Machine Translation of "RS 941.210.5 DFJP order of 7 December 2012 on measuring instruments for ionising radiation (OIMRI)" (Switzerland)

941.210.5

DFJP Guidelines on the Measurement of Ionizing Radiation

Mobile reference dosimetry systems used in radiotherapy

Surface Contamination Monitors

Activimeters

Radiation protection instruments for the measurement of external radiation

Systems of well ionization chambers used in brachytherapy HDR at Ir 192

Diagnostic X-ray equipment and other measuring instruments used in the control of diagnostic facilities

Radon Measuring Apparatus

Radon dosimeters

RS 941.210.5 DFJP order of 7 December 2012 on measuring instruments for ionising radiation (OIMRI)

(OIMRI)

Original Language Title: RS 941.210.5 Ordonnance du DFJP du 7 décembre 2012 sur les instruments de mesure des rayonnements ionisants (OIMRI)

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Art. 1 Purpose

Art. 2 Scope of application

Art. 3 Definitions

Art. 4 Essential requirements

Art. 5 Marketing Procedures

Art. 6 Procedures for maintaining measurement stability

Art. 7 Essential requirements

Art. 8 Marketing Procedures

Art. Procedures for maintaining measurement stability

Art. 10 Essential requirements

Art. 11 Marketing Procedures

Art. 12 Procedures for maintaining measurement stability

Art. 13 Essential requirements

Art. 14 Marketing Procedures

Art. 15 Procedures for maintaining measurement stability

Art. 16 Essential requirements

Art. 17 Marketing Procedures

Art. 18 Procedures for maintaining the stability of the measure

Art. 19 Essential requirements

Art. Marketing Procedures

Art. Procedures for maintaining the stability of the measure

Art. Essential requirements

Art. Marketing Procedures

Art. 24 Procedures for maintaining the stability of the measure

Art. 25 Essential requirements

Art. 26 Marketing Procedures

Art. 27 Procedures for maintaining the stability of the measure

Art. 28 Repeal of the law in force

Art. Transitional provisions

Art. Entry into force

Definitions

This Order fixes:

A.: Requirements for measuring instruments for ionizing radiation;
B.: The procedures for placing these measuring instruments on the market;
C.: Procedures to maintain the stability of measurement of these measuring instruments.

The following ionizing radiation instruments are subject to the provisions of this order:

A.

Mobile reference dosimetry systems used in radiotherapy;

B.

Surface contamination monitors used as follows:

1.: Stationary and mobile systems for the monitoring of people, the workplace and equipment at nuclear facilities,
2.: Stationary and mobile systems in the Type A and B work areas under s. 69 ORA;

C.

The activimeters which are based on the principle of the well ionization chamber and are used to measure, in nuclear medicine laboratories, the activity of unsealed radioactive sources used in medicine;

D.

Radiation protection instruments to measure external radiation, used as follows:

1.: Stationary and mobile systems for monitoring ambient dose rates in the environment under s. 104 ORO,
2.: Mobile systems for monitoring the ambient dose rates of the workplace and equipment at nuclear facilities,
3.: Mobile systems for monitoring ambient dose rates within controlled areas of industrial, medical or research facilities where ambient dose rates may be greater than 100 ìSv/h.

E.

Well-operated ionization chamber systems that are used in HDR (high dose rate) brachytherapy for the measurement of sources of Ir 192;

F.

The following measuring instruments, which are used in the acceptance testing and state control of diagnostic facilities:

1.: Radiodiagnostic dosimeter,
2.: Kilovoltmeter,
3.: Coulombmeter
4.: Exposure chronometer,
5.: Sensitometer,
6.: Densitometer
7.: Luxmeter;

G.

Radon measuring devices for official measurement performed by the measurement services approved by the Federal Office of Public Health (FOPH);

H.

Radon dosimeters for official measures performed by the metering services approved by the FOPH.

The terms used in this order are defined in Schedule 1.

Mobile reference dosimetry systems used in radiotherapy must meet the essential requirements set out in Schedule 1 OIMes and Schedule 2 of this order.

Mobile reference dosimetry systems used in radiotherapy are subject to regular approval and initial verification according to Schedule 5 OIMes and Schedule 2 of this order.

Mobile reference dosimetry systems used in radiotherapy are subject to a subsequent verification in accordance with Annex 7, c. 1, OIMes and Schedule 2 of this Order, conducted every four years by the Federal Institute of Metrology (METAS) or by an audit laboratory.

Surface contamination monitors must meet the essential requirements set out in Schedule 1 OIMes and Schedule 3 of this order.

Surface contamination monitors are subject to regular approval and initial verification according to Schedule 5 OIMes and Schedule 3 of this order.

¹ Surface contamination monitors are subject to a subsequent audit in accordance with Schedule 7, c. 1, OIMes and Schedule 3 of this Order, conducted every three years by METAS or by an audit laboratory.

² The proper operation and stability of the equipment shall be checked regularly by the user according to Annex 7, c. 5, OIMes.

³ The scope of controls and the intervals of controls shall be defined in accordance with the directives of the supervisory authorities.

⁴ If, during the stability test, the measurement deviation of the device is greater than the permitted tolerance, the measuring instrument shall be subjected to a subsequent verification.

The actuators shall meet the essential requirements set out in Annex 1 OIMes and Annex 4 to this order.

The activimeters are subject to regular approval and initial verification according to Annex 5 OIMes and Annex 4 to this order.

¹ The activimeters shall be submitted annually to a comparative measure according to Annex 7, c. 4, OIMes and Schedule 4 of this order, carried out by METAS or by an audit laboratory.

² The activimeters are submitted every three years to a subsequent verification in accordance with Annex 7, c. 1, OIMes and Schedule 4 of this order, carried out by METAS or by an audit laboratory.

