BS EN ISO 14644-3-2005 Cleanrooms and associated controlled environments - Test methods《洁净室和相关控制环境 试验方法》.pdf

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1、BRITISH STANDARD BS EN ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods The European Standard EN ISO 14644-3:2005 has the status of a British Standard ICS 13.040.35 BS EN ISO 14644-3:2005 This British Standard was published under the authority of the Standards

2、Policy and Strategy Committee on 20 December 2005 BSI 20 December 2005 ISBN 0 580 47150 0 National foreword This British Standard is the official English language version of EN ISO 14644-3:2005. It is identical with ISO 14644-3:2005. The UK participation in its preparation was entrusted to Technical

3、 Committee LBI/30 Cleanroom technology, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and E

4、uropean developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Ca

5、talogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its

6、correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front 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

7、to 65 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO146443 December2005 ICS13.040.35 EnglishVersion Cleanroomsandassociat

8、edcontrolledenvironmentsPart3: Testmethods(ISO146443:2005) Sallespropresetenvironnementsmatrissapparents Partie3:Mthodesdessai(ISO146443:2005) ReinrumeundzugehrigeReinraumbereicheTeil3: Prfverfahren(ISO146443:2005) ThisEuropeanStandardwasapprovedbyCENon12September2005. CENmembersareboundtocomplywith

9、theCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandar

10、dexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepub

11、lic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORM

12、UNG ManagementCentre:ruedeStassart,36B1050Brussels 2005CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO146443:2005:E Foreword This document (EN ISO 14644-3:2005) has been prepared by Technical Committee ISO/TC 209 “Cleanrooms and associated contr

13、olled environments“ in collaboration with Technical Committee CEN/TC 243 “Cleanroom technology“, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2006,

14、 and conflicting national standards shall be withdrawn at the latest by June 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Esto

15、nia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 14644-3:2005 has been approved by CEN as EN ISO

16、14644-3:2005 without any modifications. EN ISO 14644-3:2005 Reference number ISO 14644-3:2005(E)INTERNATIONAL STANDARD ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments Part 3: Test methods Salles propres et environnements matriss apparents Partie 3: Mthodes dess

17、ai EN ISO 14644-3:2005ii EN ISO 14644-3:2005 iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 3.1 General. 2 3.2 Airborne particle measurement. 2 3.3 Air filters and systems . 4 3.4 Airflow and other physical states . 5 3.5 Electrostatic

18、measurement 5 3.6 Measuring apparatus and measuring conditions 6 3.7 Occupancy states . 7 4 Test procedures 8 4.1 Cleanroom tests 8 4.2 Principle. 9 5 Test reports . 11 Annex A (informative) Choice of recommended tests of an installation and the sequence in which to carry them out. 12 Annex B (infor

19、mative) Test methods 16 Annex C (informative) Test apparatus 51 Bibliography . 64 EN ISO 14644-3:2005 iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is norm

20、ally 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 take part in t

21、he 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 2. The main task of technical committees is to prepare

22、 International Standards. Draft International Standards adopted 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

23、 of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14644-3 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environements. ISO 14644 consists of the following

24、parts, under the general title Cleanrooms 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: Test methods Part 4: Design, construction and start-up Part 5: Operatio

25、ns Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) Part 8: Classification of airborne molecular contamination The following part is under preparation: Part 6: Vocabulary v Introduction Cleanrooms and associated controlled environments provide for the control

26、 of airborne contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include those in such industries as aerospace, microelectronics, pharmaceuticals, medical devices, healthcare and food

27、. This part of ISO 14644 sets out test methods that may be used for the purpose of characterizing a cleanroom as described and specified in other parts of ISO 14644. NOTE Not all cleanroom parameter test procedures are shown in this part of ISO 14644. The procedures and apparatus to characterize oth

28、er parameters, of concern in cleanrooms and clean zones used for specific products or processes, are discussed elsewhere in other documents prepared by ISO/TC 209 for example, procedures for control and measurement of viable materials (ISO 14698), testing cleanroom functionality (ISO 14644-4), and t

