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판매
ISO 11608-4:2022
Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics- 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 needle-based injection systems (NISs) containing electronics with or without software (NIS-Es). The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider). This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use. This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use. This document does not specify requirements for software in programmable NIS-E. NOTE IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes. This document does not specify requirements for cybersecurity. |
| 국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
| 페이지수 | 63 |
| Edition | 2 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11608-4:2022상세보기 | Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics | 2022-04-07 | 표준 |
| 2 | ISO 11608-4:2006상세보기 | Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors | 2006-03-17 | 구판 |
| 3 | ISO/DIS 11608-4상세보기 | Needle-based injection systems for medical use - Requirements and test methods — Part 4: Needle-based injection systems containing electronics | 폐지 |
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 11608-5:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
- ISO 11608-3:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
다른 사람이 함께 구입한 상품
- IEC 60601-2-65:2012/AMD1:2017 - Amendment 1 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
- IEC 60601-2-65:2012/AMD2:2021 - Amendment 2 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
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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