Radiation protection instruments for the measurement of external radiation shall meet the essential requirements set out in Annex 1 OIMes and Annex 5 to this order.

Radiation protection instruments for the measurement of external radiation are subject to regular approval and initial verification according to Annex 5 OIMes and Annex 5 to this order.

¹ Radiation protection instruments for the measurement of external radiation are subject to a subsequent verification according to Annex 7, c. 1, OIMes and Schedule 5 of this Order, conducted every three years by METAS or by an audit laboratory.

² The proper operation and stability of the equipment shall be checked regularly by the user according to Annex 7, c. 5, OIMes.

³ The scope of controls and the intervals of controls shall be defined in accordance with the directives of the supervisory authorities.

⁴ If, during the stability test, the measurement deviation of the device is greater than the permitted tolerance, the measuring instrument shall be subjected to a subsequent verification.

The well-operated ionization chamber systems used in HDR brachytherapy at Ir-192 shall meet the essential requirements set out in Annex 1 OIMes and Annex 6 to this order.

The well-operated ionization chamber systems used in HDR brachytherapy at Ir-192 are subject to regular approval and initial verification according to Annex 5 OIMes and Annex 6 to this order.

The well-operated ionization chamber systems used in HDR brachytherapy at Ir-192 are subject to a subsequent verification according to Annex 7, c. 1, OIMes and Schedule 6 of this Order, conducted every four years by METAS or by an audit laboratory.

The radiodiagnostic dosimeters and other measuring instruments used for the control of diagnostic facilities shall meet the essential requirements set out in Annex 1 OIMes and Annex 7 to this order.

The radiodiagnostic dosimeters and other measuring instruments used for the control of diagnostic facilities shall be subject to regular approval and initial verification according to Annex 5 OIMes and Annex 7 of the This order.

The radiodiagnostic dosimeters and other measuring instruments used for the control of diagnostic facilities shall be subject to a subsequent verification according to Annex 7, c. 1, OIMes and Schedule 7 of this Order, conducted every three years by METAS or by an audit laboratory.

Radon measuring devices must meet the essential requirements set out in Schedule 1 OIMes and Schedule 8 of this order.

Radon measuring devices are subject to regular approval and initial verification according to Schedule 5 OIMes and Schedule 8 of this order.

Radon measuring devices are subject to a subsequent verification in accordance with Annex 7, c. 1, OIMes and Schedule 8 of this order, performed every 4 years by METAS or by an audit laboratory.

Radon dosimeters must meet the essential requirements set out in Schedule 1 OIMes and Schedule 9 of this order.

Radon dosimeters are subject to regular approval according to Annex 5 OIMes.

Radon dosimeters are subject to intercomparison, according to Appendix 7, c. 4, OIMes, conducted every two years by METAS or by a mandated testing laboratory.

The DFJP Order of November 29, 2008 on Radon Measuring Instruments ¹ Is repealed.

¹ [ RO 2009 179 ]

¹ The measuring instruments for ionizing radiation that have been placed on the market before the entry into force of this order and that the verification laboratories announce to METAS within six months of its entry into force are Considered as authorized.

² Devices for measuring ionizing radiation within the meaning of s. 2, let. A to g, which have been subject to a subsequent audit prior to the coming into force of this order, may be used until the expiry of the verification period set out in the last subsequent audit. They are then subject to subsequent audits within the meaning of this order.

³ Radon dosimeters that have been subject to intercomparison prior to the coming into force of this order may be used up to the next intercomparison.

This order shall enter into force on 1 ^Er January 2013.

(art. 3)

For the purposes of this order:

