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The third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971. [ 5 ] Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production.
ISO 15784-1:2008 Part 1: General principles and documentation framework of application profiles; ISO 15784-2:2015 Part 2: Centre to field device communications using SNMP; ISO 15784-3:2008 Part 3: Application profile-data exchange (AP-DATEX) ISO 15785:2002 Technical drawings – Symbolic presentation and indication of adhesive, fold and pressed ...
Researchers from the University of British Columbia have developed a "groundbreaking coating" that could make blood-contacting devices safer. Dr. Jayachandran Kizhakkedathu discusses the benefits.
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.
ISO/TR 24014-3:2013 Part 3: Complementary concepts to Part 1 for multi-application media; ISO 24097 Intelligent transport systems – Using web services (machine-machine delivery) for ITS service delivery ISO 24097-1:2017 Part 1: Realization of interoperable web services; ISO/TR 24097-2:2015 Part 2: Elaboration of interoperable web services ...
(The Center Square) — New York's population could decline by more than 2 million people over the next 25 years as fewer people are born in the state and more people move out, according to a new ...
Honda is recalling over 200,000 SUVs in the United States due to a fuel leak concern, according to the National Highway Traffic Safety Administration.. The recall, which includes 205,760 vehicles ...
An update to ISO 31000 was added in early 2018. The update is different in that it "provides more strategic guidance than ISO 31000:2009 and places more emphasis on both the involvement of senior management and the integration of risk management into the organization." [6] The new version (ISO 31000:2018) was approved and became the new ...
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