AAMI CN3 pdf free download

AAMI CN3 pdf free download.Small-bore connectors for liquids and gases in healthcare applications-Part 3: Connectors for enteral applications.
4 General requirements
4.1 General requirements for ENTERAL SMALL-BORE CONNECTORS
SMALL-BORE CONNECTORS of MEDICAL DEVICES or ACCESSORIES intended for use in ENTERAL APPLICATIONS comply with ISO 80369-1:2010 unless otherwise indicated in this standard.
Because the following CONNECTORS are inadequately specified, SMALL-BORE CONNECTORS for use in ENTERAL APPLICATIONS should not, but may connect with:
– the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
the temperature sensor and mating ports made in compliance with in Annex DD of ISO 81 85:2007: and the nipples of EN 13544-2:2002.
The reference CONNECTOR for evaluation of the NON-INTERCONNECTABLE characteristics is 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 MANUFACTURER shall verify the NONINTERCONNECTABLE characteristics.
Check compliance by applying the tests of ISO 80369-1:2010, 5.1 and Annex B. Compliance to ISO 80369-1:2010,
Annex B also 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 NONINTERCONNECTABLE 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 80369-1:2010, Annex B.
NOTE 1 The summary of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION is provided in informative Annex D.
NOTE 2 The summary of the usability requirements ENTERAL SMALL-BORE CONNECTORS IS provided in informative Annex E.
NOTE 3 The summary of ENTERAL SMALL-BORE CONNECTORS criteria and requirements is provided in informative Annex F.
NOTE 4 The summary of assessment of the design of ENTERAL SMALL-BORE CONNECTORS according to ISO 80369-1:2010, Clause 7, is contained in informative Annex G.
4.2 MaterIal used for SMALL-BORE CONNECTORS
In addition to the requirements of ISO 80369-1 :2010, Clause 4, ENTERAL SMALL-BORE CONNECTORS of MEDICAL DEVICES or ACCESSORIES shall be made of materials with a modulus of elasticity either in flexure or in tension greater than 700 MPa.
5 Dimensional requirements for ENTERAL SMALL-BORE CONNECTORS
SMALL-BORE CONNECTORS for the ENTERAL APPLICATION shall comply with the relevant dimensions and tolerances as given in
— Figure B.l and Table B.l for a male CONNECTOR (El); and
Figure B.2 and Table B.2 for a female CONNECTOR (El).
NOTE ISO 80369-1, 5.8, specifies alternative methods of compliance with the ISO 80369 (series), for SMALL- BORE CONNECTORS intended to for use with ENTERAL APPLICATIONS MEDICAL DEVICES or ACCESSORIES, which do not comply with this International Standard.
Check compliance by verifying the dimensions and tolerances specified in Annex B, as appropriate.
6 Performance requirements
6.1 General performance requirements
The tests described in this International Standard are TYPE TESTS.
6.2 Fluid leakage
6.2.1 FluId leakage requirement
ENTERAL SMALL-BORE CONNECTORS shall either be evaluated for leakage using the leakage by pressure decay TEST METHOD or be evaluated for leakage using the positive pressure liquid leakage TEST METHOD.AAMI CN3 pdf download.