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    IEC 60601-2-31:2020 RLV

    Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
    • 발행일 : 2020-01-17
    • 발행기관 : IEC
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    • [영어]PDF(레드라인) 945,800원

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  • 레드라인이란?

    * RLV (Red-Line Version) : 구판과 최신판의 변경 사항을 빨간펜으로 표시해서 비교할 수 있게 만든 버전
    * CMV (Commented version) : 표준의 개정 시 변경 부분(레드라인)에 대한 코멘트(메모)가 추가된 버전
    * RLV 혹은 CMV를 구입하시면 최신판(Final version)은 별도로 구매하지 않아도 됩니다.

상세정보

분야
적용범위 IEC 60601-2-31:2020 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition.

IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT. IEC 60601-2-31:2020 cancels and replaces the second edition published in 2008 and Amendment 1:2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) The requirement for testing for energy reduction has been removed;
b) The test for exposure to external defibrillation has been completely revised;
c) The exclusion for testing ESD immunity only with respect to air discharges has been removed;
d) Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117;
e) Additional rationale for all changes.
국제분류(ICS)코드 11.040.01 : 일반 의료장비
페이지수 167
Edition 3.0

이력정보

No. 표준번호 표준명 발행일 상태
1 IEC 60601-2-31:2020 RLV상세보기 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source 2020-01-17 표준
2 IEC 60601-2-31:2020상세보기 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source 2020-01-17 표준
3 IEC 60601-2-31:2008+AMD1:2011 CSV상세보기 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source 2011-09-29 구판
4 IEC 60601-2-31:2008/AMD1:2011상세보기 Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source 2011-06-29 구판
5 IEC 60601-2-31:2008상세보기 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source 2008-03-26 구판
6 IEC 60601-2-31:1994/AMD1:1998상세보기 Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source 1998-01-01 구판
7 IEC 60601-2-31:1994상세보기 Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source 1994-10-12 구판

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