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ISO 15883-4:2018
Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes- 발행일 : 2018-11-12
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document. NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection. WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5). 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 3 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector. NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products. |
| 국제분류(ICS)코드 | 11.080.10 : 소독 환경 |
| 페이지수 | 81 |
| Edition | 2 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA ISO 15883-4:19상세보기 | Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (Adopted ISO 15883-4:2018, second edition, 2018-11) | 2019-01-01 | 표준 |
| 2 | ISO 15883-4:2018상세보기 | Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes | 2018-11-12 | 표준 |
| 3 | ISO 15883-4:2008상세보기 | Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes | 2008-04-29 | 구판 |
| 4 | ISO/DIS 15883-4상세보기 | Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes | 폐지 |
관련상품
- ISO/DIS 15883-4 - Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
- ISO/DIS 15883-3.2 - Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
- ISO/DIS 15883-2 - Washer-disinfectors — Part 2: Requirements and tests for washer disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, hollowware, utensils, glassware, etc.
- ISO/DIS 15883-1.2 - Washer-disinfectors — Part 1: General requirements, definitions and tests
- 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
다른 사람이 함께 구입한 상품
- ISO 11737-2:2019 - Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- 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 11607-2:2019 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
- ISO 14971:2019 - Medical devices — Application of risk management to medical devices
- ISO 10993-15:2019 - Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
추천 상품
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- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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