on the
the form "mandatory reporting of tuberculosis and other mykobakterióz"
(b)) for persons followed up in a group of active tuberculosis is served
Once a year, on the form "reporting of Tuberculosis Control and other
mykobakterióz "; This form is used even when a death of a person
dispenzarizované in the Group of active tuberculosis and in finding that the
natural person dispenzarizovaná in the Group of active tuberculosis
or mykobakteriózu, and after the reclassification of such persons to the Group
inactive tuberculosis
(c)) for persons included in the Group of active tuberculosis and other
mykobakterióz subject to change reporting last name, social security number and
dispenzarizujícího equipment serves on the form "reporting a change
data on persons in the register of tuberculosis ",
d) positive result mykobakteriologického examination is served on
the form "reporting a positive result mykobakteriologického
examination ",
(e)) about venereal diseases, including the suspected disease [syphilis
(syphilis), gonorrhea (gonorrhoea), chancroid (ulcus molle), fourth
venereal disease (Lymphogranuloma venereum), Granuloma venereum
(Donovanosis) and venereal diseases caused by viral agents] and the akantomů
deaths and suspected deaths on her serves in the form "reporting
venereal disease ",
(f) the number of positive tests) of the laboratories carrying out the investigation to
Chlamydia trachomatis serovar D card-to these laboratories shall transmit to the
the fifth day of the following month after summarizing locally
the competent authority of the protection of public health, which is immediately send
National reference laboratory for Chlamydia,
(g)) of suspected occurrence or death on other infectious diseases, with
the exception of infectious diseases referred to in annex 1 to this
the decree is made on a form labeled "infectious diseases".
(3) the reporting of infectious diseases are served by the person providing
the care of the public health protection authority competent according to the place of occurrence
infectious diseases. Reports shall be submitted in accordance with its type on forms
referred to in paragraph 2.
(4) the infectious disease, which is reported only when their collective
occurrence, are listed in annex 1 to this notice. Reports are
served immediately by telephone and subsequently, without undue delay,
confirm by fax or e-mail.
(5) to Report a life-threatening or fast the airborne infectious disease
disease or suspected infectious disease or epidemic
the presence of the person providing the care immediately served the authority to protect public
health the competent according to the place of occurrence of infectious disease personally,
by phone, by fax or by electronic mail. The current list of persons
that is, the report is regularly uveřejňován on the Web
website of the public health authorities.
(6) the Reporting of infectious diseases must be in accordance with the standard
definitions of selected infectious diseases according to the regulation of the European
Union ^ 1).
§ 2
Method for reporting of hospital infections
[To section 16, paragraph 2 (b)) of the Act]
(1) Reports of mass occurrence of hospital infection and hospital infection,
that led to serious damage to health or death, is served
immediately, usually by telephone, fax or electronic
by post locally competent authority to protect public health by location
hlásícího provider of health services and subsequently confirmed at
the form marked "infectious diseases". When reporting to the hospital
diseases, based on the evidence of the occurrence of these diseases on the individual
wards, which contains the identification of the person with the hospital infection
including other findings on the diagnosis and course of the disease.
(2) Reporting of hospital infections is subject to
and severe damage to health), for natural persons as a result of
hospital infection in at least one of the following situations, and to
1. reoperaci,
2. rehospitalizaci,
3. transfer to another place of employment intensive, acute care
4. the initiation of intensive volumoterapie, antibiotic therapy or circulatory
support,
(b)), and bulk the occurrence of more than one disease in hospital
the number according to the severity of the infection, which together time and stay locally
in the medical device, and is invoked by the same infectious agents
or similar clinical symptoms,
c) disease, which led to the death of a patient, and at the time of death was
serious infectious process, which was launched intensive
antibiotic therapy, volumoterapie or circulation support functions.
§ 3
List of infectious diseases, which directs the insulation in the
health care, and inpatient diseases whose treatment is
mandatory
(To section 45, paragraph 3, and article 70, paragraph 1, of the Act)
List of infectious diseases, the occurrence of which must always be
ordered the isolation and treatment of the infectious department or Department
tuberculosis or venerologickém Department of medical equipment
inpatient care and treatment which are natural persons are obliged to submit to,
is given in annex 2 to this Decree.
§ 4
Medical examinations for individuals pursuing activities
epidemiologically significant
[To section 20 of the Act)]
Natural person executing activities of the epidemiologically significant shall be subjected to
medical inspections and testing,
and if affected) is a diarrheal disease, fever or festering or
other infectious diseases and or is suspected of having the disease, or
(b)) if she was in contact with the sick epidemiologically significant with
diarrheal diseases, viral hepatitis or other serious
infectious diseases in the workplace, in the home or in the place of its
the stay.
§ 5
The principles for the collection and testing of biological material, and requirements
requisitions
[To section 62, paragraph 4, point (a) and (b))) of the Act]
(1) for the collection of biological material and its examination shall
According to the following requirements:
and biological material) the provider of health services can be
carried out in rooms or spaces, intended for the handling of
biological material, meeting the basic health requirements for
the collection of biological material,
(b)) to the collection of biological material, the use of sterile medical
resources including disposable gloves, and always only for one
application per natural person; permeability of gloves must comply with their
use and risk of biological agents,
c) biological material is taken usually before starting treatment
chemotherapeutic chemical or antimicrobial products
d) biological material for infectious diseases is taken with regard to the
the pathogenesis of infectious disease; to establish a diagnosis, material
Removes a rule in the acute stage of infectious diseases; in the case of
serological examination shall be taken a second sample after 2-3 weeks
After the collection of the first sample, or, as appropriate,
e) biological material must be stored in a standardized containers and into the
dekontaminovatelných crates, with the exclusion of the risk of contamination
request forms,
(f) biological material moves) so as to avoid
the depreciation of the physical effects and to the threat of natural persons.
(2) the Request for the examination of biological material must include the name,
where appropriate, the name, last name, social security number, the address of the place of stay of the investigated
people in the Czech Republic, identification number of the provider of the health
services and its address, label, signature and telephone number of the physician
applying for the examination of biological material, the code number of the health
the insurance company that insured the natural person is examined, the kind of
material, date and time of sampling, the date of the first symptoms of infectious
the disease, a type of antibiotic therapy and its beginning, clinical
the diagnosis and the type of examination.
(3) reports on laboratory finding is served immediately to the provider
health services, that the biological material to be examined.
Laboratory findings confirming the cause of infectious disease reports
the laboratory of the locally competent authority to protect public health by
the place where the patient at the time of collection of the biological material is located.
(4) in the case of reactive result examination of syphilis, with the exception of the
patients with syphilis and already léčenou or without a suspected relapse or
reinfection, the biological material shall be sent to the national reference
the laboratory set up by the Ministry of health for syphilis in order to ensure
of confirmation tests.
§ 6
The requirements on the location and instrumentation and material equipment of the laboratory
conducting laboratory tests on the human immunodeficiency virus
[To section 72, paragraph 1, of the Act)]
For the detection of antigens and antibodies to human immunodeficiency virus in
the use of standard laboratory methods for the laboratory equips
certified laboratory instruments and equipment.
section 7 of the
The reception and care of individuals in health facilities and
social care institutions
(Section 17, paragraph 1, of the Act)
(1) the health requirements for reception and treatment of natural persons in care
provider of health services inpatient care, day care and
outpatient care are set out in the operating system of each provider
health services, always taking into account the nature and extent of the activities of the
and the form of healthcare.
