On 27 Aug 2012 CSA announced it is transitioning the certification of Electro Medical Devices from CAN/CSA-C22.2 No.601.1-M90 AM1+AM2 to CAN/CSA C22.2 No 60601-1-08. The implementation date of the CAN/CSA C22.2 No. 60601-1:08 standard is July 1, 2014.
To see the full CSA Transition announcement click here.
The CSA class Numbers affected are:
8750 01, MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS
8750 02, MEDICAL ELECTRICAL EQUIPMENT – Electromechanical Lifting Devices
8750 81, MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS – Certified to US Standards
8750 82, MEDICAL ELECTRICAL EQUIPMENT – Electromechanical Lifting Devices – Certified to US Standards
The Important details of the transition are noted below:
The CAN/CSA-C22.2 No. 601.1-M90 (Canadian adopted IEC 60601-1 2nd edition) was published in 1990. This standard along with its amendments (AM1+AM2) have been successfully used for certification of electro-medical devices in Canada for many years and has been replaced by the CAN/CSA-C22.2 No. 60601-1:08. The CAN/CSA-C22.2 No. 601.1-M90 and AM1+AM2 standards shall be going through a phase out transition period as follows:
- New or alternative construction of medical devices can continue to be evaluated to the CAN/CSA-C22.2 No. 601.1-M90 until June 30th , 2014
- All new medical devices or alternative construction of previously certified medical devices shall be evaluated to CAN/CSA C22.2 No 60601-1:08 after June 30th , 2014
- All medical devices already certified to the CAN/CSA-C22.2 No. 601.1-M90 before July 1st, 2014 can continue to be manufactured with no change in construction.
The CAN/CSA-C22.2 No. 60601-1:08, published in Canada in 2008, is a Canadian adoption of the IEC 60601-1, 3rd edition, which was published by IEC in 2005. This Risk Management based standard now addresses new additional requirements. Please contact us at Eisner Safety Consultants if you have any questions on the transition, we would be happy to assist you in your quest for proper compliance to the CSA standards.