관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
표준
판매
Aseptic processing of health care products — Part 1: General requirements
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series. |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 72 |
| Edition | 3 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 13408-1:2023 | Aseptic processing of health care products — Part 1: General requirements | 2023-08-15 | 표준 |
| 2 | ISO 13408-1:2008/Amd 1:2013 | Aseptic processing of health care products — Part 1: General requirements — Amendment 1 | 2013-04-17 | 구판 |
| 3 | ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements | 2008-06-10 | 구판 |
| 4 | ISO 13408-1:1998 | Aseptic processing of health care products — Part 1: General requirements | 1998-07-23 | 구판 |
ISO 13408-4:2005 - Aseptic processing of health care products — Part 4: Clean-in-place technologies 상세보기
ISO 13408-3:2006 - Aseptic processing of health care products — Part 3: Lyophilization 상세보기
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
ISO 13408-2:2018 - Aseptic processing of health care products — Part 2: Sterilizing filtration 상세보기
ISO 13408-2:2018 - Aseptic processing of health care products — Part 2: Sterilizing filtration 상세보기
ISO 2859-1:1999 - Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection 상세보기
ISO 13408-5:2006 - Aseptic processing of health care products — Part 5: Sterilization in place 상세보기
ISO 13408-4:2005 - Aseptic processing of health care products — Part 4: Clean-in-place technologies 상세보기
ISO 13408-3:2006 - Aseptic processing of health care products — Part 3: Lyophilization 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
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
KS표준
핸드북
