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GB 9706.1-2020Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (English PDF)

医用电气设备第1部分：基本安全和基本性能的通用要求

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Issued by

SAMR; SAC

Level / Type

National · Mandatory

Issue date

April 9, 2020

Implementation date

May 1, 2023

Scope

GB 9706.1-2020 is the English-translated version of 医用电气设备第1部分：基本安全和基本性能的通用要求.

This Part of GB 9706 specifies the general requirements for basic safety and essential performance of ME EQUIPMENT and ME SYSTEMS. It applies to medical electrical equipment and medical electrical systems. Where a clause is intended to apply only to ME EQUIPMENT or only to ME SYSTEMS, its title and content say so; otherwise it applies to both. Hazards inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS are not covered by specific requirements in this Part. Modified adoption of IEC 60601-1:2012.

Document preview — GB 9706.1-2020

National Standard of the People's Republic of China

ICS: 11.040
Classification: C 30
Replacing: GB 9706.1-2007, GB 9706.15-2008

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC.

Foreword4
1 Scope, object and related standards11
2 Normative references12
3 * Terminology and definitions17
4 General requirements51
5 * General requirements for testing ME EQUIPMENT62
6 * Classification of ME EQUIPMENT and ME SYSTEMS69
8 * Protection against electrical HAZARDS from ME EQUIPMENT96
I ME EQUIPMENT, with or without APPLIED PART (see 8.7.4.5)
9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
10 * Protection against unwanted and excessive radiation HAZARDS204
11 Protection against excessive temperatures and other HAZARDS207
12 * Accuracy of controls and instruments and protection against hazardous outputs
13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
15 Construction of ME EQUIPMENT246
16 * ME SYSTEMS265
17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS274
Annex A (Informative) General guidance and rationale
Annex G - Protection against HAZARDS of ignition of flammable
Annex B (Informative) Sequence of testing
Annex C Guide to marking and labelling requirements for ME EQUIPMENT and
Annex D (Informative) Symbols on marking
L ® _J
Annex E Examples of the connection of the measuring device (MD) for
Annex F Suitable measuring supply circuits
Annex G Protection against HAZARDS of ignition of flammable anaesthetic
Annex H PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentation
Annex I ME SYSTEMS aspects
33 Items A and Bare
Annex J Survey of insulation paths (see 8.5.1)
Annex K Simplified PATIENT LEAKAGE CURRENT diagrams
Annex L Insulated winding wires for use without interleaved insulation (8.8.2)
Annex M Reduction of pollution degrees (see 8.9.1.8)
Bibliography

Foreword

GB 9706 "Medical electrical equipment" is divided into the following parts:

- Part 1: General requirements for basic safety and essential performance;

the range 1 MeV to 50 MeV;

- Part 2-4: Particular requirements for the safety of cardiac defibrillators;

of therapeutic X-ray equipment operating in the range 10 kV to 1 MV;

performance of gamma beam therapy equipment;

performance of automatically-controlled brachytherapy after-loading equipment;

performance of surgical, cosmetic, therapeutic and diagnostic laser equipment;

performance of X-ray tube assemblies for medical diagnosis;

performance of equipment for extracorporeally induced lithotripsy;

performance of ultrasonic medical diagnostic and monitoring equipment;

performance of X-ray equipment for computed tomography;

performance of X-ray equipment for radiography and radioscopy;

performance of dental extra-oral X-ray equipment;

performance of dental intra-oral X-ray equipment;

performance of hearing instruments and hearing instrument systems.

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

This Part replaces GB 9706.1-2007 "Medical electrical equipment - Part 1: General requirements for safety" and GB 9706.15-2008 "Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems". This Part is based on GB 9706.1-2007 and integrates all the contents of GB 9706.15-2008. Compared with GB 9706.1-2007, in addition to editorial changes, the main technical changes are as follows:

- Incorporate the contents of GB 9706.15 and YY/T 0708 into this Part;

- ADD requirements for essential performance (see Clause 4);

- ADD the concept of expected service life (see 4.4);

- ADD content related to risk management (see 4.2);

- ADD different requirements for operator protection and patient protection (see Clause 8);

- Modify the test requirements for protection against electric shock (see

Clause 8; Clause 3 of the 2007 edition);

- ADD relevant requirements for mechanical safety (see Clause 9);

- ADD fire prevention requirements (see 11.3).

This Part uses the redraft law to modify and adopt IEC 60601-1:2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance".

The technical differences between this Part and IEC 60601-1:2012 and their reasons are as follows:

- As for the normative references, this Part has made adjustments with technical differences, to adapt to the technical conditions of China. The adjustments are reflected in Clause 2 “Normative references”. The specific adjustments are as follows:

2011 which modifies and adopts the international standard;

- ADD the requirements for the mains plug to 8.11.3.1.

- Modify the footnote of Table 20 to read "a The values in this table are taken This Part also made the following editorial changes:

CSV/COR1:2012; USE a vertical double line (ǁ) to mark the blank position on the outer side of the corresponding clause;

- Include the technical errata content of IEC 60601- 1:2005/AMD1:2012/COR1:2014; USE a vertical double line (ǁ) to mark the blank position on the outer side of the corresponding clause;

- ADD A.5 to Annex A, which lists the abbreviations and acronyms used in the standard;

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority of this document shall not be held responsible for identifying any or all such patent rights.

This Part was proposed by and shall be under the jurisdiction of National Medical Products Administration.

Drafting organizations of this Part: Shanghai Testing and Inspection Institute for Medical Devices, Beijing Institute of Medical Device Testing, Liaoning Medical Device Test Institute, Zhejiang Institute of Medical Device Testing, Shenzhen Mindray Bio-medical Electronics Co., Ltd., General Electric Medical System Trade Development (Shanghai) Co., Ltd., Siemens Shanghai Medical Equipment Ltd., Philips Healthcare (Suzhou) Co., Ltd.

Main drafters of this Part: He Jun, Li Wen, Liu Jingbo, Du Kun, Shao Lingyun, Sun Zhuohui, Liu Pu, Shu Jian.

The previous editions of the standard replaced by this Part were released as follows:

1 Scope, object and related standards

1.1 * Scope

This Part of GB 9706 specifies the GENERAL REQUIREMENTS for BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS. This Part applies to MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this Part are not covered by specific requirements in this Part except in 7.2.13 and 8.4.1. EQUIPMENT, which is covered by the IEC 61010 series [61]; medical gas pipeline systems covered by ISO 7396-1 [68]. […]

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. GB/T 5023.1-2008 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements (IEC 60227-1:2007, IDT) GB/T 5465.2 Graphical symbols for use on electrical equipment - Part 2: Graphical symbols (GB/T 5465.2-2008, IEC 60417:2007, IDT) GB/T 6346.14-2015 Fixed capacitors for use in electronic equipment - Part 14: Sectional specification - Fixed capacitors for electromagnetic interference suppression and connection to the supply mains (IEC 60384- 14:2005, IDT) GB 18278.1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18278. […]

3 * Terminology and definitions

r.m.s. values of an alternating, direct or composite voltage or current unless stated otherwise. other electrical equipment. This Part also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in the context of an ME SYSTEM (see 3.64). mean "safety" as defined in YY/T 0316-2016, but rather is used to mean "the state of being protected from or guarded against hurt or injury; freedom from danger”. Part of an ENCLOSURE or GUARD providing the possibility of access to electrical equipment parts for the purpose of adjustment, inspection, replacement or repair. Part of electrical equipment other than an APPLIED PART that can be touched by means of the standard test finger. […]

4 General requirements

Unless otherwise specified, the requirements of this Part shall apply in NORMAL USE and reasonably foreseeable misuse.

When applying this Part to ME EQUIPMENT or ME SYSTEMS intended for the compensation or alleviation of disease, injury or disability, the definitions and requirements that use the term PATIENT shall be considered as applying to the person for whom the ME EQUIPMENT or ME SYSTEM is intended.

4.2.1 Introduction to RISK MANAGEMENT

Subclause 4.2 specifies the RISK MANAGEMENT PROCESS that is required for compliance with this Part. This RISK MANAGEMENT PROCESS is intended to serve the following purposes: a) To identify whether the normative requirements specified in Clauses 5 to 17 of this Part, together with the requirements of applicable collateral and particular standards, address all the HAZARDS associated with the particular ME EQUIPMENT or ME SYSTEM under consideration. […]

4.2.3 Evaluating RISK

4.10 * Power supply

5 * General requirements for testing ME EQUIPMENT

5.1 * TYPE TESTS

The tests described in this Part are TYPE TESTS. The tests to be performed are determined taking into consideration the requirements of Clause 4, in particular 4.2.

A test need not be performed if analysis shows that the condition being tested has been adequately evaluated by other tests or methods.

