In addition to the national guidelines, in Germany e.g. the VDI guideline
series no. 2083, there are several internationally applicable guidelines.
The Federal Standard 209 /1/ in its latest, the "E", version is
widely known but will certainly be superseded by the ISO 14644 guideline
series.
The first generation of the international
standards for cleanroom technology will comprise a total of 10 titles.
Seven of these are devoted to general cleanroom technology and three
specifically to the control of biocontamination.
ISO/TC 209: Cleanrooms
and associated controlled environments
Standards projects in
process
|
Document no. |
Short title |
Status 07-01 |
|
ISO 14644-1 |
Classes of air
cleanliness |
Standard 05-99 |
|
ISO 14644-2 |
Specifications for
testing and monitoring to prove continued compliance with ISO
14644-1 |
Standard 09-00 |
|
ISO 14644-3 |
Metrology and test
methods |
CD 11-98 |
|
ISO 14644-4 |
Design,
construction and start-up of cleanrooms |
Standard 04-01 |
|
ISO 14644-5 |
Operations |
DIS 07-01 |
|
ISO 14644-6 |
Vocabulary |
CD 06-01 |
|
ISO 14644-7 |
Separative
enclosures (clean air hoods, gloveboxes, isolators,
mini-environments)
|
DIS 02-01 |
|
ISO 14698-1 |
Biocontamination control: General
principles and measurement of biocontamination of air, surfaces,
liquids and textiles |
DIS 02-99 |
|
ISO 14698-2 |
Evaluation and interpretation of
biocontamination data |
DIS 02-99 |
|
ISO 14698-3 |
Measurement of the efficiency of
processes of cleaning and/or disinfection |
DIS 02-99 |
The table provides an overview and
illustrates at the same time the progress of the work. The column Status
07-01 indicates the state of development of the individual documents,
namely when and in what stage of maturity these were last circulated.
There are three different stages of circulation, namely:
Committee Draft CD,
an advance circulation limited to the countries participating actively in
ISO/TC 209
Draft International Standard DIS,
the first official circulation to all ISO and CEN nations for survey
purposes (ISO and CEN enquiry)
Final Draft International Standard FDIS,
the second official circulation to all ISO and CEN nations for survey
purposes (ISO and CEN voting).
Three documents already have the status
of a definitively approved and effective standard and are also already
available as a DIN standard:
DIN EN ISO 14644-1:
Cleanrooms and associated controlled
environments – Part 1: Classification of air cleanliness
DIN EN ISO 14644-2:
Cleanrooms and associated controlled
environments – Part 2: Specifications for testing and monitoring to
prove continued compliance with ISO 14644-1
DIN EN ISO 14644-4:
Cleanrooms and associated controlled
environments – Part 4: Design, construction and start-up.
Work on a second generation of cleanroom
technology standards has started. The preparation of the definitions for
molecular contamination, i.e. the contamination risks emanating from
gaseous foreign matter in the air, has made the greatest progress.
Standards on surface cleanliness and on high-purity gases, high-purity
water and other high-purity liquids are to follow.
What effects do the new international
standards have on the practice of planning, construction, start-up and
qualification as well as on the operation of cleanrooms? The implications
are far-reaching; namely as soon as an international standard achieves DIS
status or the equivalent CEN status prEN:
- the drafts may be purchased via the
national standards associations or specialist bookshops;
- they may be made use of as the basis
for specifications as well as for agreements between planners, plant
builders and service providers, on the one hand, and their customers,
on the other hand;
- they are regarded in court as state of
the art.
It is therefore recommended that these
standards be given priority over national codices as well as over
guidelines issued by specialist associations as soon as they achieve DIS
status.
Source: Dr H. H. Schicht
Writer:
Harald Martin,
CONCEPT HEIDELBERG
|
