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Aseptic processing of health care products — Part 6: Isolator systems
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions. This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application. This document does not define biosafety containment requirements. |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 25 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 13408-6:2021 | Aseptic processing of health care products — Part 6: Isolator systems | 2021-04-13 | 표준 |
| 2 | ISO 13408-6:2005/Amd 1:2013 | Aseptic processing of health care products — Part 6: Isolator systems — Amendment 1 | 2013-03-12 | 구판 |
| 3 | ISO 13408-6:2005 | Aseptic processing of health care products — Part 6: Isolator systems | 2005-06-20 | 구판 |
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ISO 13408-5:2006 - Aseptic processing of health care products — Part 5: Sterilization in place 상세보기
ISO 13408-7:2012 - Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products 상세보기
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