ANSI AAMI ISO 80369-5-2016 pdf download
ANSI AAMI ISO 80369-5-2016 pdf download.Small-bore connectors for liquids and gases in healthcare applications
1 Scope
This part of International Standard 80369 specifies dimensions and requirements for the design and functional performance of SMALL – BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS of MEDICAL DEVICES and ACCESSORIES . Limb cuff inflation APPLICATIONS include CONNECTIONS between a sphygmomanometer and its cuff. [3] [7] 1 This part of International Standard 80369 does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS . Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES . This part of International Standard 80369 does not specify requirements for pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive MEDICAL DEVICES in place. NOTE 1 M ANUFACTURERS are encouraged to incorporate the SMALL – BORE CONNECTORS specified in this part of International Standard 80369 into MEDICAL DEVICES , medical systems or ACCESSORIES , even if currently not required by the relevant particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL – BORE CONNECTORS , as specified in this part of International Standard 80369, will be included. NOTE 2 The requirements for SMALL – BORE CONNECTORS intended to be used with neonatal PATIENTS to connect a cuff to a sphygmomanometer are intended to be added to this standard by an amendment or new edition. IEC 80601 -2-30 [7] defines the age range for neonatal mode usage of sphygmomanometers. NOTE 3 The requirements for SMALL – BORE CONNECTORS intended to be used to connect a tourniquet to its inflating equipment are intended to be added to this standard by an amendment or new edition.
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 :201 0, 5.1 , and ISO 80369-1 :201 0, 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 :201 0, 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 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 D. 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 :201 0, Clause 7, is contained in informative Annex G.
This annex provides a rationale for some requirements of IEC 80369-5 and is intended for those who are familiar with the subject of IEC 80369-5 but who have not participated in its development. An understanding of the rationale underlying these requirements is considered to be essential for their proper application. Furthermore, as clinical practice and technology change, it is believed that a rationale will facilitate any revision of this part of International Standard 80369 necessitated by those developments.
