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  • BSI
    BS EN ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications - Connectors for intravascular or hypodermic applications
    Edition: 2021
    $526.05
    / user per year

Description of BS EN ISO 80369-7:2021 2021

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 the medical 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:

  1. haemodialyser, haemodiafilter and haemofilter blood compartment ports ( ISO 8637 [ 5 ] and applicable portion of ISO 8638 [ 6 ] referencing blood compartment ports);

  2. haemodialysis, haemodiafiltration and haemofiltration equipment connectors ( ISO 8637 [ 5 ]);

  3. infusion system closure piercing connectors ( ISO 8536-4 [ 4 ]).

NOTE 3

Manufacturers are encouraged to incorporate the small-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.



Standard NumberBS EN ISO 80369-7:2021
TitleSmall-bore connectors for liquids and gases in healthcare applications - Connectors for intravascular or hypodermic applications
StatusDefinitive
Publication Date2021-05-24
ReplacesBS EN ISO 80369-7:2017, BS EN ISO 80369-7:2017
Identical National Standard OfENISO 80369-7, ISO 80369-7, EN ISO 80369-7:2021
DescriptorsSafety measures, Parenteral infusion equipment, Drug administration, Fluids handling equipment (medical), Blood transfusion equipment, Conical fittings (syringes), Catheters, Risk assessment, Medical equipment, Pipe connections, Medical breathing apparatus, Liquids, Small, Gases
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/210
ISBN978 0 539 06119 2
PublisherBSI
Pages56

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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