| Part B: Supplementary Information Sheet (SIS) |
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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/Abstract| ISO 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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Transition Period
| FDA recognition of ISO 14644-10 First edition 2013-03 [Rec# 14-390] will be superseded by recognition of ISO 14644-10 Second edition 2022-05 [Rec# 14-591]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-390] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 14-390] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
| 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 Contacts
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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. |
