60601-1 Deadlines Update
January 12, 2012
Certification deadlines are top-of-mind to medical device manufacturers. Why? Meeting deadlines for this industry not only guarantees certification and global compliance, but it also will allow new medical products to enter the market place.
Below is a list of deadlines that are pertinent to the medical device industry for 2012:
Medical Third Edition Compliance
- EU Certification via the MDD – All products compliant by June 1, 2012 unless there are particular standards within the certification, which moves the compliance date till three years after the publication of the final particular standard
- Canadian Certification – All new products compliant by June 1, 2012
- US Certification – All new products compliant by July 1, 2013
Medical Products within the RoHS Directive
- Medical Products – All products compliant by July 22, 2014
- In-Vitro Diagnostic Medical Products – All products compliant by July 22, 2016
Rechargeable Battery Cells
- IECEE CB Scheme – All products compliant with UL 1642 with delta testing to IECEE 62133 by April 30, 2012. All products compliant with IEC 62133 by May 1, 2012
Laboratory Third Edition Compliance
- EU Certification via the LVD – All products compliant by October 1, 2013 unless there are particular standards within the certification, which moves the compliance date till three years after the publication of the final particular standard
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