National foreword

This British Standard is the official English language version of EN ISO 14644‑5:2004. It is identical with ISO 14644‑5:2004. It supersedes BS 5295‑3:1989 which is withdrawn. It, together with BS EN ISO 14644‑4:2001, supersedes DD ENV 1631:1996 which is now withdrawn.

The UK participation in its preparation was entrusted to Technical Committee LBI/30, Cleanroom technology, which has the responsibility to:

aid enquirers to understand the text;
present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;
monitor related international and European developments and promulgate them in the UK.

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

Cross-references

The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard does not of itself confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 20 August 2004

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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 14644‑5 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments.

ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments:

Part 1: Classification of air cleanliness
Part 2: Specifications for testing and monitoring to prove continued compliance withISO 14644‑1
Part 3: Test methods
Part 4: Design, construction and start-up
Part 5: Operations
Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Part 8: Classification of airborne molecular contamination

The following part is under preparation:

Part 6: Terms and definitions

Introduction

Industries and organizations of all kinds utilize cleanrooms. Operational procedures have a profound effect on the cleanliness levels achieved during the operation of the cleanroom and equipment. Consistent quality is cleanliness dependent. Operational cleanliness can only be attained and maintained through a deliberate programme established to specify, measure and enforce defined operational procedures. Regulatory agencies that have authority over processes and products produced in the cleanroom may require additional procedures and measures of cleanliness not covered in this general operating standard.

This part of ISO 14644 addresses normative and informative operational requirements related to:

providing a system that defines policies and operational procedures;
clothing used to isolate human-generated contamination from the cleanroom environment;
training of personnel inside the cleanroom and monitoring their compliance to specified procedures and disciplines;
transfer, installation and maintenance of stationary equipment (selection criteria is not discussed);
selection and use of materials and portable equipment in the cleanroom;
maintaining the cleanliness of the cleanroom through systematic cleaning and monitoring procedures.

Foreword

This document (EN ISO 14644‑5:2004) 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 February 2005, and conflicting national standards shall be withdrawn at the latest by February 2005.

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

Endorsement notice

The text of ISO 14644‑5:2004 has been approved by CEN as EN ISO 14644‑5:2004 without any modifications.

1 Scope

This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference is made to ISO 14644‑2 and ISO 14644‑3 for monitoring particles and ISO 14698‑1 and ISO 14698‑2 for monitoring micro-organisms.

2 Normative references

3 Terms and definitions

3.1 General Terms

3.2 Occupancy states

4 Specification of requirements

4.1 Operational systems

4.2 Cleanroom clothing

4.3 Personnel

4.4 Stationary equipment

4.5 Materials and portable and mobile equipment

4.6 Cleanroom cleaning

Bibliography

BS EN ISO 14644-5:2004

Cleanrooms and associated controlled environments - Operations

Published:

20 Aug 2004

Withdrawn:

5 Jun 2025