(2) the provider of health services, the receiving physician inpatient care,
day care or doctor institutes of social care records
anamnestické information important for the possible emergence of hospital infection, including
Discovery travel and epidemiological history, where appropriate, be carried out
the relevant examination with regard to the overall state of health of natural persons.
Children also finds that infectious diseases have endured and are
properly vaccinated.
(3) the physician performed clinical and serological tests for syphilis with
using a non-specific and one specific response for
and) all pregnant women in the third and the seventh month of pregnancy,
(b)), each newborn's cord blood
(c)) every woman before performing the abortion,
(d)) of all persons aged 15 to 65 years received the first hospitalization
the Department of venerologické,
(e)) of persons aged 15 to 65 years received on other than venerologická
the Department, if the doctor considers it justified.
(4) on receipt of addicts to the health care provider
services, bed care to carry out the examination of basic detoxification
markers of viral hepatitis.
(5) If, having regard to the health status of the physical person's receipt of the necessary
even when starting from an infectious disease, it is necessary to perform
insulating and barrier measures, where applicable, the receiving physician shall ensure that
transferred to the appropriate Department. A similar obligation is also valid for the
general practitioner, specialist and physician counseling outpatient
the device.
(6) a natural person shall be placed in the care of a provider of health services
inpatient care by health status and the manner or the extent of
health care in the consideration and implementation of epidemiological aspects,
in particular, when the risk of transmission of infection, colonization, multirezistentními
nosičství of pathogenic micro-organisms, microorganisms, or stay at
the outbreak of the disease.
(7) in the income of natural persons to medical facilities and institutes
social care and health care must be observed
the requirements referred to in annex 3 to this notice; in institutions, social
care progresses according to the nature and type of services provided as
to receive and care for natural persons, mutatis mutandis.
§ 8
Sterilization, higher degree of disinfection, disinfection
(Section 17, paragraph 1, and 5 of the Act)
Sterilization, higher degree of disinfection, disinfection methods, ways and
the procedures for their execution, including their control are listed in the
Annex No 4 to this notice.
§ 9
Handling the laundry
(Section 18, paragraph 1, of the Act)
(1) the exchange of personal laundry and bedding the patient in health care
the establishments shall be carried out as necessary, but at least once a week, always after
contamination and after operating performance, or převazu, and always after
the release or transfer of the patient.
(2) in social care institutions, the exchange of bed linen made according to the needs,
but always after contamination of biological materials; the frequency of replacement
established in the operation of the device.
(3) when changing the bedding after the release or the death of a patient
sanitize bed and mattress. A, grossly polluted and damaged
mattress and bedding is excluded from the application.
(4) the used underwear is determined, if necessary, directly only in the
room designed with natural or mechanical ventilation, delayed
allocated directly to the packaging. When sorting laundry are used of personal
protective equipment.
(5) the Bed is after disinfection and assembling linen cover
a clean bed sheet or packaging to the arrival of the next patient.
(6) the Washing of personal protective equipment is provided, taking into account
the nature of the operation of the medical device and taking account of the
options, the risk of transmission of infectious diseases.
(7) In healthcare facilities to cover the investigation and
lounge chairs, where the contact with the exposed parts of the body of the patient, uses
single material that is being changed after each patient.
(8) the way to store laundry from the operation of health care facilities, institutions
social care or establishments to receive underwear, its transport, money
and handling, as well as laundry facilities laid down in annex 5 to the
This Decree.
§ 10
Hygiene requirements for cleaning
(Section 17, paragraph 1, of the Act)
(1) Cleaning of all area medical facilities and institutions of social care
is done daily wet methods, more often if necessary. This method of
cleaning according to the nature of the operation must match the flooring. On
operating and intervention halls, where they are carried out invasive procedures,
the cleaning is always done prior to the beginning of the operational programme and always after
each patient. The acute care, intensive and
rooms where the collection of biological material, cleaning
performs three times a day. The frequency of cleaning on the other workplaces is
adapted to the nature of the operation. In the case of cleaning carried out body
different from the provider of health services or social care
the designated officer shall proceed in accordance with the Treaty and disinfectant
or úklidového.
(2) at workplaces with acute in-patient care standard can be cleaned
use normal cleaning agents. Acute care at the workplace
intensive, on the operating and intervention halls, on surgical and
infectious workplaces, in laboratories, and where there is a collection
biological material and invasive procedures, toilets and bathrooms
and on the other set the operating regulations are used
normal cleaning agents and disinfectants with virucidním effect.
(3) every workplace has earmarked according to purpose of use custom cleaning
agents or cleaning the machine, the only exceptions are the standard
outpatient and inpatient Department of the same type and character songs
natural persons.
(4) when the contamination of surfaces biological material shall be made immediately
decontamination of potřísněného places in particular, overriding the cellulose wadding with cotton wool,
paper one-time cloth virucidním disinfectant
solution or smothering absorption granules with disinfectant effect.
Contaminated site is cleaned in the usual way. Used beds and
the mattresses are disinfected either in the room by washing with disinfectant
or in a central processing plant beds after each release of the patient.
(5) the Waste is classified in the place of, hazardous waste is stored in
marked, separate indoor, uzaviratelných, leak-proof and
mechanically resistant packaging, if possible, without the need of combustible
other waste handling. Sharp waste is stored in designated,
combustible, pevnostěnných, nepropichnutelných, and leak-proof packaging.
Hazardous wastes, in particular the sharp objects are not stored in paper
packaging. Hazardous waste generated at the beds of patients eliminates
immediately, from the workplace is ongoing, at least once a
24 hours. The collection of this waste is carried out in accordance with the operating regulations
the device in the Assembly containers which must conform to other
the legislation of the ^ 2). Assembly of the waste before final disposal
in an enclosed space can be reserved for a maximum of 3 days. Storage
hazardous waste (anatomical and infectious) is possible for 1
months in the freezer, or chilled to a temperature of space up to 8 ° c.
The highly infectious waste ^ 3) must be immediately in direct follow-up to the
the formation of the modified certified decontamination technology
device. When the removal of body parts and organs as
other legislation ^ 4). Registration of waste, its transport and forwarding
authorized person for the purpose of removing edit other legal
^ 5 rules). In a similar way is followed in the handling of waste
and in means of transport, a provider of medical rescue
services, medical transport services and transport provider to patients
urgent care and the health care provider, which provides
health care in the guestbook service.
(6) Painting the rooms of medical equipment shall be carried out according to the
the nature of the activity; operational and operating rooms, acute
inpatient intensive care room, sampling, laboratory, infectious
Department, children's and infant Department with paint once a year,
the other, with the exception of medical devices nesloužících to space
the provision of health services once every 2 years. Painting a room
medical devices is carried out always, if there is contamination of the walls and the
ceilings of biological material. In the case of the application of antibacterial
paints shall be treated in accordance with the manufacturer's instructions.
(7) transport provider medical rescue
services, medical transport services and transport provider to patients
urgent care cleaning and disinfection prior to inclusion in the service,
Once a day in the driver's cabin and in the patient's compartment. In the case of
contamination transport biological material shall be made
always disinfection and mechanical cleansing before transporting. In the case of
the transfer of individuals suspected of having an infectious disease or with
infectious diseases shall be carried out for the patient after disinfection of the area
each transfer of disinfectant at least with virucidním effect.
