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2. ISO 14971 - Wikipedia

   en.wikipedia.org/wiki/ISO_14971

   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.

3. List of ISO standards 14000–15999 - Wikipedia

   en.wikipedia.org/wiki/List_of_ISO_standards_14000...

   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 ...

4. List of ISO standards 30000–99999 - Wikipedia

   en.wikipedia.org/wiki/List_of_ISO_standards_30000...

   ISO 55002:2014 Asset management – Management systems – Guidelines for the application of ISO 55001; ISO 56000:2020 Innovation management — Fundamentals and vocabulary; ISO 56002:2019 Innovation management — Innovation management system — Guidance; ISO 56003:2019 Innovation management - Tools and methods for innovation partnership ...

5. Risk management - Wikipedia

   en.wikipedia.org/wiki/Risk_management

   The management of risks for medical devices is described by the International Organization for Standardization (ISO) in ISO 14971:2019, Medical Devices—The application of risk management to medical devices, a product safety standard. The standard provides a process framework and associated requirements for management responsibilities, risk ...

6. List of ISO standards - Wikipedia

   en.wikipedia.org/wiki/List_of_ISO_standards

   Main page; Contents; Current events; Random article; About Wikipedia; Contact us; Help; Learn to edit; Community portal; Recent changes; Upload file

7. IEC 62304 - Wikipedia

   en.wikipedia.org/wiki/IEC_62304

   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.