GB 9706.12-1997 English PDF (GB9706.12-1997)

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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
GB 9706.12-1997
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
idt 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
ISSUED ON. JUNE 28, 1997
IMPLEMENTED ON. SEPTEMBER 01, 1998
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the PRC
Table of Contents
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 
SECTION 5. PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION ... 14 
29 X-RADIATION ... 14 
29.201 RADIATION QUALITY ... 14 
29.202 Limitation and indication of the extent of the X-RAY BEAM ... 20 
29.203 Relationship between X-RAY FIELD and IMAGE RECEPTION AREA ... 25 
29.204 LEAKAGE RADIATION ... 29 
29.205 FOCAL SPOT TO SKIN DISTANCE ... 33 
29.206 ATTENUATION of the X-RAY BEAM ... 34 
29.207 PRIMARY PROTECTIVE SHIELDING ... 35 
29.208 Protection against STRAY RADIATION ... 39 
Annex AAA (informative) Recommendations for the protection against STRAY
RADIATION ... 49 
Annex BBB (informative) Index of defined terms ... 53 
Annex CCC (informative) Normative references to ACCOMPANYING
DOCUMENTS, INSTRUCTIONS FOR USE and ASSEMBLING
INSTRUCTIONS ... 56 
Table 208a -- Application categories ... 38 
Table 208b -- Requirements for PRIMARY PROTECTIVE SHIELDING ... 39 
Figure 201 -- Zone of extra-focal radiation ... 45 
Figure 202 -- Discrepancies in visual indication of the X-RAY FIELD ... 46 
Figure 203 -- Discrepancies in covering the IMAGE RECEPTION AREA 46 
Figure 204 -- Testing for STRAY RADIATION (under-table tube with X-RAY
BEAM horizontal) ... 47 
Figure 205 -- Testing for STRAY RADIATION (under-table tube with X-RAY
BEAM vertical) ... 47 
Figure 206 -- Testing for STRAY RADIATION (over-table tube with X-RAY
BEAM horizontal) ... 48 
Figure 207 -- Testing for STRAY RADIATION (over-table tube with X-RAY
BEAM vertical) ... 48 
Figure 208 -- Example of presentation of data on STRAY RADIATION ... 49 
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