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BS EN ISO 14971 / BS EN ISO 11607 - Medical Devices Package

Risk and Package of Medical Devices: BS EN ISO 14971, BS EN ISO 11607-1 and BS EN ISO 11607-2 (British Standard)

BS EN ISO 14971 / BS EN ISO 11607 - Medical Devices Package provides the requirements and test methods for packaging intended to maintain the sterility of terminally sterilized medical devices until the point of use. It also provides the requirements for the development and validation of processes including forming, sealing, and assembly of packaging used for sterilized medical devices. The BS EN ISO 14971 / BS EN ISO 11607 - Medical Devices Package also allows for a process that enables manufacturers to identify hazards associated with medical devices. It includes:

  • BS EN ISO 14971:2019
  • BS EN ISO 11607-1:2020
  • BS EN ISO 11607-2:2020

BS EN ISO 14971 / BS EN ISO 11607 - Medical Devices Package includes:


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British Standards Institution [BSI]


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