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YY 0318-2000: Protective device against diagnostic medical X-radiation. Part 3: Protective clothing and protective devices for gonads
YY 0318-2000
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
C 43
Record number: 7057-2000
idt IEC 61331-3:1998
Protective device against diagnostic medical X-
radiation - Part 3: Protective clothing and protective
devices for gonads
ISSUED ON: JANUARY 31, 2000
IMPLEMENTED ON: JULY 01, 2000
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
IEC Foreword ... 5 
1 Scope and object ... 7 
2 Reference standards ... 8 
3 Terminology ... 8 
4 General ... 9 
5 PROTECTIVE APRONS ... 11 
6 PROTECTIVE GLOVES ... 14 
7 PROTECTIVE MITTENS ... 17 
8 PROTECTIVE GONAD APRONS ... 20 
9 SCROTUM SHIELDS ... 21 
10 OVARY SHIELDS ... 23 
11 SHADOW SHIELDS ... 25 
Annex A (Informative) Index of defined terms ... 27 
Annex B (Informative) Bibliography ... 28 
Foreword
This Standard is identical to the International Electrotechnical Commission IEC
61331-3:1998 "Protective devices against diagnostic medical X-radiation - Part
3: Protective clothing and protective devices for gonads".
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.
This Standard was proposed by National Medical Products Administration.
This Standard shall be under the jurisdiction of National Technical
Subcommittee on Medical X-Ray Equipment and Appliance of Standardization
Administration of China.
Drafting organization of this Standard: Liaoning Medical Device Research
Institute.
Main drafter of this Standard: Wang Shoumin.
Protective device against diagnostic medical X-
radiation - Part 3: Protective clothing and protective
devices for gonads
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;