-: Activimeter: Measuring instrument for determining the activity of certain non-sealed radioactive sources used in medicine;
-: Activity: Number of disintegrations per unit time expressed in becquerels (Bq);
-: Radon measurement device: Measuring apparatus for determining the concentration of radon activity;
-: Becquerel (Bq): SI unit of a radionuclide activity, 1 Bq = 1 disintegration per second;
-: HDR brachytherapy to Ir 192: Radiotherapy which consists of placing a sealed radioactive source of Ir 192 inside or adjacent to the area of the body to be treated;
-: Ionization chamber: Measuring instrument used to determine the intensity of ionizing ionizing radiation of the air it contains and the release of the electric charge carriers connected to it;
-: Well ionization chamber: Cylindrical ionization chamber having an opening on its axis, allowing the introduction of the substance to be measured;
-: Exposure chronometer: Measuring instrument used to determine the exposure time of a diagnostic facility;
-: Concentration of radon activity: Volume activity of radon;
-: Surface contamination: Surface soiling of an object by radioactive substances;
-: Lumbar: Measuring instrument used to determine the charge accumulated in the dosimeter of a diagnostic facility;
-: Current of background noise: current measured by an electrometer when the ionization chamber is connected and in the absence of ionizing radiation;
-: Control current: Electrical current produced in an ionization chamber as part of a stability test;
-: Dose rate: Dose per unit time;
-: Ambient dose rate: Intensity in the time of the equivalent ambient dose H* (10) in the case of penetrating radiation or intensity in the time of the equivalent directional dose H ' (0.07) (dose) in the case of a low penetrant radiation measured in one point in a Radiation field;
-: Densitometer: Measuring instrument for determining the optical density of a radiological film of a diagnostic X-ray facility;
-: Control device comprising a radioactive source: Radioactive source used to produce a known radiation intensity for the stability test;
-: Dose: Energy deposited in the material during the interaction of ionizing radiation per unit mass of matter; expressed in grays (Gy);
-: Radon dosimeter: Measuring instrument for determining radon exposure;
-: Radiodiagnostic dosimeter: Electronic dosimeter used to determine the radiation intensity of a diagnostic facility;
-: Electrometer: Measuring instrument used to determine the electric charge which is produced in the ionization chamber by absorption of ionizing radiation;
-: Beta emitter: Radioactive source that emits ionizing radiation primarily in electronic form;
-: Gamma emitter: a radioactive source that emits ionizing radiation primarily in the form of photons;
-: Radon exposure: Concentration of radon activity multiplied by exposure duration;
-: Water phantom: A plexiglass container filled with water, holding the role of the biological tissue in the definition of radiation dose;
-: Gray (Gy): SI unit of absorbed dose of ionizing radiation;
-: Control indication: Indication of the control current of a control device comprising a radioactive source;
-: Source intensity: Activity of a radioactive source, expressed in becquerels (Bq)
-: Air kerma: Energy released into the air by light irradiation per unit mass;
-: KeV: Kilo-electronvolt, energy unit valant 1,602 10 ^-16 Joule;
-: Kilovoltmeter: Measuring instrument used to determine the high voltage of a diagnostic facility;
-: Luxmeter: Measuring instruments used to determine the luminous intensity in the black rooms of a diagnostic facility;
-: MeV: Megaelectronvolt, energy unit valant 1,602 10 ^-13 Joule;
-: Surface contamination monitor: Measuring instrument for determining surface contamination;
-: Confidence level: The probability that the quantity of true values of a measure is in a specific range;
-: Nucleid: Atomic species that is defined by its atomic number (number of protons) and by its mass number;
-: Depth of half attenuation (R ₅₀): Distance, in a water phantom, to which the intensity of the electronic radiation falls by half;
-: Radiation quality: Designation of the spectral composition of electronic, photonic and X-ray radiation;
-: Radionuclide: Nucleid, which spontaneously disintegrates by emitting radiation;
-: External radiation: Ionizing radiation that acts on the outside body;
-: Radon: Rn-222 radioactive radon isotope;
-: Electronic radiation: Radiation ionizing radiation composed of high-energy electrons (> 1 MeV);
-: Photonic radiation: Radiation-ionizing radiation composed of high-energy photons (> 100 keV);
-: X-rays: Ionizing radiation, which consists of low-energy photons within a range of 10 keV to 300 keV;
-: Sensitometer: Measuring instrument to determine the sensitivity of the radiological film of a diagnostic x-ray facility;
-: Source of control: Radioactive source used to produce a known radiation intensity for the stability test of a radiation measuring instrument;
-: S Reference source for surface contamination monitors: Radiation transmitter for large surfaces of an active surface of 100 cm ² With a certified surface emission rate for the calibration of surface contamination monitors;
-: Mobile reference dosimetric system: Measurement system used in a radiotherapy centre and used as a local reference system to determine the dose or dose rate of photonic, electronic and hadronic radiation in the patient, composed of a chamber Ionization, an electrometer and a control device;
-: Stability test: A measurement method for controlling the stability over time of a measurement system;
-: Guideline value: The value of a radiation intensity which is deduced from a limit value and whose exceedance implies certain measures to be taken or whose respect guarantees that of the limit concerned.

(art. 4 to 6)

1	Construction, metrological qualities

Each system consists of an ionization chamber, an electrometer and a control device comprising a radioactive source. The construction and metrological qualities of these components must correspond to the intended use and to the current state of the technique.

2	Verification

2.1: At the time of the audit, systems must be accompanied by a technical description and instructions for use.
2.2: During the audit, the operation of the system will be monitored and calibration will be carried out. The control device comprising a radioactive source shall be expertised and the indication corresponding to the control current shall be carried over on the verification certificate as an indication of control.
2.3: The system shall be declared compliant for the use in question, where it can be calibrated with a total relative measurement uncertainty of less than ± 3 % or ± 4 % for soft X radiation produced with a voltage less than or equal to 100 kV to a 95 % confidence level.
2.4: During the verification for photonic radiation, the system will be calibrated with the radiation qualities for which it is used. Calibration will be carried out as close as possible to these qualities. In general, each quality will be calibrated at a single dose rate.
During the verification of electronic radiation, the half-attenuation depths for which the calibration of the systems is carried out, taking into account METAS means of measurement, shall be chosen as follows: R-mitigation R ₅₀, for which the system is used, shall be located between two half-attenuation depths for which the calibration is performed and the difference shall be a maximum of 2 g-cm ^-2In general, each quality will be calibrated at a single dose rate.

3	Maximum Tolerable Errors During Controls

3.1

Where systems are used more often than once per semester, they shall be checked at least every six months by means of the control device comprising a radioactive source, both in terms of their operation and Stability. Otherwise, this control must be carried out before each use.

During this inspection, the correction for the density of the air shall be carried out using a metrologically attached thermometer and barometer. It must be defined with a precision of at least ± 0.3 % at a confidence level of 95 %. The following data will be reported in writing:

-: Date of control, visa of the person carrying out the control;
-: Identification of the appliance, the chamber, the adapter, the control device comprising a radioactive source;
-: Indication of control, indication of the current of background noise, including the leakage current, before and after the control measure, temperature and pressure of the air;
-: Control indication corrected by the density of the air relative to the reference temperature T ₀ = 293.15 K and the reference air pressure p ₀ = 1013.25 hPa, as well as the indication of control given in the certificate, corrected for the decrease of the source at the date of control.

3.2

During the stability test, the indication of control shall not deviate from the value specified in the verification certificate, corrected at the date of the test, more than:

-: 1.5 % for soft X radiation (≤100 kV);
-: 0.5 % for high-energy and hard photonic radiation (> 100 kV);
-: 1.0 % for electronic radiation.

