《BS-EN-ISO-14644-2-2000.pdf》由会员分享，可在线阅读，更多相关《BS-EN-ISO-14644-2-2000.pdf（20页珍藏版）》请在三一文库上搜索。
1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 14644-2:2000 Th
2、e European Standard EN ISO 14644-2:2000 has the status of a British Standard ICS 13.040.30 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO
3、 14644-1 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and co
4、mes into effect on 15 December 2000 BSI 12-2000 ISBN 0 580 36803 3 BS EN ISO 14644-2:2000 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN ISO 14644-2:2000. It is identical with ISO 14644-2:2000.This stand
5、ard supersedes BS 5295-4:1989 which was withdrawn in 1999. The UK participation in its preparation was entrusted to Technical Committee LBI/30, Cleanroom technology, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any
6、 enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. This British Standa
7、rd is one of a series, the other Parts of BS EN ISO 14644 being as follows: Part 1: Classification of air cleanliness; Part 3: Metrology and test methods; Part 4: Design, construction and start-up; Part 5: Operations; Part 6: Terms and definitions; Part 7: Separative enclosures (clean airhoods, glov
8、eboxes, isolators, mini-environments); Part 8: Molecular contamination. Part 1 has been published, while the numbering and titles of Parts 3 to 8 were provisional at the time of publication of Part 2. Attention is also drawn to BS 5295 Parts 0, 2 and 3 and PD 6609, all updated in 2000, which will re
9、main current documents until further Parts of BS EN ISO 14644 are published. Cross-references Attention is also drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. Th
10、e British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A Brit
11、ish Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a fron
12、t cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 7, the annex ZA page, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. L
13、icensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14644-2 September 2000 ICS 13.040.30 English version Cleanrooms and associated controlled environments - Part 2: Specifications for testi
14、ng and monitoring to prove continued compliance with ISO 14644-1 (ISO 14644-2:2000) Salles propres et environnements matriss apparents - Partie 2: Spcifications pour les essais et la surveillance en vue de dmontrer le maintien de la conformit avec lISO 14644-1 (ISO 14644-2:2000) Reinrume und zugehri
15、ge Reinraumbereiche - Teil 2: Festlegungen zur Prfung und berwachung zum Nachweis der fortlaufenden bereinstimmung mit ISO 14644-1 (ISO 14644-2:2000) This European Standard was approved by CEN on 15 September 2000. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipu
16、late the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. This European Standard exis
17、ts in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodie
18、s of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Ma
19、nagement Centre: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-2:2000 E Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
20、Foreword The text of the International Standard ISO 14644-2:2000 has been prepared by Technical Committee ISO/TC 209 “Cleanrooms and associated controlled environments“ in collaboration with Technical Committee CEN/TC 243 “Cleanroom technology“, the secretariat of which is held by BSI. This European
21、 Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2001, and conflicting national standards shall be withdrawn at the latest by March 2001. According to the CEN/CENELEC Internal Regulations, the national st
22、andards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. NOTE : N
23、ormative references to International Standards are listed in the Annex ZA (normative). Endorsement notice The text of the International Standard ISO 14644-2:2000 was approved by CEN as a European Standard without any modification. EN ISO 146442:2000 Licensed Copy: sheffieldun sheffieldun, na, Sat No
24、v 18 01:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 14644-2:2000(E) INTERNATIONAL STANDARD ISO 14644-2 First edition 2000-09-15 Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
25、 Salles propres et environnements matriss apparents Partie 2: Spcifications pour les essais et la surveilance en vue de dmontrer le maintien de la confirmit avec lISO 14644-1 EN ISO 146442:2000 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
26、 ii EN ISO 146442:2000 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii ContentsPage Foreword.iv Introduction.v 1Scope 1 2Normative references1 3Terms and definitions .1 3.1General terms.1 3.2Terms concerning frequency intervals .2 4Demon
27、stration of continued compliance2 4.1Principle2 4.2Testing for continued compliance.2 4.3Monitoring 4 4.4Documentation.4 4.5Records.5 Annex A (informative) Optional tests6 Annex B (informative) Guidance on the influence of risk assessment on cleanroom or clean zone tests and monitoring.7 EN ISO 1464
28、42:2000 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Stan
