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GB 9706.12-1997Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (English PDF)

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Issued by

General Administration of Quality Supervision, Inspection and Quarantine of the PRC

Level / Type

National · Mandatory

Issue date

June 28, 1997

Implementation date

September 1, 1998

Scope

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) is available as an English-translated PDF.

GB 9706.12-1997 — This Collateral Standard applies to medical diagnostic X-RAY EQUIPMENT and to sub-assemblies of such EQUIPMENT.

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Document preview — GB 9706.12-1997

National Standard of the People's Republic of China

ICS: 11.040.50
Classification: C 43

Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the PRC

Foreword...4
IEC foreword...5
SECTION 1.GENERAL...7
1 Scope, object and relationship to other standards...7
1.201 Scope...7
1.202 Object...7
1.203 Relationship to other standards...7
2 Terminology and definitions...10
2.201 Defined terms...10
2.202 Qualifying conditions for defined terms...10
2.203 Composition of reference materials...11
2.204 Degrees of requirement and miscellaneous terms (omitted)...11
2.205 RADIATION QUANTITIES and units...11
4 General requirements for tests...11
4.201 Compliance...11
6 Identification, marking and documents...12
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts...12
6.1.201 Marking requirements...12
6.1.202 General requirements...12
6.8 ACCOMPANYING DOCUMENTS...12
6.8.201 References in subclauses...12
6.8.202 General requirements...13

Foreword

This Standard is identical to the International Electrotechnical Commission IEC

601-1-3.1994 "Medical electrical equipment - Part 1.General requirements for

safety 3.Collateral standard. General requirements for radiation protection in

diagnostic X-ray equipment" (first edition).

The purpose of developing this Standard is to provide uniform general

requirements for radiation protection in medical diagnostic X-ray equipment, to

meet the needs of international trade, technical and economic exchanges, and

adoption of development of international standards.

This Standard is implemented in conjunction with GB 9706.1-1995 "Medical

electrical equipment - Part 1.General requirements for safety" (hereinafter

referred to as the General Standard).

Annexes AAA, BBB, and CCC in this Standard are for information only.

To ensure the applicability of terms, the terms appearing in this Standard are

explained as follows.

Installation instructions are also referred to as assembling instructions.

Significant zone of occupancy is also referred to as significant zone of

occupancy of space occupying area. Beam applicator, in some cases, is also

referred to as a beam emitter or beam concentrator. Primary protective

shielding is also referred to as the primary protective screen. Maker is also

known as the manufacturer or producer. Beam limiting device is also known as

the beam limiter.

This Standard was proposed by National Medical Products Administration.

This Standard shall be under the jurisdiction of National Technical

Subcommittee 1 on Medical X-ray Equipment and Appliances of

Standardization Administration of China.

Drafting organization of this Standard. Liaoning Medical Device Test Institute.

Main drafters of this Standard. He Yuhua, Wang Shoumin, Xia Lianji, Li Chuan,

Shen Hua.

Medical electrical equipment

Part 1.General requirements for safety

3 Collateral standard. General requirements for

radiation protection in diagnostic X-ray equipment

SECTION 1.GENERAL

1 Scope, object and relationship to other standards

1.201 Scope

This Collateral Standard applies to medical diagnostic X-RAY EQUIPMENT and

to sub-assemblies of such EQUIPMENT.

1.202 Object

The object of this Collateral Standard is to establish general requirements for

protection against IONIZING RADIATION in medical diagnostic X-RAY

EQUIPMENT, in order that the DOSE EQUIVALENT to the PATIENT, the

OPERATOR and other staff can be kept as low as reasonably achievable.

Some of the requirements in this Collateral Standard include variations for

different types of X-RAY EQUIPMENT. This is intended to widen the scope

within which the Collateral Standard can be applied usefully without addition or

modification, especially in respect of types of X-RAY EQUIPMENT that are

commonly used in MEDICAL DIAGNOSTIC RADIOLOGY.

The requirements in this Collateral Standard apply mainly in respect of X-

RADIATION after its generation. Requirements for the control of the electrical

energy used to generate X-RADIATION, which is also an important aspect of

RADIATION PROTECTION, are included in GB 9706.1 "Medical electrical

equipment - Part 1.General requirements for safety" and in Particular

Standards for the safety of the EQUIPMENT concerned.

1.203 Relationship to other standards

1.203.1 GB 9706.1

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 13 pages — is available in the English PDF.

Referenced standards

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