With regard to the possible spread of infectious diseases carried out providers
health services the normal protective disinfection, and meanwhile, the
the frequency of which is laid down in the operating regulations.
§ 11
Cancellation provisions
Decree No. 195/2005 Coll., which govern the conditions for the prevention of
the emergence and spread of infectious disease and public health requirements for operation
medical facilities and institutions of social care, is hereby repealed.
§ 12
The transitional provisions of the
According to annex No 4, part III, point 2 (a). and proceed to the time)
the equipment of the workplace in the field of Gastroenterology care referred to in annex No. 2
Part II (a). (B) point 1.10. (a). I) Decree No. 92/2012 Coll.
minimum technical requirements and equipment, medical
equipment and home care contact centres, within the time limits laid down in
§ 2 (2). 1 of Decree No. 92/2012 Sb.
section 13
The effectiveness of the
This Decree shall take effect on 1 January 2005. October 2012.
Minister:
doc. MUDr. Heger, CSc., r.
Annex 1
List of infectious diseases, which is reported to the authority, the protection of public
health to collective occurrence of
1. Acute respiratory diseases, including flu and the flu similar
(for example, dg. J03 J04, J00-J06, J10-J18, J20-J22),,
2. Conjunctivitis (such as dg. H10, B30)
3. Mastitis (such as dg. 091)
4. Skin inflammatory infectious and fungal diseases (for example, dg. L00-
L08, B00, B07, B08, B09, B35-B37,)
According to the International statistical classification of diseases and related
health problems in the texts of the 10. Decenální revision.
Annex 2
List of infectious diseases, which directs the insulation on the
the inpatient wards of hospitals or medical institutions, and disease, which
healing is obligatory
1. Acute viral infections of the liver
2. Anthrax
3. Dengue fever
4. the hemorrhagic fever
5. Cholera
6. Infections of the CNS mezilidsky portable
7. Plague
8. Paratyphoid fever
9. Syphilis in i. and II. stage of the
10. Portable polio
11. Whooping cough in the acute stage
12. Ricketsiózy
13. SARS and febrile States unknown etiology with positive travel
a history of
14. The measles
15. Trachoma
16. Tuberculosis
17. Typhus abdominal
18. amoebic Dysentery
19. in acute bacillary Dysentery, disease stage (in the case of
bezpříznakového nosičství of the agent of the disease is possible layoff
the patient in the home environment protection authority only with the consent
public health).
20. Diphtheria
21. Other reportable infections World Health Organization
22. The manifestations of disease or an event that represents the possibility of outbreaks of
diseases referred to in article 1 of the International Health Regulations (IHR 2005), which
It is according to the annex to decision No 2119/98/EC of diseases transmissible.
Annex 3
Hygiene requirements for the reception and care of patients in the medical
the device and the Institute of social care
and clothing and footwear) for natural persons residing in a care provider
health services inpatient care and social care institutions with the exception of the
acute care, intensive workplaces are stored in a central closet,
into the wardrobe in the rooms or cabinets in the premises intended for that purpose;
(b)) health professionals providers of health services a day
or inpatient care including laboratory staff must wear clean personal
protective equipment earmarked only for its own Department.
Committed work shoes can be used also for other departments like
character. While working on another workplace use personal protective
working resources of this site. A health care professional shall not in
personal protective devices leave the area of the provider
health services. Health professionals for health providers
ambulatory care services, use appropriate personal protective
resources, and taking into account the nature of their activities;
(c)) at the workplace, where it is carried out by surgical or sanitary
disinfection of hands, health care workers must wear on the hands of any
jewelry. Health care workers in operating plants must not carry on
the hands of the watch. The adjustment of the nails should not jeopardise the health status of the patient
in particular, with regard to the possible spread of hospital infections and may not prevent
the provision of health care in full. Natural nails must be
modified, short, clean;
(d)) for the operating performance of healthcare professionals must use sterile
protective clothing and sterile gloves, mask, Cap (protective oral drape
and CAP must be used to cover the hair, beard, Chin, nose and
mouth), earmarked only for the shoes of the workplace; for operating theatres
must not be used and stored, jewelry, watches and other personal
items, mobile phones can be used only in special areas
operating rooms;
(e)) for the other performances, which is violated or has violated
the integrity of the skin and mucous membranes or made communication with the body
cavities, or nefyziologický entry into the organism, with protective
AIDS chosen in relation to the performance, stress and the risk for the patient; protective
AIDS must be individualizovány for each person and should be
Eject immediately after the performance;
(f)) for providers of health services outpatient care is range
the measures provided for in points (b) to (d))) adapted to the nature of the
carried out by performance;
(g)) for the investigation and treatment of healthcare professionals can access up to
After washing the hands; hygienic hand disinfection must be done always after
contact with infectious material, and that after each individual
the medical performance of individual natural persons, always before treatment
the patient, always after handling biological material and articles and
AIDS contaminated biological material, including used
and hazardous waste, and before each performance and parenteral
always in the application of barrier mode ošetřovacího to prevent and
Prevention of hospital infections; for wiping your hands must be used
disposable material, which is stored in covered containers;
(h)) for the treatment of patients, health care workers must use
barrier treatment techniques on all workplaces must be used
only decontaminated equipment; the desktop on all workplaces
medical devices must be allocated according to the nature of the carried out
activity. Barrier treatment technique must be used when
translation and transfer of patients and on joint investigation
and medical workplaces;
even) the determination of infection or colonization of multirezistentními
micro-organisms, this finding shall be identified in medical documentation
patient and layoff reports. Colonization of the patient
multirezistentními micro-organisms is not a reason to reject the
the patient's hospitalization or admission to a nursing home;
j) to parenteral procedures including drainage and body cavities,
Download urinary catheters must be health professionals use only
sterile medical devices and comply with each parenteral
treatment principles of asepsis; When replacing the collection bags must be used exclusively
exhaust system and fluid collection with security against possible reflux
flow;
to) for endoscopes and other optical devices introduced into the sterile
body cavities must ensure at least a higher degree of disinfection; for
flexible and rigid endoscopes and digestive (in addition to operating) and
laryngoscopes must ensure two stage disinfection;
l) for each patient, it is necessary to always use a separate sterile
needle and sterile syringe; at insulinových per article
the manufacturer's instructions;
m) care dental kits and other instrumentation techniques
carried out according to the manufacturer's instructions;
n) in the investigation of sterile body cavities must use sterile
If the fluid is indicated by their use;
about) podávky for handling sterile material are stored in the
a preservative or disinfectant solution to that purpose, and shall
up to 24 hours;
p) repeatedly used medical devices are cleaned and disinfected,
sterilize according to manufacturer's instructions. Disposable equipment must not be
reuse even after their sterilization;
q) used instruments and equipment contaminated with biological material
health care workers must manually clean without prior decontamination
disinfectant products with virucidním effect;
r) disposable syringes and needles without manual separation shall be destroyed; to
Department of the needle from the syringe may serve only special widget or
the appliance. Returning guards on the needle is with the exception of insulin pens
inadmissible;
with the persons in care) providers of health services inpatient care and
social care institutions must be ensured supervision of compliance with the principles
personal hygiene; before the performance and operations, and even after them must be ensured
proper cleansing of hygiene;
t) stay and movement of persons in the medical facilities and institutions
social care must be protected even from the protiepidemického point of view, and it
separate the location of natural persons according to the risk of developing, where appropriate,
transmission of infectious diseases;
u) visits for patients must be managed with regard to the operation, the focus of the
the workplace and the status of the patient at the time, to be determined by the doctor. Visit
use protective clothing when entering the workplace of acute care
intensive;
in the workplace), acute care, intensive and operational scope
affixed to any flowers and other plants;
w) when handling food and its preparation progresses according to the
other legislation ^ 6).
