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YY/T 0292.2-2020Protection devices against diagnostic medical X-radiation - Part 2: Translucent protective plates (English PDF)

医用诊断X射线辐射防护器具 第2部分:透明防护板

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 25, 2020

Implementation date

March 1, 2021

Scope

YY/T 0292.2-2020 is the English-translated version of 医用诊断X射线辐射防护器具 第2部分:透明防护板.

YY/T 0292.2-2020 is the Chinese pharmaceutical industry standard for translucent protective plates used for radiation protection, the leaded glass and plastic panels of screens and windows.

It is the second part of the YY/T 0292 series and sets the requirements and the test methods for such plates in X-ray diagnosis and X-ray therapy, and for protection against gamma radiation in nuclear medicine and brachytherapy, covering the attenuation they provide as lead equivalent, their optical quality and light transmission, the dimensions and the marking. It was issued on 25 February 2020 and has applied since 1 March 2021.

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Document preview — YY/T 0292.2-2020

National Standard of the People's Republic of China

Replacing
YY 0292.2-1997

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

Contents

  • Foreword3
  • 1 Scope5
  • 2 Normative references5
  • 3 Terms and definitions6
  • 4 Geometrical accuracy of translucent protective plates7
  • 5 Optical quality of material7
  • 6 ATTENUATION properties8
  • 7 Marking9
  • 8 ACCOMPANYING DOCUMENTS10
  • 9 Statement of compliance with this Part10
  • Bibliography11
  • Index12

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 2 of YY/T 0292.

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

This Part replaces YY 0292.2-1997 "Protective devices against diagnostic medical X-radiation - Part 2: Protective glass plates". Compared with YY 0292.2-1997, the main changes in this Part are as follows:

- Expand the scope of standard application to various types of translucent protective plates and various radiation qualities and gamma radiation (see Clause 1);

- Modify the term definition of protective glass plate: from protective equipment to material plate for manufacturing (see 3.3.1 of the 1997 edition);

- Delete the definitions of the terms: type SC protective glass plate and type VI protective glass plate (see 3.3.2 and 3.3.3 of the 1997 edition);

- ADD the terms of protective plastic plate and translucent protective plate (see 3.2 and 3.3);

- Delete the size requirement (see Clause 4 of the 1997 edition);

- Modify the geometrical accuracy and optical quality related requirements of protective glass plate (see Clause 5 and Clause 6 of the 1997 edition);

- Modify the relevant requirements for lead equivalent and minimum thickness (see 8.1 of the 1997 edition);

- Modify the marking requirements (see Clause 9 of the 1997 edition);

- Modify the statement of compliance with this standard (see Clause 11 of the 1997 edition).

This Part, using translation method, is identical to International Electrotechnical Commission IEC 61331-2:2014 "Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates". Compared with IEC 61331- 2:2014, this Part has made the following changes:

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

- This Part modifies the errors in IEC 61331-2:2014, involving Table 2 in Clause 7;

- Delete the normative references GB/T 3358.1-2009 (ISO 3534-1:2007, IDT), IEC 60601-2-8:2010 and ISO/IEC Guide 99:2007; because these three documents are only cited in the index.

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 TRANSLUCENT PROTECTIVE PLATES used for RADIATION PROTECTION in X-ray diagnosis and in X-ray therapy. It also applies to TRANSLUCENT PROTECTIVE PLATES used for protection against GAMMA RADIATION in nuclear medicine and BRACHYTHERAPY with automatically-controlled AFTERLOADING equipment. It does not cover other translucent RADIATION PROTECTION materials, e.g.

- leaded glasses or goggles for protection of the OPERATOR'S eyes (eye spectacles), - leaded face shields, which cover the entire face of the OPERATOR, - PATIENT eye protection, and - thyroid/neck PROTECTIVE DEVICES. This Part deals with the requirements on - geometrical accuracy;

- optical quality of the material;

- spectral TRANSMITTANCE;

- radiation ATTENUATION properties;

- marking;

- statement of compliance with this Part.

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.

YY/T 0292.1 Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials (IEC 61331-1, IDT)

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

IEC 60601-1-3 Medical electrical equipment - Part 1-3: General requirement for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment IEC/TR 60788:2004 Medical electrical equipment - Glossary of defined terms

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.

3.1 Protective glass plate

TRANSLUCENT PROTECTIVE PLATE consisting of mineral glass with SPECIFIED attenuation properties used for manufacturing of optically clear and optically transparent protective shielding.

Note: Toughening impacts neither the attenuation properties nor optical and geometrical properties of the TRANSLUCENT PROTECTIVE PLATE consisting of mineral glass.

3.2 Protective plastic plate

TRANSLUCENT PROTECTIVE PLATE consisting of translucent plastic material with specified attenuation properties used for manufacturing of optically clear and optically transparent protective shielding.

3.3 Translucent protective plate

Plate consisting of translucent material with SPECIFIED attenuation properties used for manufacturing of optically clear and optically transparent protective shielding.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of YY/T 0292.2

EditionTitleRevisionStatus
YY/T 0292.2-2020Protection devices against diagnostic medical X-radiation - Part 2: Translucent protective platescurrent editionCurrent
YY 0292.2-1997Protection devices against diagnostic medical X-radiation - Part 2: Translucent protective platesprevious editionSuperseded

This page sells the current edition, YY/T 0292.2-2020. Earlier editions are listed for reference only.

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