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

IECEE CB Scheme, CEcert GmbH, Akkrediterung, Prüflabor, Medizingeräte, Medizinprdukte, CBTL, UL Demko, UL, CE, Konformitätsprüfung, Wismar, Schwerin Rostock, Lübeck, Hamburg, Bremen, Niedersachsen, Mecklenburg-Vorpommern, Mecklenburg, Norddeutschland
DAkkS ILAC Akkreditierungslogo Medizinprodukte, CEcert GmbH, Akkrediterung, Prüflabor, Medizingeräte, Medizinprdukte, CBTL, UL Demko, UL, CE, Konformitätsprüfung, Wismar, Schwerin Rostock, Lübeck, Hamburg, Bremen, Niedersachsen, Mecklenburg-Vorpommern, Mecklenburg, Norddeutschland
DAkkS ILAC Akkreditierungslogo, CEcert GmbH, Akkrediterung, Prüflabor, Medizingeräte, Medizinprdukte, CBTL, UL Demko, UL, CE, Konformitätsprüfung, Wismar, Schwerin Rostock, Lübeck, Hamburg, Bremen, Niedersachsen, Mecklenburg-Vorpommern, Mecklenburg, Norddeutschland
KBA Benannter Technischer Dienst Logo Medizinprodukte, CEcert GmbH, Akkrediterung, Prüflabor, Medizingeräte, Medizinprdukte, CBTL, UL Demko, UL, CE, Konformitätsprüfung, Wismar, Schwerin Rostock, Lübeck, Hamburg, Bremen, Niedersachsen, Mecklenburg-Vorpommern, Mecklenburg, Norddeutschland

Contact

CEcert GmbH
Alter Holzhafen 19a
23966 Wismar (Germany)

Phone: +49 3841 30305-0

Fax: +49 3841 30305-18

Send us an e-mail

Legal information

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