Annex 4
Sterilization, higher degree of disinfection, disinfection methods, ways and
the procedures for their execution, including their controls
I. MECHANICAL CLEANSING
1. Mechanical cleansing among the decontamination procedures, which
remove impurities and reduce the number of microorganisms. If there is a
contamination of the biological material must be classified before the mechanical
the cleaning process of disinfection.
2. Cleaning with disinfectant effect are applied either by hand,
or by using the washing and cleaning of machines, pressure gun
ultrasonic devices, etc. All tools and equipment are maintained in
clean.
3. Cleaning machines and other equipment are used according to the manufacturer's instructions
including control of the cleaning process.
II. THE DISINFECTION
When choosing the procedure for disinfection is based on knowledge of the pathways and mechanisms
transmission of infection and of the possibilities of influencing the efficiency of disinfection of the factors
the external environment and the resistance of the microorganisms.
II. I. methods of disinfection
1. the Physical disinfection
and) Var at atmospheric pressure for at least 30 minutes.
(b)) Var in pressurized containers for at least 20 minutes.
(c) Disinfection in instruments) at a temperature which is governed by the parameter A0.
The instrument must guarantee at a given temperature reduce the number of viable
micro-organisms on dezinfikovaném course at a predetermined level,
that is appropriate for its further use. These requirements shall be deemed to
complied with if it is proceeded according to the specified standards ^ 7).
(d)) low temperature disinfection disinfection is carried out in the establishments referred to in
the manufacturer's instructions.
e) ultraviolet radiation is used according to the manufacturer's instructions.
(f)), filtration, annealing, burning.
g) Pasteurization (heating up to 62.5 ° c in the duration of 30 minutes).
2. Chemical disinfection
Dilution and use of chemical products, in accordance with
the manufacturer's instructions. To chemical disinfection use notified biocidal
products or disinfectants declared as medical
^ 8) resources or products registered as pharmaceuticals for use in the
health care.
In the implementation of chemical disinfection shall respect the following basic principles:
a) disinfectant solutions are prepared by dissolving a measured
(weighed) disinfectant in the water. Preparing for each
shift (8 or 12 hours), according to the degree of biological load
material more often. Multi-day disinfectants can be used only
for two stage disinfection and a higher degree of disinfection instructions
the manufacturer,
(b)) when preparing disinfectant solutions are based on the fact that their
the names are Word marks and the products shall be considered as 100%,
(c)) after consuming disinfectant in dávkovačích it is necessary to
mechanically washed dispenser, disinfectant and mark
the date of expiration and the name of the tween, and disinfectant,
d) objects and surfaces contaminated with biological material
disinfect the product with virucidním effect. When you use disinfectants
washing and cleaning preparations with properties you can join stage cleaning and
disinfection,
e) to prevent the selection of, or resistance of microbes to
the product used in the long term are interspersed with disinfectants
the various active substances,
(f)) when working with disinfectant products will comply with the principles of the protection of
health and safety at work and use personal protective
resources. Workers are instructed on the principles of first aid,
g) articles which come into contact with foodstuffs, must
disinfection, thoroughly rinse with potable water and
h) checking of parameters and verification of the effectiveness of the programme and
disinfection process in the washing and disinfection devices is carried out and
dokladuje continuously, at least once every 3 months by using the record of
equipment or physical or chemical indicators or
bioindikátorů. The parameters of the washing and disinfection devices are
decisive for the selection of the test; the user shall ensure, that the selection of the type of programme and
disinfection equipment, operating cycle, the quality of the operating media and
chemicals will match the appropriate charge. Ways to control parameters
and the effectiveness of the washing and disinfection process in the washing and disinfection
facilities must dokladovat that the washing and disinfection process shall ensure
reduce the number of viable micro-organisms on dezinfikovaném course
to a predetermined level, which is suitable for further processing
or use. These requirements shall be considered satisfied if the
at least according to specified standards followed ^ 7).
3. Physico-chemical disinfection
and Chamber-Paroformaldehydová) is used for disinfecting textiles, products of the
synthetics, wool, leather and fur at a temperature of 45 to 75 ° c.
(b)) work, washing and cleaning machines-disinfection takes place at a temperature of up to 60
° C, with the addition of Chemical disinfectants. The time parameter is
governed by the manufacturer's instructions.
II. II. Control of disinfection
When checking the disinfection methods are used:
and) chemical-qualitative and quantitative determination of active substances to
and their content in disinfectant solutions,
(b) the microbiological efficacy findings)-disinfectant solutions or
microbial contamination of the disinfected surfaces (fingerprints, smears,
away, etc.).
II. III. Documentation of the disinfection
and process control instrumentation) disinfection of invasive and
non-invasive medical devices is supported by an automatic
a statement of the values of the device or physical or chemical indicator
or bioindikátorem. All types of these devices includes the manufacturer to
class IIb medical devices.
(b) pasteurization process) documentation is accompanied by the statement or record
physical parameters.
c) Written, respectively. electronic documentation of the washing and disinfection
the device is kept for at least 5 years from the implementation of the inspection process.
III. HIGHER DEGREE OF DISINFECTION, DOUBLE DISINFECTION
1. Higher level disinfection is designed for medical devices, which
cannot be sterilized methods available and are used for performance
the investigation of mikrobiálně and physiologically unpopulated body cavities
(eg. the operational and investigative instruments other than and digestive). Before
a higher degree of disinfection of objects cleaned (mechanically or manually) and
dried. If they are contaminated with biological material, shall be placed before the
stage of the cleaning disinfection product with virucidním effect. A method of wiping
the endoscope is not considered the first level of disinfection. The disinfection
solutions for higher degree of disinfection (disinfectant with
a wide range of efficiency, sporicidní and tuberkulocidní
efficiency) of dry medical devices so that they are
filled with all the hollow parts. Dilution and use disinfectants
of the process according to the manufacturer's instructions. After the higher level
disinfection is necessary and rinse with sterile water to remove items of residues
chemical substances.
2. For medical devices, which are used to perform in the
physiologically mikrobiálně populated parts of the body (flexible and digestive
and rigid endoscopes) and that cannot be sterilized, is determined by the two
disinfection, which is carried out in accordance with the procedure referred to in point 1, with
the use of disinfectants with a broader spectrum of disinfection
efficiency (at least bactericidal, virucidal and microscopic fibrous
mushrooms) followed by
and) drinking water whose quality will be documented by at least twice a year on
the output for the health care provider under other legislation
for drinking water), or ^ 9
(b)) purified water (Aqua purificata water ^ 10)).
3. the work of disinfection solutions must store in closed and
marked containers with indication of the date of application of the solution. The frequency of the
exchanges overnight disinfection solutions is given in the instructions for use
the individual products.
4. Medical devices subject to a higher degree of disinfection are
intended for immediate use, or stored in the 8 hours of indoor
sterile, in sealed and labelled boxes or in the
Special cabinets. Medical devices having undergone a two-stage
disinfection are stored the same way. After an expiry date shall be
the last degree of disinfection.
