Standards (2000)

The new ISO [International Standards Organisation] standards 14644 Part 4 which relates to design, construction and start-up of cleanroom facilities is in the Final Vote Stage.

There are 8 sections and 8 appendices. They are completely generic. They were written this way intentionally so that they are not specific to one industry. Do you know how they apply to your industry?

[1] normative: that which you must or SHALL do and therefore it is mandatory

[2] informative: that which you SHOULD do and therefore it is non-mandatory, i.e. voluntary. Around 25% is normative; 75% is informative mostly in the form of appendices expressed as guidelines.

An example of a (normative) section, Section 6 "Construction & Start-up", states "that construction shall comply with the approved design, shall be accurate, shall be undertaken in an appropriate way".

An example of an (informative) appendix, Appendix H "Additional Specifications", looks at standby and back-up of cleanrooms, disabled people in cleanrooms and scheduling.

[1] Gordon Farquharson, Bovis Tanvec, Consultants and Engineers, Tanshire House, Shackleford Road, Elstead, Surrey, GB8 6LB, UK. Tel 01252 703 663 Fax 01252 703 968. Email: gfarquharson@tanvec.com

[2] British Standards Institution, Customers Services, 389 Chiswick High Road, London, W4 4AL. Tel 02089 969 001 Fax 02089 967 001. Web:www.bsi.org.uk Email: info@bsi.org.uk

Gordon is one of the UK experts on the ISO committee writing the ISO 14644-4 standard.

Second International Standard Issued

The British Standards Institution has just announced that BS EN ISO 14644-2 is now available, its title being Specifications for testing and monitoring to prove compliance with ISO 14644-1. This is the second in a series of standards that is being prepared by the International Standards Organisation under the overall title Cleanrooms and associated controlled environments, the series being as follows:

Part 2: Specifications for testing and monitoring to prove continued compliance with IS014644-1

There is also an other ISO standard 14698 being prepared by the same committee that consists of the following parts under the general title Cleanrooms and Associated Controlled EnvironmentsBiocontamination Control:

Part 1	General principles and methods. This covers how to establish methods for measuring microorganisms in the cleanroom.
Part 2	Evaluation and interpretation of biocontamination data. This gives information on how to deal with the results obtained from monitoring a cleanroom for micro-organisms.

All of the above standards are in preparation. Some are available in a draft form available to members of the public. Others are not as far advanced. For reasonably current information, readers should consult previous editions of The Monitor [e.g. Issue 39].

Part 2 of the BS EN ISO 14644-1 standard is are available in the UK from British Standards Institution using the following contact information:

British Standards Institution
Customer Services
389 Chiswick High Road
London, W4 4AL, UK.

ISO 14644-4 Cleanrooms and Associated Controlled Environments

Part 4 - Design, Construction & Startup

Gordon Farquharson

Second International Standard Issued