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

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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).

Basic Data

Standard ID	GB 16174.1-2015 (GB16174.1-2015)
Description (Translated English)	Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Sector / Industry	National Standard
Classification of Chinese Standard	C30
Classification of International Standard	11.040.40
Word Count Estimation	27,289
Date of Issue	2015-12-10
Date of Implementation	2017-07-01
Quoted Standard	GB/T 2423.22-2002; GB/T 2423.43-2008; GB 9706.25-2005; ISO 8601; ISO 11607; ISO 14155; ISO 15223; IEC 60068-2-14; IEC 60068-2-47; IEC 60068-2-64; IEC 61000-4-2; IEC 60601-1; IEC 60601-1-1; IEC 60601-1-2; IEC 60601-1-4; IEC 60601-2-27; IEC 60068-2-32
Adopted Standard	ISO 14708-1-2000, IDT
Regulation (derived from)	National Standard Announcement 2015 No.38
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies general requirements applicable to active implantable medical devices. The tests specified in this standard are type tests in which the conformity of the product is demonstrated by testing the samples which are not intended for routine testing of the finished product. This standard applies not only to electric active implantable medical devices, but also to other energy sources (such as gas pressure or spring) as the driving force of active implanted medical devices. This standard also applies to certain non-implantable parts and accessories for active implantable medical devices (see 3.3).