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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 ...
This is a list of published [Note 1] International Organization for Standardization (ISO) standards and other deliverables. [Note 2] For a complete and up-to-date list of all the ISO standards, see the ISO catalogue. [1] The standards are protected by copyright and most of them must be purchased.
IEC60601, a series of international standards related to medical devices. Topics referred to by the same term This disambiguation page lists articles associated with the same number.
This is a list of published [note 1] standards and other deliverables of the International Organization for Standardization (ISO). [note 2] For a complete and up-to-date list of all the ISO standards, see the ISO catalogue. [1] The standards are protected by copyright and most of them must be purchased.
IEC 80601-2-71:2015 Part 2-71: Particular requirements for the basic safety and essential performance of functional Near-Infrared Spectroscopy (NIRS) equipment; ISO 80601-2-72:2015 Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
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.
ISO 14813-5:2010 Part 5: Requirements for architecture description in ITS standards ISO 14813-6:2009 Part 6: Data presentation in ASN.1 ISO 14814:2006 Road transport and traffic telematics – Automatic vehicle and equipment identification – Reference architecture and terminology
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.