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1、 Reference number ISO 14698-2:2003(E) ISO 2003 INTERNATIONAL 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 Matr
2、ise de la biocontamination Partie 2: valuation et interprtation des donnes de biocontamination ISO 14698-2:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces
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6、ng and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland i
7、i ISO 2003 All rights reserved ISO 14698-2:2003(E) ISO 2003 All rights reserved iii 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 normally carried out thro
8、ugh 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 the work. ISO collabor
9、ates 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 International Standa
10、rds. 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 of the elements of t
11、his 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 ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14698 consists of the
12、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 biocontamination data ISO 14698-2:2003(E) iv ISO 2003 All rights reserved Introduction This part of ISO
13、 14698 presents a framework for 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. INTERNATIONAL STANDARD ISO 14698-2:2003(E) ISO 2003 All rights reserved 1 Cleanroom
14、s 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 results obtained from sampling for viable particl
15、es 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, only the edition cited applies. For undated re
16、ferences, 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 purposes of this document, the following ter
17、ms and definitions apply. 3.1 action level microbiological level set by the user in the context of controlled environments, which, when exceeded, requires immediate intervention, including investigation of cause, and corrective action 3.2 alert level microbiological level set by the user for control
18、led environments, giving early warning of a potential drift from normal conditions 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 information to be traced 3.4 bi
19、ocontamination contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles ISO 14698-2:2003(E) 2 ISO 2003 All rights reserved 3.5 cleanroom room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner t
20、o 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 1 3.6 data stratification regrouping of data so that important trends and deviatio
21、ns 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 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 fo
22、r the population from which this sample is taken ISO 3534-1:1993, 2.49 2 3.9 estimator statistic used to estimate a population parameter ISO 3534-1:1993, 2.50 2 3.10 hazard biological, chemical or physical element or factor that adversely affects individuals, the environment, process or product 3.11
23、 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 individuals, products or materials (or any combination of the above) are particularly vulnerable to biocontamination 3.13 target
24、level defined microbiological level set by the user, for its 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 3 3.15 viable particle particle that consists
25、of, or supports, one or more live microorganisms -,-,- ISO 14698-2:2003(E) ISO 2003 All rights reserved 3 3.16 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
26、(CFU). 4 Evaluation and interpretation of biocontamination data 4.1 General Information on the setting of action, alert and, where appropriate, target levels, the validation of counting methods and the collection of biocontamination data are discussed in ISO 14698-1. This part of ISO 14698 discusses
27、 the evaluation and interpretation of the data collected. Management of microbiological results from risk zones should take the following factors into account: types of result to be collected; necessary information; methods to process the collected results (e.g. statistical procedures, correlation a
28、nalysis, artificial intelligence, etc.); grouping of results to focus on important trends and deviations, i.e. data stratification; method by which the results will be expressed (e.g. qualitatively, quantitatively, graphically, numerically) and the units of measurement that will be used; robustness
29、of, and potential problems posed by, the analytical methods; trend analysis; control charting; estimation, interpretation and reporting of results. It is recommended that the evaluation of results be performed in two stages: during the initial monitoring (set-up procedure) phase and during the routi
30、ne monitoring phase. 4.2 Estimation and evaluation of data from the initial monitoring phase (set-up procedure see Figure 1) 4.2.1 Significance of biocontamination To obtain reliable estimates of biocontamination gathered according to ISO 14698-1, it is necessary to consider the following variables:
31、 sampling-adequate number and homogeneity of the sample material and accuracy of dilution of the samples, if appropriate; composition of the viable particle spectrum involved; its variability with time and the effect of stress and injury on survival and recovery; results originating from different s
