| 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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14-242
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| Standard | |
ISO 14644-3 First edition 2005-12-15
Cleanrooms and associated controlled environments - Part 3: Test methods |
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Scope/AbstractISO 14644-3:2005 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational.
ISO 14644-3:2005 is not applicable to the measurement of products or of processes in cleanrooms or separative 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| FDA recognition of ISO 14644-3 First edition 2005-12-15 [Rec# 14-242] will be superseded by recognition of ISO 14644-3 Second edition 2020-06 [Rec# 14-598]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-242] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 14-242] will not be accepted. |
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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 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. |
