ANSI AAMI ISO 80369-7-2016 pdf download
ANSI AAMI ISO 80369-7-2016 pdf download.Small-bore connectors for liquids and gases in healthcare applications
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.
5 Dimensional requirements for LUER CONNECTORS
LUER CONNECTORS shall comply with the dimensions and tolerances as given in
— Figure B.1 and Table B.1 for a male LUER SLIP CONNECTOR (L1 ),
— Figure B.2 and Table B.2 for a female LUER SLIP CONNECTOR (L1 ),
— Figure B.3 and Table B.3 for a male LUER LOCK CONNECTOR (L2), with fixed collar,
— Figure B.4 and Table B.4 for a male LUER LOCK CONNECTOR (L2), with floating or rotatable collar,
— Figure B.5 and Table B.5 for a female LUER LOCK CONNECTOR (L2),
— Figure B.6 and Table B.6 for a female LUER LOCK CONNECTOR (L2), with lugs at right angle to axis, variant A,
— Figure B.7 and Table B.7 for a female LUER LOCK CONNECTOR (L2), with lugs at right angle to axis, variant B, and
— Figure B.8 and Table B.8 for a female LUER LOCK CONNECTOR (L2), with lugs at right angle to axis, variant C.
Check compliance by confirming the dimensions and tolerances specified in Annex B, as appropriate.
6.5 Resistance to separation from unscrewing
LUER LOCK CONNECTORS shall be evaluated for separation from unscrewing. LUER LOCK CONNECTORS shall not separate from the reference CONNECTOR for a hold period between 1 0 s and 1 5 s while being subjected to an unscrewing torque of between 0,01 9 8 N·m to 0,020 0 N·m. MANUFACTURERS may use a greater applied unscrewing torque or a longer hold period. Check compliance by applying the tests of ISO 80369-20:201 5, Annex G, while using the resistance to separation from unscrewing reference CONNECTOR specified in Annex C.
