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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 small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. NOTE 1 See Annex A. NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa. This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents: - haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [ 6] referencing blood compartment ports); - haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]); - infusion system closure piercing connectors (ISO 8536-4 [4]). NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included. NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document. |
국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
페이지수 | 47 |
Edition | 2 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | ISO 80369-7:2021 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications | 2021-05-04 | 표준 |
2 | ISO 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications | 2016-10-14 | 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 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements 상세보기
ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment 상세보기
ASTM F2182-19e2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging 상세보기
ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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