SIS SS-EN 50 061-1991 医用电气设备．植入式心脏起搏器的安全性

标准号：SIS SS-EN 50 061-1991
中文标准名称：医用电气设备．植入式心脏起搏器的安全性
英文标准名称：Medical electrical equipment - Safety of implantable cardiac pacemakers
发布日期：1991/4/24 12:00:00
实施日期：1999/12/31 12:00:00
适用范围：This standard specifies safety and other requirements exclusively for all types of wholly implantable cardiac PACEMAKERS.This standard also establishes basic terminology and definitions and includes requirements for the marking of PACEMAKERS and their packaging. In addition, minimum requirements are specified for the ability of PACEMAKERS to withstand environmental stress conditions. Appropriate test methods are given. This standard specifies the requirements for the reliable operation of PACEMAKERS only insofar as they affect safety.It does not cover the antitachyarrythmia and defibrillation functions of PACEMAKERS, nor PACEMAKERS operated by isotopic cells.