ISO 14644-4:2022
Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
This 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,
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 General
3.2 Installation
4 Abbreviated terms
5 General
6 Requirements
6.1 Cleanroom requirements
6.2 Other requirements
6.3 Documentation
7 Design
7.1 General
7.2 Conceptual design
7.3 Basic design
7.4 Detailed design
7.5 Change management
8 Construction
8.1 General
8.2 Construction plan
8.2.1 General
8.2.2 Schedule
8.2.3 Quality plan
8.2.4 Clean build protocol
8.3 Construction verification
8.4 Documentation
9 Start-up
9.1 General
9.2 Commissioning
9.2.1 General
9.2.2 Setting to work
9.2.3 Functional and performance verifications
9.3 Training
9.4 Handover
9.5 Documentation
9.5.1 Commissioning documentation
9.5.2 Performance-monitoring instructions
9.5.3 Maintenance instructions
9.5.4 Maintenance record
9.5.5 Record of training
Annex A (informative) Guidance on requirements
Annex B (informative) Guidance on design
Annex C (informative) Guidance on construction
Annex D (informative) Guidance on start-up
Bibliography
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Related Information
Similar Standards
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AS/NZS 14644.2:2002
Cleanrooms and associated controlled environments - Specifications for testing and monitoring to prove continued compliance with ISO 14644.1
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AS/NZS 14644.3:2009
Cleanrooms and associated controlled environments - Test methods
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AS/NZS ISO 14644.1:2002
Cleanrooms and associated controlled environments - Classification and air cleanliness
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AS/NZS ISO 14644.4:2002
Cleanrooms and associated controlled environments - Design, construction and start-up
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 General
3.2 Installation
4 Abbreviated terms
5 General
6 Requirements
6.1 Cleanroom requirements
6.2 Other requirements
6.3 Documentation
7 Design
7.1 General
7.2 Conceptual design
7.3 Basic design
7.4 Detailed design
7.5 Change management
8 Construction
8.1 General
8.2 Construction plan
8.2.1 General
8.2.2 Schedule
8.2.3 Quality plan
8.2.4 Clean build protocol
8.3 Construction verification
8.4 Documentation
9 Start-up
9.1 General
9.2 Commissioning
9.2.1 General
9.2.2 Setting to work
9.2.3 Functional and performance verifications
9.3 Training
9.4 Handover
9.5 Documentation
9.5.1 Commissioning documentation
9.5.2 Performance-monitoring instructions
9.5.3 Maintenance instructions
9.5.4 Maintenance record
9.5.5 Record of training
Annex A (informative) Guidance on requirements
Annex B (informative) Guidance on design
Annex C (informative) Guidance on construction
Annex D (informative) Guidance on start-up
Bibliography