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ISO 15883-1:2024
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests- 발행일 : 2024-10-04
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | This document specifies general performance requirements for washer-disinfectors (WD) and washer-disinfector accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified. NOTE 1 The requirements can be applied to WD intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice. The requirements for WD intended to process specific loads are specified in ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7. For WD intended to process loads of two or more different types, the requirements of the applicable parts of ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7 apply. This document does not specify requirements intended for machines for use for laundry or general catering purposes. This document does not include requirements for machines which are intended to sterilize the load, or which are designated as “sterilizers” and addressed in other standards. The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 2 Chemicals in some cleaning agents and disinfectants can react with prion protein in a manner that can inhibit its removal or inactivation. If the presence of prion protein is considered a possibility, then this can influence the choice of cleaning agent and disinfectant. NOTE 3 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of conformity with the requirements of this document can also be employed by users to demonstrate continued conformity of the installed WD throughout its service life. Guidance on a routine test programme is given in Annex A. |
| 국제분류(ICS)코드 | 11.080.10 : 소독 환경 |
| 페이지수 | 73 |
| Edition | 2 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 15883-1:2024상세보기 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests | 2024-10-04 | 표준 |
| 2 | ISO 15883-1:2006/Amd 1:2014상세보기 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests — Amendment 1 | 2014-06-25 | 구판 |
| 3 | ISO 15883-1:2006상세보기 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests | 2006-04-06 | 구판 |
관련상품
- ISO/DIS 15883-6 - Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for noncritical medical devices and health care equipment
- ISO/FDIS 15883-7 - Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment
- ISO 15883-6:2011 - Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
- ISO 15883-7:2016 - Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
- CAN/CSA-ISO 15883-6:17 (R2022) - Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive , non-critical medical devices and healthcare equipment (Adopted ISO 15883-6:2011, first edition, 2011-04-15)
다른 사람이 함께 구입한 상품
- ISO 11137-1:2006/Amd 2:2018 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2
- ISO 11137-1:2006/Amd 1:2013 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1
- ISO 14644-1:2015 - Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration
- ISO 11137-1:2006 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- IEC 60601-2-5:2009 - Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
추천 상품
- IEC TS 63134:2020 - Active assisted living (AAL) use cases
- 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
- KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs)
- KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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