BS EN ISO 80369-7:2017 pdf free.Small-Bore Connectors For Liquids And Gases In Healthcare Applications Part7: Connectors For Intravascular Or Hypodermic Applications.
This part of ISO 80369 WaS (leveloped l)ecauSe of several incidents, with catastrophic conequence, resulting from inappropriate nwdication, liquid nutritional formula or air being admimstered intravenously. Many incidents have been reported leading to international recognition of the importance of these issues and a need has been identified to develop specific CONNECTORS for MEDICAL DEVICES and their ACCESSORIES used to deliver fluids in other APPLICATIONS.
The ISO 80369- series was developed to preVeilt misconnection between SMALL-BORE CONNECTORS used in different APPLICATIONS. ISO 80369-1 specifies the requirements necessary to verify the designs i [Id (Ii mensions of SMALL—BORE CON N ECTORS to CnSU re that
a) they do not misconnect with other SMALL-RORF. CONNECTORS, and
b) they safely and securely connect with their mating half.
ISO 80369—20 contains the corn mon TEST M ETIIOI)S to Support the performance requirements for SMALL-BORE CON N ECTORS.
This part of ISO 80369 specifies the design and the dimensions and the drawings of SMALL—BORE CONNECTORS intended to be uSed aS coflical fittings with a 6 % (Ltier) taper for CONNECTIONS in intravascular or hypodermic APPLICATIONS. Annex D to Annex C describe the methods by which this design has been assessed. Other parts of ISO 80369 include requirements for SMALL-BORE CONNECTORS used in different APPLICATION categories.
CONNECTORS manufactured to the dimensions set out within this part of ISO 80369 are dimensionally incompatible with any of the other CONNECTORS for APPLICATIONS identified in the ISO 80369- series of standards for s1ALL-iioIu: CONNECTORS, except as indicated in Ainex C. Ii fitted to the relevant r1EIICAL DEVICES afl(i ACCESSORIES, these CONNECTORS ShOul(l reduce the RISK of air, non-vascular medication and liquid nutritional formula bei rig delivered through an alternative route, such as intravenously or through an airway device.
In t his part of ISO 80369, the following pu ni types are used:
— requirements and definitions: Roman type;
— informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type;
— terms defitwd in Clause 3 or as noted: SMALL CAPITALS.
In this part of ISO 80369, the conjunctive ftorH is used as an ‘inclusive or” so a statement is true if any combinaion of the conditions is true.
This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in intravascular APPLICATIONS or hypodermic .CONNECTIONS in hypodermic APPLICATIONS of MEDICAL DEVICEs and ACCESSORIES
EXAMPLES Hypodermic syringes and needles or intravascular(V)cannulae with male and female LUER SLI CONNECTORS and LUER LOCK CONNECTORS.
NOTE 1 The LUER CONNECTOR was originally designed for use at pressures up to 300 kPa.
This part of ISO 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.