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분야 | ISO/TC 84 : Devices for administration of medicinal products and catheters |
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적용범위 | ISO 11608-2:2012 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1. |
국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
페이지수 | 17 |
Edition | 2 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | ISO 11608-2:2022 | Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles | 2022-04-07 | 표준 |
2 | ISO 11608-2:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles | 2012-03-30 | 구판 |
3 | ISO 11608-2:2000 | Pen-injectors for medical use — Part 2: Needles — Requirements and test methods | 2000-12-21 | 구판 |
ISO 11608-7:2016 - Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment 상세보기
ISO 11608-1:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems 상세보기
ISO 11608-2:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles 상세보기
ISO 11608-4:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics 상세보기
ISO 11608-6:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems 상세보기
ISO 11608-5:2012 - Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions 상세보기
ISO 3951-1:2013 - Sampling procedures for inspection by variables — Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL 상세보기
ISO 11608-3:2012 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers 상세보기
ISO 23908:2011 - Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling 상세보기
ISO 11608-4:2006 - Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors 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