Danh mục các Tiêu chuẩn quốc tế ISO về Trang thiết bị y tế

ISO 13485:2016, Medical devices -- Quality management systems -- Requirements for regulatory purposes

ISO 14971:2007, Medical devices -- Application of risk management to medical devices

ISO 15223-1:2016, Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

ISO 15223-2:2010, Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation

ISO 15225:2016, Medical devices -- Quality management -- Medical device nomenclature data structure

ISO 15378:2015, Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

ISO 16142-1:2016, Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

ISO/PAS 18761:2013, Use and handling of medical devices covered by the scope of ISO/TC 84 -- Risk assessment on mucocutaneous blood exposure

ISO/TS 19218-1:2011, Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes

ISO/TS 19218-1:2011/Amd 1:2013

ISO/TS 19218-2:2012, Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes

ISO/TR 19244:2014, Guidance on transition periods for standards developed by ISO/TC 84 -- Devices for administration of medicinal products and catheters

ISO/TR 24971:2013, Medical devices -- Guidance on the application of ISO 14971

IEC 62304:2006, Medical device software -- Software life cycle processes

IEC 62304:2006/Amd 1:2015

IEC 62366-1:2015, Medical devices -- Part 1: Application of usability engineering to medical devices

IEC 62366-1:2015/Cor 1:2016

IEC/TR 62366-2:2016, Medical devices -- Part 2: Guidance on the application of usability engineering to medical devices

IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities

IEC/TR 80001-2-1:2012, Application of risk management for IT-networks incorporating medical devices -- Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples

IEC/TR 80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices -- Part 2-2: Guidance for the communication of medical device security needs, risks and controls

IEC/TR 80001-2-3:2012, Application of risk management for IT-networks incorporating medical devices -- Part 2-3: Guidance for wireless networks

IEC/TR 80001-2-4:2012, Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for Healthcare Delivery Organizations

IEC/TR 80001-2-5:2014, Application of risk management for IT-networks incorporating medical devices -- Part 2-5: Application guidance -- Guidance for distributed alarm systems

ISO/TR 80001-2-6:2014, Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements

IEC/TR 80001-2-8:2016, Application of risk management for IT-networks incorporating medical devices -- Part 2-8: Application guidance -- Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2

ISO/TR 80001-2-7:2015, Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

IEC/TR 80002-1:2009, Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software

ISO/TR 80002-2:2017, Medical device software -- Part 2: Validation of software for medical device quality systems

IEC/TR 80002-3:2014, Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

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