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Standards Development
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated “STERILE”. Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
To update the Foreword and Annexes to meet the latest formats and introduce Annexes ZD and ZE to show the relationship with the Regulations for Medical Devices (EU 2017/745) and In Vitro Diagnostic Medical Devices(EU 2017/746) in response to the draft Standardization Request from the European Commission.
To update the normative references to the latest version and delete reference to an obsolete standard.
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