The 4 th edition is strictly one of these collateral standards known as, iec 60601 12 electromagnetic disturbances. Your new and existing medical devices must demonstrate compliance with the latest revision of iec 60601. Missing page numbers correspond to the frenchlanguage pages. Changes from 2nd to 3rd edition 8 while the 3rd edition of iec 60601 1 now includes ep requirements, the manufacturers ep requirements may vary from the standards, depending on the proposed use of the device. The main iec 60601 1 standard referred to in europe as en 60601 1 and in canada as csa 60601 1 is an umbrella for numerous subsidiary standards, variously known as collateral or particular standards. For example, a laser device used for the removal of. Iec 606011 medical design standards for power supplies.
The 3rd edition of iec 60601 1 represents a shift in philosophy from the 2nd edition, including a greater emphasis on risk management and essential performance. Publication numbering as from 1 january 1997 all iec publications are issued with a designation in the. Why did a new edition of the basic standard become necessary and which are the most important. This third edition constitutes a collateral standard to iec 606011. The operating manual may be provided in electronic not internet. Understanding the central differences between the 3rd and. Understanding the central differences between the 3rd and 4th edition of iec 60601 12 medical device emc standard published on october 5, 2017 october 5, 2017 21 likes 0 comments. The new philosophy of the 3rd edition september 2010 intertek 70 codman hill road. All medical equipment on the market shall meet this requirement. It was extremely difficult for people to pass the threshold test for the. Iec 60601 is a widely accepted series of international standards for the basic safety and essential performance of medical electrical equipment.
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