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ABNT NBR ISO 13408-7
Aseptic processing of health care products Part 7: Alternative processes for medical devices and combination products
Edition
2022-08-24
ABNT NBR ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes
Edition
2016-05-31
ABNT NBR ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice
Edition
2024-06-19
ABNT NBR ISO 14708-1
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
ABNT NBR ISO 14708-3
Implants for surgery - Active implantable medical devices Part 3: Implantable neurostimulators
Edition
2020-01-27
ABNT NBR ISO 14708-4
Implants for surgery - Active implantable medical devices Part 4: Implantable infusion pumps
Edition
2016-09-16
ABNT NBR ISO 14708-5
Implants for surgery - Active implantable medical devices Part 5: Circulatory support devices
Edition
2017-06-22
ABNT NBR ISO 14708-6
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
ABNT NBR ISO 14708-7
Implants for surgery - Active implantable medical devices Part 7: Particular requirements for cochlear implant systems
Edition
2017-10-09
ABNT NBR ISO 14937
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