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The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1]
The 80000 series is reserved for multi-part standards jointly developed by ISO and IEC, in which some parts are published by ISO and others by IEC. ISO/IEC 80000 Quantities and units; ISO/IEC 80001 Application of risk management for IT-networks incorporating medical devices IEC 80001-1:2010 Part 1: Roles, responsibilities and activities
ISO 15375:2010 Medical infusion bottles – Suspension devices for multiple use – Requirements and test methods; ISO/TR 15377:2007 Measurement of fluid flow by means of pressure-differential devices – Guidelines for the specification of orifice plates, nozzles and Venturi tubes beyond the scope of ISO 5167
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.
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 ...
Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. [1] Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. [2]
ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device; ISO 10985:2009 Caps made of aluminium-plastics combinations for infusion bottles and injection vials – Requirements and test methods; ISO 10991:2009 Micro process engineering – Vocabulary
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices. [2]