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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 ...
MOPP safety standards aim to set basic safety requirements for medical electrical equipment. "With hazardous voltages present in a system a robust and reliable approach to isolation is needed such that multiple and un-related insulation system failures would need to occur before an operator or patient is put at risk.
IEC TR 62296 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements; IEC 62297 Triggering messages for broadcast applications; IEC 62298 Teleweb application; IEC 62300 Consumer audio/video equipment digital interface with plastic optical fibre
The new International Standard IEC 60601 for home healthcare electro-medical devices defining the requirements for devices used in the home healthcare environment. 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 ...
CISPR is the acronym of Comité International Spécial des Perturbations Radio, [1] or the International Special Committee for Radio Protection of IEC. CISPR Standards aim to the protection of radio reception in the range 9 kHz to 400 GHz from interference caused by operation of electrical or electronic appliances and systems in the electromagnetic environment.
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.
IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
IEC 61000-4-2 is the International Electrotechnical Commission's immunity standard on electrostatic discharge (ESD). The publication is one of the basic EMC standards of the IEC 61000–4 series. The European equivalent of the standard is called EN 61000-4-2. The current version of the IEC standard is the second edition dated 2008-12-09. [1]