The combination of simultaneous independent faults that could result in a HAZARDOUS SITUATION shall be documented in the RISK MANAGEMENT FILE (see also 4.7). When testing is necessary to demonstrate that BASIC SAFETY and ESSENTIAL PERFORMANCE are maintained under such simultaneous independent faults, the related testing may be limited to worst case situations.

EQUIPMENT, see Annex K of IEC/TR 62354 (production line tests) or see IEC 62353 (recurrent tests).

5.2 * Number of samples

TYPE TESTS are performed on a representative sample of the item being tested.

5.9.1 APPLIED PARTS

APPLIED PARTS are identified by inspection and by reference to the ACCOMPANYING DOCUMENTS. See also 4.6.

5.9.2 ACCESSIBLE PARTS

6 * Classification of ME EQUIPMENT and ME SYSTEMS

6.2 * Protection against electric shock

ME EQUIPMENT energized from an external electrical power source shall be classified as CLASS I ME EQUIPMENT or CLASS II ME EQUIPMENT (see 7.2.6). Other ME EQUIPMENT shall be classified as INTERNALLY POWERED ME EQUIPMENT. INTERNALLY POWERED ME EQUIPMENT having a means of connection to a SUPPLY MAINS shall comply with the requirements for CLASS I ME EQUIPMENT or CLASS II ME EQUIPMENT while so connected, and with the requirements for INTERNALLY POWERED ME EQUIPMENT while not so connected. APPLIED PARTS shall be classified as TYPE B APPLIED PARTS, TYPE BF APPLIED PARTS or TYPE CF APPLIED PARTS (see 7.2.10 and 8.3). APPLIED PARTS may be classified as DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5). ENCLOSURES shall be classified according to the degree of protection against harmful ingress of water and particulate matter as detailed in GB/T 4208 (see 7.2.9 and 11.6.5). […]

7.1 General

7.1.2 * Legibility of markings

The markings required by 7.2, 7.3, 7.4, 7.5 and 7.6 shall be CLEARLY LEGIBLE under the following conditions: for FIXED ME EQUIPMENT: when the ME EQUIPMENT is mounted in its position of NORMAL USE; EQUIPMENT that is not FIXED ME EQUIPMENT: in NORMAL USE or after dislodging the ME EQUIPMENT from a wall against which it has been positioned, or after turning the ME EQUIPMENT from its position of NORMAL USE and, in the case of dismountable rack units, after their removal from the rack; when viewed from the intended position of the person performing the related function. Compliance for clear legibility is checked by the following test: The ME EQUIPMENT or its part is positioned so that the viewpoint is the intended position of the OPERATOR. […]

7.2.3 * Consult ACCOMPANYING DOCUMENTS

When appropriate, symbol of ISO 7000:2004 (see Table D.1, symbol 11) may be used to advise the OPERATOR to consult the ACCOMPANYING DOCUMENTS. […]

7.2.8 Output connectors

7.6 Symbols

7.7 Colours of the insulation of conductors

7.8 * Indicator lights and controls

7.9 ACCOMPANYING DOCUMENTS

7.9.2 Instructions for use (see also Table C.5)

7.9.3 Technical description (see also Table C.6)

8 * Protection against electrical HAZARDS from ME EQUIPMENT

8.1 Fundamental rule of protection against electric shock

The limits specified in 8.4 shall not be exceeded for ACCESSIBLE PARTS and APPLIED PARTS in NORMAL CONDITION or SINGLE FAULT CONDITION. For other HAZARDOUS SITUATIONS in SINGLE FAULT CONDITION, see 13.1. a) * NORMAL CONDITION includes all of the following simultaneously: current from other electrical equipment that is permitted to be connected according to the ACCOMPANYING DOCUMENTS as specified in 7.9, or, if the ACCOMPANYING DOCUMENTS place no restrictions on such other electrical equipment, the presence of the MAXIMUM MAINS VOLTAGE as specified in 8.5.3; connection to a SUPPLY MAINS by means of a MAINS PLUG; short circuit of any or all insulation that does not comply with the requirements of 8.8; that do not comply with the requirements of 8.9; open circuit of any or all earth connections that do not comply with the requirements of 8.6, including any functional earth connection. […]

8.2 Requirements related to power sources

8.4 Limitation of voltage, current or energy

8.5 Separation of parts

8.5.1 * MEANS OF PROTECTION (MOP)

8.5.2 Separation of PATIENT CONNECTIONS

8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS

8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS

8.7.4 Measurements

I ME EQUIPMENT, with or without APPLIED PART (see 8.7.4.5)

S1 open is SINGLE FAULT CONDITION.

