Standard No.:	GB 16174.1-1996
English Name:	Cardiac pacemakers-Part 1: Implantable pacemakers
Chinese Name:	心脏起搏器 第一部分:植入式心脏起搏器
Chinese Classification:	C36    Other special devices
Professional Classification:	GB    National Standard
ICS Classification:	11.040.60 11.040.60    Therapy equipment 11.040.60
Issued by:	AQSIQ
Issued on:	1996-3-7
Implemented on:	1996-10-1
Status:	abolished
Superseded by:	GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers
Superseded on:	2017-7-1
Abolished on:	2017-07-01
Language:	English
File Format:	PDF
Word Count:	11000 words
Price(USD):	270.0
Delivery:	via email in 1 business day

1 Scope and field of application 1.1 .This standard establishes basic terminology and definitions, and specifies requirements for marking implantable cardiac Pacemakers and their packaging. Minimum requirements for the ability of Pacemaker pulse generators to withstand environmental stress conditions are also specified along with appropriate test methods. Annex A explains the coding System for identifying the mode of operation of pulse generators. Test methods to assess the basic electrical Parameters for conformance with Claims are included in annex B; annex C describes the estimation and expression of the nominal Service life of a pulse generator; annex D provides an example of a technical information sheet; annex E provides a rationale for certain of the provisions of this standard and-annex F provides optional Symbols to be used in place of written words. 1.2 This standard applies to all types of wholly implantable cardiac Pacemakers; it does not cover antitachyarrythmia and defibrillation functions of Pacemakers, nor Pacemakers powered by isotopic cells (nuclear-powered pacemakers).