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판매
ISO 11608-3:2012
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers- 발행일 : 2012-09-20
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 84 : Devices for administration of medicinal products and catheters |
|---|---|
| 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 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11608-3:2022상세보기 | Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths | 2022-04-07 | 표준 |
| 2 | ISO 11608-3:2012상세보기 | Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers | 2012-09-20 | 구판 |
| 3 | ISO 11608-3:2000상세보기 | Pen-injectors for medical use — Part 3: Finished cartridges — Requirements and test methods | 2000-12-21 | 구판 |
관련상품
- ISO/DIS 11608-4 - Needle-based injection systems for medical use - Requirements and test methods — Part 4: Needle-based injection systems containing electronics
- ISO/DIS 11608-6 - Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
- ISO 11608-7:2016 - Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment
- ISO 11608-6:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
- ISO 11608-5:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
다른 사람이 함께 구입한 상품
- ISO 11608-7:2016 - Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment
- ISO 13926-2:2017 - Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use
- ISO 13926-3:2019 - Pen systems — Part 3: Seals for pen-injectors for medical use
- ISO 11608-5:2012 - Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
- ISO 11608-1:2014 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
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
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