This Mutual Recognition Agreement on standards and conformity assessment between Australia and the European Community has been in effect since 1 Jan 1999. But the list of Conformity Assessment Bodies (CAB) for the EU doesn’t cover every EU Medical Device
NWIP – Collateral Std IEC60601-1-XX Emergency Med Srvcs
A New Work Item Proposal for Medical Electrical Equipment & Medical Electrical Systems used in the Emergency Medical Services Environment will be submitted to ISO by the end of November 2010. This proposed standard follows the structure of the Collateral
QuadTech 5th Ed. Electrical Safety Testing Guide
The QuadTech 5th Edition Electrical Safety Testing Guide is a useful document to help you understand the basics of Leakage Current and Dielectric Tests for 60601-1 and for additional standards. This document is a useful resource for understanding some of
Stricter 510(k) Process Offers Challenges, Promises
From MDDI Magazine – Sept 2010 – “FDA has released its long-awaited plans to shore up the 510(k) clearance system used to get many medical devices to market. In August, the agency published a 120-page report to define which devices
Proposed Rules for Li Batteries Will Cause Serious Impact
By Rose Electronics – Oct 2010 – The Department of Transportation has proposed new regulations for air shipment of lithium batteries that would designate small lithium batteries and cells as Class 9 materials to be handled as potentially hazardous. Only