CLASS I ME equipment only: Measure with S1 open (SINGLE FAULT CONDITION) and with S1 closed under all possible combinations of S5, S9, S10 and S12.

For CLASS II ME equipment, the PROTECTIVE EARTH CONNECTION and S1 are not used.

Transformer T2 is used if required (see 8.1 a)) Example with the measuring supply circuit of Figure F.1.

8.8 Insulation

8.8.4 Insulation other than wire insulation

8.9 * CREEPAGE DISTANCES and AIR CLEARANCES

8.9.1 * Values

8.9.3 * Spaces filled by insulating compound

8.10 Components and wiring

8.10.4 * Cord-connected HAND-HELD parts and cord-connected foot-

8.11 MAINS PARTS, components and layout

8.11.3 POWER SUPPLY CORDS

8.11.4 MAINS TERMINAL DEVICES

9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS

9.1 MECHANICAL HAZARDS of ME EQUIPMENT

For general requirements on design and manufacture of ME EQUIPMENT, see Clause 4 and 15.3.

Table 19 identifies the subclauses that address the MECHANICAL HAZARDS.

9.2 * MECHANICAL HAZARDS associated with moving parts

9.2.1 * General

ME EQUIPMENT with moving parts shall be designed, built and laid out so that, when PROPERLY INSTALLED and used as indicated in the ACCOMPANYING DOCUMENTS or under reasonably foreseeable misuse, the RISKS associated with those moving parts are reduced to an acceptable level.

The RISK from contact with the moving parts shall be reduced to an acceptable level by use of RISK CONTROL measures, bearing in mind the ease of access, the ME EQUIPMENT’S function, the shape of the parts, the energy and speed of the motion and the benefits to the PATIENT.

The RESIDUAL RISK associated with moving parts is considered acceptable if exposure is needed for the ME EQUIPMENT to perform its intended function, and RISK CONTROL measures have been implemented (e.g. warnings).

9.2.2 TRAPPING ZONE

9.2.2.4 * GUARDS and other RISK CONTROL measures

9.4 * Instability HAZARDS

9.4.2 * Instability - overbalance

9.4.2.4 * Castors and wheels

9.5 * Expelled parts HAZARD

9.6.2 * Acoustic energy

9.7.8 RATED maximum supply pressure

9.8 * MECHANICAL HAZARDS associated with support systems

9.8.4 * Systems with MECHANICAL PROTECTIVE DEVICES

10 * Protection against unwanted and excessive radiation HAZARDS

10.1 X-Radiation

For ME EQUIPMENT not intended to produce X-radiation for diagnostic or therapeutic purposes, but which might produce ionizing radiation, the AIR KERMA rate shall not exceed 5 μGy/h at a distance of 5 cm from a surface of the ME EQUIPMENT taking account of the background radiation. If the INTENDED USE of the ME EQUIPMENT requires a permanent proximity to a PATIENT, the resulting annual exposure should be made acceptable taking into account the irradiated body part and national regulations and/or international recommendations. Compliance is checked by following test: The amount of radiation is determined by means of a radiation monitor of the ionizing chamber type with an effective area of 10 cm2 or by measuring equipment of other types giving equivalent results. […]

11 Protection against excessive temperatures and other HAZARDS

11.1 * Excessive temperatures in ME EQUIPMENT

11.1.1 * Maximum temperature during NORMAL USE

When ME EQUIPMENT is operated in worst-case NORMAL USE including the maximum ambient operating temperature specified in the technical description (see 7.9.3.1):

- ME EQUIPMENT parts shall not reach temperatures exceeding the values

given in Table 22 and Table 23;

the ME EQUIPMENT shall not cause the surfaces of the test corner to

- THERMAL CUT-OUTS shall not operate in NORMAL CONDITION.

