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관심표준 등록 : 표준업데이트 시 알림서비스

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    IEC 60601-1-11:2015 RLV

    Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
    • 발행일 : 2015-01-20
    • 발행기관 : IEC
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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 60601-1-11:2015 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 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes:
- the dwelling place in which a patient lives;
- other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.
This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications:
- correction of test method for relative humidity control at temperatures above 35 °C;
- redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and
- harmonizing with the changes to the amendments to the general standard and other collateral standards.
국제분류(ICS)코드 11.040.01 : 일반 의료장비
11.020.10 : 헬스 케어 서비스 일반
페이지수 190
Edition 2.0

이력정보

No. 표준번호 표준명 발행일 상태
1 IEC 60601-1-11:2015/AMD1:2020상세보기 Amendment 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 2020-07-22 표준
2 IEC 60601-1-11:2015+AMD1:2020 CSV상세보기 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 2020-07-22 표준
3 IEC 60601-1-11:2015상세보기 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 2015-01-20 표준
4 IEC 60601-1-11:2015 RLV상세보기 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 2015-01-20 표준
5 IEC 60601-1-11:2010/COR1:2011상세보기 Corrigendum 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 2011-04-20 구판
6 IEC 60601-1-11:2010상세보기 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 2010-04-28 구판

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