5. Success of higher level disinfection is evidenced by the journal of higher
the degree of disinfection for each medical device that cannot be
the classic method of sterilization. In the journal higher level disinfection is
indicate the date of preparation of disinfectant solution, the name, the last name of the patient,
the name of the disinfectant concentration, exposure, name and
signature of performing medical worker, identification number
used medical device. About disinfectants
used for two stage disinfection leads journal entry with the date
prepare the working solution, on behalf of the worker, concentrations and exposure,
the identification number of a used medical device. Written by or
electronic documentation is kept for at least five years from the implementation of
higher level of disinfection.
IV. STERILIZATION
IV. I. General procedures:
1. Apparatus and articles intended to be sterilized and to
předsterilizační preparation is used in accordance with the manufacturer's instructions.
2. To Sterilise all the medical devices health provider
creates a service, documents, and maintains a certified system
quality assurance of sterilization, including controlled release system
medical devices.
3. An integral part of sterilization are the předsterilizační preparation
items, sterilization process control and sterilized material,
monitoring and recording of the set parameters pointing and registration
device embedded in the steriliser and check the efficiency of the
nebiologickými and biological indicators of sterilization. Each
the sterilization cycle is documented.
4. Putting the equipment into operation for sterilization, their repair and
recurring service carried out only the credentials of the service personnel.
Technical control of sterilization equipment is carried out in the range
specified by the manufacturer, the technical documentation for equipment without one
a year. Provider of health services is responsible for the quality of the
media required by the manufacturer of the sterilization of instruments, the accuracy of the
the sterilization process and its monitoring, training of health-care
workers performing sterilization, sterilization control trained
the employee, checking the effectiveness of sterilizers.
5. Sterilization carried out by trained health professionals. On
central sterilization is responsible for the operation and the quality of health care
the worker, who graduated from specialized study or certification
course ^ 11) or another health care professional medical instructed
scope.
6. When sterilising drugs and excipients shall proceed according to the Czech
Pharmacopoeia.
IV. II. Předsterilizační preparation:
1. Předsterilizační preparation of the file activity, which consists of
disinfection, cleansing, drying, setování and packaging, the previous
own sterilization, which results in a clean, dry, functional and
the packed medical device intended to be sterilized. The same procedure
It is valid for flash sterilization with the exception of the requirement for packaging
the medical device.
2. Preparations and procedures for disinfecting and washing is chosen so that
damaging the treated material.
3. All the used tools and utilities are considered to be contaminated, and
If they are intended for re-use, dekontaminují, immediately after the
the use of the.
4. methods of decontamination:
and decontamination and wash) disinfectant device in progress way
Thermic or termochemickým at a temperature that ensures the reduction of the number of
viable micro-organisms on dezinfikovaném course on advance
set level, which is crucial for its future use. These
requirements shall be considered satisfied if it is proceeded according to
designated standards ^ 7),
(b) follow-up of the washing parameters) and disinfection process in washing
the establishments shall be carried out regularly by using physical or chemical
tests or bioindikátorů, at least once a week, in the Central
sterilization sterilization departments, centres and in the preparation of medical
resources for the sterilization Centre once a day. Service washing
the device on the indicators checks whether the washing and disinfection cycle
takes place according to the selected program,
(c) check the disinfectant and detergent) process is evidenced by the statement of the temperature
or chemical or biological test indicator. The parameters of the programme and
disinfector are decisive for the selection of the test. When manual
higher level disinfection procedures and two stage disinfection
the effectiveness of the disinfectant solution checks for a method that guarantees the
the minimum level of active ingredients for effective disinfection of medical
resource,
(d) the written or electronic documentation) washing and disinfection
the device is kept for at least 5 years from the implementation of process control,
e) all types of washing and disinfection of the equipment belongs to the class
IIb medical devices, the certificate. Validation
disinfection process is carried out in the central sterilization departments at least
Once a year,
(f)) after manual cleaning tools and utilities after the disinfection in the resource
with a virucidal effect is required from subsequent rinse with water to remove
any residues of the substances.
5. Cleaning the ultrasound is used to supplement the cleansing after the previous
hand or machine washing and disinfecting.
6. After the decontamination, medical devices before packing
thoroughly dried, reviewers and damaged. Proper drying is
an important prerequisite for the desired effect each sterilization
the way.
7. The last phase of předsterilizační training is the insertion of articles intended
to sterilize in suitable packaging (with the exception of flash sterilization)
protects them from microbial contamination after sterilization. The material is in the
sterilization Chamber stores so as to allow the easiest penetration
sterilization of the media. When the sterilization Chamber is filling up only 3/4
the volume and material stores so that it does not touch the walls. The performance is
the same for all types of sterilization.
8. For the decontamination of instruments and equipment used in operating rooms
must be structurally separate space available.
IV. III. Sterilization
1. To sterilize medical devices may only be used
sterilization of the device under the conditions laid down for the medical
resources. Sterilization is carried out by physical or chemical methods
or a combination thereof.
2. The sterilization unit (STJ) is a block of content of 54 litres.
3. Pressure (kPa, bar) means the absolute pressure, relative to a vacuum
(normal atmospheric pressure is 100 kPa 1 bar).
4. the saturated steam is water vapor, which exactly correspond to the temperature and pressure
the steam saturation curve.
5. the safe Level of sterility Assurance Level-SAL/Sterility/SAL < =
10-6 is the likelihood of a maximum of one sterile aluminium subject
among the one million products.
6. methods of sterilization
6.1. physical sterilization by moist heat is carried out, pouring hot
air, plasma, or any other way of sterilization).
6.1.1 sterilization by moist heat (saturated steam) steam
equipment is suitable for medical devices made of metal, glass,
porcelain, ceramics, textiles, rubber, plastics and other materials resistant
These parameters: sterilization
--------------------------------------------------------------------------------------------------------------------------------------
The nominal
sterilization Pressure Pressure Time
temperature (to) (rounded) sterilization Note
(the temperature of the filling exposure
water vapor)
--------------------------------------------------------------------------------------------------------------------------------------
° C kPa bar kPa bar min
--------------------------------------------------------------------------------------------------------------------------------------
121 205 2.05 105 1.05 20 Mandatory BD test and, where appropriate, the vacuum test.
--------------------------------------------------------------------------------------------------------------------------------------
134 304 204 3.04 2.04 4 only for bulk metal tools for immediate use
sterilized in instruments where the vacuum
and the BD test and which are in the phase of venting
the pressure of at least 13 kPa-flash sterilization.
Not used in CS and SC.
--------------------------------------------------------------------------------------------------------------------------------------
134 304 204 3.04 2.04 7 only in instruments where the vacuum and BD test
which are in the phase of venting pressure at least 13 kPa
--------------------------------------------------------------------------------------------------------------------------------------
134 304 204 3.04 2.04 10 Mandatory BD test and, where appropriate, the vacuum test.
--------------------------------------------------------------------------------------------------------------------------------------
134 304 204 Proinaktivaci 3.04 2.04 60 prions, in conjunction with alkaline washing ^ +
--------------------------------------------------------------------------------------------------------------------------------------
+ Tools that have been in contact with the tissues of patients with proven disease CJD must be destroyed, it must not be re-sterilized,
sterilization is intended only for the instruments used on patients with suspect illness.