32、ampling sites in risk zones and other controlled environments; -,-,- ISO 14698-2:2003(E) 4 ISO 2003 All rights reserved culturing technique and the methodology of counting; selection of method of analysis and relationship between direct and indirect testing. 4.2.2 Corrective action To maintain contr
33、ol over the performance of the testing laboratory, it is very important to identify and eliminate the cause of any errors that may occur. Prompt investigation of out-of-specification results should include attention to the possibility of testing error. The investigation should include: a standard me
34、thod for highlighting abnormal results; elimination of gross or systematic errors; evaluation of change; establishment of the recovery efficiency of the revised method; verification of equipment; justification and documentation; clear rules to decide how the final result is derived when an analysis
35、has been repeated. 4.2.3 Records All regular and periodical checks of methods, instruments and internal audits, as well as records of original observations, calculations, derived data and final reports should be appropriately filed and retained. It is essential that the records include the identity
36、of personnel involved in sampling, preparation, testing, evaluation and reporting. It should be possible to conduct an audit trail to show the details of how and when any results have been changed. Records of signatures, initials or signs should be maintained and updated as appropriate. Reports shou
37、ld be distributed as required. This may include mail, facsimile transmission and electronic data transfer. It is essential that appropriate protection of data and records, including those held in the computer, be provided. ISO 14698-2:2003(E) ISO 2003 All rights reserved 5 1 Establish sampling point
38、s and sampling plan Identification of data to be collected (as described in ISO 14698-1) establish data collection parameters establish sampling plan establish/prepare data collection/recording sheets set preliminary limits ? 2 Preliminary measurement phase (as described in ISO 14698-1) determine th
39、e presence of biocontamination select methods conduct sampling and microbiological examinations ? 3 Analysis and monitoring of data tabulate data, e.g. in evaluation table/matrix stratify (sort/steamline) preliminary data express results apply statistical evaluation procedures with the determination
40、 of precision and accuracy establish control charts ? 4 Data evaluation evaluate initial limits at control points assign target/alert/action levels from preliminary measurements consider out-of-specification results ? 5 Standardization and validation sampling, measuring methods electronic data proce
41、ssing personnel training ? 6 Data storage/Documentation/Archive Figure 1 Estimation and evaluation of data from initial monitoring phase -,-,- ISO 14698-2:2003(E) 6 ISO 2003 All rights reserved 4.3 Estimation and evaluation of biocontamination data resulting from the routine monitoring phase (see Fi
42、gure 2) 4.3.1 Sampling and sample tracking Information on the most important step for valid results, i.e. sampling, is given in ISO 14698-1. In addition, the laboratory should have suitable and dependable procedures that allow for the clear identification and handling of samples from their reception
43、 and progress through the entire analytical process to the final results and their correct identification with the original sample. 4.3.2 Collection of results The general guidelines for a sampling plan, outlined in ISO 14698-1, should be followed. In addition, to avoid collection of erroneous resul
44、ts, the following factors should be considered: particular application; identification of application-specific parameters; data collection points in the process/system; limit of detection and sensitivity of test system; operation and operational data collection. 4.3.3 Data recording To ensure that a
45、ll information of practical relevance to the tests performed is readily available during a defined period of time, clear procedures for data recording and handling should be developed and implemented, and should cover the following aspects: raw data; list of types of information held in the records;
46、 identification and location of laboratory documents, or computerized records; use of workbooks, worksheets or computers or other appropriate means to record the various types of observations, calculations and other relevant information; procedures to be followed for recording, checking, correcting,
47、 signing and countersigning of observations, calculations and reports; recommendations for consistent interpretation; specific, legal or regulatory requirements; requirements appropriate to the field of application with effect on action, alert and target levels. ISO 14698-2:2003(E) ISO 2003 All righ
48、ts reserved 7 1 Monitoring of control points in risk zones examine samples taken according to sampling plan enumerate cfu/VU record cfu/VU data ? 2 Analysis and monitoring of data data stratification-group measurements: tabulate data or use descriptive statistics express results examine time trends establish control charts ? 3 Data evaluation and interpretation statistics/correlation analysis control analysis/artificial intelligence ? 4 Verification of data calculations electronic data processing of results microbiological