Medical Equipment

The Telematics Laboratory is organized to deal with the acquiring of approval for medical equipment as required by the target markets of the exporter.
The activity of the laboratory in this field covers the requirements for the product and for the manufacturer’s quality assurance system that includes:

 

  • Identifying the applicable requirements;
  • Identifying the defects and their prevention in the development stage;
  • Formal tests and handling the attainment of the appropriate approvals;
  • Handling the approval of the manufacturer’s quality system;
  • Management of the technical file.



The Standards in accordance with which the tests are performed:

 

  • IEC 60601-2    
  • EN 60601-1    
  • IEC 60601-1
  • EN 60601-2    
  • EN 60601-2-X    
  • IEC 60601-2-X
  • CSA 22.2 NO. 601.1    
  • UL 2601

 

The Laboratory performs the following:

 

  • Software tests in accordance with IEC 60601-1-4 in accordance with the FDA requirements;
  • CE MARK medical equipment in accordance with the Directive:
    EEC/93/42: Annexes II, III IV, V and VI;
  • UL MARK certificate for the Medical Standard UL 2601-1;
  • FDA services: GMP, IDE, PMA, 510(k);


SII has agreements with the leading certification bodies in the medical equipment field (KEMA, UL, TUV and MDC).

For details:
Dr. Irina Antonov – Branch Head
Tel: 03-6467804; Fax: 03-6467779
email: antonovi@sii.org.il