How Scary Is IEC 60601-1?

There's a new column over at MD+DI in which Grant Ramaley, director of regulatory affairs for Aseptico Inc., discusses the scariness—and costliness—of the third edition of IEC 60601-1:
 
As an experiment, I recently sent out a comparative quote to investigate my theories. The quote showed that two testing labs I use, Underwriters Laboratories (UL) and Intertek Testing are charging $18,000 to evaluate a low risk device to the older 2nd Edition, and $39,000 to evaluate the same device with the 3rd Edition. This is an extraordinary cost difference. The story doesn’t end there though.
 
He goes on to say that OSHA does not recognize the third-edition version of the standard, apparently wary of the standard’s reliance on and use of risk management standard ISO 14971. Ramaley also says that testing labs are tacking on costs for collateral standards, significantly raising the price of meeting these standards for medical device OEMs.
 
Is Ramaley off base? Are these concerns valid? Has your company prepared for these less-talked-about consequences of the third edition of IEC 60601-1? Let us know what you think. —Lawrence Lloyd

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IEC 60601-1

It is unfortunate that the article written by Grant Ramaley, The New (and Scary) Standard for Medical Electronic Equipment, in the January 2011 issue of MDDI is not fully informed of the situation around IEC 60601-1 3rd edition. He takes a limited purely US market view of the standard in his remarks. Medical devices are sold around the world, and most medical device manufacturers are developing products for a world market. Canada and the European Union will withdraw recognition of the 2nd edition next year on May 31 and June 1 respectively. To sell medical devices in the world market, compliance with the 3rd edition will be required, period, and soon.

His view also ignores the FDA position on the standard, and this is dangerous for a medical device company to ignore. IEC 60601-1 3rd edition and its family of collateral and particular standards, was recognized in June 2010 by FDA as the voluntary standard covering medical electrical devices, and will replace the 2nd edition in FDA's recognized standards list in June 2013, when the second edition is withdrawn from that list. While voluntary, FDA considers compliance to standards in their product review process, and most of their reviewers expect compliance to standards such as IEC 60601-1.

IEC, as indicated on its website, will withdraw the 2nd edition from its list of standards in 2013. The use of the 2nd edition will become problematic when it no longer exists. OSHA will be forced to recognize some alternative standard then. It is interesting that Mr. Ramaley indicates that OSHA is concerned about the risk management requirements of the 3rd edition, as these only formalize the equivalent safety alternative compliance clauses which exist in the 2nd edition. Manufacturers had the ability to use a risk management type of process in the 2nd edition for compliance, but there was no formal documented process and this left lots of variability in the certification process, which has now been addressed. And while OSHA has a narrow interest in employee safety, FDA has the broader responsibility to only clear devices which are safe for everyone to use including employees, medical professionals, service personnel, patients, care givers in various markets, and even persons who come in contact with the device, such as hospital room visitors. The OSHA issues will have to be addressed, and work is underway to clear these concerns.

The international body of certifying test houses, IECEE, the IEC System for Conformity Testing and Certification of Electrical Equipment, is developing a test report form for Certifying Body test reports to address the compliance documentation issues with the 3rd edition. A recent draft of that document covered 186 pages and included many reviews of the risk management file for documentation of design decisions based on risk management. The purpose of this document is to have an agreed upon common set of requirements for all test houses.

The 3rd edition was developed to permit the standard to move with the rapidly evolving medical electrical technology. It was obvious that the 2nd edition, released in 1989 and amended through 2000 was no longer up to date with technology, and since standards are considered "state of the art" the 2nd edition had to be updated. The 3rd edition gives designers much more freedom to include new technology, and use risk management to demonstrate safety of the device. Certainly this is a valuable aspect of this new document.

Another question Mr. Ramaley raised was the collateral [and particular] standards that are a part of the IEC 60601 family. The 3rd edition makes the entire 60601 family normative (or required). The fact that they were not normative in the 2nd edition was the result of an oversight by the standards committee. All of the collaterals were expected to be required, but this was not specifically included in the requirements. The particular standards (60601-2-xx) were also supposed to be required as well, but test houses each had their own interpretation of the list of required standards and manufacturers often shopped around until they could find the cheapest route to certification, rather than a rigorous certificate that showed a recognized high level of product safety.

Mr. Ramaley also seemed to indicate that the ISO 10993 family of standards were collateral to IEC 60601-1. This is not true, only IEC 60601-1-xx standards are collateral. Other standards are normative, or required where applicable, in fact the 3rd edition includes nearly 3 pages of normative standards for compliance. Second edition had a similar list, though not so lengthy.

It appears that Mr. Ramaley is sticking his head in the sand and trying to avoid IEC 60601-1 3rd edition, rather than trying to move his company forward in time to get his products in compliance. Test houses report that their calendars are rapidly filling and getting products through the certification process in time to meet deadlines will be a problem. While IEC 60601-1 is "new", it has been around since 2005, and under development since 1996, so maybe it is not so new. And while, the costs in his estimate may be nearly double, they are not so high to be scary for those who have planned ahead.

There continues to be some question on regulatory bodies acceptance of existing 2nd edition products on the market after the withdrawal of the second edition recognition. So his problems may be even larger than he believes.

(also posted at MDDI)

IEC 60601-1

So Ed, do you think that the costs Ramaley cited in his article will strike fear in small companies? Do you think most companies accounted for the additional costs of collateral standards somewhere along the way?