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Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 15883-4:2008 specifies the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. ISO 15883-4:2008 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be required to achieve the necessary performance. 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 re-validation, periodically and after essential repairs, are also specified. ISO 15883-4:2008 can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also by users. |
| 국제분류(ICS)코드 | 11.080.10 : 소독 환경 |
| 페이지수 | 49 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA ISO 15883-4:19 | 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 15883-4:2018 | Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes | 2018-11-12 | 표준 |
| 3 | ISO 15883-4:2008 | Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes | 2008-04-29 | 구판 |
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 상세보기
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 상세보기
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 상세보기
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) 상세보기
CAN/CSA-ISO 15883-7:17 (R2022) - Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (Adopted ISO 15883-7:2016, first edition, 2016-02-01) 상세보기
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