Connection between iec 62304 and chapter 14 of iec 606011. Iec 60601257 medical electrical equipment part 257. Rent, buy or lease test equipment for evaluating immunity of medical electrical equipment in accordance to iec 6060112. Xx are aligned with the changes to the amendments project. Leo eisners free webinar will provide a status update on iec 60601. Iec 60601 is a series of technical standards for the safety and essential performance of. The emc shop specializes in compliance test and evaluation. Software requirements according to iec 60601 1 clause 14 3rd ed. Iso and iec standards for software in medical devices in a. Particular requirements for the basic safety and essential. The particular standards in iec 606012, however, address minimum. Two other standards apply to software, although they are not limited to it. Software requirements according to iec 606011 clause 14.
This means you must test on a representative sample of the device and determine if the device meets the requirements of the standard as. Pems iec 606011 section 14 doesnt apply if the software doesnt provide support for basic safety or essential performance or if failure of. Particular requirements for the basic safety and essential performance of nonlaser light source equipment intended for therapeutic, diagnostic, monitoring and cosmeticaesthetic use. The redline version is not an official document, it is available in english only and provides you with a quick and easy way to compare all the changes between the official iec standard and its previous edition. We leverage our product qualification and emc expertise to help ensure that your medical devices and products are in compliance with iec 60601 standards, and ready for export to global markets combining industry experience with stateoftheart laboratory. Greenlight gurus medical device qms software is the right choice for medical device. Iec 606011 and iec 610101, versus iec 62304 software in. The next piece of the iec60601 series puzzle is that the particular standards i. General requirements for basic safety and essential performance collateral standard. It is quite literally referring to which functions of the product are considered essential.
Although emission and immunity tests for medical products are very similar to those applied to other product types, such as radio equipment, networking equipment and multimedia equipment, iec 6060112 requires that basic safety and essential performance of the medical device be maintained as opposed to the emc compliance for other type of products. Iec 60601 1 adds requirements mainly about network, software interfaces and hardware, and iec 62366 adds requirements about ergonomics. Used in countries around the world, iec 60601 helps ensure the safety and effectiveness of electrical and electronic medical devices. Iec 60601 standards status update for medical electrical equipment. Software in medical devices pems decomposition into hardware and. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and.