December Update from British Standards

December (1997) Update from British Standards

International Standards

Cleanroom standards being produced for world use by the International Organization for Standardization technical committee ISO/TC209 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:

DIS 14644-1: Cleanrooms and Associated Controlled Environments, Part 1: Classification of airborne particulate cleanliness for cleanrooms and clean zones. This draft has been approved for issue as FDIS 14644-1.

CD 14644-2: Cleanrooms and Associated Controlled Environments, Part 2: Specification for monitoring and testing cleanrooms and associated controlled environments to prove continued compliance with ISO 14644-1. This draft has been approved for issue as DIS 14644-2.

CD 14644-4: Cleanrooms and Associated Controlled Environments, Part 4: Design, construction and start up of cleanroom facilities. This draft has been approved for issue as DIS 14644-4.

CD 14698-1: Cleanrooms and Associated Controlled Environments, Biocontamination control, Part 1: General principles. This draft has been approved for issue as DIS 14698-1.

CD 14698-2: Cleanrooms and Associated Controlled Environments, Biocontamination control, Part 2: Evaluation and interpretation of biocontamination data. This draft has been approved for issue as DIS 14698-2.

CD 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 biocontamination wet soiling or biofilms.

WD xxxx: Working Draft Documents for

Metrology and test measurements
Operation of cleanrooms
Minienvironments and isolators
Terms and definitions.

A change of policy has been introduced by the British Standards Institution whereby ISO Committee Drafts (CD) will be issued for public comment in advance of the Draft International Standard (DIS) stage. This affects some of the above documents. The present position is:

DIS 14644-1: Public comment terminated on 27th March, 1997 but the Draft is still publicly available. Any further comments received at this stage may not necessarily be accommodated.

CD 14644-2: When issued as DIS 14644-2, this draft will be circulated for public comment in the United Kingdom.

CD 14644-4: Public comment terminated on 27th March, 1997 but the Draft is still publicly available. Any further comments received at this stage may not necessarily be accommodated. Issue of DIS 14644-4 will be announced in the Cleanroom Monitor BSI update.

CD 14698-1: Public comment terminated on 30th November, 1996 but the Draft is still publicly available. Any further comments received at this stage may not necessarily be accommodated. Issue of DIS 14698-1 will be announced in the Cleanroom Monitor BSI update.

CD 14698-2: Public comment terminated on 30th November, 1996 but the Draft is still publicly available. Any further comments received at this stage may not necessarily be accommodated. Issue of DIS 14698-2 will be announced in the Cleanroom Monitor BSI update.

CD 14698-3: Public comment terminated on 30th November, 1996 but the Draft is still publicly available. Any further comments received at this stage may not necessarily be accommodated.

European Standards
Although, under the terms of the Vienna Agreement, the above draft ISO standards will be "parallel voted" as draft European Standards when they reach the DIS stage, the Comité Européen de Normalisation technical committee CEN/TC243 continued to work on one document for which there was a perceived need and which would later be replaced by a maturing ISO document. This European "pre-standard" (ENV) has now been published in the United Kingdom as:

DD ENV 1631 : 1996: Cleanroom Technology: Design, construction and operation of cleanrooms and clean air devices.

DIS 14644-1 was issued in parallel by CEN as prEN ISO 14644-1 for public enquiry. The next drafts to reach parallel enquiry in CEN and ISO will be the forthcoming DIS 14644-2, DIS 14644-4, DIS 14698-1 and DIS 14698-2.

British Standards
Whilst the current British Standard for cleanrooms may not be altered while the CEN work is in progress, a need has been recognized to give further guidance on the in situ testing of HEPA filters that is a requirement of BS 5295. For this purpose, BSI published the following document:

PD 6609 : 1996: In situ Aerosol Testing of HEPA filters.

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.