ANSI AAMI ISO 80369-5 pdf free download

ANSI AAMI ISO 80369-5 pdf free download.Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff infation applications.
4 General requirements 4.1 General requirements for the limb cuff inflation APPLICATION S MALL – BORE CONNECTORS of MEDICAL DEVICES or ACCESSORIES intended for use in limb cuff inflation APPLICATIONS made in compliance with this standard shall comply with ISO 80369-1 :201 0 unless otherwise indicated in this standard. Because the following CONNECTORS are inadequately specified, SMALL – BORE CONNECTORS for use in limb cuff inflation APPLICATIONS should not, but may connect with: – the cones and sockets of ISO 5356-1 :2004, ISO 5356-1 :201 5, ISO 5356-2:2006 and ISO 5356-2:201 2; – the temperature sensor CONNECTOR and mating ports made in compliance with Annex DD of ISO 81 85:2007; and – the nipples of EN 1 3544-2:2002 and EN 1 3544-2:2002+EN 1 3544-2:2002/AMD1 :2009. The reference CONNECTORS for evaluation of the NON – INTERCONNECTABLE characteristics are described in Annex C. Where the design of the SMALL – BORE CONNECTOR of this standard relies on dimensions or features of the MEDICAL DEVICE or ACCESSORY to ensure NON – INTERCONNECTABLE characteristics, the NON – INTERCONNECTABLE characteristics shall be VERIFIED . Check compliance by applying the tests of ISO 80369-1 :201 0, 5.1 , and ISO 80369-1 :201 0, Annex B. Compliance also may be shown by applying a computer aided design (CAD) analysis of the dimensions of all of the International Standard 80369 series SMALL – BORE CONNECTORS and the SMALL – BORE CONNECTOR under test, in conjunction with physical testing of the SMALL – BORE CONNECTOR per Annex B of ISO 80369- 1 :201 0, where the CAD analysis does not demonstrate the NON – INTERCONNECTABLE characteristics. When necessary, the SMALL – BORE CONNECTOR may be installed on the MEDICAL DEVICE or ACCESSORY to demonstrate compliance with the NON – INTERCONNECTABLE characteristics test requirements of ISO 80369- 1 :201 0, Annex B.NOTE 1 M EDICAL DEVICES using the SMALL – BORE CONNECTORS of this standard that do not rely on the dimensions or features of the MEDICAL DEVICE or ACCESSORY to ensure NON – INTERCONNECTABLE characteristics are presumed to comply with the NON – INTERCONNECTABLE characteristics test requirements of this standard.NOTE 2 The summary of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION is provided in informative Annex D. NOTE 3 The summary of the usability requirements for these SMALL – BORE CONNECTORS is provided in informative Annex E. NOTE 4 The summary of these SMALL – BORE CONNECTORS criteria and requirements is provided in informative Annex F. NOTE 5 The summary of assessment of the design of these SMALL – BORE CONNECTORS according to ISO 80369-1 :201 0, Clause 7, is contained in informative Annex G. 4.2 Materials used for SMALL – BORE CONNECTORS In addition to the requirements of ISO 80369-1 :201 0, Clause 4, SMALL – BORE CONNECTORS for this APPLICATION shall be made of materials with a nominal modulus of elasticity either in flexure or in tension greater than 700 MPa. Check compliance by applying the tests of ASTM D638-1 4 or ASTM D790-1 0. 4.3 T YPE TESTS Compliance with the requirements of this International Standard shall be determined by TYPE TESTS . 5 Dimensional requirements for sphygmomanometer and cuff SMALL – BORE CONNECTORS 5.1 * Requirements for adult or paediatric PATIENT SMALL – BORE CONNECTORS (S1) S MALL – BORE CONNECTORS intended to be used with adult or paediatric PATIENTS to connect a cuff to a sphygmomanometer shall comply with the relevant dimensions and tolerances as given in – Figure B.1 and Table B.1 for the male S1 CONNECTOR . – Figure B.2 and Table B.2 for the female S1 CONNECTOR . The male CONNECTOR shall be used for the cuff CONNECTOR . NOTE Annex H describes an obsolete CONNECTOR that has been used to connect a cuff and sphygmomanometer and that does not comply with this standard. Check compliance by confirming the relevant dimensions and tolerances specified in Annex B.ANSI AAMI ISO 80369-5 pdf download.