Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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038
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Date of Entry 01/27/2015
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FR Recognition Number
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14-390
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Standard | |
ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration |
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Scope/AbstractISO 14644-10:2012 defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). It is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environment, tools, equipment and devices. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
AAMI TIR52:2014/(R)2017, Environmental Monitoring for Terminally Sterilized Healthcare Products.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |