관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
분야 | ISO/TC 121/SC 3 : Respiratory devices and related equipment used for patient care |
---|---|
적용범위 | ISO 80601-2-12:2011 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment:
ISO 80601-2-12:2011 is also applicable to those accessories intended by their manufacturer to be connected to a breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. ISO 80601-2-12:2011 is not applicable to me equipment or an me system operating in ventilation modes intended for patients who are not dependent on mechanical ventilation. ISO 80601-2-12:2011 is not applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. 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. ISO 80601-2-12:2011 is not applicable to continuous positive airway pressure (CPAP) me equipment, sleep apnoea therapy me equipment, home healthcare environment ventilators, ventilatory support me equipment, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs). ISO 80601-2-12:2011 does not specify the requirements for me equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for anaesthetic applications which are given in ISO 80601-2-13. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients which are given in ISO 10651-2. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for emergency and transport which are given in ISO 10651-3. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home-care ventilatory support devices which are given in ISO 10651-6. |
국제분류(ICS)코드 | 11.040.10 : 마취제. 호흡 및 소생장비 |
페이지수 | 78 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | ISO 80601-2-12:2023 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | 2023-11-03 | 표준 |
2 | ISO 80601-2-12:2020 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | 2020-02-25 | 구판 |
3 | ISO 80601-2-12:2011/Cor 1:2011 | 2011-10-11 | 구판 | |
4 | ISO 80601-2-12:2011 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | 2011-04-07 | 구판 |
ISO/DIS 80601-2-67 - Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment 상세보기
ISO/DIS 80601-2-69 - Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment 상세보기
ISO 80601-2-56:2017 - Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement 상세보기
ISO 80601-2-61:2017 - Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 상세보기
ISO 80601-2-55:2018 - Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors 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