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분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
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적용범위 | ISO 80369-1:2010 specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for:
Small-bore connectors as specified in ISO 80369-1:2010 are non-interconnectable with:
ISO 80369-1:2010 provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications and to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed under future parts of this series of standards. It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. |
국제분류(ICS)코드 |
11.040.10 : 마취제. 호흡 및 소생장비
11.040.20 : 수혈. 주입. 주사장비 |
페이지수 | 17 |
Edition | 1 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | ISO 80369-1:2018 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements | 2018-11-05 | 표준 |
2 | ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements | 2010-12-08 | 구판 |
ISO/FDIS 80369-1 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements 상세보기
ISO 80369-20 - Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods 상세보기
ISO/DIS 80369-6 - Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neural applications 상세보기
ISO 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods 상세보기
ISO 80369-6:2016 - Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications 상세보기
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