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Eisner Safety Consultants: Qmed Qualified Supplier
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BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s

This article focuses on BSI’s new White Paper Series for the Medical Devices & IVD’s industries, First one on the EU Proposed Regulations 9 April 2014 – Today marks the beginning of a series of white papers that BSI has just released.   White Paper on Proposed EU Regulations This initial white paper is on [...]

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CAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) Recently Released

This blog reviews the release of Canadian Standard CAN/CSA C22.2 No. 60601-1:14 & where accessible (Safety Test Agencies vs Health Canada) Recently Released CAN/CSA C22.2 No. 60601-1:14

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IEC 60601-1-2, 4th ed. (Electromagnetic disturbances in M.E.E. Environment) recently published

The fourth edition of IEC 60601-1-2 was published on 25 February 2014.  It constitutes a significant change in the standard from the third edition of the standard which was published back in 2007.

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RoHS 2 Directive (2011/65/EU) Changes to Annex IV (Med Dvcs & Control/Monitoring Instruments) Exemptions Listing

(Originally posted March 5, 2014 & updated March 6, 2014)  The changes made to these 16 Delegated Directives to the RoHS 2 Directive (2011/65/EU) add more exemptions to Annex IV of the Directive.  Annex IV is for the “Applications exempted from the restrictions in Article 4(a) specific to medical devices and monitoring and control instruments”. [...]

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IEC 60601-1 PATIENT APPLIED PARTS of MEE – Notes 1, 2, & 3 – Part 2 of 2

In this blog, we continue our discussion on Patient Applied Parts, in Part 2, by explaining the 3 notes associated with the definition of Applied Parts, 3.8 of IEC 60601-1, 3rd ed & ed. 3.1.  We use several figures to explain these critical concepts. If you need help with the IEC 60601 series of Standards, [...]