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ISO 15883-1:2006
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests- 발행일 : 2006-04-06
- 발행기관 : ISO
상세정보
| 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 |
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 |
| 4 | ISO/DIS 15883-1.2상세보기 | Washer-disinfectors — Part 1: General requirements, definitions and tests | 폐지 |
관련상품
- ISO/DIS 15883-1.2 - Washer-disinfectors — Part 1: General requirements, definitions and tests
- 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 15883-3.2 - Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
- ISO/DIS 15883-4 - Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
- 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 13779-4:2018 - Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength
- ISO 13779-3:2018 - Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity
- ISO 10993-18:2020/Amd 1:2022 - Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor
- ISO 11737-1:2018/Amd 1:2021 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
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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