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
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices.
| 분야 | |
|---|---|
| 적용범위 | Marking, Sterile equipment, Medical instruments, Quality assurance, Quality control, Sterilization (hygiene), Medical equipment, Microorganisms |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 20 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | BS EN 556-1:2024 - TC | Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices. | 2024-07-08 | 표준 |
| 2 | BS EN 556-1:2024 | Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices. | 2024-07-03 | 표준 |
| 3 | BS EN 556-1:2001 | Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Part 1. Requirements for terminally sterilized medical devices. | 2006-11-30 | 폐지 |
BS EN 556-2:2003 - Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices. 상세보기
BS EN 556-1:2001 - Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Part 1. Requirements for terminally sterilized medical devices. 상세보기
BS EN 556-2:2015 - Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices. 상세보기
BS EN 556-2:2015 - TC - Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices. 상세보기
BS EN 556-1:2024 - TC - Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices. 상세보기
IEC 62366-1:2015/AMD1:2020 - Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
BS EN ISO 10993-18:2020+A1:2023 - Biological evaluation of medical devices. Chemical characterization of medical device materials within a risk management process. 상세보기
BS EN ISO 10993-10:2023 - Biological evaluation of medical devices. Tests for skin sensitization. 상세보기
BS EN 868-5:2018 - Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods. 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
