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EN60601-1:2006 + A1:2013 Has Been Harmonized Under the MDD

This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD. This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile. What’s The Big News About? On 16 May 2014 the Official Journal of the European Union (OJEU) published an [...]

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Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ

EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.

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What is the Scope of IEC 60601-1:2005 (3rd edition)?

This blog will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product.  Definitions, third-party testing, etc. discussed. One of the first questions clients ask before a project starts is, “Does this medical electrical product fall under IEC 60601-1?” Another common question clients ask is whether IEC 60601-1 applies to battery operated [...]

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NB-MED issues FAQ on Implementation of EN62304:2006 w.r.t. MDD, V1.0

18 April 2013 – The NB-MED EN62304:2006 issues team released their first official version (V1.0) dated 5 April 2013 of this importnat implementation document in regards to EN 62304 with respect to the Medical Device Directive 93/42/EEC on the NB-MED website.  EN 62304 is the standard for MEDICAL DEVICE software – Software life-cycle processes. The document is [...]

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EU MDD, AIMDD, IVDD Harmonized Standards (EN980 & EN ISO 15223-1) Ooopppss!

The EN 980 Symbols for use in the labeling of medical devices standard was mistakenly taken off of the EU Harmonized List of standards on the Jan 24, ’13 release and EN ISO 15223-1 Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General [...]