BS EN ISO 14644-6-2007 Cleanrooms and associated controlled environments Vocabulary《无菌室和相关控制环境 词汇表》.pdf

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1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Part 6: VocabularyThe European Standard EN ISO 14644-6:2007 has the status of a British StandardICS

2、 13.040.35Cleanrooms and associated controlled environments BRITISH STANDARDBS EN ISO 14644-6:2007BS EN ISO 14644-6:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2007 BSI 2007ISBN 978 0 580 56134 4Amendments issued since publi

3、cationAmd. No. Date Commentscontract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.National forewordThis British Standard is the UK implementation of EN ISO 14644-6:2007. It supersedes BS 5295-0:1989 which is withd

4、rawn. The UK participation in its preparation was entrusted to Technical Committee LBI/30, Cleanroom technology.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a EUROPEAN ST

5、ANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 14644-6July 2007ICS 13.040.35English VersionCleanrooms and associated controlled environments - Part 6:Vocabulary (ISO 14644-6:2007)Salles propres et environnements matriss apparents -Partie 6: Vocabulaire (ISO 14644-6:2007)Reinrume und zugehrige Reinraumbe

6、reiche - Teil 6:Terminologie (ISO 14644-6:2007)This European Standard was approved by CEN on 10 May 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration.

7、 Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationu

8、nder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece,

9、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre

10、: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14644-6:2007: EForeword This document (EN ISO 14644-6:2007) has been prepared by Technical Committee ISO/TC 209 “Cleanrooms and associated

11、 controlled 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 Janu

12、ary 2008, and conflicting national standards shall be withdrawn at the latest by January 2008. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech R

13、epublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 14644-6:2007 has

14、been approved by CEN as EN ISO 14644-6:2007 without any modifications. EN ISO 14644-6:2007Reference numberNumro de rfrenceISO 14644-6:2007(E/F)INTERNATIONAL STANDARD NORME INTERNATIONALE ISO14644-6First editionPremire dition2007-07-15Cleanrooms and associated controlled environments Part 6: Vocabula

15、ry Salles propres et environnements matriss apparents Partie 6: Vocabulaire EN ISO 14644-6:2007ii iiiContents Page Foreword .v Introduction.vii 1 Scope1 2 Terms and definitions.1 Bibliography30 Alphabetical index31 French alphabetical index (Index alphabtique) .33 EN ISO 14644-6:2007iv Sommaire Page

16、 Avant-propos. vi Introduction . viii 1 Domaine dapplication . 1 2 Termes et dfinitions . 1 Bibliographie 30 Index alphabtique anglais (Alphabetical index) 31 Index alphabtique 33 EN ISO 14644-6:2007vForeword ISO (the International Organization for Standardization) is a worldwide federation of natio

17、nal standards bodies (ISO member bodies). The work of preparing International Standards 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. Internati

18、onal organizations, governmental and non-governmental, in liaison with ISO, also take 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 rul

19、es given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare 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

20、least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some 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 14644-6 was prepared by Technical Committee ISO/T

21、C 209, Cleanrooms and associated controlled environments. ISO 14644 consists of the following 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 wi

22、th ISO 14644-1 Part 3: Test methods Part 4: Design, construction and start-up Part 5: Operations Part 6: Vocabulary Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) Part 8: Classification of airborne molecular contamination EN ISO 14644-6:2007vi Avant-propos

23、LISO (Organisation internationale de normalisation) est une fdration mondiale dorganismes nationaux de normalisation (comits membres de lISO). Llaboration des Normes internationales est en gnral confie aux comits techniques de lISO. Chaque comit membre intress par une tude a le droit de faire partie

24、 du comit technique cr cet effet. Les organisations internationales, gouvernementales et non gouvernementales, en liaison avec lISO participent galement aux travaux. LISO collabore troitement avec la Commission lectrotechnique internationale (CEI) en ce qui concerne la normalisation lectrotechnique.

25、 Les Normes internationales sont rdiges conformment aux rgles donnes dans les Directives ISO/CEI, Partie 2. La tche principale des comits techniques est dlaborer les Normes internationales. Les projets de Normes internationales adopts par les comits techniques sont soumis aux comits membres pour vot

26、e. Leur publication comme Normes internationales requiert lapprobation de 75 % au moins des comits membres votants. Lattention est appele sur le fait que certains des lments du prsent document peuvent faire lobjet de droits de proprit intellectuelle ou de droits analogues. LISO ne saurait tre tenue

27、pour responsable de ne pas avoir identifi de tels droits de proprit et averti de leur existence. LISO 14644-6 a t labore par le comit technique ISO/TC 209, Salles propres et environnements matriss apparents. LISO 14644 comprend les parties suivantes, prsentes sous le titre gnral Salles propres et en

28、vironnements matriss apparents: Partie 1: Classification de la propret de lair Partie 2: Spcifications pour les essais et la surveillance en vue de dmontrer le maintien de la conformit avec lISO 14644-1 Partie 3: Mthodes dessai Partie 4: Conception, construction et mise en fonctionnement Partie 5: E

29、xploitation Partie 6: Vocabulaire Partie 7: Dispositifs sparatifs (postes air propre, botes gants, isolateurs et mini-environnements) Partie 8: Classification de la contamination molculaire aroporte EN ISO 14644-6:2007viiIntroduction Cleanrooms and associated controlled environments provide for the

30、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 those in the aerospace, microelectronic, pharmaceutical, medical device, food, and healthca

31、re industries. EN ISO 14644-6:2007viii Introduction Les salles propres et les environnements matriss apparents permettent de matriser la contamination particulaire aroporte des niveaux appropris la conduite dactivits sensibles la contamination. Parmi les produits et procds qui bnficient de cette mat

