BS EN ISO 14698-2-2003 Cleanrooms and associated controlled environments - Biocontamination control - Evaluation and interpretation of biocontamination data《洁净室和相关控制环境 生物污染控制 生物污染数.pdf

1、BRITISH STANDARD BS EN ISO 14698-2:2003 Incorporating Corrigendum No. 1 and Technical Corrigendum No. 2 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data The European Standard EN ISO 14698-2:2003 has the status o

2、f a British Standard ICS 13.040.35 BS EN ISO 14698-2:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 24 October 2003 BSI 21 February 2005 ISBN 0 580 42779 X National foreword This British Standard is the official English language version

3、 of EN ISO 14698-2:2003. It is identical with ISO 14698-2:2003, including Technical Corrigendum 01-11-2004. 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 committe

4、e 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 Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Sear

5、ch” 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 correct application. Compliance with a British Standard does not of itself confer immunity from legal ob

6、ligations. aid enquirers to understand 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. Summar

7、y 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 iv, pages 1 to 11, the Annex ZA page, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when th

8、e document was last issued. Amendments issued since publication Amd. No. Date Comments 14880 Corrigendum No. 1 28 November 2003 Incorporating corrected EN ISO foreword page and adding Annex ZA page 15552 Technical Corrigendum No. 2 21 February 2005 Corrections to 3.1, 3.2, 3.10 and 3.13EUROPEANSTAND

9、ARD NORMEEUROPENNE EUROPISCHENORM ENISO146982 September2003 ICS13.040.35 Englishversion Cleanroomsandassociatedcontrolledenvironments BiocontaminationcontrolPart2:Evaluationandinterpretation ofbiocontaminationdata(ISO146982:2003) Sallespropresetenvironnementsmatrissapparents Matrisedelabiocontaminat

10、ionPartie2:Evaluationet interprtationdesdonnesdebiocontamination(ISO 146982:2003) ReinrumeundzugehrigeReinraumbereiche BiokontaminationskontrolleTeil2:Auswertungund InterpretationvonBiokontaminationsdaten(ISO14698 2:2003) ThisEuropeanStandardwasapprovedbyCENon10July2003. CENmembersareboundtocomplywi

11、ththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandar

12、dexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denma

13、rk,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels

14、 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO146982:2003EINESO41896:2002(3E) 2 CORRECTED20031105 Foreword Thisdocument(ENISO146982:2003)hasbeenpreparedbyTechnicalCommitteeISO/TC209 “Cleanroomsandassociatedcontrolledenvironments“incollabor

15、ationwithTechnicalCommittee CEN/TC243“Cleanroomtechnology“,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationof anidenticaltextorbyendorsement,atthelatestbyMarch2004,andconflictingnational standardsshallbewithdrawnatthelatestbyMarch2004

16、. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy, Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Sp

17、ain,Sweden,Switzerlandand theUnitedKingdom. Endorsementnotice ThetextofISO146982:2003hasbeenapprovedbyCENasENISO146982:2003withoutany modifications. NOTENormativereferencestoInternationalStandardsarelistedinAnnexZA(normative). ENISO146982:2003 Reference number ISO 14698-2:2003(E) OSI 3002INTERNATION

18、AL STANDARD ISO 14698-2 First edition 2003-09-15 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data Salles propres et environnements matriss apparents Matrise de la biocontamination Partie 2: valuation et interprt

19、ation des donnes de biocontamination ENISO146982:2003IS-89641 O2:(3002E) DPlcsid Fremia ihTs PDF file mc yatnoaie nmt deddebyfepca.se Icca ncnadrow eitA hebods licsneilop gnic,y tihs file mirp eb yatniv ro deewb detu slahl ton ide ebtlnu desse tt ehyfepacse wihce era hml era deddebicsnede to i dnasn

20、tlalde t noeh comtupfrep remroign tide ehti.gn Iwod nnlidaogn tihs fil,e trapies ccatpe tiereht nsnopser ehiiblity fo ton ifnriignA gnebods licnesilop gnic.y I ehTStneC Oarl Scerteiraat cacpets l oniibality it nihs .aera Ai ebods a tedarmfo kra Aebod SystemI snctaropro.de teDials fo ts ehfotworp era

21、cudts ust dec ortaet eihs PDF filc eeb na fi dnuot nlareneG eh Ifnler otait evt of ehil;e tP ehD-Fcrtaeiarap nomtesre wretpo eimizf deirp rotni.gn Evyre csah era t neebkat nesne ot eruaht tf ehili es siutlbaf esu roI yb eSO memidob rebse. It neh lnuikletneve y ttah a lborpem leratign ti ot is fnuo,d

22、 lpsaee ifnrom ttneC ehlar Secrteirata at tsserdda eh igleb nevwo. ISO 3002 Athgir lls serevr.de selnUs towrehise specfi,dei trap on fo this ilbupctanoi may cudorper ebtu ro deziliyna ni de fomr yb ro nam y,snae lecetinorc m roecinahcal, inclidutohp gnocpoiym dna gnicrfoilm, wittuoh repmissii now nr

23、itif gnrom ietreh ISa Ot tserdda ehs lebwo I roSOs membre ydob it neh ctnuoo yrf ttseuqer eh.re ISO cirypothg fofice saCe tsopale 65 eneG 1121-HC 02 av leT. 4 + 10 947 22 1 11 xaF0 947 22 14 + 9 74 E-mial coirypthgis.oc h Web ww.wiso.ch ii ISO 3002 Allr ihgtsser edevrENISO146982:2003IS-89641 O2:(300

24、2E) I SO 3002 All irhgts seredevr iiiForeword ISO (the International 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

25、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 the work. ISO collaborates closely with the International Electrotech

