National foreword

This British Standard is the official English language version of EN ISO 14644-4:2001. It is identical with ISO 14644-4:2001. It supersedes BS 5295-2:1989 which is withdrawn.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 European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;
monitor related international and European developements and promulgate them in the UK.

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

This British Standard is one of a series, the other parts of BS EN ISO 14644 being as follows:

Part 1: Classification of air cleanliness;

Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1;

Part 3: Metrology and test methods;

Part 5: Operations;

Part 6: Terms and definitions;

Part 7: Separative enclosures (clean airhoods, gloveboxes, isolators, mini-environments);

Part 8: Molecular contamination.

Parts 1 and 2 have been published, while the numbering and titles of parts 3 and 5 to 8 were provisional at the time of publication of part 4.

Attention is also drawn to BS 5295 Parts 0 and 3 PD 6609, all updated in 2000, which will remain current documents until further Parts of BS EN ISO 14644 are published.

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 puport 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.

Foreword

The text of the International Standard ISO 14644-4:2001 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 lastest by October 2001, and conflicting national standards shall be withdrawn at the lastest by October 2001.

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

Endorsement notice

The text of the International Standard ISO 14644-4:2001 was approved by CEN as a European Standard without any modification.

NOTE: Normative references to International Standards are listed in annex ZA (normative).

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 3.

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 part of ISO 14644 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

International Standard ISO 14644-4 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: Metrology and test methods
Part 4: Design, construction and start-up
Part 5: Operations
Part 6: Vocabulary
Part 7: Separative enclosures (clean air hoods, glove boxes, isolators, mini-environments)

Users should note that the titles listed for parts 3 and 5 to 7 are working titles at the time of the release of part 4. In the event that one or more of these parts are deleted from the work programme, the remaining parts may be renumbered.

Annexes A to H of this part of ISO 14644 are for information only.

Introduction

Cleanrooms and associated controlled environments provide for the control of airborne particulate contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include those in such industries as aerospace, microelectronics, pharmaceuticals, medical devices and healthcare.

This part of ISO 14644 specifies the requirements for the design and construction of cleanroom facilities. It is intended for use by purchasers, suppliers and designers of cleanroom installations and provides a check list of important parameters of performance. Construction guidance is provided, including requirements for start-up and qualification. Basic elements of design and construction needed to ensure continued satisfactory operation are identified through the consideration of relevant aspects of operation and maintenance.

This part of ISO 14644 is one of a series of standards concerned with cleanrooms and associated subjects. Many factors besides design, construction and start-up should be considered in the operation and control of cleanrooms and other controlled environments. These are covered in some detail in other International Standards prepared by ISO/TC 209.

1 Scope

This part of ISO 14644 specifies requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements. It is intended for use by purchasers, suppliers and designers of cleanroom installations and provides a checklist of important parameters of performance. Construction guidance is provided, including requirements for start-up and qualification. Basic elements of design and construction needed to ensure continued satisfactory operation are identified through the consideration of relevant aspects of operation and maintenance.

NOTE Further guidance in respect of the above requirements is given in annexes A to H. Other parts of ISO 14644 may provide complementary information.

Application of this part of ISO 14644 is restricted in the following:

user requirements are represented by purchaser or specifier;
specific processes to be accommodated in the cleanroom installation are not specified;
fire and safety regulations are not considered specifically; the appropriate national and local requirements should be respected;
process media and utility services are only considered with respect to their routing between and in the different zones of cleanliness;
regarding initial operation and maintenance, only cleanroom construction-specific requirements are considered.

2 Normative references

3 Terms and definitions

4 Requirements

4.1

4.2

4.3

4.4

4.5

4.6

4.7

4.8

4.9

4.10

4.11

4.12

4.13

4.14

4.15

4.16

4.17

4.18

5 Planning and design

5.1 Planning procedure

5.2 Design

6 Construction and start-up

6.1

6.2

6.3

6.4

6.5

6.6

6.7

6.8

6.9

7 Testing and approval

7.1 General

7.2 Construction approval

7.3 Functional approval

7.4 Operational approval

8 Documentation

8.1 General

8.2 Record of an installation

8.3 Operational instructions

8.4 Instructions for performance monitoring

8.5 Maintenance instructions

8.6 Maintenance record

8.7 Record of operation and maintenance training

Bibliography

Major multi-national cleanroom relevant standards/recommendations

Surveys of contamination control standards/recommendations

Major contamination control handbooks

Dictionaries for contamination control terms

BS EN ISO 14644-4:2001

Cleanrooms and associated controlled environments - Design, construction and start-up

Published:

15 Sep 2001

Withdrawn:

8 Dec 2022