Regulatory Resources
Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools
ISO 11607-2:2019 — Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11607-1:2019 — Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11137-2:2013/AMD1:2023 — Sterilization — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-1:2006/AMD2:2023 — Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control
ISO 11135:2014 — Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control
IEC 60601-1-11:2015/AMD1:2020 — Medical electrical equipment — Part 1-11: Requirements for medical electrical equipment used in the home healthcare environment
IEC 60601-1-8:2006/AMD2:2020 — Medical electrical equipment — Part 1-8: General requirements — Alarm systems
IEC 60601-1-6:2010/AMD2:2020 — Medical electrical equipment — Part 1-6: Collateral standard: Usability
IEC 60601-1-2:2014/AMD1:2020 — Medical electrical equipment — Part 1-2: Electromagnetic disturbances — Requirements and tests
IEC 60601-1:2005/AMD2:2020 — Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
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