If the deviation is greater than these values, the measuring instrument shall be subject to subsequent verification.

4	Period of validity of the audit

The validity of the audit is four years. For certain types of manufacturer's measuring instruments, METAS may extend or shorten the time limits if the metrological qualities of the measuring instruments permit or require.

State 1 ^Er January 2013

(art. 7-9)

1	Construction, metrological qualities

1.1: The construction and metrological qualities of the instruments must correspond to the current state of the technique, as is in particular described in IEC 60325 3 ^E Ed. (2002-06) ¹ And the intended use.
1.2: The instruments must indicate a multiple of the guideline value of surface contamination, specific to the nucleid according to Annex 3 of the ORaP, or a count rate. When specifying a multiple of the guideline value, the counting rate must also be read.
1.3: Where an instrument indicates only the counting rate, the net metering rate corresponding to the guideline value for the relevant nuclease (steering count rate, TCD) shall be indicated separately on the instrument.

2	Verification

2.1: The instruments shall be accompanied, at each verification, by a method of use, a technical description and a list of nuclides for which the instrument is to be verified.
2.2: At the time of the verification, it is checked that for a specified surface contamination of a given nucllide, the measurement result is located within the error limits prescribed during the verification.
2.3: For fixed-time instruments (e.g. exit monitors), one will control whether contamination corresponding to the guideline value triggers the alarm within the measurement duration.
2.4: The maximum tolerated errors during the verification are ± 50 %.

3	Maximum Tolerable Errors During Controls

If, in an official check outside the verification, the instrument's measurement gap is greater than the maximum error tolerated in the verification, the instrument must be subjected to a subsequent verification.

4	Verification procedure

4.1: The reference quantities for instrument verification are the surfacic emission rates of radioactive sources for surface contamination monitors used during the verification. The verification relates to the surface of these 100 cm reference sources ².
4.2: The reference quantity is the TCD. The calculation of this size is based on the following formula:
TCD = CS-W-Ój (åi, j-åd, j-ås, j)
The values are defined as follows:

	å _{I, j}:	Sensitivity (or surface emission response) of an instrument for the type of radiation j,
	å _{D, d}:	Frequency of emission for a given nucleid for the type of radiation j,
	å _{S, j}:	Rate of surface emission of a source of contamination divided by the rate of production of particles or photons of the same type of radiation j, one admits å _S = 0.5 for sources ã as well as for sources with an average energy ≥140 keV å _S = 0.25 for sources with an average energy between 40 keV and 140 keV and for the sources,
	W:	The active surface of the 100 cm reference surface ²,
	CS:	The guideline value of surface contamination as per Annex 3 of the RFMO.

4.3: The response of the contamination monitor for a given nucleide is obtained from its response to selected nuclides. For this you must use a reference surface of 100 cm ² According to Annex 3 of the ORaP. These nuclides are given in the following table for the different types of radiation.

Nucleide	Period	Average radiation energy â
		40 to 70 keV	70 to 140 keV	140-400 keV	> 400 keV

¹⁴C	5700 a	50 keV


⁹⁹Tc	2.115-10 ⁵ A		85 keV


³⁶Cl	3.02-10 ⁵ A			250 keV


⁹⁰Sr/ ⁹⁰Y	28.80 a			190 keV	940 keV

Nucleide	Period	Radiation energy ã
		5 to 15 keV	15 to 90 keV	90 to 300 keV	> 300 keV

⁵⁵Fe	2.747 a	6 keV


¹²⁹I ^(a)	1.61-10 ⁷ A		32 keV


⁵⁷Co ^(a)	0.744 a			124 keV


¹³⁷Cs ^(a)	30.05 a				662 keV


⁶⁰Co ^(a)	5.27 a				1253 keV


^(a) ^{The sources in question must be equipped with a radiation filter according to ISO 8769:2010}2 .

4.4: The radio elements for which the instrument is intended determine the selection of the nuclides used in the verification.
4.5: Reference sources used in the verification of instruments must conform to ISO 7503-1:1988 part 1 and ISO 7503-3:1988 part 3, ISO 8769:2010 and IEC 60325 3 ^E Ed. (2002-06) ³In the event of a difference in these standards, it will be ensured that this difference does not affect the outcome of the audit.
4.6: When testing takes place in a testing laboratory, measurements will be made under the usual environmental conditions in the workplace. The background noise must correspond to the background noise.
4.7: The distance between the source and the detection window is 5 mm, provided that no other distance is designated in the mode of use.

5	Period of validity of the audit

5.1: The validity of the audit is three years. For certain types of manufacturer's measuring instruments, METAS may extend or shorten the time limits if the metrological qualities of the measuring instruments permit or require.
5.2: In order for a device to be used up to the next regular check after maintenance work that has no influence on the calibration, the supervisory authorities may, in accordance with METAS, authorize individuals to Seal the device after maintenance work with private sealing marks.

¹ CEI 60325 3 ^E Ed. (2002-06): Alpha, beta and alpha/beta contamination monitors and monitors (beta energy > 60 keV). This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
² ISO 8769:2010, Reference sources-Calibration of surface contamination controllers-Alpha, beta and photonic transmitters. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
³ ISO 7503-1:1988 part 1 and ISO 7503-3:1988 part 3: Evaluation of surface contamination; ISO 8769:2010, Reference sources-Calibration of surface contamination controllers-Alpha, beta and photonic transmitters; IEC 60325 3 ^E Ed. (2002-06): Alpha, beta and alpha/beta contamination monitors and monitors (beta energy > 60 keV). These standards may be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.

State 1 ^Er January 2013

(art. 10-12)

1	Construction, metrological qualities

1.1

The construction and metrological qualities of the actuators must correspond to the current state of the technique and to the intended use. The activimeters shall indicate the activity in the legal unit of measurement, namely the becquerel (Bq).

