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YY/T 0292.1-2020Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials (English PDF)

医用诊断X射线辐射防护器具 第1部分:材料衰减性能的测定

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 25, 2020

Implementation date

March 1, 2021

Scope

YY/T 0292.1-2020 is the English-translated version of 医用诊断X射线辐射防护器具 第1部分:材料衰减性能的测定.

YY/T 0292.1-2020 is the Chinese pharmaceutical industry standard for the sheet materials from which protective devices against X-radiation are made, such as the lead and lead-free sheet of aprons, screens and curtains.

It is the first part of the YY/T 0292 series and gives the requirements and the test methods for determining the attenuation these materials provide, expressed as lead equivalent, for X-radiation generated at tube voltages up to 400 kV and for gamma radiation from radionuclides up to the photon energies it names, together with the way a material is designated and marked. It was issued on 25 February 2020 and has applied since 1 March 2021.

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Document preview — YY/T 0292.1-2020

National Standard of the People's Republic of China

Replacing
YY 0292.1-1997

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword3
  • 1 Scope5
  • 2 Normative references6
  • 3 Terms and definitions6
  • 4 Methods to determine the ATTENUATION RATIO7
  • 5 Determination of ATTENUATION properties19
  • 6 Statement of compliance23
  • Annex A (Informative) Tables of ATTENUATION RATIOS, BUILD-UP FACTORS and first HALF-VALUE LAYERS24
  • Bibliography27
  • Index28

Foreword

YY/T 0292 "Protective devices against diagnostic medical X-radiation" is divided into three parts.

- Part 1: Determination of attenuation properties of materials;

- Part 2: Translucent protective plates;

- Part 3: Protective clothing, eyewear and protective patient shields. This Part is Part 1 of YY/T 0292.

This Part is drafted in accordance with the rules given in GB/T 1.1-2009.

This Part replaces YY/T 0292.1-1997 "Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials". Compared with YY/T 0292.1-1997, the main changes in this Part are as follows.

- ADD the inverse broad beam condition (see 4.4);

- ADD the methods to determine the attenuation ratio (see 4.4 and 4.5);

- INCREASE the scope of application and extend to photon-emitting radionuclides (see 4.5);

- ADD the method for calculation of the attenuation ratio for photon-emitting radionuclides (see 4.5);

- ADD new standard for X and gamma-ray radiation quality for testing (see 4.5.4);

- ADD the lead equivalent class (see 5.5);

- ADD the tables of attenuation ratios, build-up factors and first half-value layers under standard radiation qualities filtered by different thicknesses of lead (see Annex A).

This Part, using translation method, is identical to IEC 61331-1:2014 "Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials". Compared with IEC 61331-1:2014, this Part has made the following editorial changes.

- According to GB/T 1.1, modify some layout formats;

- This Part revises IEC 60601-1:2005 and IEC 60601-1:2005/AMD1.2012 in the normative references to IEC 60601-1; revises IEC 60601-1-3:2008 and

IEC 60601-1-3:2008/AMD1.2013 to IEC 60601-1-3.

China's documents which have a consistent correspondence with the international documents normatively referenced in this Part are as follows.

- GB 9706.1-2007 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988, IDT);

- GB 9706.12-1997 Medical electrical equipment - Part 1: General requirements for safety - 3.Collateral standard. General requirements for radiation protection in diagnostic X-ray equipment (IEC 601-1-3:1994, IDT).

1 Scope

This Part of YY/T 0292 applies to materials in sheet form used for the manufacturing of PROTECTIVE DEVICES against X-RADIATION of RADIATION QUALITIES generated with X-RAY TUBE VOLTAGES up to 400 kV and gamma radiation emitted by radionuclides with photon energies up to

2 Normative references

The following documents are indispensable for the application of this document.

For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document.

IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC/TR 60788:2004, IEC 60601-1 and IEC 60601-1-3 and the following apply.

4 Methods to determine the ATTENUATION RATIO

The ATTENUATION RATIO FN for a given test material (or test object) shall be measured according to the arrangement for NARROW BEAM CONDITION as shown in Figure 1.

Photon energies Ei and photon emission probabilities p(Ei) shall be taken from the Monographie BIPM-5.2013, Table of Radionuclides.

5 Determination of ATTENUATION properties

The ATTENUATION RATIOS FN, FB, FIB and FN,R shall be determined according to 4.2, 4.3, 4.4 and 4.5, respectively.

5.1.2 Indication

The BUILD-UP FACTOR shall be indicated by its numerical value together with the RADIATION QUALITY in terms of the beam code, the X-RAY TUBE VOLTAGE and HALF-VALUE LAYER (see Clause 6).

6 Statement of compliance

If for SPECIFIED ATTENUATION properties compliance with YY/T 0292.1 shall be stated, this shall be indicated as follows, e.g..

Annex A (Informative)

Tables of ATTENUATION RATIOS, BUILD-UP FACTORS and first HALF- VALUE LAYERS Tables A.1 to A.5 contain calculated values of ATTENUATION RATIOS, BUILD- UP FACTORS and first HALF-VALUE LAYERS of the RADIATION QUALITIES of Table 1 when filtered with additional layers of the reference material lead.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 28 pages — is available in the English PDF.

Referenced standards

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Editions of YY/T 0292.1

EditionTitleRevisionStatus
YY/T 0292.1-2020Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materialscurrent editionCurrent
YY 0292.1-1997Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materialsprevious editionSuperseded

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