Remaining clauses in the full document

11.2 * Fire prevention
11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS
12 * Accuracy of controls and instruments and protection against hazardous outputs
12.1 Accuracy of controls and instruments
12.2 USABILITY of ME EQUIPMENT
12.3 ALARM SYSTEMS
12.4 Protection against hazardous output
13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
13.1 Specific HAZARDOUS SITUATIONS
13.2 SINGLE FAULT CONDITIONS
14.1 * General
14.3 * RISK MANAGEMENT plan
14.4 * PEMS DEVELOPMENT LIFE-CYCLE
14.5 * Problem resolution
14.6 RISK MANAGEMENT PROCESS
14.7 * Requirement specification
14.8 * Architecture
14.9 * Design and implementation
14.10 * VERIFICATION
14.11 * PEMS VALIDATION
14.12 * Modification
15 Construction of ME EQUIPMENT
15.2 * Serviceability
15.3 Mechanical strength
15.4 ME EQUIPMENT components and general assembly
16 * ME SYSTEMS
16.2 * ACCOMPANYING DOCUMENTS of an ME SYSTEM
16.3 * Power supply
16.4 ENCLOSURES
16.5 * SEPARATION DEVICES
16.6 * LEAKAGE CURRENTS
16.7 * Protection against MECHANICAL HAZARDS
16.9 ME SYSTEM connections and wiring
17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Annex A General guidance and rationale
A.1 General guidance
A.3 Guidance to the third edition
A.4 Rationale for particular clauses and subclauses
Annex G - Protection against HAZARDS of ignition of flammable
A.5 Index of abbreviations and acronyms
Annex B Sequence of testing
B.3 General requirements
B.4 Classification of ME EQUIPMENT and ME SYSTEMS
B.5 Determination of APPLIED PARTS and ACCESSIBLE PARTS
B.6 ME EQUIPMENT identification, marking and documents
B.8 Limitation of voltage, current or energy
B.10 CREEPAGE DISTANCES and AIR CLEARANCES
B.11 HAZARDS associated with moving parts
B.12 HAZARD associated with surfaces, corners and edges
B.15 Instability HAZARDS
B.16 Noise, vibration and acoustic energy
B.19 Excessive temperatures in ME EQUIPMENT
B.21 Humidity preconditioning treatment
B.23 Defibrillation protection
B.24 Expelled parts HAZARD
B.26 HAZARDS associated with support systems
B.27 Mechanical strength
B.28 HAZARDOUS SITUATIONS and fault conditions
B.30 ME EQUIPMENT components and general assembly
B.31 MAINS PARTS, components and layout
B.35 CATEGORY AP and CATEGORY APG ME EQUIPMENT
B.36 VERIFICATION of markings
Annex C Guide to marking and labelling requirements for ME EQUIPMENT and
C.3 Marking of controls and instruments
C.5 ACCOMPANYING DOCUMENTS, Instructions for use
C.6 ACCOMPANYING DOCUMENTS, technical description
Annex D Symbols on marking
L ® _J
Annex E Examples of the connection of the measuring device (MD) for
Annex F Suitable measuring supply circuits
Annex G Protection against HAZARDS of ignition of flammable anaesthetic
G.1 Introduction
G.2 Locations and basic requirements
G.3 Marking, ACCOMPANYING DOCUMENTS
Annex H PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentation
H.1 Examples for PEMS/PESS structures
H.2 PEMS DEVELOPMENT LIFE-CYCLE model
H.3 Software PROCESSES
H.4 Design and implementation
H.5 Documentation
H.7 Design considerations for IT-NETWORKS
Annex I ME SYSTEMS aspects
I.1 Combinations of ME EQUIPMENT and non-ME EQUIPMENT
33 Items A and Bare
I.2 Examples of application of MULTIPLE SOCKET-OUTLETS
Annex J Survey of insulation paths (see 8.5.1)
Annex K Simplified PATIENT LEAKAGE CURRENT diagrams
Annex L Insulated winding wires for use without interleaved insulation (8.8.2)
L.1 Introduction
L.2 Wire construction
L.3 TYPE TEST
L.4 Tests during manufacture
Annex M Reduction of pollution degrees (see 8.9.1.8)
Bibliography

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 508 pages — is available in the English PDF.

Referenced standards

Normative references

IEC 60227 · IEC 60417 · GB/T 6346.14-2015 · IEC 60384 · GB 18278.1 · GB 18278.1-2015 · ISO 17665 · GB 18279.1-2015 · ISO 11135 · ISO 11137 · GB/T 19212.2 · GB/T 19212.2-2012 · IEC 61558 · GB/T 28164 · GB/T 28164-2011 · IEC 62133 · ISO 15223 · YY 0709 · YY 0709-2009 · IEC 60601 · ISO 2882 · ISO 3864 · ISO 7000 · ISO 7010 · ISO 9614

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