1.2

When verifying the device, a technical description, instructions for use and the following documents must be available:

-: Results of the last semi-annual linearity and reproducibility check except for new acquisitions;
-: Results of the most recent audit, or more recent intercomparison, except for new acquisitions;
-: List of all radionuclides used in practice and during verification, with their specific calibration factor as specified by the manufacturer.

1.3

It should be noted from the literature that the activimeter is adapted to the measurement of the radionuclides with which it is to be verified and those for which it is used.

1.4

A long period control source used to measure the stability of the activimeter shall be available, for example, caesium 137. The activity of the source must be sufficiently high to achieve sufficient stability of the measurement according to the c. 2.3. The control source activity must be at least 4 MBq.

2	Verification

2.1: The meter must be checked every three years.
2.2: The verification is performed on the location of the activimeter.
2.3: The meter will be tested only if the uncertainty associated with the stability of the measure is less than 3 % at a confidence level of 95 %.
2.4: The source of control is expertized and the associated value entered in the verification certificate.
2.5: During the verification of the activimeter for gamma emitters and beta emitters with a significant gamma component, the maximum tolerated errors are ± 10 %.
During the verification of the activimeter for beta emitters without a significant gamma component according to the c. 4.3, maximum tolerated errors are ± 20 %.
2.6: The nuclear medicine laboratory and the FOPH will be notified immediately by METAS or by the competent verification laboratory, where the meter no longer fulfils the conditions of the verification.

3	Maximum Tolerable Errors During Controls

If, in an official check outside the verification, the instrument's measurement gap is greater than the maximum error tolerated in the verification, the instrument must be subjected to a subsequent verification.

4	Verification procedure

4.1: The actum reference quantity is the activity.
4.2: Verification takes place with radioactive sources in a glass vial.
4.3: During the verification of the activimeter for gamma emitters, and beta emitters with a significant gamma component, the following radionuclides are used: cobalt 57, caesium 137, and cobalt 60.
If the nuclear medicine laboratory uses the activimeter also to measure beta emitters without a significant gamma component, namely, the radionuclides phosphorus 32, strontium 89, yttrium 90 and erbium 169 will be used for the Verification of phosphorus 32 or a source of strontium 90, in which the two radionuclides strontium 90 and yttrium 90 are found in the secular equilibrium.
4.4: The verification will verify the effect of the difference between the type of vial used in the verification and the type of vial used in a laboratory.
4.5: In order to set the reference values for stability tests, and to control the specific calibration factors for each radionuclide, the activimeter is controlled using the long period control source for radionuclides Used (background noise and signal).

5	Period of validity of the audit

5.1: The period of validity of the audit is one year. For certain types of manufacturer's measuring instruments, METAS may extend or shorten the time limits if the metrological qualities of the measuring instruments permit or require.
5.2: If the instrument is subject to a successful intercomparison measure, the validity of the verification shall be extended by one year, but shall not extend to more than three years from the date of verification. This is also valid when the activimeter of the nuclear medicine laboratory is used to measure sources containing beta emitters without a significant gamma component or when the intercomparison is performed with a gamma transmitter Or a beta transmitter with a significant gamma component.

6	Intercomparison Measure

6.1

The intercomparison measure is organized by METAS, by an audit laboratory or by a mandated testing laboratory. The staff of the nuclear medicine laboratory performs the measurements themselves with the activimeter to be examined.

6.2

If the FOPH does not have other requirements, the intercomparison measures are carried out with the alternating use of the radionuclides technetium 99m or iodine 131.

6.3

The Nuclear Medicine Laboratory has the option of choosing between the following two procedures:

-: Type A: the verification laboratory sends to the nuclear medicine laboratory a source for which it measured the activity (ch. 6.3.1)
-: Type B: the nuclear medicine laboratory sends to the verification laboratory a source for which it has determined activity with the activimeter to be examined (c. 6.3.2).

6.3.1

Procedure for an intercomparison of type A

A.: The Nuclear Medicine Laboratory registers for a type A intercomparison with the executing agency.
B.: A source and instruction on the execution of the intercomparison measure, as well as a form for communicating the test result, are sent to the nuclear medicine laboratory.
C.: In order to be able to measure the effect of the difference between the type of vial used in the intercomparison measure and the current use measure, the nuclear medicine laboratory receives an empty bottle from the control body Corresponding to the one used in the intercomparison metric.
D.: The value of the activity of the source as measured by the control body shall be communicated to the nuclear medicine laboratory after the latter has given its result in Bq.
E.: The inspection body sends a certificate to the nuclear medicine laboratory.

6.3.2

Procedure for Type B Intercomparison

A.: The Nuclear Medicine Laboratory registers for a type B intercomparison with the executing agency.
B.: The nuclear medicine laboratory receives two bottles, the packaging to be used for transport, an instruction on the execution of the intercomparison measure and a form for the announcement of the result of the control.
C.: The control body shall set the lower and upper limits of the activity of the source, taking into account the transport requirements.
D.: The nuclear medicine laboratory fills one of the bottles with the corresponding radioactive solution and determines the activity of this source in Bq.
E.: The second vial can be used to measure the effect of the difference between the type of vial used in the intercomparison measure and the current use.
F.: The nuclear medicine laboratory sends the source and the results of the control to the control body.
G.: The monitoring body measures the activity of this source.
H.: The inspection body sends a certificate to the nuclear medicine laboratory.

6.4

In order for the intercomparison measure to be considered valid, the difference between the activity of the source used as measured by the control body and the activity measured using the activimeter to be examined shall not exceed the following margins:

-: ± 10 % for an intercomparison with a gamma emitter, or a beta transmitter with a significant gamma component.
-: ± 20 % for an intercomparison measure with a beta-transmitter without a significant gamma component.

