GB 9706.15-2008 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 9706.15-2008 | English | 145 |
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Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
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| GB 9706.15-1999 | English | 959 |
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Medical electrical equipment Part 1: General requiements for safety 1. Collateral standard: Safety requirements for medical electrical systems
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GB 9706.15-2008: Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB9706.15-2008
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 30
GB 9706.15-2008 / IEC 60601-1-1.2000
Replacing GB 9706.15-1999
Medical electrical equipment - Part 1.General
requirements for safety - 1.Collateral standard.
Safety requirements for medical electrical systems
(IEC 60601-1-1.2000, IDT)
Issued on. DECEMBER 15, 2008
Implemented on. FEBRUARY 01, 2010
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the PRC;
Standardization Administration of the PRC.
Table of Contents
Foreword... 5
SECTION ONE - GENERAL... 7
1 Scope and object... 7
2 Terminology and definitions... 7
3 General requirements... 8
6 Identification, marking and documents... 10
SECTION TWO - ENVIRONMENTAL CONDITIONS... 11
10 Environmental conditions... 11
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
... 12
16 ENCLOSURES and PROTECTIVE COVERS... 12
17 Separation... 12
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
... 13
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS... 14
22 Moving parts... 14
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION... 14
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES... 14
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS... 15
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization, disinfection and compatibility... 15
49 Interruption of the power supply... 15
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT... 15
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS... 15
52 Abnormal operation and fault conditions... 15
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS... 16
56 Components and general assembly... 16
57 MAINS PARTS, components and layout... 16
58 Protective earthing - Terminals and connection... 17
59 Construction and layout... 18
Annex AAA (informative) General guidance and rationale... 19
Annex BBB (informative) Examples of combinations of MEDICAL ELECTRICAL
EQUIPMENT and non-medical electrical equipment... 26
Annex CCC (normative) Normative references... 30
Annex DDD (informative) Bibliography... 31
Annex EEE (normative) Requirements for MULTIPLE PORTABLE SOCKET-
OUTLETS... 32
Annex FFF (informative) Examples of application of MULTIPLE PORTABLE
SOCKET-OUTLETS... 35
Figure 201 -- Example of PATIENT ENVIRONMENT... 18
Foreword
The full technical content of this Part of GB 9706 is mandatory.
“Medical electrical equipment” safety series standard consists of two parts.
- Part 1.General requirements for safety;
- Part 2.Particular requirements for safety.
Part 1 includes, in addition to this Part, other standards.
- GB 9706.1 Medical electrical equipment - Part 1.General requirements for
safety;
- YY 0505 Medical electrical equipment - Part 1-2.General requirements for
safety - Collateral standard. Electromagnetic compatibility - Requirements
and tests;
- GB 9706.12 Medical electrical equipment - Part 1.General requirements
for safety - 3.Collateral standard. General requirements for radiation
protection in diagnostic X-ray equipment;
This Part is Part 15.
This Part equivalently adopts IEC 60601-1-1.2000 “Medical electrical
equipment - Part 1-1.General requirements for safety - Collateral standard.
Safety requirements for medical electrical systems”.
The main difference between this Part and IEC 60601-1-1 is that if the
international standards referenced in the standard have been converted into
Chinese standards, then this Part replaces the referenced international
standard number with the corresponding Chinese standard number.
This Part replaces GB 9706.15-1999 “Medical electrical equipment - Part 1.
General requirements for safety - 1.Collateral standard. Safety requirements
for medical electrical systems”.
As compared with GB 9706.15-1999, the main changes in this Part are as
follows.
- The terms and definitions have been adjusted accordingly;
- ADD some requirements for accompanying documents of a system
(6.8.201);
- The contents of continuous LEAKAGE CURRENTS and PATIENT
AUXILIARY CURRENTS (Clause 19) have been adjusted accordingly;
- ADD some requirements for connections (56.3.201);
- Delete some requirements for protection of wiring (59.201);
- The contents of Annex BBB have been adjusted.
Annexes CCC and EEE of this Part are normative annexes. Annexes AAA, BBB,
DDD, and FFF are informative annexes.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee 10 on
Medical Electrical Equipment of Standardization Administration of China
(SAC/TC 10).
This Part was drafted by Shanghai Testing and Inspection Institute for Medical
Devices.
Main drafters of this Part. He Jun, Huang Jiahua, Lu E.
The previous edition replaced by this Part is as follows.
- GB 9706.15-1999.
Medical electrical equipment Part 1.General
requirements for safety - 1.Collateral standard.
Safety requirements for medical electrical systems
SECTION ONE - GENERAL
1 Scope and object
This Part applies to the safety of MEDICAL ELECTRICAL SYSTEMS, as
defined in 2.201.It describes the safety requirements necessary to provide
protection for the PATIENT, the OPERATOR and surroundings.
2 Terminology and definitions
In this Collateral Standard, terms printed in small capitals are used in
accordance with their definitions in GB 9706.1.
Connection, electrical or otherwise, including those intended to transfer signals
and/or power and/or substances.
3 General requirements
MEDICAL ELECTRICAL EQUIPMENT shall comply with the requirements of
GB 9706.1 and its relevant particular standards.
Compliance is checked by inspection of appropriate documents or certificates.
After installation or subsequent modification, the SYSTEM shall be in
compliance with the requirements of this Collateral Standard.
6 Identification, marking and documents
A SYSTEM (including a modified SYSTEM) shall be accompanied by
documents containing all the data necessary for safe and intended use.
These documents shall include.
10 Environmental conditions
A power supply from another equipment for EQUIPMENT in a SYSTEM shall
be specified by the manufacturer.
16 ENCLOSURES and PROTECTIVE COVERS
Parts of non-medical electrical equipment in the PATIENT ENVIRONMENT that,
after removal of covers, connectors, etc., without the use of a TOOL, may be
contacted by the OPERATOR during routine maintenance, calibration, etc.,
shall operate at a voltage not exceeding 25 V a.c.
17 Separation
The terminals of each of these parts are connected together during the test.
The test voltage is chosen from Table 5 of GB 9706.1-2007.
22 Moving parts
See informative note in Annex AAA.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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