26、nical 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 International Standards. Draft International Standards adopted by t

27、he 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 14698 may be the subject of pat

28、ent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 14698-2 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14698 consists of the following parts, under the general title Cleanr

29、ooms and associated controlled environments Biocontamination control: Part 1: General principles and methods Part 2: Evaluation and interpretation of biocontamination data ENISO146982:2003IS-89641 O2:(3002E) iv I SO 3002 All irhgts seredevrIntroduction This part of ISO 14698 presents a framework for

30、 the evaluation of biocontamination data collected following the principles and methods given in ISO 14698-1. It may also be applied to biocontamination data collected by other systems. ENISO146982:2003INTENRATIONAL TSANDADR IS-89641 O2:(3002E)I SO 3002 All irhgts seredevr 1Cleanrooms and associated

31、 controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data 1 Scope This part of ISO 14698 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones

32、 for biocontamination control. It should be used, where appropriate, in conjunction with ISO 14698-1. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the la

33、test edition of the referenced document (including any amendments) applies. ISO 14698-1:2003, Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods 3 Terms and definitions For the purposes of this document, the following terms and definitio

34、ns apply. 3.1 action level level set by the user in the context of controlled environments, which, when exceeded, required immediate intervention, including investigation of cause, and corrective action 3.2 alert level level set by the user in the context of controlled environments, giving early war

35、ning of a drift from normal conditions, which, when exceeded, should result in increased attention to the process. NOTE When alert levels are exceeded, this should result in increased attention to the process. 3.3 audit trail chain of related documents, or entries within records, that allows related

36、 information to be traced 3.4 biocontamination contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles ENISO146982:2003IS-89641 O2:(3002E) 2 I SO 3002 All irhgts seredevr3.5 cleanroom room in which the concentration of airborne particles is controlled,

37、 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 14644-1:1999, 2.1.1 13.6 data stratification regroupin

38、g of data so that important trends and deviations can be more easily seen and understood 3.7 estimate value of an estimator obtained as a result of an estimation ISO 3534-1:1993, 2.51 23.8 estimation operation of assigning, from the observations in a sample, numerical values to the parameters of a d

39、istribution chosen as the statistical model for the population from which this sample is taken ISO 3534-1:1993, 2.49 23.9 estimator statistic used to estimate a population parameter ISO 3534-1:1993, 2.50 23.10 hazard potential source of harm 3.11 risk combination of the probability of the occurrence

40、 of harm and the severity of that harm ISO/IEC Guide 51:1999, 3.2 83.12 risk zone defined and delimited space where individuals, products or materials (or any combination of the above) are particularly vulnerable to biocontamination 3.13 target level defined level set by the user as a goal for routi

41、ne operations, for the users own purpose 3.14 validation confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled ISO 9000:2000, 3.8.5 33.15 viable particle particle that consists of, or supports, one or more live

42、 microorganisms ENISO146982:2003 ISO 14698-2:2003(E) 2 ISO 2003 All rights reserved5.3 naelcorom rmoo w niciht hc ehcnonertoitafo n riaroben rapcitlse is crtnoellona ,dd whcisi h csnortcua detsu dnde m a nirenna m otiminizt ei ehrtndocuoitneg ,nreta,noi r dnatetneoifo n rapcitlse isnidr eht eomoni d

43、na , whcihto hre rleavetn rapmaretes, met .g.ereputarmuh ,etidiy arp dnsesru,e rac ertnoollsa de censesray OSI 1464-41:1,999 1.2.1 16.3 adat straifitcatnoi rrgepuogni fo atad sht oi tamroprt tnatsdne ad dnveitaisno cb nam erosae eliy seena nnu dredstood 7.3 tsetamie aveul fo se natimrota iatboden sa

44、 r aseufo tl na semitoitan OSI 3-4351:91,39 15.2 28.3 tsetamioin repotaoifo n sasiingf ,gnrmo sbo ehtrevitasno ni s amamun ,elpreciav laseul tp eht oramaretes fo sid atritubnoi csohsa ne ts ehttasicitam ledof lor p ehtopualoitn frmo cihwh siht sampel si katne OSI 3-4351:91,39 94.2 29.3 tsetamior sts

45、itacit sueot d semita eta upoptaliorap nmarete OSI 3-4351:91,39 05.2 201.3 ahazrd mrah fo ecruos laitnetop 11.3 ksir comtanibnoi fo eht rpaboibilty fo eht cocrurcnefo e rahm s eht dnavereity fo hth taram ISO/IEC Guide 51:1999, 3.5 821.3 z ksirone feddeni adn edmils detipace wrehe idnividslau, rpocud

46、st ro mretaials (ro any cmotanibnoi fo hte oba)ev rae rapciturally uvrenlable ib otcomatnotaninoi 31.3 vel tegratel feddeni microloibocigal lves lete by eht suref ,ro sti owrup npsoe 41.3 vanoitadil cfnorimrht ,noitaguoeht h rpvosioifo n jbocevitve edicneht ,er eht taeriuqmestne fro a scepfici dnetn

47、ide suro e ppaciltanoi ahev ebf neuflliled OSI 9:0000023 ,0.5.8 351.3 vicitrap elbael rapcitlht ec tasnosist foro , sroppusto ,en ro mroevil e mircroosinagms 3002:289641OSINEIS-89641 O2:(3002E) I SO 3002 All irhgts seredevr 33.16 viable unit VU one or more viable particles that are enumerated as a single unit NOTE When VU are enumerated as colonies on agar media, it is common usage to name them colony-forming units (CFU). 4 Evaluation and interpretation of biocontamination data 4.1 General Information on the setting of action, alert and, where appropriate, targ