In the image above, you will see a descriptive break out of how the IEC committee has decided to delineate the IEC 60601 family of standards. You mentioned collateral and particular standards earlier, how do those connect to moving from IEC 60601 to the EMC testing I am required to perform under IEC 6? Once you are able to get into this regulatory mindset, what you will find is that IEC 6, 4th Edition is actually pretty reasonable and approachable in the greater context of IEC 6. For the teams of designers & quality standards who are left with reviewing the guidelines of ISO 14971 and coming up with a Risk Management File, we can certainly sympathize.Īs we work through IEC 60601 and lead into IEC 6 testing, just keep in your mind the regulatory goal of the standard: minimizing risk, but not completely eliminating. We also agree, the concept of removing “as much risk” as possible is hopelessly undefined from an engineering perspective. Put loosely, the goal is not to remove all possible risks and demonstrate through testing that no risk could exist – the goal is to remove as much risk as possible and still be economically profitable and viable as a product. The entire goal of IEC 60601 is to manage medical device risk. The generality of the IEC 60601 standards, is really the best way to understand the idea of “Risk Management”. In terms of having to use language to describe and encapsulate all the possible devices which could qualify and are used for “medical” purposes, the actual standards need to be written in a certain tone and purpose which leave them generic enough to be applied to a wide range of products. Much of the difficulty in dealing with the IEC 60601 standards relates back to the subject matter and the approach taken by the IEC subcommittee who drafted the standards.įrom a breadth of product perspective, there is no singular “medical device” which functions like a toaster oven and the enormity of functional variation is really almost infinite. As a product manufacturer, you are not alone in in trying to tease out the nuts and bolts of what is required for testing your medical product. In terms of complexity of testing and regulatory verbosity, the IEC 60601 standards towers above any another IEC standard that is currently published. Why is IEC 60601 so difficult to work with and understand? In fairness though to the IEC ensuring medical products are safe for use is quite a task as well. You could not hire us to write one page of how dense the standard is for $1/page either!). (Fun fact, we also would guess purchasing the entire series of the standard probably is also close to $10,000 USD – $1/page. It is not an easy set of documents to work with. If you were to print out all of the standards which make up the IEC 60601 family, you are likely in the over 10,000 pages category.Īs we said earlier, IEC 60601 is by far the largest standard and family of related standards that the IEC publishes. The entire IEC 60601 standards, in its current iteration, stands with the general standard, 10 major collateral standards, and around 80 particular standards. The first edition of IEC 60601 was created in 1977, and has been a true work in progress from the IEC since then. The only major variation across the world is which specific versions of IEC 60601 standard is accepted in a specific country. While the IEC is based in Geneva Switzerland, membership extends across the world and the IEC standards form the basis of all product safety testing.įor purposes of medical device testing, IEC 60601, is one of hundreds of family standards the IEC has developed for safety testing different types of products.įrom a global perspective, every major medical device market of the world expects testing of your end product to IEC 60601. The IEC was founded in Europe in 1906, and currently has 89 member countries across the world. Who created the IEC 60601 standard in the first place?Īs with all CE Testing the original authors of the IEC 60601 standards is the International Electrotechnical Commission, which is commonly referred to as IEC. In this guide, we will at the cursory level examine IEC 60601, discuss how IEC 60601 dovetails into the EMC testing required for IEC 6, and then go straight into an analysis of IEC 6, 4th edition and explain what is required for the testing. What is IEC 6 and what is required to EMC test my medical device so I can submit my product for approval medical regulators?Īs one of the leading IEC 6 testing labs, Sunfire Testing has extensive experience working in the voluminous IEC 60601 standards, and specializes in EMC testing to the IEC 6, 4th Edition.Ĭhances are you have not typed IEC 6 by mistake and you have an actual medical product (or an idea for medical product), and are trying to determine what type of EMC testing is required in order for your product to be approved by end regulators.
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