National foreword

This British Standard is the UK implementation of EN ISO 14644‑5:2025. It is identical to ISO 14644‑5:2025. It supersedes BS EN ISO 14644‑5:2004, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee LBI/30, Cleanroom technology.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2025.

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 document 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).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

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) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments, in collaboration with the European Committee for Standardisation (CEN) Technical Committee CEN/TC 243, Cleanroom technology, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 14644‑5:2004), which has been technically revised.

The main changes are as follows:

new normative content for development of an impact assessment, development of an Operations Control Programme and the associated programmes that support cleanroom operation, and updated information concerning the movement of goods and materials into and out of the cleanrooms;
informative sections have been condensed so as not to duplicate information available in books and papers.

A list of all parts in the ISO 14644 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

Cleanrooms and associated controlled environments provide for the control of contamination to air and surface cleanliness levels appropriate for accomplishing contamination-sensitive activities.

Consistent quality depends, in part, on cleanliness. Specified cleanliness levels for all contaminants addressed in the ISO 14644 series can be attained and maintained through a deliberate programme to establish and implement adequate design and operational procedures. Regulatory agencies that have authority over processes and products produced in the cleanroom can require additional procedures and measures.

Processes and products that benefit from the control of contamination include those in industries such as aerospace, automotive, assorted consumer products, defence, microelectronics, optics, nuclear, scientific research and life sciences (pharmaceuticals, biotechnology, medical devices, food, healthcare).

This document specifies basic requirements for cleanroom operations. It is intended for those who design, construct, start up or operate a cleanroom. For guidance about consumables and equipment used in cleanrooms refer to the ISO 14644 series.

This European Standard was approved by CEN on 25 May 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

European foreword

This document (EN ISO 14644‑5:2025) has been prepared by Technical Committee ISO/TC 209 "Cleanrooms and associated controlled environments" in collaboration with Technical Committee CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2025, and conflicting national standards shall be withdrawn at the latest by December 2025.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 14644‑5:2004.

Any feedback and questions on this document should be directed to the users’ national standards body/national committee. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.

Endorsement notice

The text of ISO 14644‑5:2025 has been approved by CEN as EN ISO 14644‑5:2025 without any modification.

1 Scope

This document specifies requirements for the establishment of an operations control programme (OCP) to ensure efficient cleanroom operation within specified cleanliness levels. The OCP includes management of personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring.

This document specifies operational requirements that relate to:

providing a system that specifies policies and operational procedures for maintaining cleanliness levels;
training of personnel;
transferring, installing and maintaining stationary equipment;
transferring material and portable equipment into and out of the cleanroom;
maintaining a personnel management programme that includes a gowning programme;
maintaining a cleaning programme that addresses special cleaning;
maintaining a cleanroom maintenance programme;
establishing an appropriate monitoring programme.

This document gives additional information in annexes for:

personnel management;
gowning;
training;
cleaning.

This document does not specifically address biocontamination control. For details on this topic, see ISO 14698‑1 andISO 14698‑2.

This document does not apply to the following topics:

aspects of health and safety management that have no direct bearing on contamination control;
specific requirements for individual industries;
specific requirements for equipment and materials used or associated with processes and products;
design details of equipment;
cleaning agent compatibility with cleanroom materials.

2 Normative references

3 Terms and definitions

4 Abbreviations

5 General

6 Impact assessment

7 Operations Control

7.1 General

7.2 Operations control programme

7.3 Materials Flow

7.4 Personnel management programme

7.5 Cleaning programme

7.6 Maintenance programme

8 Monitoring programme

Bibliography

BS EN ISO 14644-5:2025

Cleanrooms and associated controlled environments - Operations

Current

Published:

30 Jun 2025