SIST-TP CEN/CR 13825:2005

SIST-TP CEN/CR 13825:2005 is a technical report published by the Slovenian Institute for Standardization (SIST). Its full title is "Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"". This standard covers: Luer connectors are used in medical devices with a wide range of functions, raising the possibility of accidental cross connection between devices. We assessed the hazards arising from accidental misconnection, and reviewed adverse incidents known to have involved Luer connectors. We considered three possible strategies for reducing the risk of misconnection being made: 1) The use of different male/female sequences for different applications. 2) The use of colour coding. 3) The restriction of the applications for which the use of Luer connectors is permitted. Only the last of these offered real benefits.

Luer connectors are used in medical devices with a wide range of functions, raising the possibility of accidental cross connection between devices. We assessed the hazards arising from accidental misconnection, and reviewed adverse incidents known to have involved Luer connectors. We considered three possible strategies for reducing the risk of misconnection being made: 1) The use of different male/female sequences for different applications. 2) The use of colour coding. 3) The restriction of the applications for which the use of Luer connectors is permitted. Only the last of these offered real benefits.

SIST-TP CEN/CR 13825:2005 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

SIST-TP CEN/CR 13825:2005 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

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