--------------------------------------------------------------------------------------------------------------------------------------
Explanatory notes:
CS-Central sterilization-carried out a complete předsterilizační preparation and sterilization of medical devices
SC-sterilization Center-sterilization of medical devices only
BD-Bowie-Dick test or an alternative test
--------------------------------------------------------------------------------------------------------------------------------------
6.1.1.1. Sterilization by moist heat must guarantee when using the
the parameters of safe medical device free of all viable
Agent, or in the specified/specified the kind of packaging that ensures the
the sterile barrier. These requirements shall be considered satisfied if the
at least according to specified standards followed ^ 7).
6.1.1.2. The healthcare provider is responsible for the correct choice
sterilization equipment, sterilization program and matching them
the test of the body when performing daily Bowie-Dick test.
6.1.1.3. Steam sterilizers must be equipped with an anti bacterial
the filter. An exception may be allowed at the small table in the industrial
equipped with only the sterilizačními cycles of N type Filter regularly.
changes according to the manufacturer's instructions.
6.1.1.4. The deviation of the actual temperature in the sterilization area from
set during the sterilization exposure ranges for the devices to 1
sterilization units in the range of 0 ° c to + 4 ° c for instruments larger than 1
the sterilization unit in the range of 0 ° c to + 3 ° c.
6.1.1.5. Flash sterilization cycle must not be used for medical
resources with a cavity.
6.1.2. Sterilization (pouring) of the circulating hot air is intended
for medical devices made of metal, glass, porcelain, ceramics and
stoneware. Hot-air sterilization is performed in devices with a compulsory
air circulation when the parameters according to the manufacturer's instructions:
---------------------------------------------
Temperature (° c) time (min)
---------------------------------------------
160 60
---------------------------------------------
170 30
---------------------------------------------
180 20
---------------------------------------------
Deviation of the actual temperature in the sterilization area from the set in
during the sterilization exposure is between-1 ° c to + 5 ° c.
6.1.3. plasma Sterilization-uses plasma generated in the
high-frequency electromagnetic field, or vysokonapěťovém, which
in high vacuum acts on pairs of hydrogen peroxide or other chemical
the substance when the parameters according to the manufacturer's instructions.
6.1.4. radiation Sterilization must guarantee when using the parameters
for gamma rays safe medical device free of all
viable agent in the specified/specified the kind of packaging that ensures the
the sterile barrier. These requirements shall be considered satisfied if the
at least according to specified standards followed ^ 7).
It is used for the industrial manufacture of sterile medical devices,
or to sterilize medical supplies expirovaného
sterilized milk the same method.
6.2. Chemical sterilization-is intended for material that cannot be
sterilize the physical ways.
6.2.1. Sterilization medium are written composition and
concentration.
6.2.2. Sterilization takes place in devices for the fixed overpressure or
the vacuum at a temperature of 80 ° c. If the device operates in a vacuum,
aeration Chamber at the end of the sterilization cycle takes place over
the antibacterial filter. Instruments are equipped with a program
6.2.3. After sterilization, ethylene oxide, the material odvětrává in the Special
cabinets (aerátorech) or at least in a dedicated rubbish bag closed well
ventilated space. Duration of ventilation depends on the time and the quality of the
the rinsing phase after the end of the exposure, the type of sterilization
sterilization sterilized material, media on the temperature and on the
technical equipment of the breather space. controlling its tightness
prior to each sterilization cycle.
6.2.4. When setting up a new central sterilization or sterilisation
the center of the building is separated from the chemical sterilization sterilization
physical (in addition to the plants with combined unit). Building Department
shall not be required in the event that they are not proven to exceeded the value of the
the permissible exposure limit (NPEL) and maximum permissible concentrations
(NPK-P) chemical substances such as sterilization of the media by the Government
No 361/2007 Coll., laying down the conditions for the protection of health at work.
In existing buildings must be separated by at least a clean party.
6.2.5. In terms of sterilization used media recognizes:
and formaldehyde sterilization) must guarantee when using the parameters
When exposed to gas mixtures of formaldehyde with water vapour in vacuum
safe medical device free of all viable agents in
specified/specified the type of packaging to ensure sterile barrier; These
requirements shall be considered satisfied if it is proceeded according to
designated standards ^ 7),
(b)) of ethylene oxide sterilization must guarantee when using the parameters
and exposure to ethylene oxide in vacuum or overpressure safe medical
free resource of all viable agent in the specified/specified
the package, which will ensure the sterile barrier; These requirements shall be deemed to
complied with if it is proceeded according to the specified standards ^ 7),
(c)) the sterilization systems in life support for the use of chemical substances
(for example, perkyselin)-a procedure that must be followed by the manufacturer.
IV. IV. Packaging
1. Packaging is used to protect articles from secondary vysterilizovaných
contamination until their use. Each package is sterile barrier system
required to implement the specific functions required for the
medical packaging. It must facilitate the process of sterilization, provide
microbial barrier and allow the aseptic manipulation. These requirements are
be deemed to be met if it is proceeded according to the specified
^ 7) standards.
2. Disposable packaging paper, polyamide, polypropylene and
the combined paper-plastic wrap and other packaging bearing the procesovým test,
zatavují weld seam wide at least 8 mm or 2 x 3 mm if the distance is not
welds from each greater than 5 mm, or gluing the joints on the original packaging.
Material into the blanks will be packed in a standard way and přelepuje with tape
with the procesovým test. Health aid bottled up sheets of paper or
non-woven fabrics obálkovým way to double the packaging přelepuje
adhesive tape with the procesovým indicator.
3. Fixed, repeatedly used the tunneler sterilization cassette and the containers are
containers that are marked as a medical device by the manufacturer.
On each hard sterilization packaging is necessary to place the process test
containers are used according to the manufacturer's instructions.
4. Cover with vysterilizovaným material indicates the date of sterilisation,
expiration date vysterilizovaného material according to how to save and
central sterilization and sterilization center code worker
appropriate for the integrity of the package and also control the process test
and lots of sterilization.
5. Types of packaging:
1. Primary packaging (unit)-sealed or closed system container,
that creates a microbial barrier and enters into a medical device,
featured procesovým indicator.
2. Secondary packaging-package containing one or more medical
resources, each of which is packaged in its primary packaging.
3. Transport packaging (transport)-package containing one or more
units of the primary and/or secondary packaging intended to provide
the necessary protection during transport and storage.
Vysterilizovaný-protected material is the material stored in the manner
to prevent condensation, dust, mechanical damage.
IV. Storage and transport in the. vysterilizovaného material
1. Packaging with vysterilizovaným material shall be stored in compartments
central sterilization and sterilization centers in aseptickém
space best in closed cabinets. The health care workplace
stored either in the short or the longer bag with expirations
protected from dust in the closet, storage container,
socket or in the packaging. For long term expiration shall apply
a double cover, which is inserted into the closing after sterilization
the storage container.
2. Packaging with vysterilizovaným material, is transferred in the earmarked
closed containers or cabinets, to be protected from damage
and pollution.
IV.VI. Expiration of sterile material
Packaging for sterilization methods and their corresponding expiration
-----------------------------------------------------------------------------------------------
Type of packaging material sterilization Method for Expiration
-----------------------------------------------------------------------------
PS 1) HS 2 PLS 3) FS 4) EC 5 Freely stored Protected
-----------------------------------------------------------------------------------------------
Cassette-+-24 hours. 48 hours.
