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The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
Download as PDF; Printable version; In other projects ... with the international recycling symbol ISO 7000-1135 ... safety aspects in the second edition of IEC 60601 ...
Download as PDF; Printable version; In other projects ... move to sidebar hide. 60601 may refer to: The year in the 61st millennium; The Chicago Loop; IEC60601, a ...
Product specific tests are instead defined in standards such as EN 50130-4 for alarm systems, EN 50121-4-2 for railway applications or IEC 60601-1-2 for medical equipment. The product, or equipment under test (EUT) , is seen from an operator's point of view during test.
IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.
EN ISO 13982: Protective clothing for use against solid particulates Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates (type 5 clothing) EN 14033: Railway applications — Track — Railbound construction and maintenance machines
The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability. Manufacturers of medical electrical equipment who comply with IEC 60601-1-6 need to also comply by extension to IEC 62366 as part of IEC 60601-1 Edition 3.1.
IEC 60601-1-11 (2010) must now be incorporated into the design and verification of a wide range of home use and point of care medical devices along with other applicable standards in the IEC 60601 3rd edition series. The mandatory date for implementation of the EN European version of the standard is June 1, 2013.