Note the change of title from the first (1977) edition.For particular requirements see series 601-2 below.).If the document is revised or amended, you will be notified by email.
You may delete a document from your Alert Profile at any time. To add a document to your Profile Alert, search for the document and click alert me. Iec 60601 1 Download And OpenYou can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server. Some copyright holders may impose other restrictions that limit document printing and copypaste of documents. ![]() In 2018, MET joined the Eurofins Scientific network and has become a key component in Eurofins product testing portfolio. IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles have been clarified, the amended standard includes more than 20 new requirements and 60 modifications to existing requirements for medical devices. Read below for IEC 60601-1 Edition 3.1 Introduces New Product Safety Requirements for Medical Electrical Equipment. The amended standard also includes a number of new or revised technical specifications for electrical and mechanical hazards, as well as new product labeling and documentation requirements. Iec 60601 1 Full ISO 14971The rewrite clarifies that a full ISO 14971 assessment and post-production monitoring are not required for compliance. In addition to these changes, essential performance is now a test criteria in assessing if a hazard is present after a specific test. Also, manufacturers must declare specific essential performance criteria in the products technical description. In addition, electronic versions of all accompanying documentation must apply the usability engineering process as covered in the collateral standard, IEC 60601-1-6, Usability, in determining what information must be presented. There are new limits for leakage current testing for functional earth connections. Protective earth testing with a power supply cord is required for devices equipped with appliance inlets. Permanently installed equipment must include a power lockout device if reconnection presents a potential hazard to a user. For overflow, equipment must be designed to ensure that basic safety and essential performance are maintained at all times. In addition, Amendment 1 incorporates validation requirements for equipment connected to a network. Requirements for the construction of transformers have reverted to IEC 60601-1 Edition 2.0. Lithium batteries must comply with IEC 60086-4 (primary cells) and IEC 62133 (secondary cells). Both of these national standards are deemed the equivalent of IEC 60601-1 Edition 3.1, but they may also include national deviations that trigger additional requirements for regulatory approval. In the European Union (EU), EN 60601-1:2006A1:2013 (the EUs equivalent of IEC 60601-1 Edition 3.1) has been published in the Official Journal (OJ) as a harmonized standard under the EUs Medical Device Directive (9342EEC). So, as of Dec. 31, 2017, compliance with the provisions of EN 60601-1: 2006 (equivalent to IEC 60601-1 Edition 3.0) will no longer be accepted as evidence of conformity with the essential requirements of the Directive. Adding another level of complexity, transition dates for equipment and systems subject to the requirements of a collateral andor particular standard in the IEC 60601 series (designated IEC 60601-1-xx and IEC 60601-2-xx) may differ from those applicable to other types of devices. For device manufacturers that use the IECEEs CB Scheme, a further challenge is the requirements presented in the IECEEs Operational Document OD-2055. Published in 2014, OD-2055 requires manufacturers seeking certification to IEC 60601-1 as amended to also comply with the usability engineering process that is detailed in IEC 62366-1:2015. Iec 60601 1 Free Quotation ToContact us for questions about Edition 3.1 or for a free quotation to test your device(s).--. In 1989, MET broke the UL monopoly for product safety testing and certification in the United States and is approved to certify products in over 200 UL standard categories. Today, MET is a global service leader for product approvals and regulatory certification of electrical products. MET Labs is a service leader and trusted provider of product testing and regulatory certification of electrical products for leading brands and companies in the United States, Europe and worldwide.
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