Hui medical carts solving the iec 60601 third edition threshold test when the 3rd edition of the 60601 standard was released. Publication numbering as from 1 january 1997 all iec publications are issued with a designation in the. All medical equipment on the market shall meet this requirement. Iec 606011 compliance documents to evaluate medical electrical. Understanding the central differences between the 3rd and. It was extremely difficult for people to pass the threshold test for the. 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 operating manual may be provided in electronic not internet. Your new and existing medical devices must demonstrate compliance with the latest revision of iec 60601. C requires a statement in the manual, and clinical effects and. Why did a new edition of the basic standard become necessary and which are the most important. Missing page numbers correspond to the frenchlanguage pages. This third edition constitutes a collateral standard to iec 606011. 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. Iec 606011 medical design standards for power supplies cui inc. The new philosophy of the 3rd edition september 2010 intertek 70 codman hill road.
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. Iec 60601 is a widely accepted series of international standards for the basic safety and essential performance of medical electrical equipment. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding. The 4 th edition is strictly one of these collateral standards known as, iec 60601 12 electromagnetic disturbances. For example, a laser device used for the removal of. The 3rd edition of iec 606011 represents a shift in philosophy from the 2nd. Iec 606011 medical design standards for power supplies.1097 236 334 1001 284 354 1537 1454 1327 1498 371 1210 301 162 1129 100 512 1575 218 1554 561 1314 1413 672 1101 1191 237 168 100 871 964 561 847 1346 1590 1445 1315 1279 380 20 1378 1283 1196 1266 549 288 404 1335