BS ISO 8573-7-2003 Compressed air - Test method for viable microbiological contaminant content《压缩空气 活微生物污染物含量的试验方法》.pdf

1、BRITISH STANDARD BS ISO 8573-7:2003 Compressed air Part 7: Test method for viable microbiological contaminant content ICS 71.100.20 BS ISO 8573-7:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 25 June 2003 BSI 25 June 2003 ISBN 0 580 42

2、123 6 National foreword This British Standard reproduces verbatim ISO 8573-7:2003 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee MCE/8, Compressors, pneumatic tools, pneumatic machines and vacuum technology, which has the r

3、esponsibility 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 publications referred to in this document may be found in the BSI Catalogue under the section entitled “Internatio

4、nal 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 its correct application. Compliance with a British

5、 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 interests informed; monitor related international and E

6、uropean developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to iv, pages 1 to 9 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendme

7、nts issued since publication Amd. No. Date Comments Reference number ISO 8573-7:2003(E)INTERNATIONAL ADNATSDR ISO 8-3757 tide tsriFino -300210-50 Compressed air Part 7: Test method for viable microbiological contaminant content Air comprim Partie 7: Mthode dessai pour la dtermination de la teneur en

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9、booloigseuq vilbase BSISO85737:2003IS-3758 O7:(3002E) ii BSISO85737:2003IS-3758 O7:(3002E) iiiContents Page Foreword iv 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Method for verifying presence of viable micro-organisms by partial flow sampling 2 5 Operating conditions 2 6 Dete

10、rmination of viable, colony-forming organisms. 3 7 Test report statement . 3 Annex A (informative) Determination of viable microbiological particle content in compressed air Sample test report. 4 Annex B (normative) Quantitative sampling method . 5 Annex C (informative) Sampling endotoxins . 7 Annex

11、 D (informative) Preparation of Petri dish with culturable media 8 Bibliography . 9 BSISO85737:2003IS-3758 O7:(3002E) iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International S

12、tandards 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, governmental and non-governmental, in liaison with ISO, als

13、o 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 Directives, Part 2. The main task of technical committe

14、es 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 bodies casting a vote. Attention is drawn to the possi

15、bility 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 8573-7 was prepared by Technical Committee ISO/TC 118, Compressors, pneumatic tools and pneumatic machines, Subcommittee SC 4, Q

16、uality of compressed air. ISO 8573 consists of the following parts, under the general title Compressed air: Part 1: Contaminants and purity classes Part 2: Test methods for aerosol oil content Part 3: Test methods for measurement of humidity Part 4: Test methods for solid particle content Part 5: Te

17、st methods for oil vapour and organic solvent content Part 6: Test methods for gaseous contaminant content Part 7: Test method for viable microbiological contaminant content Part 8: Test methods for solid particle content by mass concentration Part 9: Test methods for liquid water content BSISO85737

18、:2003INTENRATIONAL TSANDADR IS-3758 O7:(3002E)1Compressed air Part 7: Test method for viable microbiological contaminant content 1 Scope This part of ISO 8573 specifies a test method for distinguishing viable, colony-forming, microbiological organisms (e.g. yeast, bacteria, endotoxins) from other so

19、lid particles which may be present in compressed air. One of a series of standards aimed at harmonizing air contamination measurements, it provides a means of sampling, incubating and determining the number of microbiological particles. The test method is suitable for determining purity classes in a

20、ccordance with ISO 8573-1, and is intended to be used in conjunction with ISO 8573-4 when there is need to identify solid particles that are also viable, colony-forming units. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated

21、references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 8573-1, Compressed air Part 1: Contaminants and purity classes ISO 8573-4, Compressed air Part 4: Test methods for solid particle content 3 Terms

22、and definitions For the purposes of this document, the following terms and definitions apply. 3.1 microbiological organisms particles characterized by their ability to form viable colonies NOTE These can be identified as bacteria, yeast or fungi. 3.2 number of viable micro-organisms number of micro-

23、organisms having a potential for metabolic activity 3.3 culturable number number of micro-organisms, single cells or aggregates able to form colonies on a solid nutrient medium 3.4 colony-forming unit CFU unit by which the culturable number is expressed BSISO85737:2003IS-3758 O7:(3002E) 2 4 Method f

24、or verifying presence of viable micro-organisms by partial flow sampling The method for verifying the presence of viable micro-organisms is to expose an agar nutrient to the compressed air sample. A quantitative assessment may be made by the method given in Annex B. See Annex D for details on the pr

