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ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications- 발행일 : 2016-10-14
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
|---|---|
| 적용범위 | ISO 80369-7:2016 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 The luer connector was originally designed for use at pressures up to 300 kPa. ISO 80369-7:2016 does not specify 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. ISO 80369-7:2016 does not specify requirements for the following small-bore connectors, which are specified in other International Standards: - haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports); - haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637); - infusion system closure piercing connectors (ISO 8536‑4). NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices 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, requirements for small-bore connectors, as specified in ISO 80369, will be included. NOTE 3 ISO 80369‑1:2010, 5.8, specifies alternative methods of compliance with ISO 80369‑1:2010, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not comply with this part of ISO 80369. |
| 국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
| 페이지수 | 44 |
| Edition | 1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 80369-7:2021상세보기 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications | 2021-05-04 | 표준 |
| 2 | ISO 80369-7:2016상세보기 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications | 2016-10-14 | 구판 |
관련상품
- ISO/DIS 80369-2 - Small bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for breathing systems and driving gases applications
- ISO 80369-6 - Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neural applications
- ISO/FDIS 80369-1 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
- ISO 80369-3:2016/DAmd 1 - Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications — Amendment 1: .
- ISO 80369-3:2016/DAmd 2 - Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications — Amendment 2: .
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