GB 16174.1-2015 English PDF (GB16174.1-2015)

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GB 16174.1-2015: Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
GB 16174.1-2015
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 30
GB 16174.1-2015 / ISO 14708-1:2000
Implants for surgery - Active implantable medical devices
- Part 1: General requirements for safety, marking and for
information to be provided by the manufacturer
(ISO 14708-1:2000, IDT)
ISSUED ON: DECEMBER 10, 2015
IMPLEMENTED ON: JULY 1, 2017
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China;
Standardization Administration of the People's Republic of
China.
Table of Contents
Foreword ... 4
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 8
4 Symbols and abbreviated terms ... 11
5 General requirements for non-implantable parts ... 11
6 Requirements for particular active implantable medical devices ... 12
7 General arrangement of the packaging ... 12
8 General markings for active implantable medical devices ... 12
9 Markings on the sales packaging ... 12
10 Construction of the sales packaging ... 14
11 Markings on the sterile pack ... 15
12 Construction of the non-reusable pack ... 16
13 Markings on the active implantable medical device ... 16
14 Protection from unintentional biological effects caused by the active implantable
medical device ... 17
15 Protection from harm to the patient or user caused by external physical features of
the active implantable medical device ... 19
16 Protection from harm to the patient caused by electricity ... 19
17 Protection from harm to the patient caused by heat ... 20
18 Protection from ionizing radiation released or emitted from the active implantable
medical device ... 20
19 Protection from unintended effects caused by the device ... 21
20 Protection of the device from damage caused by external defibrillators ... 22
21 Protection of the device from changes caused by high-power electrical fields applied
directly to the patient ... 24
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments ... 25
23 Protection of the active implantable medical device from mechanical forces ... 26
24 Protection of the active implantable medical device from damage caused by
electrostatic discharge ... 28
25 Protection of the active implantable medical device from damage caused by
atmospheric pressure changes ... 28
26 Protection of the active implantable medical device from damage caused by
temperature changes ... 29
27 Protection of the active implantable medical device from electromagnetic non-
ionizing radiation ... 29
28 Accompanying documentation ... 30
Annex A (informative) Rationale ... 34
Bibliography ... 43
Foreword
All technical contents of this Part of GB 16174 are mandatory.
GB 16174 consists of the following 7 parts, under the general title “Implants for surgery
- Active implantable medical devices”:
- Part 1: General requirements for safety, marking and for information to be provided
by the manufacturer;
- Part 2: Cardiac pacemakers;
- Part 3: Implantable neural stimulators;
- Part 4: Implantable infusion pumps;
- Part 5: Circulation support equipment;
- Part 6: Particular requirements for active implantable medical devices for the
treatment of tachyarrhythmias (including implantable cardiac defibrillators);
- Part 7: Implantable cochlear implant system.
This Part is Part 1 of GB 16174.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
This Part uses translation method to equivalently adopt ISO 14708-1:2000 “Implants
for surgery - Active implantable medical devices - General requirements for safety,
marking and for information to be provided by the manufacturer”.
China’s documents that are identical to the International documents normatively
referenced in this Part are as follows:
- GB/T 2423.8-1995 Environmental testing for electric and electronic products - Part
2: Test methods - Test Ed: Free fall (IEC 60068-2-32:1990, IDT);
- GB/T 2423.56-2006 Environmental testing for electric and electronic products -
Part 2: Test methods - Test Fh: Vibration, broad-band random (digital control) and
guidance (IEC 60068-2-64:1993, IDT);
- GB/T 7408-2005 Data elements and interchange formats - Information
interchange - Representation of dates and times (ISO 8601:2000, IDT);
- GB 9706.1-2007 Medical electrical equipment - Part 1: General requirements for
safety (IEC 60601-1:1988, IDT);
- GB 9706.15-2008 Medical electrical equipment - Part 1: General requirements for
safety - 1. Collateral standard: Safety requirements for medical electrical systems
(IEC 60601-1-1:2000, IDT);
- GB/T 17626.2-2006 Electromagnetic compatibility (EMC) - Testing and
measurement techniques - Electrostatic discharge immunity test (IEC 61000-4-
2:2001, IDT);
- GB/T 19633-2005 Packaging for terminally sterilized medical devices (ISO
11607:2003, IDT);
- YY/T 0297-1997 Clinical investigation of medical devices (ISO 14155:1996, IDT);
- YY 0466-2003 Medical devices - Symbols to be used with medical device labels
labelling and information to be supplied (ISO 15223:2000, IDT);
- YY 0505-2012 Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standards: Electromagnetic compatibility - Requirements and
tests (IEC 60601-1-2:2004, IDT);
- YY/T 0708-2009 Medical electrical equipment - Part 1-4: General requirements for
safety - Collateral standard: Programmable electrical medical systems (IEC
60601-1-4: 2000, IDT).
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. The issuing organizations of this document shall not be
held responsible for identifying any or all such patent rights.
This Part is proposed by the State Food and Drug Administration.
This Part shall be under the jurisdiction of the Subcommittee on Medical Electronic
Instruments of the National Technical Committee on Medical Electrical Equipment of
Standardization Administration of China (SAC/TC 10/SC 5).
Drafting organizations of this Part: Shanghai Medical Devices Testing Institute,
Medtronic Medical Supplies Technical Services (Shanghai) Co., Ltd.
Main drafters of this Part: Yu Ji and Wen Xuan.
Implants for surgery - Active implantable medical devices
- Part 1: General requirements for safety, marking and for
information to be provided by the manufacturer
1 Scope
This Part of GB 16174 specifies requirements that are generally applicable to active
implantable medical devices.
NOTE: For particular types of active implantable medical devices, these general requirements
are supplemented or modified by the requirements of particular standards which form additional
parts of GB 16174. Special care is required in applying this Part to active implantable medical
devices where no particular standard exists.
The tests that are specified in this Part are type tests intended to be carried out on
samples of a device to show compliance, and are not intended to be used for the
routine testing of manufactured products.
This Part is applicable not only to active implantable medical devices that are
electrically powered, but also to those powered by other energy sources (for example
gas pressure or springs).
This Part is also applicable to some non-implantable parts and accessories of the
devices (see 3.3).
2 Normative references
The following referenced documents are indispensabl...