Safety - medical devices

	safety-related tests on the basis of harmonised standards (e.g. EN 60601)
	risk anlysis according to DIN EN ISO 14971
	product classification according to 93/42/EEC, Annex IX
	standard research system Perinorm, VDE standards
	medical software assessment according to EN 60601-1-4
	EMC tests according to EN 60601-1-2
	radiation protection

devices for the determination and monitoring of vital parameters respiratory, oxygen therapy and inhalation devices surgical and auxiliary surgical devices devices for imaging techniques using ionising and non-ionising radiation stimulation current devices, acupuncture devices, defibrillators radiotherapy devices with ionising and non-ionising radiation ophthalmological devices dental devices devices for disinfection and sterilisation rehabilitation devices and hearing aids patient bedding and transport equipment medical care units medical software hyperthermia devices

Downloads Information leaflet on tests of medical devices Risk analysis for medical devices in compliance with MDD (93/42/EEC) [PDF - German version] Information on drawing up an expert opinion for the clinical assessment of a medical device [PDF] Questionnaire for the conformity assessment and certification in compliance with the Medical Device Directive 93/42/EEC (MDD) / ISO 13485 [PDF]