1、BRITISH STANDARD BS EN ISO 14644-5:2004 Cleanrooms and associated controlled environments Part 5: Operations The European Standard EN ISO 14644-5:2004 has the status of a British Standard ICS 13.040.35 BS EN ISO 14644-5:2004 This British Standard was published under the authority of the Standards Po
2、licy and Strategy Committee on 20 August 2004 BSI 20 August 2004 ISBN 0 580 44320 5 National foreword This British Standard is the official English language version of EN ISO 14644-5:2004. It is identical with ISO 14644-5:2004. It supersedes BS 5295-3:1989 which is withdrawn. It, together with BS EN
3、 ISO 14644-4:2001, supersedes DD ENV 1631:1996 which is now withdrawn. The UK participation in its preparation was entrusted to Technical Committee LBI/30, Cleanroom technology, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its s
4、ecretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Ca
5、talogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understan
6、d the text; present to the responsible international/European committee any 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. Summary of pages This document comprises a
7、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 to 44, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issu
8、ed since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO146445 August2004 ICS Englishversion CleanroomsandassociatedcontrolledenvironmentsPart5: Operations(ISO146445:2004) Sallespropresetenvironnementsmatrissapparents Partie5:Exploitation(ISO146445:2004) Reinru
9、meundzugehrigeReinraumbereicheTeil5: Betrieb(ISO146445:2004) ThisEuropeanStandardwasapprovedbyCENon29July2004. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbib
10、liographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotif
11、iedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia
12、, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2004CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO14
13、6445:2004:E Foreword This document (EN ISO 14644-5:2004) 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 Standar
14、d shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2005, and conflicting national standards shall be withdrawn at the latest by February 2005. According to the CEN/CENELEC Internal Regulations, the national stan
15、dards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, S
16、lovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 14644-5:2004 has been approved by CEN as EN ISO 14644-5:2004 without any modifications. ENISO146445:2004 Reference number ISO 14644-5:2004(E)INTERNATIONAL ADNATSDR ISO 144645- tide tsriFino -400251-8
17、0 Cleanrooms and associated controlled environments Part 5: Operations Salles propres et environnements matriss apparents Partie 5: Exploitation Referecne unbmer OSI -4464102:5)E(40INTERNATIONAL STANDARD ISO 14644-5 First edition 2004-08-15 ornaelCmona sossa detaicd ocellortnd nevioremnn st :5 traP
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21、aem lertaign ti ot is f,dnuo lpsaee ifnrom ttneC ehlar Secterirata ta teh serddaig sleb nevwo. ii ENISO146445:2004 iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 Specification of requirements . 3 Annex A (informative) Operational systems
22、 7 Annex B (informative) Cleanroom clothing 13 Annex C (informative) Personnel 18 Annex D (informative) Stationary equipment. 22 Annex E (informative) Materials and portable equipment 26 Annex F (informative) Cleanroom cleaning . 33 Bibliography . 43 ENISO146445:2004iv Foreword ISO (the Internationa
23、l Organization for Standardization) is a worldwide federation of national 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 es
24、tablished has the right to be represented on that committee. International 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 standardi
25、zation. 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 International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for vot
26、ing. 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all suc
27、h patent rights. ISO 14644-5 was prepared by Technical Committee ISO/TC 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: Spec
28、ifications 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: Operations Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) Part 8: Classification of airborne molecula
29、r contamination The following part is under preparation: Part 6: Terms and definitions ENISO146445:2004 vIntroduction Industries and organizations of all kinds utilize cleanrooms. Operational procedures have a profound effect on the cleanliness levels achieved during the operation of the cleanroom a
30、nd equipment. Consistent quality is cleanliness dependent. Operational cleanliness can only be attained and maintained through a deliberate programme established to specify, measure and enforce defined operational procedures. Regulatory agencies that have authority over processes and products produc
31、ed in the cleanroom may require additional procedures and measures of cleanliness not covered in this general operating standard. This part of ISO 14644 addresses normative and informative operational requirements related to: a) providing a system that defines policies and operational procedures; b)
32、 clothing used to isolate human-generated contamination from the cleanroom environment; c) training of personnel inside the cleanroom and monitoring their compliance to specified procedures and disciplines; d) transfer, installation and maintenance of stationary equipment (selection criteria is not
33、discussed); e) selection and use of materials and portable equipment in the cleanroom; f) maintaining the cleanliness of the cleanroom through systematic cleaning and monitoring procedures. ENISO146445:2004INTENRATIONAL TSANDADR IS-44641 O5:(4002E)Cleanrooms and associated controlled environments Pa
34、rt 5: Operations 1 Scope This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national an
35、d local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within clean
36、rooms are not covered in detail in this part of ISO 14644 but reference is made to ISO 14644-2 and ISO 14644-3 for monitoring particles and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms. 2 Normative references The following referenced documents are indispensable for the application of t
37、his document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14644-1:1999, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness ISO 14644-2:2000
38、, Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 ISO 14644-3: 1) , Cleanrooms and associated controlled environments Part 3: Test methods ISO 14644-4:2001, Cleanrooms and associated controlled environ
39、ments Part 4: Design, construction and start-up ISO 14698-1:2003, Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods ISO 14698-2:2003, Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and inte
40、rpretation of biocontamination data 1) To be published. ENISO146445:2004ENISO146445:20041 3 Terms and definitions For the purposes of this part of ISO 14644, the following terms and definitions apply. 3.1 General Terms 3.1.1 biocleanroom cleanroom used for products and processes that are sensitive t
41、o microbiological contamination 3.1.2 changing room room where people entering or leaving a cleanroom put on or take off cleanroom clothing NOTE Adapted from ISO 14644-4:2001, 3.1. 3.1.3 cross-over bench bench that is used as an aid to changing of cleanroom clothing and which provides a barrier to t
42、he tracking of floor contamination 3.1.4 disinfection removal, destruction or de-activation of micro-organisms on objects or surfaces 3.1.5 fibre particle having an aspect (length-to-width) ratio of 10 or more ISO 14644-1:1999, 2.2.7 3.1.6 operator person working in the cleanroom performing producti
43、on work or carrying out process procedures 3.1.7 particle minute piece of matter with defined physical boundaries NOTE For classification purposes refer to ISO 14644-1:1999. 3.1.8 personnel persons entering the cleanroom for any purpose 3.1.9 separative device equipment utilizing constructional and
44、dynamic means to create assured levels of separation between the inside and the outside of a defined volume EXAMPLES Some industry-specific examples of separative devices are clean air hoods, containment enclosures, gloveboxes, isolators and minienvironments. 3.1.10 unidirectional airflow controlled
45、 airflow through the entire cross-section of a clean zone with a steady velocity and approximately parallel airstreams NOTE This type of airflow results in a directed transport of particles from the clean zone. ISO 14644-4:2001, 3.11 ENISO146445:2004ENISO146445:20042 3.2 Occupancy states 3.2.1 as-bu
46、ilt condition where the installation is complete with all services connected and functioning but with no production equipment, materials or personnel present ISO 14644-4:2001, 2.4.1 3.2.2 at-rest condition where the installation is complete with equipment installed and operating in a manner agreed u
47、pon by the customer and supplier, but with no personnel present ISO 14644-4:2001, 2.4.2 3.2.3 operational condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon ISO 14644-4:2001, 2.4.3 4 Specificat
48、ion of requirements 4.1 Operational systems 4.1.1 A system of operational procedures shall be established and documented that will provide a framework for producing the quality products and processes for which the cleanroom was designed. 4.1.2 A set of risk factors, appropriate for the use of the cleanroom, shall identify the areas where there is a risk of contamination to the process. A method for monitoring these risks shall be instituted so that action can be taken when conditions viol
