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분야 | ISO/TC 84 : Devices for administration of medicinal products and catheters |
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적용범위 | This part of ISO 11608 specifies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser integrated in the NIS or assembled with the NIS at the time of use. This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential containers, including syringes to be used with a NIS. This part of ISO 11608 is not applicable to cartridges intended for dental use. Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this part of ISO 11608. NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes). |
국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
페이지수 | 10 |
Edition | 2 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | ISO 11608-3:2022 | Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths | 2022-04-07 | 표준 |
2 | ISO 11608-3:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers | 2012-09-20 | 구판 |
3 | ISO 11608-3:2000 | Pen-injectors for medical use — Part 3: Finished cartridges — 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 13926-2:2017 - Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use 상세보기
ISO 11608-1:2014 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems 상세보기
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 11608-5:2012 - Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions 상세보기
ISO 11608-2:2012 - Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles 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