BS EN 80369-5:2016 ✓ Most Recent

BS EN 80369-5:2016 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 SMALLBORE CONNECTORS intended for limb cuff inflation APPLICATIONS of MEDICAL DEVICES or ACCESSORIES which do not comply with this part of ISO 80369.


Cross References:
EN 13544-2:2002
EN 13544-2:2002+A1:2009
ISO 5356-1:2004
EN ISO 5356-1:2004
ISO 5356-1:2015
EN ISO 5356-1:2015
ISO 5356-2:2006
EN ISO 5356-2:2007
ISO 5356-2:2012
EN ISO 5356-2:2012
ISO 8185:2007
EN ISO 8185:2009
ISO 14971:2007
EN ISO 14971:2012
ISO 80369-1:2010
EN ISO 80369-1:2010
ASTM D638-14
ASTM D790-10
93/42/EEC
ISO 3040:2009
EN ISO 3040:2012
ISO 81060-1:2007
EN ISO 81060-1:2012
IEC 60601-1-11:2015
EN 60601-1-11:2015
IEC 60601-1-12:2014
EN 60601-1-12:2015
IEC 62366-1:2015
EN 62366-1:2015
IEC 80601-2-30:2009
EN 80601-2-30:2010
IEC 80601-2-30:2009/A1:2013
EN 80601-2-30:2010/A1:2015
ISO 80369-20:2015
EN ISO 80369-20:2015
ISO 80369-6:2016
EN ISO 80369-6:2016
ISO 80369-2
EN ISO 80369-2
ISO 80369-3:2016
EN ISO 80369-3:2016
ISO 594-1:1986
CEN CR 13825
ASME/ANSI B1.1:2003
ISO 80369-4
ISO 594-2:1986
ISO/TR 16142:2006


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