Clinical laboratories

Medical laboratory services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients. Such services include arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.

BS EN ISO 15189:2007
Medical laboratories. Particular requirements for quality and competence

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

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 ISO 10993-2:2006
Biological evaluation of medical devices. Animal welfare requirements 

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 15190:2003
Medical laboratories. Requirements for safety

BS EN ISO 15195:2003
Laboratory medicine. Requirements for reference measurement laboratories

BS EN ISO 18812:2003
Health informatics. Clinical analyser interfaces to laboratory information systems. Use profiles

Do you use cleanrooms?

BSI publishes a wide range of standards for cleanrooms. Visit the cleanrooms page to view them.

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