A Q&A post based on questions in the 25 Nov ‘13 post on OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards
IEC 60601-1 Definition of Patient Applied Parts – Part 1 of 2
This blog will you understand the definition of Patient Applied Parts for medical electrical equipment under the IEC 60601-1 Standard. This blog discusses the following points: Definition of APPLIED PART Examples of APPLIED PARTS for specific medical devices Examples of different
EU Council Meets Tues 10 Dec Proposals for Med Dvc & IVD Regulations
medicaldeviceslegal.com comes through again with another fantastic post of 7 Dec 2013 by Erik Vollebregt of Axon Lawyers that is full of valuable information and is a good summary of where things stand and what is expected to happen when
OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards
OSHA adding AAMI ES 60601-1 to the ‘List of Appropriate’ NRTL Program Test Standards is discussed in this blog. BIG News!!! News, I have been waiting for many years now is that OSHA, finally, under it’s NRTL (Nationally Recognized Test
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.