ANSI AAMI ISO 80369-20 pdf free download

ANSI AAMI ISO 80369-20 pdf free download.Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods.
1 *Scope 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 : General requirements 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. 3.1 TEST 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]The committee attempted to harmonize the functional test methods for the connectors of each application in this part of ISO 80369. The test method annexes in this part of ISO 80369 describe a specific test procedure for a type test, but allow for modification to specific test conditions or acceptance criteria as necessary for each application. Many of the test methods in this part of ISO 80369 were extracted from the ISO 594- series of standards. The committee attempted to minimize changes to these test methods. However, changes were made to test methods which contained subjective acceptance criteria. The assembly procedure in each Annex mimics the assembly procedure that was extracted from ISO 594. An additional clarification was made for connectors with a floating or rotatable locking collar. Test sample preconditioning and environmental test condition requirements were added to each Annex. NOTE Manufacturer should also consider performing functional performance testing using a representative sample of the SMALL BORE CONNECTOR being evaluated with a representative sample of appropriate mating connectors.The ease of assembly test method that was part of the ISO 594- series has been removed as a requirement from the application parts of ISO 80369 and is not present in this part of ISO 80369. The acceptance criterion of the ISO 594- series for ease of assembly was subjective. It was underdefined for a standardized test method, i.e. “a satisfactory fit” is not repeatable. Furthermore, the intent of the ease of assembly test was to ensure that the user can complete the connection using the mating halves of the connector. This requirement is satisfied by the requirement for usability validation for all new connectors being added to ISO 80369. Therefore, the ease of assembly test method has been omitted from the ISO 80369- series of standards. This part was given the −20 designation to leave space for connectors in new applications that might be developed in the future using the numbers ISO 80369-8 through ISO 80369-1 9.ANSI AAMI ISO 80369-20 pdf download.