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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 ? Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:59:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 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 Febr
3、uary 2005 ISBN 0 580 42779 X National foreword This British Standard is the official English language version 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
4、, Cleanroom technology, which has the responsibility to: 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 B
5、SI Catalogue 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
6、 its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. 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 inte
7、rests informed; monitor related international and European developments and promulgate them in the UK. 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 iv, pages 1 to 11, the Annex ZA page,
8、 an inside back cover 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. DateComments 14880 Corrigendum No. 1 28 November 2003 Incorporating corrected EN ISO foreword page and adding Annex ZA
9、 page 15552 Technical Corrigendum No. 2 21 February 2005Corrections to 3.1, 3.2, 3.10 and 3.13 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:59:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14698-2 September 2003 ICS 13.040.35 Engl
10、ish version Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003) Salles propres et environnements matriss apparents - Matrise de la biocontamination - Partie 2: Evaluation et interprtation des
11、 donnes de biocontamination (ISO 14698-2:2003) Reinrume und zugehrige Reinraumbereiche - Biokontaminationskontrolle - Teil 2: Auswertung und Interpretation von Biokontaminationsdaten (ISO 14698- 2:2003) This European Standard was approved by CEN on 10 July 2003. CEN members are bound to comply with
12、the CEN/CENELEC Internal Regulations which stipulate 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 o
13、r to any CEN member. This European Standard exists 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 versio
14、ns. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDA
15、RDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14698-2:2003 E Licensed Copy: sheffieldun sheffi
16、eldun, na, Sat Nov 18 01:59:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI I NESO 41-896:2002( 3E) 2 CORRECTED 2003-11-05 Foreword This document (EN ISO 14698-2:2003) has been prepared by Technical Committee ISO/TC 209 “Cleanrooms and associated controlled environments“ in collaboration with Technica
17、l 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 March 2004, and conflicting national standards shall be with
18、drawn at the latest by March 2004. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
19、 Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14698-2:2003 has been approved by CEN as EN ISO 14698-2:2003 without any modifications. NOTE Normative references to International Standards are l
20、isted in Annex ZA (normative). EN ISO 146982:2003 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:59:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 14698-2:2003(E) OSI 3002 INTERNATIONAL STANDARD ISO 14698-2 First edition 2003-09-15 Cleanrooms and associated controlled
21、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 interprtation des donnes de biocontamination EN ISO 146982:2003 Licensed Copy: sheffieldun she
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26、wittuoh repmissii now nritif 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 edevr EN ISO
27、146982:2003 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:59:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-89641 O2:(3002E) I SO 3002 All irhgts seredevr iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO m
28、ember 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. International organizations, governm
29、ental 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 rules given in the ISO/IEC Dir
30、ectives, 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 least 75 % of the member bo
31、dies 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 patent 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
32、ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14698 consists of the following parts, under the general title Cleanrooms and associated controlled environments Biocontamination control: Part 1: General principles and methods Part 2: Evaluation and interpretation of biocontaminati
33、on data EN ISO 146982:2003 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:59:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-89641 O2:(3002E) iv I SO 3002 All irhgts seredevr Introduction This part of ISO 14698 presents a framework for the evaluation of biocontamination data collected fo
34、llowing the principles and methods given in ISO 14698-1. It may also be applied to biocontamination data collected by other systems. EN ISO 146982:2003 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:59:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADR IS-89641 O2:(3002E
35、) I SO 3002 All irhgts seredevr 1 Cleanrooms and associated 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 result
36、s obtained from sampling for viable particles in risk zones 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, onl
37、y the edition cited applies. For undated references, the latest 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 p
38、urposes of this document, the following terms and definitions 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
39、in the context of controlled environments, giving early warning 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 relate
40、d documents, or entries within records, that allows related information to be traced 3.4 biocontamination contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles EN ISO 146982:2003 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:59:56 GMT+00:
41、00 2006, Uncontrolled Copy, (c) BSI IS-89641 O2:(3002E) 2 I SO 3002 All irhgts seredevr 3.5 cleanroom room 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 roo
42、m, and in which other relevant parameters, e.g. temperature, humidity and pressure, are controlled as necessary ISO 14644-1:1999, 2.1.1 1 3.6 data stratification regrouping of data so that important trends and deviations can be more easily seen and understood 3.7 estimate value of an estimator obtai
43、ned as a result of an estimation ISO 3534-1:1993, 2.51 2 3.8 estimation operation of assigning, from the observations in a sample, numerical values to the parameters of a distribution chosen as the statistical model for the population from which this sample is taken ISO 3534-1:1993, 2.49 2 3.9 estim
44、ator statistic used to estimate a population parameter ISO 3534-1:1993, 2.50 2 3.10 hazard potential source of harm 3.11 risk combination of the probability of the occurrence of harm and the severity of that harm ISO/IEC Guide 51:1999, 3.2 8 3.12 risk zone defined and delimited space where individua
45、ls, 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 routine operations, for the users own purpose 3.14 validation confirmation, through the provision of objective evidence, that the
46、requirements for a specific intended use or application have been fulfilled ISO 9000:2000, 3.8.5 3 3.15 viable particle particle that consists of, or supports, one or more live microorganisms EN ISO 146982:2003 ISO 14698-2:2003(E) 2 ISO 2003 All rights reserved 5.3 naelcorom rmoo w niciht hc ehcnone
47、rtoitafo 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 dna , whcihto hre rleavetn rapmaretes, met .g.ereputarmuh ,etidiy arp dnsesru,e rac ertnoollsa de censesray OSI 1464-41:1,
48、999 1.2.1 1 6.3 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 r aseufo tl na semitoitan OSI 3-4351:91,39 15.2 2 8.3 tsetamioin repotaoifo n sasiingf ,gnrmo sbo ehtrevitasno ni s ama
49、mun ,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 2 9.3 tsetamior stsitacit sueot d semita eta upoptaliorap nmarete OSI 3-4351:91,39 05.2 2 01.3 ahazrd mrah fo ecruos laitnetop 11.3 ksir comtanibnoi fo eht rpaboibilty fo eht cocrurcnefo e rahm s eht dnavereity f