EUCOMED on 25 July 2012 wrote a nice summary of the Impact on the Medical Devices Industry of the long awaited revision of the Waste Electrical and Electronic Equipment (WEEE2 or WEEE recast) Directive (2012/19/EU) was published in the EU
Eisner Safety Consultants to Restart Monthly Newsletter Service
It has been over 2 years since we sent out our last newsletter. Our apologies. We have decided to send out a monthly update of our blog posts for each month which are all located at www.EisnerSafety.com/Industry_News/. We have been working
Amendment 1 of IEC 60601-1:05 (3rd edition) has been published by IEC
On 13 July 2012 IEC formally published the long awaited IEC 60601-1:05 (also known as third edition) Amendment 1 (A1). It is available on the IEC.ch website’s store. Refer to my previous post of 11 July announcing the imminent release
EU Competent Authorities formed Central Management Committee (CMC) & Issued Decisions
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther, and many thanks to NSAI the Irish Notified Body: The European Competent Authorities have formed a Central Management Committee (CMC) to achieve greater consistency in the
JIS T 0601-1:2012 Just Published (Japan’s National Version of IEC 60601-1:2005)
On June 1, 2012 Japan issued their national version of IEC 60601-1:2005 (or 3rd ed.). The transition period has started as of June 1, 2012 but I am still determining what products under Japan’s MHLW’s (Ministry of Health, Labour