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Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply. ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes. ISO 15883-1:2006 does not include requirements for machines which are intended to sterilize the load, or which are designated as "sterilizers", these are specified in other standards e.g. EN 285. The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. ISO 15883-1:2006 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given. |
| 국제분류(ICS)코드 | 11.080.10 : 소독 환경 |
| 페이지수 | 70 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 15883-1:2024 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests | 2024-10-04 | 표준 |
| 2 | ISO 15883-1:2006/Amd 1:2014 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests — Amendment 1 | 2014-06-25 | 구판 |
| 3 | ISO 15883-1:2006 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests | 2006-04-06 | 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
ISO 12107:2012 - Metallic materials — Fatigue testing — Statistical planning and analysis of data 상세보기
ISO/TS 17665-2:2009 - Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 상세보기
BS EN 1642:2011 - Dentistry. Medical devices for dentistry. Dental implants. 상세보기
ISO 14644-3:2019 - Cleanrooms and associated controlled environments — Part 3: Test methods 상세보기
ISO 11137-3:2017 - Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control 상세보기
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
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KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
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