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Eisner Safety Consultants: Qmed Qualified Supplier
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IEC 60601-1-2:2014 (4th ed.) What is the Impact of this Puzzle on Your Product Design?

This is a summary of some of the changes in EMC requirements of IEC 60601-1-2, 4th ed. & a discussion of timing of requirements in different world regions. Darryl Ray, of Darryl Ray EMC Consulting, provided the technical and regulatory content for this Blog Post.  Thx for your insight Darryl! What is the impact of [...]

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Pre-release of IEC 60601-2-52 1st ed + Amendment 1 – Medical Beds

This post is the early release of IEC 60601-2-52, 1st ed. + Amendment 1 (A1) before being issued as an International Standard (IS).  It is currently available as an FDIS (Final Draft International Standard) for purchase from IEC.  IEC website states: “By purchasing this FDIS now, you will automatically receive, in addition, the final publication.”  [...]

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OSHA NRTL’s approved for AAMI ES 60601-1 3rd edition + Amendment 1 (or edition 3.1)

  This post discusses NRTL’s approved for AAMI ES 60601-1 3rd ed. + A1 & can issue NRTL Marks vs which are in process. There has been a lot of activity from OSHA with respect to the NRTL (Nationally Recognized Test Laboratory) program of late for medical device testing.  UL 60601-1 is still an approved [...]

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Eucomed Pleased with EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices

Eucomed Press Release Welcomes the EU Commission’s Conclusions on Joint Plan for Immediate Actions for Medical Devices   This post is on the Eucomed Press Release is Pleased with the EU Commissions’s work on the Joint Plan for Immediate Actions for Medical Devices. On 18 June 2014 Eucomed released a Press Release about a document [...]

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BSI White Paper on Generating Clinical Evaluation Reports

Blog focus BSI’s 2nd in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports White Paper on Generating clinical evaluation reports This white paper is on “Generating clinical evaluation reports – A guide to effectively analysing medical device safety and performance” and is focused on “…guidance on how [...]