Laboratorní medicína, klinická patologie a biologická bezpečnost

Komise : CEN/CLC/JTC 3 (Quality Management and corresponding general aspects of medical devices)
Původce: CEN
K připomínkám do: 3.12.2019
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This part of ISO 80369 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.

This part of ISO 80369 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 part of ISO 80369 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 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 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 3       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 part of ISO 80369.

Komise : CEN/CLC/JTC 3 (Quality Management and corresponding general aspects of medical devices)
Původce: CEN
K připomínkám do: 23.12.2019
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Amendment

Komise : CEN/CLC/JTC 3 (Quality Management and corresponding general aspects of medical devices)
Původce: CEN
K připomínkám do: 23.12.2019
Zobraz více Zobraz méně
 

Amendment