| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 12/18/2023
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FR Recognition Number
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14-589
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| Standard | |
ISO 14644-4 Second edition 2022-11
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up |
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Scope/AbstractThis document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom.
NOTE Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments).
The following subjects are mentioned but not addressed in this document:
- specific operational activities, processes to be accommodated and process equipment in the cleanroom installation;
- fire and safety regulations;
- ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5. |
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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 14644-4 First edition 2001-04-01 [Rec# 14-141] will be superseded by recognition of ISO 14644-4 Second edition 2022-11 [Rec# 14-589]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-141] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 14-141] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
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Relevant FDA Guidance and/or Supportive Publications*
1. Quality System Information for Certain Premarket Application Reviews: Guidance for Industry and FDA Staff, issued February 2003.
2. Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice: Guidance for Industry, issued October 2004.
3. Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff, issued December 2018.
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. |
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