When challenged, the national experts explained that the DIS had been opened to broader scrutiny than had originally been available within their national mirror committees. Whilst this was extremely disappointing, it was felt, that it was more important to work through the issues to ensure the broader acceptance of a revised standard in the future. Sadly, it has to be reported that many of the nations' comments on the draft standard challenged or contradicted some of the important principles developed by their own experts during the two year evolution of the new draft. These are clearly outside the range of expectation envisaged during the evolution of cleanroom standards from the earliest US Federal Standard 209, up to the current ISO 14644-1:1999, and also the ISO DIS 14644-1:2010. To help experts understand scale, a Chinese presentation was made that illustrated single cleanroom facilities of up to 40,000 m², with working zones of up to 10,000 m². One of the most interesting of these was a serious concern about how the standard should deal with super-large cleanrooms.
This will inevitably mean a delay to the revision project but the topic of cleanroom classification was considered to be of such importance that the concerns of industry had to be addressed.Ī majority of the comments came from the pharmaceutical and life sciences industries, but there were also some very important comments made by the semiconductor and display screen manufacturing industries. The nature of the comments, and the likely changes to the DIS were so significant that it was decided that a second DIS enquiry and vote would be required. ISO TC209 WG1 met on the 8th and 9th October 2011 to consider the comments and the main issues raised by industry. Indeed there were more than 100 substantive technical comments and many more simply editorial. Not only is ISO DIS 4644-1:2010 the more important of the two standards, but it was also the one that received the majority of substantive comments.
In this case, the National voting was in favour of approval of both ISO DIS 14644-1 and ISO DIS 14644-2 subject to comments being addressed. The ISO and CEN rules require that every single comment is considered, adjudicated upon and reported for the record.
The comments are then submitted back to the ISO central secretariat, together with a national vote. Equivalent English, French, and German language versions are published by national standards bodies, and formal comments are sought. The DIS enquiry and vote is a very important stage in the standardisation process because it is the first time that the draft documents are opened beyond ISO TC209 for broader public and industry scrutiny. A convention, called the Vienna Convention, put in place to prevent unnecessary parallel work being carried out in CEN and ISO environments, has been applied to this work. As has been the case with the complete family of ISO TC209 cleanroom standards, the technical enquiry and vote was undertaken in parallel within the CEN (Committee for European Normalisation) standards community. Publication of ISO DIS14644-1:2010 for review and national voteClose followers of the ISO standardisation process for cleanrooms under ISO TC209 will recall that a DIS (draft international standard), ISO DIS 14644-1, was published at the end of 2010 for the statutory six month DIS review, comment and vote. This present paper builds on the principles developed in that paper, and sets out to explain the areas of concern and some of the technical arguments. Some of the issues have been reported on previously (3)(4) and in a paper by Haertvig et Al in the EJPPS (5), explaining the basis of the sampling statistics in the ISO DIS 14644- 1:2010 (6) (DIS - Draft International Standard). The role of the experts is to bring to the table current scientific and technical knowledge on the subject, and also to table the opinions and requirements developed through national mirror organisations such as BSI (British Standards Institute). The process of revision involves input by technical experts within an ISO committee environment, in this case WG (Working Group) 1 of ISO TC (Technical Committee) 209 which met in Milan, Italy in November 2011 and Copenhagen in February 2012. The parallel process of the revision of ISO 14644-2:2000 (2) is not described since the issues at large are not as fundamental to the cleanroom community. This article describes some very important issues relating to the revision of the fundamental cleanroom standard ISO 14644-1:1999 (1).
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