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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 dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors. 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. The following examples of medical devices are intended to use the connectors of this document: — Apheresis tubing sets and mating reservoirs containing citrate-based anticoagulant solution. — Apheresis tubing sets may include, but are not limited to those for use in blood collection, therapeutic applications, and plasma collection. Some apheresis sets are manufactured with a pre-connected reservoir containing citrate-based anticoagulant solution. These medical devices are not intended to use the connectors of this document. NOTE Manufacturers are encouraged to incorporate the connectors specified in this document into apheresis 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 apheresis AC reservoir connectors, will be included. |
국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
페이지수 | 24 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | ISO 18250-8:2018 | Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications | 2018-08-21 | 표준 |
ISO 18250-3:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral 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 18250-7:2018 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion 상세보기
ISO 18250-6:2019 - Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications 상세보기
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