December (1999) Update from British Standards

International Standards

Cleanroom standards being produced for world use by the International Organization for Standardization Technical Committee 209 are progressing.

The defined development stages carry prefixes as follows:

WD Working Draft. Circulation of developing document within the Working Group set up by the ISO/TC209 Committee
CD Committee Draft. Circulation of approved Working Draft within ISO/TC209 for approval and or comments by the National Technical Bodies of the participating countries (British Standards Institution in the case of the United Kingdom).
DIS Draft International Standard. Circulation of the ISO-approved Committee Draft by ISO for public enquiry in all ISO member countries.
FDIS Final Draft International Standard. Circulation of approved DIS for final vote.

The following ISO/TC209 documents are at the stages described:

ISO 14644-1 Cleanrooms and Associated Controlled Environments, Part 1:Classification of air cleanliness. ISO 14644-1: 1999 has been published.
ISO 14644-2 Cleanrooms and Associated Controlled Environments, Part 2:Specifications for testing and monitoring to prove continued compliance with ISO 14644-1. This draft is in translation for issue as FDIS 14644-2.
ISO 14644-3 Cleanrooms and Associated Controlled Environments, Part 3:Metrology and test methods. This draft has been issued as CD 14644-3.
ISO 14644-4 Cleanrooms and Associated Controlled Environments, Part 4:Design, construction and start-up. This draft is in preparation for issue as FDIS 14644-4.
ISO 14644-5 Cleanrooms and Associated Controlled Environments, Part 5:Operations. This draft has been agreed for issue as CD 14644-5.
ISO 14644-6 Cleanrooms and Associated Controlled Environments, Part 6:Terms and Definitions. Document under development.
ISO 14644-7 Cleanrooms and Associated Controlled Environments, Part 7:Minienvironments and isolators. This draft has been issued as CD 14644-7.
ISO 14698-1 Cleanrooms and Associated Controlled Environments, Biocontamination Control, Part 1: General principles.  This draft has been issued as DIS 14698-1
ISO 14698-2 Cleanrooms and Associated Controlled Environments, Biocontamination Control, Part 2: Evaluation and interpretation of biocontamination data. This draft has been issued as DIS 14698-2
ISO 14698-3  Cleanrooms and Associated Controlled Environments, Biocontamination Control, Part 3: Methodology for measuring the efficiency of processes of cleaning and/or disinfection of inert surfaces bearing biocontaminated wet soiling or biofilms. This draft has been issued as DIS 14698-3
Drafts issued by BSI for public comment in the United Kingdom. The present situation is as follows.
DIS 14644-2 Public comment terminated on 30th October, 1998, but the draft is still publicly available. No further comments on this draft will be accommodated.
CD 14644-4 Public comment terminated on 27th March, 1997 but the Draft is still publicly available. DIS 146444 has now also been issued. No further comments on this draft will be accommodated.
CD 14698-1 Public comment terminated on 30th November, 1996 but the Draft is still publicly available. DIS 14698-1 has now also been issued. Any further comments received at this stage may not necessarily be accommodated.
CD 14698-2 Public comment terminated on 30th November, 1996 but the Draft is still publicly available. DIS 14698-2 has now also been issued. Any further comments received at this stage may not necessarily be accommodated.
CD 14698-3 Public comment terminated on 30th November, 1996 but the Draft is still publicly available. DIS 14698-3 has now also been issued. Any further comments received at this stage may not necessarily be accommodated.

European Standards

ENV 1631:1996: Cleanroom Technology, Design, construction and operation of cleanrooms and clean air devices. This is a published European pre-standard available from BSI as DD [Draft for Development] ENV 1631 1996. It will be superseded when 14644-4 and 14644-5 are published.
ISO 14644-1:1999 has been implemented as EN ISO 14644-1:1999, for publication by the national standards bodies that are members of CEN (see below for United Kingdom).
DIS 14644-2, DIS 14644-4, DIS 14698-1, DIS 14698-2 and DIS 14698-3 have also been issued in parallel by CEN as prEN ISO 14644-2, prEN ISO 14644-4, prEN ISO 14698-1, prEN ISO 14698-2 and prEN ISO 14698-3 respectively.

British Standards

EN ISO 14644-1 :1999 has been published in the United Kingdom as BS EN ISO 14644-1:1999.
Parts 1 and 4 of BS 5295 have been withdrawn, while amendments to Parts 0, 2 and 3 of BS 5295 are in preparation.
PD 6609:1996, In situ aerosol testing of HEPA filters, which was prepared originally as a supplement to BS 5295-1, will also be subject to change.

Some of these are available from the S2C2 sales department :

Publicly available documents covered in this update report can be obtained from: BSI Standards, 389 Chiswick High Road, London, W4 4AL, Sales Tel: 0181-996 7000, Sales Fax: 0181-996 7001.