관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
표준
판매
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
| 분야 | TC 62/SC 62D : Particular medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-2-19:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS 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. IEC 60601-2-19:2020 specifies safety requirements for INFANT INCUBATORS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. IEC 60601-2-19:2020 does not apply to: - INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-19:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-19:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references. |
| 국제분류(ICS)코드 | 11.040.10 : 마취제. 호흡 및 소생장비 |
| 페이지수 | 80 |
| Edition | 3.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-19:2020/AMD1:2023 | Amendment 1 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | 2023-11-09 | 표준 |
| 2 | IEC 60601-2-19:2020+AMD1:2023 CSV | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | 2023-11-09 | 표준 |
| 3 | IEC 60601-2-19:2020 RLV | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | 2020-09-02 | 표준 |
| 4 | IEC 60601-2-19:2020 | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | 2020-09-02 | 표준 |
| 5 | IEC 60601-2-19:2009/AMD1:2016 | Amendment 1 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | 2016-04-29 | 구판 |
| 6 | IEC 60601-2-19:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | 2016-04-29 | 구판 |
| 7 | IEC 60601-2-19:2009/COR1:2012 | Corrigendum 1 - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | 2012-02-29 | 구판 |
| 8 | IEC 60601-2-19:2009 | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators | 2009-02-20 | 구판 |
| 9 | IEC 60601-2-19:1990/AMD1:1996 | Amendment 1 - Medical electrical equipment. Part 2: Particular requirements for the safety of baby incubators | 1996-10-25 | 구판 |
| 10 | IEC 60601-2-19:1990 | Medical electrical equipment. Part 2: Particular requirements for the safety of baby incubators | 1990-12-21 | 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
함께 구입한 상품이 존재하지 않습니다.
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
KS표준
핸드북
