Overview

This standard has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" in collaboration with Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" with the participation of German experts. The competent national standards committee is Working Committee NA 063-01-11 AA "Kleinlumige Konnektoren für Flüssigkeiten und Gase zur Verwendung im Gesundheitsbereich" ("Small bore connectors for liquids and gases in health care applications") at DIN Standards Committee Medicine (NAMed). This part of ISO 80369 specifies the test methods to evaluate the performance requirements for smallbore connectors for use in medical device connections and related accessories of the DIN EN ISO 8069 series. These include test methods to evaluate the tightness in the event of pressure drop, the tightness in the event of overpressure and underpressure, the stress cracking, the tensile strength, the unscrewing resistance, the resistance to overturning and the unscrewing capability. This part of ISO 80369 does not specify the functional requirements for the medical devices or accessories with which these connectors are used. Such requirements are specified in the individual standards for specific medical devices or accessories.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-05-02 AA - Small bore connectors for liquids and gases in health care applications  

Responsible european committee

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