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In vitro medical devices

If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:

In vitro diagnostic medical equipment applies to the instruments and apparatus used in the diagnosis of disease or other conditions in order to cure, mitigate, treat, or prevent disease. Such instruments or apparatus are intended for use in the collection, preparation, and examination of specimens taken from the human body.

IVD medical devices that are designed, manufactured or distributed within the European Economic Area must comply with the requirements set out in European Directive: In Vitro Diagnostic Directive (IVDD) Council Directive 98/79/EC (1998).

The purpose of the Directive is to ensure that only safe and functional products are sold in the European market, with clearly outlined regulations regarding manufacturing, import and marketing. Compliance to the Directive was obligatory from 6th December 2003.

BSI’s European standards specify the requirements that are generally applicable to In vitro diagnostic electrical equipment for measurement, control and laboratory use.

 
BS ISO 17593:2007
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

This International Standard specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance and user training and procedures for the verification and validation of performance by the intended users under actual and simulated conditions of use. 

BS EN ISO 20776-1:2006
Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases 

BS EN 61326-2-6:2006
Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical equipment  

BS ISO 15198:2004
Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer

BS EN 14254:2004
In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans

BS EN ISO 10993-5:2009
Biological evaluation of medical devices. Tests for in vitro cytotoxicity

BS EN ISO 15193:2009
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures

BS EN ISO 15194:2009
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation

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