top of page

Electrical Safety (SEB)

Manufacturers of medical devices must ensure compliance with essential requirements in accordance with MDD 93/42 / EEC Medical Device Directive in order to place their products on the market. We test active medical devices for basic safety and essential performance according to IEC 60601-1 as well as for other applicable special specifications and collateral standards.

​

We are accredited by the > DAkkS and recognized by the IECEE in the > CB Scheme. In addition, we are a member of the > Third Party Test Data Program of Unterwriters Laboratories (UL).

​

We support you in the creation of a test plan tailored to your requirements, both for normative tests and for developmen tests. Please introduce us to your product.

Our services in the field of safety of medical devices

  • Research of relevant standards

  • Safety tests

  • Usability Assessment

  • EMC tests

  • Assessment of risk management

  • Evaluation of medical software

  • Laser classification

  • Evaluation of accompanying documentation (instructions, technical descriptions, markings, construction)

Some standards for electrical safety testing

  • IEC 60950-1

  • IEC 62368-1

​

  • IEC 60601-1

  • IEC 60601-1-2

  • IEC 60601-1-4

  • IEC 60601-1-6

  • IEC 60601-1-8 

  • IEC 60601-1-11 

  • IEC 60601-1-12

  • IEC 60601-2-2

  • IEC 60601-2-4

  • IEC 60601-2-10

  • IEC 60601-2-12

  • IEC 60601-2-13

  • IEC 60601-2-16

  • IEC 60601-2-18

  • IEC 60601-2-22

  • IEC 60601-2-23

  • IEC 60601-2-24

  • IEC 60601-2-25

  • IEC 60601-2-26

  • IEC 60601-2-27

  • IEC 60601-2-30

  • IEC 60601-2-34

  • IEC 60601-2-40

  • IEC 60601-2-41

  • IEC 60601-2-46

  • IEC 60601-2-49

  • IEC 60601-2-57

  • ISO 80601-2-12

  • ISO 80601-2-13

  • IEC 80601-2-30

  • IEC 80601-2-35

  • ISO 80601-2-55

  • ISO 80601-2-56

  • IEC 80601-2-60

  • ISO 80601-2-61

  • ISO 80601-2-69

  • ISO 80601-2-70

  • ISO 80601-2-72

  • ISO 81060-1

  • IEC 60598-2-25

  • IEC 61010-2-101

  • ...

Information technology equipment - Safety - Part 1: General requirements

Audio/video, information and communication technology equipment -
Part 1: Safety requirements

Basic standard - Medical electrical equipment

Collateral standard: Electromagnetic disturbances

Collateral standard: Programmable electrical medical systems

Collateral standard: Usability

Collateral Standard: General requirements, tests and guidance for alarm systems

Collateral Standard: Medical electrical systems used in the home healthcare environment

Collateral Standard: Medical electrical systems used in emergency medical services environment

Particular Requirements: High frequency surgical equipment and accessories

Particular Requirements: Cardiac defibrillators

Particular Requirements: Nerve and muscle stimulators

Particular Requirements: Lung ventilators - Critical care ventilators

Particular Requirements: Anaesthetic systems

Particular Requirements: Haemodialysis, haemodiafiltration and haemofiltration equipment

Particular Requirements: Endoscopic equipment

Particular Requirements: Surgical, cosmetic, therapeutic and diagnostic laser equipment

Particular Requirements: Transcutaneous partial pressure monitoring equipment

Particular Requirements: Infusion pumps and controllers

Particular Requirements: Electrocardiographs

Particular Requirements: Electroencephalographs

Particular Requirements: Electrocardiographic monitoring equipment

Particular Requirements: Automatic cycling non-invasive blood pressure monitoring equipment

Particular Requirements: Invasive blood pressure monitoring equipment

Particular Requirements: Electromyographs and evoked response equipment

Particular Requirements: Surgical luminaires and luminaires for diagnosis

Particular Requirements: Operating tables

Particular Requirements: multifunction patient monitoring equipment

Particular Requirements: Non-laser light source equipment intended for therapeutic, diagnostic,...

Particular Requirements: Critical care ventilators

Particular Requirements: Anaesthetic workstation

Particular Requirements: Automated non-invasive sphygmomanometers

Particular Requirements: Heating devices using blankets, pads and mattresses

Particular Requirements: Respiratory gas monitor (rgm)

Particular Requirements: Clinical thermometers for body temperature measurement

Particular Requirements: Dental equipment

Particular Requirements: Pulse oximeter equipment

Particular Requirements: Oxygen concentrator equipment

Particular Requirements: Sleep apnoea breathing therapy equipment

Particular Requirements: Home healthcare environment ventilators for ventilator-dependent patients

Non-invasive sphygmomanometers with non-automated measurement type

Luminaires for use in clinical areas of hospitals and health care buildings

Particular requirements for in vitro diagnostic (IVD) medical equipment

bottom of page