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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 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. This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields include, but are not limited to: — breathing systems and driving gases; — enteral; — limb cuff inflation; — neuraxial; — intravascular or hypodermic. This document 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 as specified in this document as well as those that will be developed under future parts of the ISO 80369 series. This document 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. NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series. NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered. NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur. NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series. |
국제분류(ICS)코드 |
11.040.10 : 마취제. 호흡 및 소생장비
11.040.20 : 수혈. 주입. 주사장비 |
페이지수 | 31 |
Edition | 2 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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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
ISO 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods 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 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process 상세보기
KS P ISO 10555-4 - 혈관내 카테터 — 멸균 및 일회용 카테터 — 제4부: 풍선확장식 카테터 상세보기
DIN EN 556-1:2002-03 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; English version of DIN EN 556-1 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