IEC 80369-5 pdf free download
IEC 80369-5 pdf free download.Small-bore connectors for liquids and gases in healthcare applications一 Part 5: Connectors for limb cuff inflation applications.
4 General requirements
4.1 General requirements for the limb cuff inflation APPLICATION
SMALL-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- 1:2010 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 5356-1:2015, ISO 5356-2:2006 and ISO 5356-2:2012;
— the temperature sensor CONNECTOR and mating ports made in compliance with Annex DD of ISO 8185:2007; and
— the nipples of EN 13544-2:2002 and EN 13544-2:2002+EN 13544-2:2002/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 80369-1:2010, 5.1, and ISO 80369-1:2010, 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 80369-1:2010, 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- 1:2010, Annex B.
NOTE 1 MEDICAL 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 0.
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 80369-1:2010, Clause 7, is contained in informative Annex G.
4.2 Materials used for SMALL-BORE CONNECTORS
In addition to the requirements of ISO 80369-1:2010, 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 D638-14 or ASTM D790-10.
6 Performance requirements
6.1 Air leakage
The engaged SMALL-BORE CONNECTORS for limb cuff inflation APPLICATIONS shall be evaluated for air leakage. The leakage flowrate of paediatric and adult SMALL-BORE CONNECTORS for limb cuff inflation APPLICATIONS shall not exceed 80 Pa•cm3/s (0,60 mmHg•cm3/s) while being subjected to an applied pressure of between 50 kPa (375,0 mmHg) and 55 kPa (4 12,5 mmHg) for a hold period of 95 s to 100 s. MANUFACTURERS may use a greater applied pressure or a longer hold period.
Check compliance by applying the tests of Annex I, while using the leakage reference CONNECTOR specified in Annex C.
6.2 * Resistance to separation from axial load
SMALL-BORE CONNECTORS for limb cuff inflation APPLICATIONS shall be evaluated for separation from axial load. Paediatric and adult CONNECTORS shall not separate from the reference CONNECTOR over the hold period while being subjected to a disconnection applied axial force between 2 N and 3 N for use in the home healthcare environment or for a CONNECTOR on a sphygmomanometer and 32 N and 35 N, otherwise. MANUFACTURERS may use a greater disconnection applied axial force or a longer hold period.
Check compliance by applying the tests of Annex J, while using the separation from axial load reference CONNECTOR specified in Annex C.IEC 80369-5 pdf download.