32、rise de la contamination aroporte figurent, entre autres, ceux que lon trouve dans des secteurs industriels tels que larospatiale, la microlectronique, la pharmacie, les dispositifs mdicaux, lalimentation et la sant. EN ISO 14644-6:20071Cleanrooms and associated controlled environments Part 6: Vocab

33、ulary Salles propres et environnements matriss apparents Partie 6: Vocabulaire 1 Scope This part of ISO 14644 establishes a vocabulary of terms and definitions related to cleanrooms and associated controlled environments. This part of ISO 14644 is a compendium of the terms and definitions given in t

34、he other parts of ISO 14644. It also includes the terms and definitions given in ISO 14698-1 and ISO 14698-2. 1 Domaine dapplication La prsente partie de lISO 14644 tablit les termes et dfinitions relatifs aux salles propres et aux environnements maitriss apparents. La prsente partie de lISO 14644 e

35、st un recueil de termes et de dfinitions donns dans les autres parties delISO 14644. Elle comprend galement les termes et dfinitions donns dans lISO 14698-1 et lISO 14698-2. 2 Terms and definitions 2 Termes et dfinitions 2.1 6 months updating that occurs at an average interval not exceeding 183 days

36、 throughout periods of operational (2.97) use, subject to no interval exceeding 190 days ISO 14644-2:2000, 3.2.3 2.1 surveillance 6 mois renouvellement des mesurages intervenant un intervalle moyen infrieur ou gal 183 jours conscutifs dinstallation en activit (2.97), condition quaucun intervalle ne

37、dpasse 190 jours conscutifs ISO 14644-2:2000, 3.2.3 2.2 12 months updating that occurs at an average interval not exceeding 366 days throughout periods of operational (2.97) use, subject to no interval exceeding 400 days ISO 14644-2:2000, 3.2.4 2.2 surveillance 12 mois renouvellement des mesurages i

38、ntervenant un intervalle moyen infrieur ou gal 366 jours conscutifs dinstallation en activit (2.97), condition quaucun intervalle ne dpasse 400 jours conscutifs ISO 14644-2:2000, 3.2.4 EN ISO 14644-6:20072 2.3 24 months updating that occurs at an average interval not exceeding 731 days throughout pe

39、riods of operational (2.97) use, subject to no interval exceeding 800 days ISO 14644-2:2000, 3.2.5 2.3 surveillance 24 mois renouvellement des mesurages intervenant un intervalle moyen infrieur ou gal 731 jours conscutifs dinstallation en activit (2.97), condition quaucun intervalle ne dpasse 800 jo

40、urs conscutifs ISO 14644-2:2000, 3.2.5 2.4 access device device for manipulation of processes, tools or products within the separative device (2.118) ISO 14644-7:2004, 3.1 2.4 dispositif daccs dispositif permettant la manipulation de procds, doutils ou de produits lintrieur du dispositif sparatif (2

41、.118) ISO 14644-7:2004, 3.1 2.5 acid substance whose chemical reaction characteristic is to establish new bonds by the acceptance of electron pairs ISO 14644-8:2006, 3.2.1 2.5 acide substance qui a pour caractristique, en matire de raction chimique, dtablir de nouvelles liaisons par acceptation de p

42、aires dlectrons ISO 14644-8:2006, 3.2.1 2.6 action level general level set by the user in the context of controlled environments (2.45), which, when exceeded, requires immediate intervention, including the investigation of cause, and corrective action (2.46) ISO 14644-7:2004, 3.2 ISO 14698-1:2003, 3

43、.1.1 2.6 niveau daction sens gnral niveau tabli par lutilisateur dans le contexte dun environnement matris (2.45) qui, lorsquil est dpass, ncessite une intervention immdiate, y compris la recherche de la cause, et une action corrective (2.46) ISO 14644-7:2004, 3.2 ISO 14698-1:2003, 3.1.1 2.7 action

44、level microbiological microbiological level set by the user in the context of controlled environments(2.45), which, when exceeded, requires immediate intervention, including the investigation of cause, and corrective action (2.46) ISO 14698-2:2003, 3.1 2.7 niveau daction en microbiologie niveau micr

45、obiologique tabli par lutilisateur dans le contexte dun environnement matris (2.45) qui, lorsquil est dpass, ncessite une intervention immdiate, y compris la recherche de la cause, et une action corrective (2.46) ISO 14698-2:2003, 3.1 2.8 aerosol challenge challenging of a filter or an installed fil

46、ter system(2.83) by test aerosol (2.131) ISO 14644-3:2005, 3.3.1 2.8 essai par arosol contrle dun filtre ou dun lment de filtration install (2.83) par exposition un arosol dessai(2.131) ISO 14644-3:2005, 3.3.1 EN ISO 14644-6:200732.9 aerosol generator instrument capable of generating particulate mat

47、ter having appropriate size range (e.g. 0,05 m to 2 m) at a constant concentration, which may be produced by thermal, hydraulic, pneumatic, acoustic, or electrostatic means ISO 14644-3:2005, 3.2.1 2.9 gnrateur darosol appareil capable de gnrer une matire particu-laire possdant une tendue granulomtri

48、que approprie (par exemple entre 0,05 m et 2 m) une concentration constante, que lon peut produire par des moyens thermiques, hydrauliques, pneumatiques, acoustiques ou lectrostatiques ISO 14644-3:2005, 3.2.1 2.10 aerosol photometer light-scattering airborne particle (2.13) mass concentration measuring apparatus, which uses a forward-scattered-light optical chamber to make measurements ISO 14644-3:2005, 3.6.1 2.10 photomtre darosols appareil de mesure de la concentration en mas