29、dards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also t
30、ake part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted
31、by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 14644 may be the subject of
32、 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 14644-2 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14644 consists of the following parts, under the general title Cl
33、eanrooms and associated controlled environments: Part 1: Classification of air cleanliness ?Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 ?Part 3: Metrology and test methods ?Part 4: Design, construction and start-up ?Part 5: Operations ?Part 6: Ter
34、ms and definitions ?Part 7: Separative enclosures (clean airhoods, gloveboxes, isolators, mini-environments) Users should note that the titles listed for parts 3 to 7 are working titles at the time of the release of part 2. In the event that one or more of these parts are deleted from the work progr
35、amme, the remaining parts may be renumbered. Annexes A and B of this part of ISO 14644 are for information only. EN ISO 146442:2000 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Introduction This part of ISO 14644 provides a process to p
36、rove continued compliance with ISO 14644-1 and specifies minimum requirements for testing and monitoring. In any testing plan, consideration should also be given to the particular operational requirements, risk assessment of the installation, and its use. Cleanrooms and associated controlled environ
37、ments provide for the control of airborne particulate contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include aerospace, microelectronics, pharmaceuticals, medical devices, health
38、care, food and others. Many factors besides airborne particulate cleanliness should be considered in the design, specification, operation and control of cleanrooms and other controlled environments. In some circumstances, relevant regulatory agencies may impose supplementary policies or restrictions
39、. In such situations, appropriate adaptations of the standard testing procedures may be required. EN ISO 146442:2000 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 146442:2000 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01
40、:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 1Scope This part of ISO 14644 specifies requirements for periodic testing of a cleanroom or clean zon
41、e to prove its continued compliance with ISO 14644-1 for the designated classification of airborne particulate cleanliness. These requirements invoke the test described in ISO 14644-1 for classification of a cleanroom or clean zone. Additional tests are also specified, to be carried out in accordanc
42、e with the requirements of this part of ISO 14644. Optional tests, to be applied at the users discretion, are also identified. This part of ISO 14644 also specifies requirements for monitoring of a cleanroom or clean zone (hereafter referred to as an installation) to provide evidence of its continue
43、d compliance with ISO 14644-1 for the designated classification of airborne particulate cleanliness. 2Normative references The following normative document contains provisions which, through reference in this text, constitute provisions of this part of ISO 14644. For dated references, subsequent ame
44、ndments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 14644 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest editio
45、n of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 14644-1:1999, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness. ISO 14644-3:1), Cleanrooms and associated controlled e
46、nvironments Part 3: Metrology and test methods. 3Terms and definitions For the purposes of this part of ISO 14644, the terms and definitions given in ISO 14644-1 and the following apply. 3.1General terms 3.1.1 requalification execution of the test sequence specified for the installation to demonstra
47、te compliance with ISO 14644-1 according to the classification of the installation, including the verification of the selected pre-test conditions 1)To be published. EN ISO 146442:2000 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:51:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 3.1.2
48、test procedure undertaken in accordance with a defined method to determine the performance of an installation or an element thereof 3.1.3 monitoring observations made by measurement in accordance with a defined method and plan to provide evidence of the performance of an installation NOTEThis inform
49、ation may be used to detect trends in operational state and to provide process support. 3.2Terms concerning frequency intervals 3.2.1 continuous updating that occurs constantly 3.2.2 frequent updating that occurs at specified intervals not exceeding 60 minutes during operation 3.2.3 6 months updating that occurs at an average interval not exceeding 183 days throughout periods of operational use, subject to no interval exceeding 190 days 3.2.4 12 months updating that occurs at an average interval not exceeding 366 days throughout per