Electrical Safety, Medical Devices

The Electrical and Electronics Laboratory is specially equipped and has a professional team that specializes in tests and authorizations of medical devices for different target markets worldwide.

Examples of medical devices that the Electrical and Electronics Laboratory at the Standards Institution of Israel tests:

  • CT scanners
  • Gamma cameras
  • MRI scanners
  • ECG and ECG monitors and peripherals
  • High-frequency surgical equipment
  • Infusion pumps
  • Lung ventilators
  • Monitors
  • Ultrasound diagnostic devices
  • Mammography devices
  • Endoscopic devices
  • Aesthetic devices

Professional assistance for:

  • Setting the relevant regulatory requirements per the target market
  • Providing full technical support from the early design stage, through finding flaws in the product stage, and helping fix them
  • Technical support for preclinical and clinical trials
  • Full and comprehensive of the formal tests and handling the obtaining of appropriate authorizations
  • Technical file review

The laboratory performs the following actions:

  • Writing test reports pursuant to the specifications of US Food and Drug Administration (FDA), China Food and Drug Administration (CFDA), Republic of Korea Ministry of Food and Drug Safety (MFDS), and the Brazilian Health Registry Agency (ANVISA) and certification process (INMETRO)
  • Compliance test for European CE Mark Directive
  • EEC/93/42 (MDD) & MDR
  • NRTL certification - (cCSAus, cTUVus, cULus)

The Standards Institution of Israel is accredited by top medical devices accrediting bodies:

  • IECEE CB Scheme accreditation for the MED category
  • CSA Data Acceptance Program Authorization
  • TUV Partner Test Lab (PTL)

The main medical devices standards applicable on the laboratory:

  • IEC/EN/CSA 60601-1
  • ANSI/AAMI EC 60601-1
  • ANSI/AAMI NS4
  • IEC/EN 60601-1-X, 60601-1-XX
  • IEC/EN 60601-2-X, 60601-2-XX
  • ISO 80601-2-XX, IEC 80601-2-XX
  • IEC 62304
  • ISO 14971

For further details:

Dr.Irina Antonov,
Head of MED Devices, Lasers and Electrical Safety Branch,
The Standards Institution of Israel
+972-3-646-7804
+972-523-285109
antonovi@sii.org.il