He Conditions For Prevention And Spread Of Infectious Diseases

Original Language Title: On Conditions For Prevention And Spread Of Infectious Diseases

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306/2012 Sb.


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


(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


(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


(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


[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.


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


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


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


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


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


3. Cleaning machines and other equipment are used according to the manufacturer's instructions

including control of the cleaning process.


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


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.


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. 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


6. When sterilising drugs and excipients shall proceed according to the Czech


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


(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

-------------------------------------------------------------------------------------------------------------------------------------- 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). 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. 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. 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. 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


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



* 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


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


(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


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,


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


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


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


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.

Related Laws