What cleanroom classification are medical device cleanrooms?

  • On 2023-05-06 11:25:06
  • By 创始人
Medical device cleanrooms classification can range from ISO-5 to ISO-8 depending on the criticality of the product, whether it is implantable, and sterility requirements. Determination of correct cleanroom classification is done under FDA GMP rules. Most common cleanroom classification are ISO-7 and ISO-8.
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