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분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
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적용범위 | This document specifies the interface dimensions and requirements for the design and functional performance of connectors intended to be used to connect intravascular infusion sets to intravascular infusion reservoirs. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular international standards for specific medical devices or accessories. EXAMPLES Medical devices which may use intravascular reservoir connectors are the following: — Administration ports on IV fluid reservoirs and the mating spikes of IV administration/intravascular infusion sets/lines, e.g., IV bags/containers and the spike inlet ends of IV sets; — Devices intended to be connected in series between the administration port of IV fluid reservoirs and the mating spikes of IV administration/giving lines; — Syringes and syringe IV sets utilizing Luer connectors. The following connectors are excluded from the scope of this document: — Stoppers for bottles as specified in ISO 8536-2; — Compounding/admixture ports on IV reservoirs and intended mating devices. EXAMPLES Rubber stoppers used for injection into the reservoir and the mating pharmacy admixture devices (syringes, needles, reconstitution devices, and other ancillary equipment used to access the compounding or admixture ports). — The fill ports of non-powered (i.e. elastomeric) pumps. NOTE 1 Details of alternative spikes that are in common use are located in Annex G for informational purposes. NOTE 2 Manufacturers are encouraged to incorporate the connectors specified in this document into intravascular infusion medical devices or accessories, even if not currently required by the particular medical device standards. It is expected that when the particular medical device standards are revised, requirements for reservoir connectors, as specified in ISO 18250, will be included. |
국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
페이지수 | 34 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | ISO 18250-7:2018 | Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion | 2018-12-17 | 표준 |
ISO 18250-3:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications 상세보기
ISO 18250-8:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications 상세보기
ISO 18250-1:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods 상세보기
ISO 18250-6:2019 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications 상세보기
ISO 80369-7:2021 - Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications 상세보기
ISO 18250-6:2019 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications 상세보기
ISO 18250-1:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods 상세보기
ISO 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods 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