This article discusses OSHA’s release of ANSI/AAMI ES60601-1:2005/(R)2012 + Amendments & timing of @ least 1 NRTL’s authorization to use it. On 27 March 2014 OSHA announced thru a Federal Register Final Notice that they are incorporating new test standards
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
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
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.
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