BEGIN:VCALENDAR VERSION:2.0 PRODID:-//PYVOBJECT//NONSGML Version 1//EN BEGIN:VTIMEZONE TZID:Europe/Stockholm BEGIN:STANDARD DTSTART:20001029T030000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=10 TZNAME:CET TZOFFSETFROM:+0200 TZOFFSETTO:+0100 END:STANDARD BEGIN:DAYLIGHT DTSTART:20000326T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=3 TZNAME:CEST TZOFFSETFROM:+0100 TZOFFSETTO:+0200 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT UID:20261028T212139Z - 93680@odoo-54dc9f858c-c7xvh DTSTART;TZID=Europe/Stockholm:20261020T090000 DTEND;TZID=Europe/Stockholm:20261020T160000 CREATED:20261028T212139Z DESCRIPTION:Basic course in IEC 60601-1 \, Ed. 3.2\nLearn how to use IEC 60601-1\, Ed. 3.2 in an effective way . Nearly all medical devices tested to IEC 60601-1 Ed 3.2 fail to comply w ith the standard requirements of the first submission. Just as many are re jected on their Risk Management File. In-depth knowledge of the standard i s a must to mitigate this risk. Failing compliance testing means redesigni ng the product and reworking the Risk Management File (RMF). The consequen ce is delayed market entry\, lost sales\, and high redesign costs\, all of which can be avoided by learning about the standard requirements. This co urse covers Technical requirements and safety philosophiesThe standardizat ion process and the development history of the standardSafety requirements such asApplied partsElectrical hazards Mechanic hazardsFire hazardsTemper ature hazardsComponent requirementsInterpretations of requirements in the standardTest methods Course objectives After the course\, you should have a good knowledge of the requirements that you as a manufacturer and your p roducts must meet. This knowledge will help you minimize the risks of expe nsive development projects and to get your product to market faster. Targe t audience The course is primarily aimed at those who work with the develo pment of medical devices. The course may also be of interest to those who work as quality managers or with regulatory affairs. Prior knowledge To ge t the most out of the training\, it is an advantage (but not essential) if you have read the standard and have some experience of design and safety requirements. ​ Course language English Please note: Intertek operates u nder strict standards of independence\, impartiality\, and integrity. Read more about how we work here: https://www.intertek.com/about/co​mpliance -governance/ Course Leader Jenny Larsson Falk Technical Leader Medical and Laboratory Equipment Jenny Larsson Falk is Technical Leader within [...] DTSTAMP:20261028T212139Z SUMMARY:Basic course in IEC 60601-1\, Ed. 3.2 X-ALT-DESC;FMTTYPE=text/html:Basic cour se in IEC 60601-1\, Ed. 3.2\nLearn how to use IEC 60601-1\, Ed. 3.2 in an effective way. Nearly all medical devices tested to IEC 60601-1 Ed 3.2 fail to comply with the standard requirements of the first submission. Ju st as many are rejected on their Risk Management File. In-depth knowledge of the standard is a must to mitigate this risk. Failing compliance testin g means redesigning the product and reworking the Risk Management File (RM F). The consequence is delayed market entry\, lost sales\, and high redesi gn costs\, all of which can be avoided by learning about the standard requ irements. This course covers Technical requirements and safety philosophie sThe standardization process and the development history of the standardSa fety requirements such asApplied partsElectrical hazards Mechanic hazardsF ire hazardsTemperature hazardsComponent requirementsInterpretations of req uirements in the standardTest methods Course objectives After the course\, you should have a good knowledge of the requirements that you as a manufa cturer and your products must meet. This knowledge will help you minimize the risks of expensive development projects and to get your product to mar ket faster. Target audience The course is primarily aimed at those who wor k with the development of medical devices. The course may also be of inter est to those who work as quality managers or with regulatory affairs. Prio r knowledge To get the most out of the training\, it is an advantage (but not essential) if you have read the standard and have some experience of d esign and safety requirements. ​ Course language English Please note: In tertek operates under strict standards of independence\, impartiality\, an d integrity. Read more about how we work here: https://www.intertek.com/ab out/co​mpliance-governance/ Course Leader Jenny Larsson Falk Technical L eader Medical and Laboratory Equipment Jenny Larsson Falk is Technical Lea der within [...] END:VEVENT END:VCALENDAR