UVEX Japan MOL validation standard medical mask parts

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    Authoritative documents such as ISO 14644 and FS 209E provide no specific instructions regarding activities carried out in medical device environments. Broadly, medical device manufacturing is conducted in an ISO 5 8 cleanroom (Class 100 100,000). Medical device packaging is conducted in an ISO Class 7 8 cleanroom.

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    The following are links to the list of national and international medical device standards recognized by the Therapeutic Products Directorate (TPD) and related information. Unless otherwise indicated, the complete standard, including appendices and attachments, is recognized. The email contact for the sponsor of the standards list is standards

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