Product Series
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Medical devices mainly include:
●Blood pressure monitor testing●Biochemical analyzer testing●Blood glucose meter testing●Ultrasonic examination equipment testing●Cochlear implants and accessories●Implantable hearing aids●Insulin pumps●Implantable infusion pumps●Cardiac pacemaker systems●Retinal implants●Basic surgical instrument testing●Testing of polymer materials and products●Testing of other medical equipment
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Reference Standards for CE Certification of Handheld Power Tools
Medical device related testing standards around the world: Medical Device Directive (MDD 93/42 EEC) MDD Directive applies to most medical devices sold into the EU. It is divided into 6 categories according to different requirements for certification bodies to evaluate. Class Design stage Production stage Class I Self-declaration of conformity Self-declaration of conformity Class I (measurement function) Self-declaration of conformity Notified body Class l (sterilization) Self-declaration of conformity Notified body Class lla Self-declaration of conformity Notified body Class ll b Notified body Notified body Class I Notified body Notified body
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The directives issued by the European Community on medical device products that need to be met are as follows:
Directive Title Name
CE Ref. Instruction
Product examples
Active Implantable Medical Devices Implantable Medical Devices Directive (medical devices implanted in the human body) 90/385/EEC Pacemaker Medical Devices-general General Medical Devices Directive 93/42/EEC Monitor Electric wheelchair ECG, ultrasound Medical devices:in vitro diagnostic In vitro diagnostic medical devices directive (laboratory equipment for extracting human secretions for testing and diagnosis) 98/79/EC Urine analyzer ELISA reader Blood glucose meter