Standards by Industry Sector

SS ISO 11137-1:2018

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

SS ISO 11139:2018+A1:2025

Sterilisation of health care products – Vocabulary of terms used in sterilisation and related eq...

SS ISO 11607-1:2019+A1:2025

Packaging for terminally sterilised medical devices – Part 1: Requirements for materials, steril...

SS ISO 11607-1:2019

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

SS ISO 11607-2:2019

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

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(2025)

Medical devices — Application of risk management to medical devices

SS ISO 15223-1 Amd 1:2025

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

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