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IEC 60601: Standards for the safety and effectiveness of medical electrical equipment

Opleiding

The IEC60601-1 standard contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. The standard is the ‘parent’ of a family of standards covering many safety and performance aspects of medical devices including electrical safety, EMC, mechanical safety and radiation safety.

The 60601 family of standards is widely accepted and compliance with the standard can or must be used to obtain market access in many countries.

After attending this one day introduction course, participants will understand the importance of the standards and will be able to use the IEC60601 standards in their own product development projects.

Praktisch

06/10/2017 9u - 17u Hasselt
Schrijf in

Prijs

LEDEN € 630
NIET-LEDEN € 725

KMO-portefeuille: vraag hier uw subsidie aan en bespaar tot 40% op uw inschrijvingsprijs.
Erkenningsnummer Allanta: DV.O105117

 

Word lid

Uw opleiding in detail

Agendapunten

  • The IEC60601 family: main standard, collaterals, particulars
  • Worldwide acceptance status of the IEC60601 family standards
  • How to select the correct standards from the family?
  • How to test compliance with IEC60601-1 family standards
  • IEC60601-1 structure and key contents
    • Relation with risk management
    • Electrical safety
    • Mechanical safety
    • Other subjects

UW LEER-
RESULTATEN

  • Have awareness of the importance of IEC60601 family standards
  • Know how to select IEC60601 family standards
  • Be able to work with external test agencies
  • Understand the structure and key contents of IEC60601-1

Uw
certificaat

All students who attend 75% of classes, will receive a certificate of participation.


Uw
docent

Paul Theunissen ondersteunt en begeleidt healthcare providers en Medical Device bedrijven met Regulatory Compliance.

Na het behalen van zijn Masterdiploma Electrical Engineering werkte Paul gedurende 15 jaar in verschillende (Medical) Device ontwikkeling en productie ondernemingen. Initieel als project manager. In deze hoedanigheid voerde hij vele multidisciplinaire ontwikkelingsprojecten uit. In 2004 zette Paul de stap naar quality & regulatory consultancy. Sindsdien faciliteerde Paul vele externe audits en FDA inspecties en lanceerde hij verscheidene producten op de markt. Sinds 2010 is Paul actief als senior consultant voor Allanta vzw.


Uw Contact-
persoon

Nele Gregoor

TEL +32 (0) 11 870 944

info@allanta.be





Sandra
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Hands-on, focus on detail, lots of extra input was given when asked for! Thank you!!  There were numerous posibilities to have discussions on certain topi...

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"The training was very well organized, the facilities and environment were quite good. I especially liked the format of 6 modules x 3 days, it allows an...

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Laurel
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  I really liked the practical tips for doing an internal audit. Often, people overlook the value of learning the soft skills.

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