29、esting of separative devices (ISO 14644-7). In addition, other standards can be considered to be applicable. Statements in this part of ISO 14644 reference the standards of ASTM, CEN, DIN, IEST, JACA, JIS and SEMI. EN ISO 14644-3:2005blank1 Cleanrooms and associated controlled environments Part 3: T

30、est methods WARNING The use of this part of ISO 14644 may involve hazardous materials, operations and equipment. This part of ISO 14644 does not purport to address all of the safety problems associated with its use. It is the responsibility of the user of this part of ISO 14644 to establish appropri

31、ate safety and health practices and to determine the applicability of regulatory limitations prior to use. 1 Scope This part of ISO 14644 specifies test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones. Per

32、formance tests are specified for two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow, in three possible occupancy states: as-built, at-rest and operational. The test methods recommend test apparatus and test procedures for determining perfor

33、mance parameters. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested. For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this p

34、art of ISO 14644 may be used if based on agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements. This part of ISO 14644 is not applicable to the measurement of products or of processes in cleanrooms or separative devices. 2 Normative reference

35、s The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 7726:1998, Ergonomics of the thermal enviro

36、nment Instruments for measuring physical quantities ISO 14644-1:1999, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness ISO 14644-2:2000, Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued c

37、ompliance with ISO 14644-1 ISO 14644-4:2001, Cleanrooms and associated controlled environments Part 4: Design, construction and start-up EN ISO 14644-3:20052 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 General 3.1.1 cleanroom room in whic

38、h the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room, and in which other relevant parameters, e.g. temperature, humidity and pressure, are controlled as necessary ISO

39、 14644-1:1999, 2.1.1 3.1.2 clean zone dedicated space in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the zone, and in which other relevant parameters, e.g. temper

40、ature, humidity and pressure, are controlled as necessary NOTE This zone may be open or enclosed, and may or may not be located within a cleanroom. ISO 14644-1:1999, 2.1.2 3.1.3 installation cleanroom or one or more clean zones, together with all associated structures, air-treatment systems, service

41、s, and utilities ISO 14644-1:1999, 2.1.3 3.1.4 separative device equipment utilizing constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume NOTE Some industry-specific examples of separative devices are clean air hoods, containment

42、enclosures, glove boxes, isolators and mini-environments. 3.2 Airborne particle measurement 3.2.1 aerosol generator instrument capable of generating particulate matter having appropriate size range (e.g. 0,05 m to 2 m) at a constant concentration, which may be produced by thermal, hydraulic, pneumat

43、ic, acoustic or electrostatic means 3.2.2 airborne particle solid or liquid object suspended in air, viable or non-viable, sized (for the purpose of this part of ISO 14644) between 1 nm and 100 m NOTE For classification purposes, refer to ISO 14644-1:1999, 2.2.1. 3.2.3 count median particle diameter

44、 CMD median particle diameter based on the number of particles NOTE For the count median, one half of the particle number is contributed by the particles with a size smaller than the count median size, and one half by particles larger than the count median size. EN ISO 14644-3:20053 3.2.4 macroparti

45、cle particle with an equivalent diameter greater than 5 m ISO 14644-1:1999, 2.2.6 3.2.5 M descriptor measured or specified concentration of macroparticles per cubic metre of air, expressed in terms of the equivalent diameter that is characteristic of the measurement method used NOTE The M descriptor

46、 may be regarded as an upper limit for the averages at sampling locations (or as an upper confidence limit, depending upon the number of sampling locations used to characterize the cleanroom or clean zone). M descriptors cannot be used to define airborne particulate cleanliness classes, but they may

47、 be quoted independently or in conjunction with airborne particulate cleanliness classes. ISO 14644-1:1999, 2.3.2 3.2.6 mass median particle diameter MMD median particle diameter based on the particle mass NOTE For the mass median, one half of mass of all particles is contributed by particles with a

48、 size smaller than the mass median size, and one half by particles larger than the mass median size. 3.2.7 particle concentration number of individual particles per unit volume of air ISO 14644-1:1999, 2.2.3 3.2.8 particle size diameter of a sphere that produces a response, by a given particle-sizing instrument, that is equivalent to the response produced by the particle being measured NOTE For discrete-particle-counting, light-scattering instruments, the equivalent optical diameter is used. ISO