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 14971:2018 | 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.
Whittington & Associates
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