ISO STANDARDS UPDATE (November 2007)
International cleanroom standards are being produced by Technical Committee 209 of the International Organization for Standardization (ISO). Some have been published and others are at a given development stage. The development stages of the standards can be recognised by the prefixes they carry. These are as follows:
WD: Working Draft |
A developing document that is circulated only within the Working Group set up by the ISO/TC209 Committee. |
CD: Committee Draft |
A committee draft of a standard that is circulated only within ISO/TC209 for approval and, or, comments by the National Technical Bodies (standards organizations) of the countries participating in the writing of the standard. |
DIS: Draft International Standard |
A draft that is ISO-approved and circulated by ISO for public enquiry and vote of approval in all ISO member countries. |
FDIS: Final Draft International Standard |
A revised and approved DIS that is circulated for final vote of approval. |
To confirm that a published ISO standard remains up-to-date a vote is taken of member countries of ISO TC 209. If the standard is confirmed as being up-to-date it continues to be published for another 5 years. If it is considered to need revision then this is done. Standards that have been published for the first time are confirmed after 3 years (previously 5 years) and subsequent reviews are after every 5 years.
The ISO/TC209 documents are at the following stages:
ISO 14644: ‘Cleanrooms and Associated Controlled Environments’
This standard consists of several parts which
are as follows:
ISO 14644-1: Classification of air cleanliness. This standard gives the airborne particle limits to classify cleanrooms. The standard was issued in 1999. Work has now started on a revision of this standard and should be completed in 2009.
ISO 14644-2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1.This gives information, including time intervals, for testing a cleanroom to demonstrate continual compliance with the ISO 14644-1. The standard was issued in 2000. Work has now started on a revision of this standard that should be completed in 2009.
ISO 14644-3: Test methods. This gives a description of the test methods that should be used to test the cleanroom to show that it is working correctly. This standard was published in December 2005.
ISO 14644-4: Design, construction, and startup. This standard was published in 2001 and has recently undergone its 5 year review. It was decided that to confirm the existing document and therefore, there are no future revisions planned until the next review.
ISO 14644-5: Operations. This standard gives general advice on how to run a cleanroom. This standard was published in 2004. A periodic review vote was issued on July 2007 with the vote due by December 2007.
ISO 14644-6: Terms and definitions.This is a collection of all the definitions of terms used in the ISO cleanroom standards. This standard was issued in 2007.
ISO 14644-7: Separative devices (clean air hoods, gloveboxes, isolators, mini-environments). This gives information on clean air devices such as isolators and minienvironments. Standard published in 2004. A periodic review vote was issued on November 2007 with the vote due by March 2008.
ISO 14644-8: Classification of airborne molecular contamination.This gives information on gaseous chemical contamination in cleanrooms. Standard published on August 2006.
Proposed new standards
Work on two new standards has started. These two new standards are as follows:
ISO/CD 14644-9: Classification of surface particle cleanliness
A new work item proposal has been issued for ‘Classification of surface chemical cleanliness’ as ISO 14644-10, and an ISO work programme will start soon.
ISO 14698:‘Cleanrooms and Associated Controlled
Environments–Biocontamination Control’.
This standard consists of two parts:
ISO 14698-1: General principles and methods.
This gives information on how to establish methods for measuring
micro-organisms in the cleanroom. This standard was published in 2003.
ISO 14698-2: Evaluation and interpretation of biocontamination data. This gives information on how to deal
with the results obtained from measuring micro-organisms in a cleanroom. This
standard was published in 2003.
The above two standards need not be considered for revision until September
2008. However, ISO TC 209 has agreed to investigate starting work on two new
standards which have the following tentative titles:
A - Classification of airborne biocontamination cleanrooms, including methods of measurement and their validation
B - Classification of surface biocontamination in cleanrooms, including methods of measurement and their validation
How to obtain ISO Standards
ISO standards are copyright and can only be obtained from approved sources. They can be obtained throughout the world from the various national standard organisations, whose communication details can be found at:
http://www.iso.ch/iso/en/prods-services/ISOstore/memberstores.html.
A member of ICCCS who sells ISO standards is IEST (USA), whose web address is www.iest.org