Cleanroom standards being produced for world use by the International Organisation for Standardisation 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 air cleanliness. This draft has been approved for issue as FDIS 14644-1. |
|
CD 14644-2 |
Cleanrooms and Associated Controlled Environments, Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1. This draft has been issued 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 issued 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
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. |
|
DIS 14644-2 |
Public comment terminates on 30th October, 1998. Draft available from BSI as document 98/123943 DC. |
|
CD 14644-4 |
Public comment terminated on 27th March, 1997 but the Draft is still publicly available. DIS 14644-4 has now also been issued. Any further comments received at this stage may not necessarily be accommodated. |
|
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. |
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. DIS 14644-2 and DIS 14644-4 have also been issued in parallel by CEN as prEN ISO 14644-2 and prEN ISO 14644-4 respectively. The next drafts to reach parallel enquiry in CEN and ISO will be the forthcoming DIS 14698-1 and DIS 14698-2. |
Whilst the current British Standard for cleanrooms may not be altered while the CEN work is in progress, a need has been recognised 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.