CEI EN 80369-5

ENGLISH

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 MANUFACTURERS 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.

NOTE 4 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for SMALL-BORE CONNECTORS intended for limb cuff inflation APPLICATIONS of MEDICAL DEVICES or ACCESSORIES which do not comply with this part of ISO 80369.

¹ Figures in square brackets refer to the Bibliography.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.