사업자등록증
해외표준
FAQ
장바구니
고객센터
해외표준 상세정보
관심표준 등록 : 표준업데이트 시 알림서비스
제공형태 더보기-
표준
판매
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- 발행일 : 2019-12-02
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | 1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. 1.2 This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility (see 3.12), NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7. |
| 국제분류(ICS)코드 |
07.100.10 : 의료 미생물학
11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 16 |
| Edition | 3 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA ISO 11737-2:21상세보기 | Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (Adopted ISO 11737-2:2019, third edition, 2019-12) | 2021-01-01 | 표준 |
| 2 | ISO 11737-2:2019상세보기 | Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | 2019-12-02 | 표준 |
| 3 | ISO 11737-2:2009상세보기 | Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | 2009-11-06 | 구판 |
| 4 | ISO 11737-2:1998상세보기 | Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process | 1998-07-09 | 구판 |
관련상품
- ISO 11737-1:2018 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
- CSA ISO 11737-1:19 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Adopted ISO 11737-1:2018, third edition, 2018-01)
- CSA ISO 11737-2:21 - Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (Adopted ISO 11737-2:2019, third edition, 2019-12)
- 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
- CSA ISO 11737-1:19/A1:23 - Amendment 1:2023 to CSA ISO 11737-1:19, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Adopted amendment 1:2021 to ISO 11737-1:2018)
다른 사람이 함께 구입한 상품
- ISO 11737-1:2018 - Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
- ISO 14971:2019 - Medical devices — Application of risk management to medical devices
- 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
- ISO 11607-1:2019 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
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
제공형태 닫기
PDF :
직접 파일 다운로드 및 인쇄(마이페이지 확인)보안PDF :
직접 파일 다운로드 및 인쇄(마이페이지 확인)* 단, 파일이동 및 복사 불가, 1회 다운로드 및 인쇄가능PRINT :
인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)BOOK :
인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)ZIP :
압축파일형태로 제공 (PDF, HTML, TXT, XLS 등으로 구성), 직접 파일 다운로드(마이페이지 확인)CD/DVD :
직접 파일 다운로드 및 인쇄(마이페이지 확인)DB :
별도 정보 제공HARDCOPY :
해외 배송 상품, 최대 3주 소요바인더 :
바인더 우편발송, 2~3일 소요온라인구독 :
WEB 접속 후 실시간 열람, 출력(1년간)