Medical Devices Standards

The following standards relate to medical devices.

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/DIS 14971:20xx Medical Devices – Application of Risk Management to Medical Devices
ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence
ISO/NP 15189:20xx Medical Laboratories – Requirements for Quality and Competence
ISO 15223-1:2016 Medical Devices – Symbols to be used with Medical Device Labels, Labeling, and Information to be supplied – Part 1: General Requirements
ISO 15223-2:2010, Medical Devices – Symbols to be used with Medical Device Labels, Labeling, and Information to be supplied – Part 2: Symbol Development, Selection, and Validation
ISO 15378:2017 Primary Packaging Materials for Medicinal Products – Particular Requirements for the Application of ISO 9001:2015, 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 16142-2: 2017 Medical Devices – Recognized Essential Principles of Safety and Performance of Medical Devices – Part 2: General Essential Principles and additional Specific Essential Principles for all IVD Medical Devices and Guidance on the Selection of Standards
ISO/TS 22367:2008 Medical Laboratories – Reduction of Error through Risk Management and Continual Improvement
ISO/CD 22367:20xx Medical Laboratories – Application of Risk Management to Medical Laboratories
ISO/TR 24971:2013 Medical Devices – Guidance on the Application of ISO 14971
ISO/DTR 24971:20xx Medical Devices – Guidance on the Application of ISO 14971

You can order these standards through ANSI at this web page.

Follow the progress of the draft standards at www.iso.org.

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