標準編號:	GB 16174.1-1996
中文名稱:	心臟起搏器 第一部分:植入式心臟起搏器
英文名稱:	Cardiac pacemakers-Part 1: Implantable pacemakers
中標分類:	C36    其他專科器械
行業分類:	GB    國家標準
ICS分類:	11.040.60 11.040.60    治療設備 11.040.60
發布機構:	國家質量監督檢驗檢疫總局
發布日期:	1996-3-7
實施日期:	1996-10-1
標準狀態:	superseded
被新標準替代:	GB 16174.2-2015 手術植入物 有源植入式醫療器械 第2部分：心臟起搏器
被替代日期:	2017-7-1
作廢日期:	2017-07-01
翻譯語言:	英文
文件格式:	PDF
中文字符數:	22000 字
翻譯價格(元):	660.0
交付時間:	付款后 1 個工作日

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).