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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-1-2:2014+A1:2020 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards. This fourth edition cancels and replaces the third edition of IEC 60601-1-2, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments; - specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition; - specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system; - specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and - better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term "life-supporting". This new edition includes the following main additions: - guidance for determination of immunity test levels for special environments; - guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable; - guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and - guidance on identification of immunity pass/fail criteria. |
| 국제분류(ICS)코드 |
33.100.20 : 내성
33.100.10 : 방사 11.040.01 : 일반 의료장비 |
| 페이지수 | 456 |
| Edition | 4.1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-1-2:2014/AMD1:2020 | Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 2020-09-01 | 표준 |
| 2 | IEC 60601-1-2:2014+AMD1:2020 CSV | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 2020-09-01 | 표준 |
| 3 | IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 2014-02-25 | 표준 |
| 4 | IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | 2007-03-30 | 구판 |
| 5 | IEC 60601-1-2:2001+AMD1:2004 CSV | Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | 2004-11-10 | 구판 |
| 6 | IEC 60601-1-2:2001/AMD1:2004 | Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | 2004-09-28 | 구판 |
| 7 | IEC 60601-1-2:2001 | Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | 2001-09-18 | 구판 |
| 8 | IEC 60601-1-2:1993 | Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests | 1993-04-07 | 구판 |
IEC/DIS 60601-2-26 - Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs 상세보기
IEC 60601-2-15:1988 - Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators 상세보기
IEC 60601-2-14:1989 - Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment 상세보기
IEC 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment 상세보기
IEC 60601-1-4:1996 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems 상세보기
IEC 62366-1:2015+AMD1:2020 CSV - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability 상세보기
IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 상세보기
ISO 20417:2021 - Medical devices — Information to be supplied by the manufacturer 상세보기
ISO 10993-10:2021 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
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