标准编号:	GB 16174.1-1996
中文名称:	心脏起搏器 第一部分:植入式心脏起搏器
英文名称:	Cardiac pacemakers-Part 1: Implantable pacemakers
中标分类:	C36    其他专科器械
行业分类:	GB    国家标准
ICS分类:	11.040.60 11.040.60    治疗设备 11.040.60
发布机构:	国家质量监督检验检疫总局
发布日期:	1996-3-7
实施日期:	1996-10-1
标准状态:	abolished
被新标准替代:	GB 16174.2-2015 手术植入物 有源植入式医疗器械 第2部分：心脏起搏器
被替代日期:	2017-7-1
作废日期:	2017-07-01
翻译语言:	英文
文件格式:	PDF
翻译字数:	22000 字
交付时间:	1 个工作日

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).