YY 0318-2000Protective device against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads (English PDF)
医用诊断X射线辐射防护器具 第3部分:防护服和性腺防护器具
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
January 31, 2000
Implementation date
July 1, 2000
Scope
YY 0318-2000 is the English-translated version of 医用诊断X射线辐射防护器具 第3部分:防护服和性腺防护器具.
YY 0318-2000 is the Chinese pharmaceutical industry standard, identical to IEC 61331-3:1998, for protective clothing and gonad protection devices against diagnostic medical X-radiation, meant to protect both staff and patients.
Part 3 of the series, it covers protective aprons, protective gloves and mittens, gonad aprons, scrotum shields, ovary shields and shadow shields, with requirements for their attenuation, expressed as lead equivalent, sizes, construction and marking.
Gloves must reach at least 0.25 mmPb and aprons now come in four types and standard sizes, with different minimum attenuation for different body areas. It replaces the apron and glove provisions of YY 0128-1993; Parts 1 and 2 of the series deal with the attenuation of materials and with protective glass plates. Issued on 31 January 2000, it has applied since 1 July 2000.
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Document preview — YY 0318-2000
National Standard of the People's Republic of China
- Replacing
- YY 0128-1993
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope and object7
- 2 Reference standards8
- 3 Terminology8
- 4 General9
- 5 PROTECTIVE APRONS11
- 6 PROTECTIVE GLOVES14
- 7 PROTECTIVE MITTENS17
- 8 PROTECTIVE GONAD APRONS20
- 9 SCROTUM SHIELDS21
- 10 OVARY SHIELDS23
- 11 SHADOW SHIELDS25
- Annex A (Informative) Index of defined terms27
- Annex B (Informative) Bibliography28
Foreword
This Standard is identical to the International Electrotechnical Commission IEC 61331-3:1998 "Protective devices against diagnostic medical X-radiation - Part
This Standard is formulated so that there is a unified requirement for protective device against diagnostic medical X-radiation in the manufacturing and quality inspection, to ensure and improve the quality of the product, to ensure safety and effectiveness.
For the protection against diagnostic medical X-radiation, in addition that the X- ray machine's own design must meet the requirements of the standard, in the practice of radiation, necessary additional protective measures shall be provided for X-radiation. Additional protections are generally divided into appliance category and device category. The appliance category includes protective chambers and protective screens, etc. The device category includes protective aprons, protective clothing, and protective gloves, etc. This Standard only involves protective devices.
As protection, it shall not be understood as just the protection of the operator.
At the same time, the protection of the patient shall be fully considered. This is a problem that cannot be ignored.
From the date of implementation, this Standard replaces the protective devices (aprons and gloves) with the same names in YY 0128-1993 "Protective appliance and device against diagnostic medical X-radiation".
Compared with the gloves and aprons in the YY 0128-1993 standard, the protective gloves and aprons in this Standard have the following main changes.
1. Protective gloves
1) It is stipulated that the lead equivalent is not less than 0.25 mmPb. The previous standard stipulates that, the lead equivalent is 0.25 mmPb, 0.35 mmPb, and 0.5 mmPb; and the deviations are given.
2) Delete the requirements for elongation-flexion life and physical properties; only give a qualitative requirement.
3) There are still three specifications. But the overall sizes have been adjusted. In terms of varieties, add the protective mitten.
2. Protective aprons
1) CHANGE from the previous three specifications to four types.
2) Adjust the specific dimensions.
3) Delete the requirements for physical properties; only give a qualitative requirement.
4) For different areas of protection, specify different minimum attenuation equivalents.
5) Stipulate the standard sizes of protective aprons; subdivide the large, medium and small sizes, which is more suitable for the needs of different people.
This Standard is Part 3 under the general heading of protective device against diagnostic medical X-radiation. Under this general heading, it includes three parts.
Part 1: Determination of attenuation properties of materials Part 2: Protective glass plates Part 3: Protective clothing and protective devices for gonads Annexes A and B in this Standard are all informative annexes.
1 Scope and object
1.1 Scope
This Standard applies to PROTECTIVE DEVICES such as PROTECTIVE CLOTHING for the protection of persons against X-RAY TUBE VOLTAGE up to 150 kV, during RADIOLOGICAL examinations and interventional procedures.
Note: PROTECTIVE DEVICES are not intended by themselves to provide complete protection of persons, but are used to reduce the dose to persons where other methods of protection against X-RADIATION are insufficient or not applicable.
1.2 Object
This Standard deals with.
- general requirements on the ACCOMPANYING DOCUMENTS, and on design and materials used;
- standard sizes, particular design features, minimum ATTENUATION properties of materials, marking and standardized forms of statements of compliance with this Standard.
This Standard covers PROTECTIVE CLOTHING and PROTECTIVE DEVICES for gonads. PROTECTIVE CLOTHING is mainly for the protection of the OPERATOR, such as.
- PROTECTIVE APRONS;
- PROTECTIVE GLOVES;
- PROTECTIVE MITTENS; and PROTECTIVE DEVICES for gonads for the protection of the PATIENT, such as.
- PROTECTIVE GONAD APRONS;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 28 pages — is available in the English PDF.
Similar standards
Editions of YY 0318
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0318-2000 | Protective device against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads | current edition | Current |
| YY 0128-1993 | Protective device against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads | previous edition | Superseded |
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