MET Laboratories’ product safety engineers undergo regular training to stay up-to-date with changing standards and regulatory requirements. When possible, we will share highlights of these sessions with customers.
Following are some of the key points of a recent training session on IEC 60601-1 3rd edition:
- It is an entirely new standard and does not match up with the second edition. The effort required by manufacturers and test labs has at least doubled, or tripled for particularly complex products.
- Risk Management is an integral part of the new standard. This will catch many manufacturers by surprise.
- The new standard references ISO 14971, Risk Management, and requires traceability for each identified hazard for the risk analysis, evaluation, implementation and verification of risk control measures and the acceptable risk.
- The risk management process for applied parts and parts that may contact the patient but that are not applied parts, is particularly onerous.
- The new standard mandates use of collateral standards in addition to particular, or Part 2, standards. This is likely to catch manufacturers by surprise too.
- The Risk Management file that a manufacturer must develop has to address the expected service life of the product.
- The effective date for the EU and Canadian versions is June 2012.
- The FDA will accept it now but will also continue to accept the previous edition until June 2013.
- OSHA has not made a decision to recognize the standard yet. They are polling NRTLs as part of their research into this new standard. To meet OSHA workplace rules, medical products may only be certified by an NRTL to the current edition of the UL standard.
- Though there has been a phase-in period for the main EU standard, collaterals and part 2s are effective upon their publication dates.
- Some new collaterals are or have been introduced. For example, included now is IEC 60601-1-9, Environmentally Conscious Design.
- Some previous collaterals, like 60601-1-1 for systems of equipment and 60601-1-4 for EMC, have been incorporated into the base standard now.
See our recent blog post for more information on the various rates of adoption of 60601-1 3rd edition in different countries and regions.
Also, find out more about EMC and Performance Testing of medical products.