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 specifies requirements for quality and competence particular to medical laboratories.
This International Standard is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
 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 |
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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 |
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