EN ISO 80369-7:2017

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)

Publication date:   Sep 20, 2017

General information

99.60 Withdrawal effective   May 19, 2021

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

European Norm

11.040.25   Syringes, needles and catheters

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Scope

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 Hypodermic use includes percutaneous infusion and injection as well as pressurizing and depressurizing the retention mechanisms (e.g. balloon) used to hold invasive medical devices in place and endoscopic devices.
NOTE 2 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.
This part of ISO 80369 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 3 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 4 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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 20594-1:1993

WITHDRAWN
EN 1707:1996

WITHDRAWN
EN 20594-1:1993/A1:1997

WITHDRAWN
EN 20594-1:1993/AC:1996

NOW

WITHDRAWN
EN ISO 80369-7:2017
99.60 Withdrawal effective
May 19, 2021

REVISED BY

PUBLISHED
EN ISO 80369-7:2021

Relations

Adopted from ISO 80369-7:2016 IDENTICAL