ANSI Standards Connect ET ( INTERNATIONAL ISO STANDARD 14644-4 Second edition 2022-11 Techno -GuestUser01-07/19/2023 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up Salles propres et environnements maitriseés apparentées Partie 4: Conception, construction et mise en service Reference number ISO 14644-4:2022(E) osi @IS02022 ANSI StandardsConnect ET IS0 14644-4:2022(E) -GuestUser01-07/19/2023 COPYRIGHTPROTECTEDDOCUMENT @ IS02022 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may or ISo's member body in the country of the requester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ Iso 2022 - All rights reserved ANSI IS0 14644-4:2022(E) Sta rds Col Contents Page lect ET Foreword ..iv (po Introduction. ..V red 1 Scope. ..1 by Eda 2 Normative references 3 Terms and definitions 3.1 General 3.2 Installation 4 Abbreviated terms. ..5 5 General ..6 Gu 6 Requirements. ..7 6.1 Cleanroom requirements .7 User 6.2 Other requirements. ..9 6.3 Documentation. .9 07/ 7 Design .9 19/2023 7.1 General. .9 7.2 Conceptual design. .10 7.3 Basic design ..10 7.4 Detailed design. 11 7.5 Change management 11 8 Construction. .12 8.1 General .12 8.2 Construction plan .12 8.2.1 General ..12 8.2.2 Schedule .12 8.2.3 Quality plan. ..12 8.2.4 Clean build protocol 12 8.3 Construction verification. ..13 8.4 Documentation. ..13 9 Start-up ..13 9.1 General ..13 9.2 Commissioning 14 9.2.1 General .. 14 9.2.2 Setting to work 14 9.2.3 Functional and performance verifications 14 9.3 Training.. .. 14 9.4 Handover .14 9.5 Documentation. .14 9.5.1 Commissioning documentation 14 9.5.2 Performance-monitoring instructions .. 15 9.5.3 Maintenance instructions .15 9.5.4 Maintenance record. .. 15 9.5.5 Record of training .. 15 Annex A (informative) Guidance on requirements ..16 Annex B (informative) Guidance on design ..24 Annex C (informative) Guidance on construction .45 Annex D (informative) Guidance on start-up .51 Bibliography. ..56 IS0 2022 - All rights reserved iii ANSI IS0 14644-4:2022(E) Foreword Iso (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out through IsO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with IsO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the IsO/IEc Directives, Part 1. In particular, the different approval criteria needed for the different types of Iso documents should be noted. This document was drafted in accordance with the editorial rules of the ISo/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. IsO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the Iso list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constituteanendorsement. For an explanation of the voluntary nature of standards, the meaning of IsO specific terms and expressions related to conformity assessment, as well as information about Iso's adherence to the World Trade Organization (WTO) principle