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ANSI AAMI ISO 80369-7 pdf free download

ANSI AAMI ISO 80369-7 pdf free download.Small-bore connectors for liquids and gases in healthcare applications— Part 7: Connectors for intravascular or hypodermic applications.
4 General requirements 4.1 General requirements for LUER CONNECTORS LUER CONNECTORS made in compliance with this part of ISO 80369 comply with the general requirements of ISO 80369-1 :201 0, unless otherwise indicated in this part of ISO 80369. In some tolerance combinations, the inside diameter of the fluid lumen of male LUER CONNECTOR may contact the sealing surfaces of the N1 male CONNECTOR (N1 ), as specified in ISO 80369-6, in LMC conditions and thereby these CONNECTORS mutually fail when evaluating the NON – INTERCONNECTABLE characteristics tests of ISO 80369-1 :201 0, Annex B. Additional information is provided in ISO 80369-1:201 0, G.2.2. Because the following CONNECTORS are inadequately specified, LUER CONNECTORS 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 5356-2:2012, — the temperature sensor CONNECTORS and mating ports made in compliance with ISO 81 85:2007, Annex DD, and — the nipples of EN 13544-2:2002 and 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 a LUER CONNECTOR of this part of ISO 80369 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 may be shown by applying a computer aided design (CAD) analysis of the dimensions of all of the ISO 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 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 LUER CONNECTORS of this part of ISO 80369 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 part of ISO 80369. NOTE 2 The summary of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION is provided in Annex D. NOTE 3 The summary of the usability requirements for LUER CONNECTORS is provided in Annex E.NOTE 4 The summary of LUER CONNECTORS criteria and requirements is provided in Annex F. NOTE 5 The summary of assessment of the design of LUER CONNECTORS according to ISO 80369-1 :201 0, Clause 7, is contained in Annex G. 4.2 Material used for LUER CONNECTORS In addition to the requirements of ISO 80369-1 :201 0, Clause 4, LUER CONNECTORS 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 5e2. 4.3 Type tests Compliance with the requirements of this part of ISO 80369 shall be determined by TYPE TESTS.6 Performance requirements 6.1 Fluid leakage 6.1.1 Fluid leakage requirement LUER CONNECTORS shall be evaluated for leakage using either the leakage by pressure decay TEST METHOD or the positive pressure liquid leakage TEST METHOD . 6.1.2 Leakage by pressure decay LUER CONNECTORS evaluated for fluid leakage performance with the leakage by pressure decay TEST METHOD shall not leak by more than 0,005 Pa·m 3 /s while being subjected to an applied pressure of between 300 kPa and 330 kPa over a hold period between 15 s and 20 s using air as the medium. MANUFACTURERS may use a greater applied pressure. Check compliance by applying the tests of ISO 80369-20:201 5, Annex B, while using the leakage reference CONNECTOR specified in Annex C.ANSI AAMI ISO 80369-7 pdf download.

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