For Medical Electrical Equipment product safety compliance in Canada, Health Canada currently recognizes both the second edition of IEC 60601-1, published in 1988, and the third edition, published in 2005. In October, 2008, Health Canada published a notice indicating that until June 1, 2012, conformity to the second edition of IEC 60601-1 and its related collateral and particular standards would be accepted. After June 1, 2012, conformity to the third edition would be required.
New editions of particular standards (specific to a particular device type and designated as IEC 60601-2-X) harmonized with the third edition of IEC 60601-1 have, in many cases, not yet been published, or have been published only recently, making a full transition to the entire family by the June 1, 2012 deadline impossible.
To address this, on March 22, Health Canada issued Additional Guidance on Transition from the Second to the Third Editions of the IEC 60601 Family of Standards on Health Canada’s List of Recognized Standards. It states:
- If there is not a particular standard that is directly applicable to the device as of June 1, 2012, it should conform to IEC 60601-1 3rd edition and its applicable collateral standards (that is, IEC 60601-1-X).
- If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1 3rd edition and its applicable collateral standards in addition to this particular standard.
- If there is a particular standard that is directly applicable to the device and the version that harmonizes with IEC 60601-1 3rd edition was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply. During this transition, Health Canada will accept conformity to both editions and related collateral standards.
These transition rules will not be applied retroactively. If the manufacturer currently holds a license for a device that was tested according to IEC 60601-1 2nd edition, you do not need to submit additional data, unless there is a significant change to the product as defined in the Guidance for the Interpretation of Significant Change of a Medical Device.
Keep in mind that provincial or territorial electrical safety requirements are separate and distinct from the requirements of the Health Canada regulations. For further information regarding these requirements, contact the applicable regulatory authorities. A listing of some of these authorities is available here.
The Health Canada website should be consulted for the most current List of Recognized Standards.
For the 3rd edition implementation schedule for the United States, see this Compliance Today post.
Later this month, MET is hosting a free Medical Equipment Regulatory Compliance Seminar in Texas. It features presentations on 60601-1 for product safety and EMC compliance, as well as CE marking.