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ISO 11608-5:2022
Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions- 발행일 : 2022-04-07
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 84 : Devices for administration of medicinal products and catheters |
|---|---|
| 적용범위 | This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO). General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions: a) medicinal product preparation (e.g. reconstitution); b) needle preparation; c) needle hiding; d) priming; e) dose setting; f) needle insertion; g) injection depth control; h) injection of the medicinal product; i) recording of device functions; NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto). j) disabling the NIS-AUTO; k) needle retraction; l) needle shielding; m) needle removal. All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user. |
| 국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
| 페이지수 | 22 |
| Edition | 2 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11608-5:2022상세보기 | Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions | 2022-04-07 | 표준 |
| 2 | ISO 11608-5:2012상세보기 | Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions | 2012-09-20 | 구판 |
관련상품
- ISO/DIS 11608-6 - Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
- ISO/DIS 11608-4 - Needle-based injection systems for medical use - Requirements and test methods — Part 4: Needle-based injection systems containing electronics
- ISO 11608-7:2016 - Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment
- ISO 11608-3:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
- ISO 11608-2:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles
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