Aseptic processing of health care products Part 7: Alternative processes for medical devices and combination products
Edition 2022-08-24

Medical devices - Quality management systems - Requirements for regulatory purposes
Edition 2016-05-31

Clinical investigation of medical devices for human subjects - Good clinical practice
Edition 2024-06-19

Implants for surgery - Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Edition 2016-06-29

Implants for surgery - Active implantable medical devices Part 3: Implantable neurostimulators
Edition 2020-01-27

Implants for surgery - Active implantable medical devices Part 4: Implantable infusion pumps
Edition 2016-09-16

Implants for surgery - Active implantable medical devices Part 5: Circulatory support devices
Edition 2017-06-22

Implants for surgery - Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
Edition 2017-05-29

Implants for surgery - Active implantable medical devices Part 7: Particular requirements for cochlear implant systems
Edition 2017-10-09

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of sterilization process for medical devices
Edition 2014-04-24