6.5

The nuclear medicine laboratory and the OFSP are informed immediately if the result obtained in the intercomparison measure does not meet the above requirement. The activimeter should no longer be used until further verification.

State 1 ^Er January 2013

(art. 13-15)

1	Construction, metrological qualities

The construction and metrological qualities of the instruments must correspond to the intended use and the current state of the technique, as it is particularly described in the IEC 60532 3 ^E Ed. (2010-08), CEI 60846 (2009-04), CEI 61005 2 ^E Ed. (2003-02), CEI 61322 1 ^Re Ed. (1994-12) ¹The instruments must indicate the dose, the dose rate, in the legal units, respectively.

2	Verification

2.1: At each audit, the instruments must be accompanied by a technical description and a means of employment.
2.2: The verification shall, as far as possible, cover the whole range of measurement of the instrument; it must at least cover the ranges for which the instrument is intended to be used.
2.3: The maximum tolerated errors during the verification are ± 20 %.

3	Maximum Tolerable Errors During Controls

If, in an official check outside the verification, the instrument's measurement gap is greater than the maximum error tolerated in the verification, the instrument must be subjected to a subsequent verification.

4	Verification procedure

4.1: The reference quantities for the measuring instruments of the equivalent dose by external irradiation are the ambient equivalent dose H* (10) and the equivalent directive H ' (0.07).
4.2: The determination of the reference quantities in the verification conditions shall belong to METAS or the competent verification laboratory.
4.3: The radiation to be used for verification depends on the type of radiation and the extent to which the device is intended.
4.4: The radiation used for the verification and the corresponding reference quantities are given in the table below:

Type of radiation	Reference Grandeur	Audit Reach
X-rays, ã	H* (10)	Cesium-137
Electrons	H ' (0.07)	Strontium 90
Neutrons	H* (10)	Americium 241/beryllium

4.5: The irradiation conditions must conform to ISO 4037-1: 1996, ISO 4037-2:1997, ISO 4037-3:1999 ², ISO 6980-2:2004 ³ And ISO 8529-2:2000 ⁴In the event of any differences in these standards, it will be ensured that these differences do not affect the outcome of the audit.
4.6: The measurements shall be carried out under the usual conditions of a work place; the results shall be corrected, if necessary, to the normal conditions of pressure and temperature.
4.7: At the request of the applicant, the verification may be carried out with a different radiation than the one mentioned in the c. 4.4 and more appropriate to the proposed application.

5	Period of validity of the audit

5.1: The validity of the audit is three years. For certain types of manufacturer's measuring instruments, METAS may extend or shorten the time limits if the metrological qualities of the measuring instruments permit or require.
5.2: In order for a device to be used up to the next regular check after maintenance work that has no influence on the calibration, the supervisory authorities may authorize individuals, in accordance with METAS, to Seal the device after maintenance work with private sealing marks.

¹ -CEI 60532 3 ^E Ed. (2010-8) Radiation Protection Instrumentation-Fixed-post discharge, alarm sets and monitors-X and gamma rays of energy between 50 keV and 7 MeV;-IEC 60846 (2009-04) Instruments for measuring and/or monitoring Equivalent dose (or dose equivalent) ambient and/or directional for beta, X and gamma radiation; - IEC 61005 2 ^E Ed. (2003-02) Apparatus for measuring equivalent ambient neutron dose (or equivalent dose rate); - IEC 61322 1 ^Re Ed. (1994-12) Fixed-shift meters, alarm sets and neutron monitors for neutron energy between thermal neutrons and 15 MeV. These standards may be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
² ISO 4037-1:1996, ISO 4037-2:1997, ISO 4037-3:1999 X and gamma rays of reference for the calibration of dosimeters and flow meters, and for the determination of their response according to the energy of the photons. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
³ ISO 6980-2:2004, Beta reference material-Part 2: Calibration concepts in relation to the fundamental quantities characterizing the radiation field. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
⁴ ISO 8529-2:2000, Neutron Reference Radiation-Calibration concepts for radiation protection devices in relation to the fundamental quantities characterizing the radiation field. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.

State 1 ^Er January 2013

(art. 16-18)

1	Construction, metrological qualities

1.1: Each system consists of a well-ionization chamber, an electrometer and a sealed, dedicated and long period radioactive source of control. The construction and metrological qualities of the system must correspond to the current state of the technique and the intended use. The intensity of the measured source shall be expressed in nominal kerma flow in the air (ìGy m ² H ^-1).
1.2: The activity of the source of control shall be sufficient to ensure a stable measure in accordance with the c. 2.3.

2	Verification

2.1: At the time of the audit, systems must be accompanied by a technical description and instructions for use.
2.2: During the audit, the operation of the system will be monitored on site and will be calibrated in comparison with the reference system of METAS or the competent audit laboratory using a source from Ir 192.
2.3: The system is declared compliant for the use in question, when it can be calibrated with a total relative measurement uncertainty of less than ± 3 % at a confidence level of 95 %.

3	Maximum Tolerable Errors During Controls

3.1

The stability of the system shall be controlled at least quarterly by means of the radioactive source of control and that of Ir 192.

3.2

During the stability test of open-well ionization chambers, the correction for the density of the air shall be carried out with a precision of at least ± 3 % at a confidence level of 95 % using a thermometer and a barometer Metrologically attached. In this control, the following data shall be recorded in writing:

A.: Date of control, visa of the person carrying out the control;
B.: Identification of the electrometer, the chamber, the adapter, the radioactive source of control and that of Ir 192;
C.: Indication of control, indication of the current of background noise, including the leakage current, before and after the control measure, temperature and pressure of the air;
D.: Control indication corrected by the density of the air relative to the reference temperature T ₀ = 293.15 K and reference air pressure p ₀ = 1013.25 hPa, as well as the indication of control given in the certificate, corrected for the decrease of the source at the date of control.