-----------------------------------------------------------------------------------------------
Container + + * + *--6 days 12 weeks
-----------------------------------------------------------------------------------------------
Paper/board # +----6 days 12 weeks
-----------------------------------------------------------------------------------------------
Paper-foil +-+ 12 weeks 6 days ago
-----------------------------------------------------------------------------------------------
Polyamide-+---6 days 12 weeks
-----------------------------------------------------------------------------------------------
Polypropylene-+--6 days 12 weeks
-----------------------------------------------------------------------------------------------
Tyvek--+ + + 12 weeks 6 days ago
-----------------------------------------------------------------------------------------------
Non-wovens +--** ** ** 6 days 12 weeks
-----------------------------------------------------------------------------------------------
Double cover # 12 weeks to 6 months
-----------------------------------------------------------------------------------------------
Double cover 1 year 1 year
storage and packaging
-----------------------------------------------------------------------------------------------
Notes:
* a container with a filter of termostabilního material
** special container according to the recommendations of the manufacturer of sterilizers
According to the manufacturer's recommendations
# always double pack in the blanks
# close the welding or gluing two layers
Explanatory notes:
1) = sterilization by moist heat
2) = flowing hot air sterilization
3) = plasma sterilization
4) = formaldehyde sterilization
5) = ethylene oxide sterilization
IV. VII. review of sterilization
1. Check the sterilization involves the monitoring of the sterilization cycle,
check the effectiveness of the sterilization of instruments and sterility
vysterilizovaného material. Control of the sterilization carried out medical
the worker or the person referred to under point 3.
2. On the control of sterilization, sterilization process documentation and leads
records that the resource has been exposed to a sterilization process.
The documentation is in the record of each sterilization (kind of sterilized milk
the material parameters, date, name, surname and signature of the natural person
the sterilization carried out, including a written evaluation of the non-biological
systems).
3. Check the sterilization carried out by an authorised person (authorities protection
public health, health institutes, the holders of the authorization).
IV. VIII. Documentation of sterilization
1. Monitoring of the sterilization cycle:
Natural person responsible for the sterilization
and the built-in) monitors measuring instruments, whether sterilization
the cycle takes place according to the selected program; for this, the
You cannot make sterilization after hours, when the staff is not
present,
(b) the recorded values and) controls the evaluation after the end of
the sterilization cycle, if the sterilizer is equipped with a recorder or
the printer.
2. The success of sterilization is evidenced by:
and writing to the journal) the sterilization or signed by the record
the registration of the instrument or the signed output from the printer,
(b) a written evaluation of the chemical) dated sterilization indicator in the
each batch,
(c) a written evaluation of the day) dated Bowie-Dick test, if it is in
the software of the device and saving the test documentation, with
the exception of outpatient health facilities of individual doctors
(non-surgery), where steam penetration test performed
Once a week, including documentation,
(d) a written evaluation of the dated daily) vacuum test, if it is in
the software of the device.
3. Written documentation of sterilization, the archives at least 5 years from the
implementation of the sterilization cycle.
IV. IX. review of the effectiveness of the sterilization equipment
1. to check the effectiveness of the sterilization equipment corresponds to the
the operator.
2. the inspection shall be carried out by biological systems, nebiologickými systems,
physical systems. All systems must guarantee the effectiveness of the control
the sterilization cycle, achieving sterility vysterilizovaných
medical devices and their safety in use.
These requirements shall be considered satisfied if it is proceeded at least
According to specified standards ^ 7).
and) biological systems governed by requirements for sterilization products for the
health care and provides specific requirements for test organisms,
suspension, inoculated carriers in required quality, biological indicators
and methods of cultivation of bioindikátorů, intended for use in the evaluation of
the effectiveness of the sterilization process, using different sterilization
media. These requirements shall be considered satisfied if is followed
at least according to specific standards ^ 7).
Test systems and process biological indicators are used by
the manufacturer's instructions.
The procedure for testing the efficiency of steam, hot air and gas
sterilizers biological indicators without the use of the test body
controls the standard methodology for porous and solid medical
the resources referred to in annex AHEM No. 2/1994. The plasma sterilizers,
proceed as with gas. For medical devices
cavity shall check via the test body, which makes it difficult to
media access to the cavity of the sterilization of medical device. These
requirements shall be considered satisfied if it is proceeded according to
designated standards ^ 7).
Pass the sterilization efficacy using multiparametrových test
systems process at least a class 4 or biological indicators are always
carried out while monitoring the physical and chemical parameters
sterilization. If any parameter is outside the limit,
the sterilization cycle is always evaluated as non-compliant, regardless of the
the results of the test systems or biological indicators.
The frequency of the use of biological indicators:
1. for new appliances and equipment after repair or relocation before
putting into service,
2. immediately when any doubts about the effectiveness of the sterilization of the device,
3. once a month-for the industrial, which are placed on the
central sterilization departments or sterilization centers, operating
the halls, the operating tract and at workplaces which sterilize the material
for other offices,
4. for all other sterilizers not older for 10 years from the date of production
at the latest after the sterilization cycles, at least 200, however, once a
a year earlier, the latest industrial 10 years after 100 sterilization
cycles, but at least once per half a year
(b) non-biological systems) requirements resource sterilization
for health care. General requirements and test methods for process
chemical indicators, using physical and/or chemical change in the substances
sterilization process used to monitor the achievement of one or
more variables to the parameters required for the sterilization cycle. Their
the function does not depend on the presence or absence of living organisms.
These requirements shall be considered satisfied if it is proceeded at least
According to specified standards ^ 7).
They are used in accordance with the instructions for use of their manufacturer. The parameters of the
must correspond to the selected program. For all medical devices
with the cavity must always perform a test check of the body that
difficult access to medical sterilization medium cavity
resource. These requirements shall be considered satisfied if is followed
at least according to specific standards ^ 7).
They are used:
1. Bowie-Dick-test is a test of the correct venting and penetrating
steam. This is done before the first sterilization cycle, and when it
sterilization cycle without charge. In the case of sterilization of medical
objects with a cavity must always perform check using test
housing according to the specified standards, which makes it difficult to access media sterilization.
2. chemical tests of the process-color changing to respond to
the presence of the sterilization of the media. Is used to distinguish the material
ready for sterilization and already vysterilizovaného. This test is
indicates each unit wrapper.
3. chemical sterilization tests-are designed to meet all card
the parameters of the sterilization cycle. For steam sterilizers to 1 STJ on
each batch uses at least one such test, from 2 to 5 of the STJ
at least 2 tests, from 6 to 10 STJ at least 3 tests and over 10 STJ
at least four tests that are stored in locations where sterilization medium
the worst penetrates. For gas and plasma sterilizers are on every
10 Pack uses a chemical test of sterilization. For hot-air
Sterilizers in the volume of 60 litres chamber uses one test, over 60
litres 2 tests, over 120 litres 3 tests.
c) physical systems
1. A daily vacuum tightness test is a test of the device, and is built in
the software of the device.
2. The apparatus or a recording to the demonstrative temperature measurement sensors have
odporovými thermometers, Thermistors or thermocouples and (or) pressure sensor
or by electronic systems and is used for continuous measurement of these quantities
during the sterilization cycle, or to control the built-in measuring
instruments.
If it is repeatedly checking the effectiveness of sterilization of the device
non-compliant, regardless of the type of media, sterilization
technical inspection of equipment in the scope of the acceptance test, which confirms the
or refute its operational capacity. These requirements shall be deemed to
complied with if it is proceeded according to the specified standards ^ 7).
IV. X Validation
1. the term "validation" means the Assembly of the individual phases of the sterilization
cycle, its documentation and confirmation that the operator is guaranteed when the correct
the reproducibility of the sterilization cycle.
