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Standards [CURRENT]

UNE-EN ISO 14708-2

Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
Edition 2023-04-12

Standards [CURRENT]

UNE-EN ISO 14708-3

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
Edition 2023-05-17

Standards [CURRENT]

UNE-EN ISO 14708-4

Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
Edition 2023-04-26

Standards [CURRENT]

UNE-EN ISO 14708-5

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
Edition 2023-05-03

Standards [CURRENT]

UNE-EN 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) (ISO 14708-6:2019)
Edition 2023-05-17

Standards [CURRENT]

UNE-EN ISO 14708-7

Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
Edition 2023-05-17

Standards [CURRENT]

UNE-EN ISO 14937

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
Edition 2010-05-26

Standards [CURRENT]

UNE-EN ISO 14971

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Edition 2020-09-23

Standards [CURRENT]

UNE-EN ISO 14971/A11

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Edition 2022-06-22

Standards [CURRENT]

UNE-EN ISO 15002

Flow control devices for connection to a medical gas supply system (ISO 15002:2023) (Endorsed by Asociación Española de Normalización in May of 2024.)
Edition 2024-05-01

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