![]() 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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