Standards by Industry Sector

SS ISO 11137-1:2018

Sterilisation of health care products — Radiation – Part 1 : Requirements for development, valid...

SS ISO 11607-2:2019

Packaging for terminally sterilised medical devices – Part 2 : Validation requirements for formi...

SS ISO 11607-1:2019

Packaging for terminally sterilised medical devices - Part 1 : Requirements for materials, steri...

SS ISO 13485:2016 (2021)

Medical devices — Quality management systems — Requirements for regulatory purposes

SS ISO 14155:2020

Clinical investigation of medical devices for human subjects — Good clinical practice

SS ISO 14971:2020

Medical devices — Application of risk management to medical devices

SS ISO 15223-2:2018

Medical devices — Symbols to be used with medical device labels, labelling and information

SS ISO 15223-1:2021

Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part ...

TR ISO/TR 24971:2020

Medical devices — Guidance on the application of ISO 14971

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