AAMI ISO 80369-1 pdf free download

AAMI ISO 80369-1 pdf free download.Small-bore connectors for liquids and gases in healthcare applications— Part 1: General requirements.
5 S MALL – BORE CONNECTOR incompatibility S MALL – BORE CONNECTORS of each APPLICATION category specified in this document shall be NON – INTERCONNECTABLE with any of the SMALL – BORE CONNECTORS of every other APPLICATION category, unless otherwise indicated in this document or within the ISO 80369 series. Check compliance by confirming that OBJECTIVE EVIDENCE demonstrates that RISKS have been reduced to acceptable levels for the acceptability criteria specified in Annex B and other acceptability criteria established by the MANUFACTURER for NON – INTERCONNECTABLE characteristics. Confirm that the SMALL – BORE CONNECTOR is NON – INTERCONNECTABLE . NOTE 1 For the purpose of this document, dimensional compliance and modulus of elasticity compliance with the requirements of the various APPLICATION parts of the ISO 80369 series is considered sufficient OBJECTIVE EVIDENCE of NON – INTERCONNECTABLE characteristics.NOTE 2 Annex E lists examples of the sort of MEDICAL DEVICES or ACCESSORIES for which the SMALL – BORE CONNECTORS within each APPLICATION are intended. 6 *C LINICAL applications 6.1 *Additional SMALL – BORE CONNECTOR designs Designs of SMALL – BORE CONNECTORS other than those specified in 6.2 to 6.5, for inclusion in the ISO 80369 series, and used in MEDICAL DEVICES or ACCESSORIES intended for use with a PATIENT , shall meet the requirements of Clause 4, Clause 7 and Annex D. When an additional SMALL – BORE CONNECTOR is created or proposed for a new APPLICATION , Annex D requires a new part of the ISO 80369 series to be created. Check compliance by application of Clause 4, Clause 7 and Annex D. 6.2 Enteral APPLICATIONS S MALL – BORE CONNECTORS intended to be used for CONNECTIONS in the enteral APPLICATION shall comply with ISO 80369- 3, unless the use of these CONNECTORS creates an unacceptable RISK for a specific MEDICAL DEVICE or ACCESSORY , or shall comply with Clause 7. Check compliance by inspection of the documentation demonstrating that the SMALL – BORE CONNECTOR conforms to the requirements of ISO 80369-3 or, in case of alternative connectors as per Clause 7, by applying the tests of ISO 80369- 3. See also Clause 7 for alternative methods of compliance.6.3 Limb cuff inflation APPLICATIONS S MALL – BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATION shall comply with IEC 80369-5, unless the use of these CONNECTORS creates an unacceptable RISK for a specific MEDICAL DEVICE or ACCESSORY , or shall comply with Clause 7. Check compliance by inspection of the documentation demonstrating that the SMALL – BORE CONNECTOR conforms to the requirements of IEC 80369-5 or, in case of alternative connectors as per Clause 7, by applying the tests of IEC 80369- 5. See also Clause 7 for alternative methods of compliance. 6.4 Neuraxial APPLICATIONS S MALL – BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATION shall comply with ISO 80369- 6, unless the use of these CONNECTORS creates an unacceptable RISK for a specific MEDICAL DEVICE or ACCESSORY , or shall comply with Clause 7. Check compliance by inspection of the documentation demonstrating that the SMALL – BORE CONNECTOR conforms to the requirements of ISO 80369-6 or, in case of alternative connectors as per Clause 7, by applying the tests of ISO 80369- 6. See also Clause 7 for alternative methods of compliance.AAMI ISO 80369-1 pdf download.