| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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020
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Date of Entry 09/09/2008
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FR Recognition Number
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14-142
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| Standard | |
ISO 14698-1:2003
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods |
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Scope/Abstract| ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used for information. |
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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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Public Law, CFR Citation(s) and Procode(s)*
| This standard is relevant for all medical devices where processing in controlled environments is a component of the development and manufacture of the product. |
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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. |
