Protect your products and processes from contamination with cleanrooms specification
10 July 2006
Manage and control cleanrooms and associated controlled environments
In industries where the manufacture or handling of items such as medical devices and microelectronic products, requires high levels of contamination control and classification of even the smallest particle or airborne molecular contaminant - a pristine cleanroom environment is required.
Cleanrooms are enclosed spaces where the air quality is managed to reduce dust, microbes, and other airborne contaminants to minimal levels. To support the management and control of such environments, BSI is pleased to announce the publication of a new standard.
An important new BSI Standard – BS EN ISO 14664-8:2006
BS EN ISO 14644-8:2006 Cleanrooms and associated controlled environments. Classification of airborne molecular contamination covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category). It provides a protocol to include test methods, analysis and time weighted factors within the specification for classification.
Within this part of BS EN ISO 14644, the presence of airborne molecules is expressed as airborne molecular contamination (AMC). Molecular contamination is a three-step event. The first step is generation due to external sources, process leakage or construction or human material outgassing. The second step is transport as AMC in air. The third step is sorption on the sensitive surface, which can be quantified as a surface molecular contamination (SMC).
ISBN 0 580 48299 5
BS EN ISO 14644-8:2006 is one of a series of standards concerned with cleanrooms and contamination control. Many factors besides AMC need to be considered in the design, specification, operation and control of cleanrooms and other controlled environments. These are covered in some detail in other parts to the standard.
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BS EN ISO 14644-1:1999 Cleanrooms and associated controlled environments. Classification of air cleanliness
This part covers the classification of air cleanliness in cleanrooms and associated controlled environments exclusively in terms of concentration of airborne particles.
ISBN 0 580 32951 8
BS EN ISO 14644-2:2000 Cleanrooms and associated controlled environments. Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
BS EN ISO 14644-2 specifies requirements for periodic testing of a cleanroom or clean zone to prove its continued compliance with BS EN ISO 14644-1 for the designated classification of airborne particulate cleanliness. These requirements invoke the test described in BS EN ISO 14644-1 for classification of a cleanroom or clean zone.
BS EN ISO 14644-2:2000 supersedes BS 5295-4:1989 which is now withdrawn.
ISBN 0 580 47150 0
BS EN ISO 14644-3:2005 Cleanrooms and associated controlled environments. Test methods
BS EN ISO 14644-3 sets out test methods that may be used for the purpose of characterizing a cleanroom as described and specified in other parts of BS EN ISO 14644.
ISBN 0 580 47150 0
BS EN ISO 14644-4:2001 Cleanrooms and associated controlled environments. Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
BS EN ISO 14644-4 specifies the requirements for the design and construction of cleanroom facilities. It is intended for use by purchasers, suppliers and designers of cleanroom installations and provides a check list of important parameters of performance. BS EN ISO 14644-4:2001 supersedes BS 5295-2:1989 which is now withdrawn.
ISBN 0 580 37985 X
BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments. Operations
This part of BS EN ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products.
ISBN 0 580 44320 5
BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments. Separative devices (clean air hoods, gloveboxes, isolators and mini-environments
BS EN ISO 14644-7 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in BS EN ISO 14644-4 and BS EN ISO 14644-5.
ISBN 0 580 44610 7
BS EN ISO 14698-2:2003 Cleanrooms and associated controlled environments. Biocontamination control. Evaluation and interpretation of biocontamination data
BS EN ISO 14698-2 presents a framework for the evaluation of biocontamination data collected following the principles and methods given in ISO 14698-1. It may also be applied to biocontamination data collected by other systems. It gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used, where appropriate, in conjunction with BS EN ISO 14698-1.
ISBN 0 580 42779 X
All BSI publications featured in this release are available for review. To make your request, please contact:
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