Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Edition 2018-03-21

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Edition 2021-12-29

Packaging for terminally sterilized medical devices - Part 10: adhesive coated nonwoven materials of polyolefines - Requirements and test methods
Edition 2018-12-19

Packaging for terminally sterilized medical devices - Part 9: uncoated nonwoven materials of polyolefines - Requirements and test methods
Edition 2018-12-19

Application of risk management for IT-networks incorporating medical devices - Part 1: roles, responsibilities and activities
Edition 2011-08-01

Sterilization of health care products - Radiation - Part 1: requirements for development, validation and routine control of a sterilization process for medical devices
Edition 2016-01-30

Packaging for terminally sterilized medical devices - Part 2: validation requirements for forming, sealing and assembly processes
Edition 2020-01-15

Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems
Edition 2020-01-15

Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems - Amendment A11
Edition 2022-06-15

Packaging for terminally sterilized medical devices - Part 2: validation requirements for forming, sealing and assembly processes - Amendment A11
Edition 2022-06-15