2. Validation of the sterilization process must guarantee that each of the sterilization
the cycle will provide the resources for health care, which will match
with predetermined specifications. These requirements shall be deemed to
complied with if it is proceeded according to specified standards.
3. the frequency of validation is performed at least once per year for sterilization
apparatus placed on the workplace central sterilization, sterilization
the Centre or workplace, which sterilises for more bodies.
IV. XI. checking sterility
Check the sterility of the material shall be carried out using standard microbiological
the methods under aseptic conditions.
Annex 5
Treatment of laundry and the washing of medical facilities and institutions
social care
And the character of the linen.
Linen has a similar character as medical material intended for
repeated use. The result of the washing procedure and the process must be linen
free of chemical and bacterial contamination. Materials that come
into direct contact with operating a bang, should not be classified as underwear.
(B). In terms of health risk is divided on:
and it is infectious)-linen contaminated with biological material and
linen used on infectious TB wards, wards and in
all laboratory operations (outside of the dental laboratory),
(b)) operating-this is the linen from the operating rooms, Department of-birth
halls, neonatal Department, ICU and CHIP,
(c)) the other not mentioned in recitals and lingerie) and (b)).
Linen contaminated emitters (radionuclides) and cytotoxic agents, included
like chemical carcinogens, it is subject to another mode, ^ 12).
Linen referred to in points (a) and (b))) from the medical device from the bed
and outpatient folder pere exclusively in establishments which have to
this purpose designed mode and there is no crossing of the medical
washing with laundry.
Washing personal protective equipment from the outpatient facility is
ensured taking into account the nature of the operation, construction and to the
options, the risk of transmission of infectious diseases in their own devoted
the washing machine.
C. treatment of used underwear referred to in part (B) (a)), and (b))
1. Between the provider of health services and laundry facilities are contracted
agree grading system and marking of packaging according to the content (e.g., color,
numerically) and documents the process that defines the quantity, the dates and the way
the transmission of the laundry.
2. The laundry is classified in the place of use and not before saving to.
packaging for underwear neroztřepává wards. Delayed bags by
the degree of soiling, type of underwear and coloring.
3. Counting the linen is possible in a dedicated rubbish bag space for the use of personal
protective equipment.
4. Used linen stores in packaging that prevents contamination of the surrounding area
dirt from the clothes. Use packaging suitable for washing or
clean and disinfect or 1 use.
5. Used linen in packages shall be stored in a dedicated rubbish bag well-ventilated
space. In the rooms for the storage of linen are the floor and
the walls to a height of 150 cm to clean and disinfect.
6. personnel handling the used linen used protective clothing,
gloves and ústenku and shall observe the principles of hygiene. When handling the laundry
at the bedside of the patient are only used basic protective equipment,
protective clothing and gloves. After the completion of the work shall carry out health
the disinfection of the hands.
7. The laundry that has been in contact with the body of parasites, treated with a suitable
insecticide and after 24 hours shall be transmitted to the laundry room. The treatment is possible
use the disinfection Chamber.
8. Used linen dares to the laundry in containers or in vehicles with
closed ložným space. The inner surface of the container (the loading space
the car) is easy to wash, clean and disinfect every transport
used clothes and always before using it for another purpose.
(D) laundry facilities.
1. the Laundry that washes the laundry is located, equipped and
operated in order to ensure the required quality of laundered linen.
2. Clean and unclean laundry to building the party and functionally separates.
Protective clothing for workers clean and unclean is distinguished. Movement of persons
It is possible only through the filter of hygiene.
E. conditions for the laundry
1. When handling your laundry in the laundry room and during transport, the transport and
handling paths clean and linen must not cross.
2. Linen leaves the medical establishment only in protective packaging.
3. Linen is washed by a process of termodezinfekce or chemotermodezinfekce
According to the manufacturer's instructions. The chemotermodezinfekce is the concentration, temperature, and
time of action governed by the instructions for use of disinfectant.
4. the Disinfection process is terminated before the rinse phase.
5. The laundry in a wet condition immediately thermal processed
procedures on the principle of physical disinfecting, and drying, pressing,
shaping.
6. Clean linen does not contain residues of detergent and disinfectants,
that could endanger the health of persons using the laundry.
7. the materials that come into direct contact with operating a bang, if
are used repeatedly, they meet the requirements for disposable
drapes. Fighting separately in special technological mode.
8. Surgical drapes, gowns and clean-room operating clothing,
used as medical devices for patients, staff and
the device must meet all criteria guaranteeing the sterility
medical devices. These requirements shall be considered satisfied if the
We at least according to specific standards ^ 7).
(F) handling of clean linen.
1. Clean linen is in transport protects from pollution and secondary
contamination by suitable packaging. You can use the packaging or packaging suitable for washing
single use. The laundry is transported in the transport of metal trolleys
cage or container. Trailers and containers are clean and
always disinfect before using at least once a day. Underwear
outweigh, in order to avoid damage to the packaging and to the crossing of the pure and
unclean operation.
2. Clean linen store in clean and disinfected regularly
cabinets or shelves in sealed warehouses clean laundry.
1) Commission decision 2002/253/EC laying down case definitions
for reporting communicable diseases to the community network under decision
The European Parliament and of the Council No 2119/98/EC, as amended.
2) Decree No. 383/2001 Coll., on details of the management of waste, in
as amended.
3) Decree No. 432/2003 Coll., laying down the conditions for the
work in categories, limit values for biological exposure indicators
the tests, the conditions of collection of biological material for the implementation of the
biological exposure tests and requirements for the reporting of work with asbestos and
biological agents.
Government Decree No. 361/2007 Coll., laying down the conditions of protection
health at work, as amended by regulation of the Government No. 68/2010 Coll. and regulation
No 93/2012 Sb.
4) Law No 372/2011 Coll. on health services and conditions of their
provision (law on health services), as amended by Act No. 167/2012
SB.
5) Law No 185/2001 Coll., on waste, as amended by later regulations.
Decree No. 64/1987 Coll., on European Agreement concerning the international carriage of
transport of dangerous goods (ADR), as amended.
6) Decree No. 137/2004 Coll. on hygienic requirements for food
services and on principles of personal hygiene and operational activities
epidemiologicjky serious, as amended.
Regulation of the European Parliament and of the Council (EC) No 852/2004 of 29 April 2004. April
20004 on food hygiene.
7) Section 4a of the Act No. 22/1997 Coll., on technical requirements for products and on the
changing and supplementing certain acts, as amended by law No 71/2000 Coll.
Act No. 205/2002 Coll. and Act No. 277/2003 Coll.
8) Law No. 123/2000 Coll., on medical devices and on the change
some related laws, as amended.
9) the Czech Pharmacopoeia 2003, Journal of the MINISTRY OF HEALTH of the CZECH REPUBLIC No. 4/2004, as amended
regulations.
10) Decree No. 252/2004 Coll., laying down the health requirements for
drinking and hot water, and the frequency and extent of monitoring drinking water, in the text of the
Decree No. 187/2005 Coll. and Decree No 193/2006 Sb.
11) Law No. 96/2004 Coll., on conditions for the acquisition and recognition
competence for the exercise of paramedical professions, as amended by
amended.
12) Government Decree No. 361/2007 Coll., laying down the conditions of protection
health at work, as amended by regulation of the Government No. 68/2010 Coll. and regulation
No 93/2012 Sb.
