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분야 | ISO/TC 84 : Devices for administration of medicinal products and catheters |
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적용범위 | This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture. This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022). This document is not applicable to the following products: — sterile hypodermic needles; — sterile hypodermic syringes; — sterile single-use syringes, with or without needle, for insulin; — containers that can be refilled multiple times; — containers intended for dental use; — catheters or infusion sets that are attached or assembled separately by the user. |
국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
페이지수 | 27 |
Edition | 3 |
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
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