Conformity Magazine - September 2008 - (Page 22)

the text that require a word-by-word search to discover. So it is not possible to comply with, say, the latest version of IEC 60601-1-2 and ensure regulatory approval worldwide for EMC for medical products. Happily, some test laboratories specialize in achieving global approvals for their customers” medical products, and they track all the various national deviations and documentation requirements. Therefore, all a manufacturer has to do is list the countries into which they want to sell their product, and the test laboratory will formulate an appropriate test plan and advise on any other requirements, such as special documentation, fees, etc., required by different countries. Since most countries’ medical EMC regulations are based on some version of IEC 60601-1-2, a good test lab will put together a plan that tests to all the national deviations in one set of tests. This approach will, of course, take a little longer than a test to just one version of IEC 60601-1-2, but will cost a great deal less than performing all the different versions, one at a time. It will be many years before the regulatory authorities in Europe and the U.S. FDA adopt the 3rd Edition of IEC 60601-1-2. As for the 4th Edition – the subject of this article – it will not be published until at least 2010 and, if and when adopted by the authorities, perhaps even some years later than that. So EMC issues that we already know to be important for safety-related performance might not become part of the regulatory approvals processes for the major markets (Europe, U.S., Canada, Japan) until about 2014, and possibly even later. Compliance, Standards, and Acceptable Risks With the above as background, it is clear that achieving regulatory approval for a given market does not necessarily guarantee that a product has safety risks that will be acceptably low. Even when the 4th Edition is eventually adopted by the regulatory authorities, “legacy” medical products supplied before then will often remain in use, possibly for decades. However, product liability and other types of safety laws exist in all developed countries, creating significant financial risks for manufacturers whose products are not safe enough. These laws vary in their application in different countries, due to their different legal traditions, and they can even vary between different states within the U.S., and even between different counties within a state. In Europe, the only practicable defense under the Product Liability Directive [8] is that the product complied with the “state of the art in safety” on the day it was supplied (note: not the day it was designed). Interpretations of what is meant by the “state of the art” differ widely, but for European product liability it means “the state of scientific 22 Conformity September 2008 and technical knowledge” at that time, which includes all published standards, even those not listed under a Directive. The maximum financial penalties that can be applied under product liability are very large (in Europe they are effectively unlimited), and prudent and aware manufacturers pay heed to product liability risks. In Europe, for example, complying with the regulatory standards for medical equipment [14] does not necessarily ensure compliance with the medical safety regulations [7], or with product liability and other safety laws. This is emphasized in Britain by the following words printed on the inside cover of every British Standard: “Compliance with a British Standard does not of itself confer immunity from legal obligations,” (quote taken from BS EN 60601-1-2:2001). Ethical manufacturers, and those who want their products to comply with the “state of the art” to reduce their exposure to product liability or other legal risks, should apply the latest versions of the relevant standards in addition to complying with the requirements of the regulatory authorities. Also, most safety standards include “informative” text, usually in notes or annexes, that can help manufacturers go beyond the minimum safety requirements, to further reduce safety risks to patients and healthcare practitioners, as well as the financial risks to themselves. Creating any international standard is a time-consuming process; so on the very day a new version of an IEC standard is finally published it embodies technical knowledge that could already be two or more years out of date. Knowing this, the very best manufacturers keep track of draft versions of relevant standards and apply the appropriate requirements from the drafts to their products. We strongly recommend that manufacturers employ the 4th Edition of IEC 60601-1-2, if not its drafts, as soon as it is published. Medical Standards Community Exempted From Safety Pilot Function of IEC 61508 The 1990s saw great developments in functional safety engineering, resulting in IEC 61508, the IEC’s basic standard on functional safety [9], first published in 2000. An IEC basic standard provides a “pilot function” for other standards. Where one exists, the IEC requires other IEC standards covering the same issues to follow its principles and respect its data. IEC 61508 requires EMI to be controlled to achieve acceptable levels of functional safety, but unfortunately does not describe the techniques that should be used. IEC 610001-2 is being developed by MT15 as the basic standard on EMC for functional safety, and was first published in 2001 as a “Technical Specification” rather than a full standard. (Technical Specifications can be used as if they were full standards, by agreement between supplier and customer.)

Table of Contents Feed for the Digital Edition of Conformity Magazine - September 2008

Conformity Magazine - September 2008 Contents Editor’s Note Commission Adopts Regulations for Internet-Based TRS Services Another Company Fined for Non-Compliance with HAC Requirements FCC Extends “Do-Not-Call” Registry Compliance Requirements Marketing Company Gets $1.4 Million Fine for Junk Faxes EU Commission Codifies Directive on TTE Market Competition EU Commission Releases Updated Standards List for the R&TTE Directive Updated Standards List for the “New” Low Voltage Directive Released New Standards List Released for the EU’s Machinery Directive The ESD Association: Voluntary Standards in Action ESD Open Forum Medical EMC Standards: Towards the 4th Edition of IEC 60601-1-2 iNARTE Informer Pre-Pulse Voltage in the HBM ESD Model Digital Interfaces and EMC Performance ESD Design Buyer’s Guide Product News Commission Publishes Updated Standards List for the EU’s Personal Protective Equipment Directive FDA Links “Human Factors” to Adverse Events with Medical Devices CPSC Actions in the News IEC Standards Update UL Standards Update Product Reviews Telcordia Standards Update From Our “You Can’t Make This Stuff Up” Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - September 2008

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