ANSI/AAMI/ISO 80369-20-2015 pdf download.Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods
This part of ISO 80369 specifies the TEST METHODS to evaluate the performance requirements for SMALL - BORE CONNECTORS specified in the ISO 80369- series.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography.
ISO 1 4971 :2007, Medical devices — Application of risk management to medical devices
ISO 80369-1 :201 0, Small-bore connectors for liquids and gases in healthcare applications — Part 1 : Generalrequirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 80369-1 :201 0, ISO 1 4971 :2007, and the following apply.
3.1TEST METHOD
definitive PROCEDURE for evaluating CONNECTORS that produces a test result
3.2 TYPE TEST
test on a representative
[SOURCE: IEC 60601 -1 :2005, definition 3.1 35]
4 T EST METHODS for SMALL - BORE CONNECTORS
Table 1 contains the list of test methods and their corresponding Annex included in this part of ISO 80369.ANSI/AAMI/ISO 80369-20 pdf download.