3.3

During the stability test, the indication of control shall not deviate from the value specified in the verification certificate, corrected at the test date, by more than 0.5 %. If the deviation is greater than these values, the measuring instrument shall be subject to subsequent verification.

3.4

The applicant and the OFSP will be notified immediately by the verification laboratory if the well-operated ionization chamber systems used in the HDR at the Ir 192 do not meet the requirements of the verification.

4	Period of validity of the audit

The validity of the audit is four years. For certain types of manufacturer's measuring instruments, METAS may extend or shorten the time limits if the metrological qualities of the measuring instruments permit or require.

State 1 ^Er January 2013

(art. 19-21)

1	Construction, metrological qualities

The construction and metrological qualities of the instruments must correspond to the intended use and the current state of the technique.

2	Verification

2.1: At each audit, the instruments must be accompanied by a technical description and a means of employment.
2.2: At the time of the verification, one will control whether, for a certain value of the measurement quantity, the measurement results, or, in the case of the sensitometer, the optical densities of the level of blackening obtained with the sensitometer to be controlled, are to Within the error limits prescribed during the audit.
2.3: Audit Scope:
2.3.1: Radiodiagnostic dosimeter, kilovoltmeter, coulombmeter, exposure stopwatch and densitometer: the verification shall, as far as possible, cover the whole range of measurement of the instrument; it shall at least cover the ranges for which It is intended to use the instrument.
2.3.2: Sensitometer: During the check, all ranges on the grayscale will be monitored.
2.3.3: Luxmeter: During the verification, reference points corresponding to the recommended values for illumination of the luminous viewfinder and for the luminance of the negatoscope will be controlled.
2.4: The maximum tolerated errors for the different types of instruments are given below:
2.4.1: Diagnostic X-ray dosimeter: ± 10 %
2.4.2: Kilovoltmeter: ± 3 %
2.4.3: Coulombmeter: ± 5 %
2.4.4: Exposure chronometer: ± 1 ms for irradiation time ≤20 ms ± 5 ms for irradiation time > 20 ms
2.4.5: Sensitometer: ± 0.05 % for optical density D ≤ 1 ± 0.1 % for optical density D > 1
2.4.6: Densitometer: ± 0.025 % for optical density D < 1 ± 2.5 % for optical density D ≥ 1
2.4.7: Luxmeter: ± 10 %

3	Maximum Tolerable Errors During Controls

If, in an official check outside the verification, the instrument's measurement gap is greater than the maximum error tolerated in the verification, the instrument must be subjected to a subsequent verification.

4	Verification procedure

4.1

When checking for radiodiagnostic dosimeters, reference quantities are as follows:

-: For instruments that measure the dose, kerma in the air;
-: For instruments that measure the dose-surface product, the product of kermas in the air and the irradiated surface;
-: For instruments that measure the dose-length product, the kerma in the integrated air on the length of the detector.

4.1.1

X-radiation used for the verification of radiodiagnostic dosimeters shall have the same energy and temporal characteristics as the radiation used in the radiodiagnostic. The determination of the reference quantities in the verification conditions shall belong to METAS or the competent verification laboratory.

4.1.2

Diagnostic radiodiagnostic dosimeters are verified in radiation beams, the quality of which corresponds to that of the use. The audit may be conducted with the following qualifications.

Conventional radiodiagnosis with the use of a tungsten-anode X-ray tube and with the RQR 5 and RQA 5 beams as reference beam quality during the verification:


Primary beam, RQR series according to IEC 61267 2 ^E Ed. (2005-11) ¹

Code	Voltage of tube (kV) *	Total Filtration (mm Al)	CDA (mm Al) * *

RQR 5	70	2.5	2.5









Seal behind a patient equivalent filter, RQA series according to IEC 61267 2 ^E Ed. (2005-11) ²

Code	Pipe Voltage (kV) ^*	Total Filtration (mm Al)	CDA (mm Al) * *

RQA 5	70	23.5	7.1


* approximate value, high frequency generator ** half-attenuation layer

Mammography with use of a molybdenum-anode X-ray tube:


Primary beam, reference quality according to IEC 61267 2 ^E Ed. (2005-11) ³

Code	Pipe Voltage (kV)	Total Filtration

RQN-M	28	0.03 mm MB


Beam behind a patient equivalent filter according to IEC 61674 1 ^Re Ed. (1997-10) ⁴

Code	Pipe Voltage (kV)	Total Filtration

-	28	0.03 mm MB + 2.0 mm Al

Tomodensitometry using tungsten anode X-ray tube:


Primary beam, reference quality according to IEC 61267 2 ^E Ed. (2005-11) ⁵

Code	Pipe Voltage (kV)	Total Filtration

-	120	2.5 mm Al


Plot behind an equivalent patient filter IEC 61674 1 ^Re Ed. (1997-10) ⁶

Code	Pipe Voltage (kV)	Total Filtration

-	120	23.5 mm Al

4.1.3: Audit conditions must be consistent with IEC 61674 1 ^Re Ed. (1997-10) ⁷ In the case of radiodiagnostic dosimeters that measure doses and dose-length products, as well as the standard IEC 60580 2 ^E Ed. (2000-01) ⁸ In the case of radiodiagnostic dosimeters that measure dose-surface products. The measurements shall be carried out under the usual conditions of the laboratory; the results shall be corrected, if necessary, to the normal conditions of pressure and temperature.
4.1.4: At the request of the applicant, the verification may be carried out with a different radiation than the one mentioned in the c. 4.1.2 and more appropriate to the proposed application.
4.2: During the verification of kilovoltmeters, the X-radiation used will have the same characteristics as the radiation normally used in radiodiagnostics.
The kilovoltmeters will be verified with the radiation qualities shown below.
Conventional radiodiagnostic using tungsten-anode X-ray tube:


Primary beam, RQR series according to IEC 61267 2 ^E Ed. (2005-11) ⁹

Code	Voltage of tube (kV) *	Total Filtration (mm Al)	CDA (mm Al) * *

RQR 5	70	2.5	2.5
RQR 7	90	2.5	3.3
RQR 9	120	2.5	4.5


* approximate value, high frequency generator ** half-attenuation layer

Mammography with use of a molybdenum-anode X-ray tube:


Primary beam, reference quality according to IEC 61267 2 ^E Ed. (2005-11) ¹⁰

Code	Pipe Voltage (kV)	Total Filtration

RQN-M	28	0.03 mm MB

4.3: During the verification of the coulombmeters, the serial load is measured with a reference instrument.
4.4: When checking stopwatches for invasive or non-invasive exposure, a comparison is made with an invasive reference instrument.
4.5: During the verification of the sensitometers, the two scales of optical density obtained on the same radiological film, one with a reference instrument, the other with the instrument to be checked, are compared by densitometry.
4.6: When verifying densitometers, a calibrated optical density scale is used
4.7: When checking the luxmeters, a comparison is made with a reference instrument; the light source will be the center of the surface of a negatoscope.

5	Period of validity of the audit

The validity of the audit is three years. For certain types of manufacturer's measuring instruments, METAS may extend or shorten the time limits if the metrological qualities of the measuring instruments permit or require.

¹ CEI 61267 ^E Ed. (2005-11), Radiation medical diagnostic equipment X-Radiation conditions for use in the determination of characteristics. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
² CEI 61267 ^E Ed. (2005-11), Radiation medical diagnostic equipment X-Radiation conditions for use in the determination of characteristics. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
³ CEI 61267 ^E Ed. (2005-11), Radiation medical diagnostic equipment X-Radiation conditions for use in the determination of characteristics. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
⁴ CEI 61674 1 ^Re Ed. (1997-10), Medical electrical equipment-Ionization chamber dosimeters and/or semiconductor detectors used in X-ray diagnostic imaging. This standard may be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
⁵ CEI 61267 ^E Ed. (2005-11), Radiation medical diagnostic equipment X-Radiation conditions for use in the determination of characteristics. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
⁶ CEI 61674 1 ^Re Ed. (1997-10), Medical electrical equipment-Ionization chamber dosimeters and/or semiconductor detectors used in X-ray diagnostic imaging. This standard may be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
⁷ CEI 61674 1 ^Re Ed. (1997-10), Medical electrical equipment-Ionization chamber dosimeters and/or semiconductor detectors used in X-ray diagnostic imaging. This standard may be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
⁸ CEI 60580 2 ^E Ed. (2000-01), Medical Electrical Equipment-Exposure-surface radiation meters. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
⁹ CEI 61267 ^E Ed. (2005-11), Radiation medical diagnostic equipment X-Radiation conditions for use in the determination of characteristics. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.
¹⁰ CEI 61267 ^E Ed. (2005-11), Radiation medical diagnostic equipment X-Radiation conditions for use in the determination of characteristics. This standard can be obtained free of charge from the Federal Institute of Metrology, 3003 Berne, or obtained from the Swiss Standards Association (SNV), 8400 Winterthur, www.snv.ch.

State 1 ^Er January 2013

(art. 22-24)

1	Construction, metrological qualities

Radon measuring devices must, in particular, meet the following requirements:
1.1: Measured: concentration of radon activity in Bq/m ³;
1.2: Minimum concentration of radon activity that must be measurable: 10 Bq/m ³ 1 hour apart;
1.3: Measurement domain: up to 100 000 Bq/m ³;
1.4: Linearity: deviation < 10 % between 10 Bq/m ³ And 10 000 Bq/m ³;
1.5: Reproducibility: standard deviation s ≤ 5 %.

2	Marketing Procedures

2.1: Anyone who presents a radon measuring device for the initial verification shall attach a technical description, a method of use and a software for the analysis of the data measured on an adequate data carrier.
2.2: The reference value used by METAS or the appropriate verification laboratory must be within the operating range of the radon measuring apparatus in the residential and working premises.
2.3: The maximum tolerated errors in the verification of radon measuring instruments are ± 20 %.

3	Procedures for maintaining measurement stability

3.1: For certain types of manufacturer's measuring instruments, METAS may extend or shorten the time limits if the metrological qualities of the measuring instruments permit or require.
3.2: The requirements set out in c. 2 and applicable for the subsequent audit are the same as for the initial audit.

4	Maximum Tolerable Errors During Controls

If, in an official check outside the verification, the instrument's measurement gap is greater than the maximum error tolerated in the verification, the instrument must be subjected to a subsequent verification.

State 1 ^Er January 2013

(art. 25 to 27)

1	Construction, metrological qualities

In particular, radon dosimeters must meet the following requirements:
1.1: Measurement: exposure to radon in kBq h/m ³;
1.2: Duration of integration: > 1 month;
1.3: Minimum radon exposure to be measurable: 50 kBq h/m ³;
1.4: Measurement domain: up to 15,000 kBq h/m ³;
1.5: Linearity: variance < 15 % between 50 kBq h/m ³ And 10,000 kBq h/m ³;
1.6: Reproducibility: standard deviation s ≤15 %.

State 1 ^Er January 2013

Radiation Energy Domain á

5390 to 5490 keV