Abstract
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 (Ïã¸ÛÁùºÏ²Ê¿ª½± 8637 [5] and applicable portion of Ïã¸ÛÁùºÏ²Ê¿ª½± 8638 [ 6] referencing blood compartment ports);
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (Ïã¸ÛÁùºÏ²Ê¿ª½± 8637 [5]);
- infusion system closure piercing connectors (Ïã¸ÛÁùºÏ²Ê¿ª½± 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 Ïã¸ÛÁùºÏ²Ê¿ª½± 80369, will be included.
NOTE 4 Ïã¸ÛÁùºÏ²Ê¿ª½± 80369-1:2018, Clause 7, specifies alternative methods of conformance with Ïã¸ÛÁùºÏ²Ê¿ª½± 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.
General information
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Status: PublishedPublication date: 2021-05Stage: International Standard published [60.60]
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Edition: 2Number of pages: 47
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Technical Committee :Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 210ICS :11.040.25
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Life cycle
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Previously
WithdrawnÏã¸ÛÁùºÏ²Ê¿ª½± 80369-7:2016
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Now
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