25、eparation of an agar plate with a culturable media. For partial-flow sampling, a slit-sampler, a type of impaction air tester (see Figure 1), shall be used together with the method given in ISO 8573-4. Isokinetic sampling of the air shall be carried out and reduced until it is within the range of th

26、e sampler as identified by the manufacturer. Pressure reduction to atmospheric conditions and flow measurements shall be performed in order to establish compatibility with the manufacturers recommendations or in accordance with ISO 8573-4. Where the flow is known, the time for the exposure of the ag

27、ar media to the compressed air sample shall be recorded. To assist in discriminating non-microbiological from microbiological particles, measurements shall be taken within 4 h. Key 1 air intake 2 rotating Petri dish with agar 3 air outlet 4 air Figure 1 Slit-sampler It is necessary to eliminate, as

28、far as possible, the influence of liquids on particle size and number so that a correct reading can be obtained. The influence of water shall not be reduced by heating or drying of air, where this might otherwise have been appropriate, in order to avoid influencing the viability of microbiological o

29、rganisms. The influence of liquids other than water shall be given due consideration. 5 Operating conditions Actual operating conditions shall be described in the test report (see Annex A). BSISO85737:2003IS-3758 O7:(3002E) 36 Determination of viable, colony-forming organisms After incubation of the

30、 sample on the agar nutrient (see B.3), the surface shall be visually examined to confirm the presence of viable, colony-forming micro-organisms. 7 Test report statement A statement shall be made in the test report, supplementary to the statement in accordance with ISO 8573-4 for solid particles, pr

31、oviding confirmation that there are viable, colony-forming microbiological particles among the solid particles. This phrase “Declared sterility of the compressed air in accordance with ISO 8573-1”, shall be followed by “Sterile” or “non-sterile”, date of sampling, date of measurements, and location.

32、 Annex A presents a sample test report. BSISO85737:2003IS-3758 O7:(3002E) 4 Annex A (informative) Determination of viable microbiological particle content in compressed air Sample test report Once the solid particle content in accordance with ISO 8573-4 has been established, a tabulated test report

33、(see Figure A.1) is used to identify those particles present as viable microbiological CFUs in a sample of air taken from the compressed air system under investigation. NOTE For information on agar media, see B.3 Value of actual, average measured value (see Annex B) for Microbiological organism CFU/

34、m 3 given at reference conditions aBacteria 100 Yeast 14 Fungi No indication Endoro-bacteria 50 Pressure to which the measurement refers MPA = bar (e) Statement regarding the applicable uncertainty (see Clause 7) Date of calibration record yyyy/mm/dd a Reference conditions: Temperature 20 C; Pressur

35、e 0,1 MPa (= 1 bar). Relative humidity does not affect volume in this application.Figure A.1 Sample test report BSISO85737:2003IS-3758 O7:(3002E) 5Annex B (normative) Quantitative sampling method B.1 Sampling with slit-sampler (see Figure 1) B.1.1 Principle The principle of capturing micro-organisms

36、 with a slit-sampler (impaction air tester) is both simple and reliable. Air from a compressed air installation is channelled through a specially designed connecting link and accelerated through a narrow slit towards a moist agar surface. The micro-organisms, due to their weight, are flung into the

37、agar surface, whereas the air molecules are deflected. Suitably incubated, they multiply into colonies, which are counted on the assumption that one micro-organism gives rise to one colony. The slit-sampler can be used for bacteria, yeast or fungi and, with special methods, for viruses and bacteriop

38、hages. As a large agar surface (e.g. 140 mm Petri dish) rotates under a radially positioned slit (0,5 mm), a large number of colonies, i.e. organisms, can be counted. B.1.2 Aseptic techniques The sampling methodology is covered by the adoption of aseptic techniques. The use of a disinfecting agent s

39、uch as 70 % ethanol is recommended. In periods when the slit-sampler is not in use (stored) precautions shall be taken to avoid the growth of micro-organisms in the equipment. All operations in which the test equipment is to be opened should be carried out with the minimum of delay in order to avoid

40、 possible ingress of contaminants from the local environment. Precautions should also be taken against the effects of draughts. B.2 Sampling procedure The following procedure shall be used for sampling. a) Sterilize all sampling equipment by disinfecting the equipment, including tubes and hoses, wit

41、h a suitable cleaning agent immediately before use. b) Allow a test sample to pass through the sampling equipment and associated tubes and hoses without the Petri dish and agar. This is done to allow evaporation of the disinfecting agent and to adjust the slit-sampler. c) Perform a blind test before

42、, and after, the actual measurement by carrying out steps d) to f) without starting the slit-sampler. The dishes used shall not subsequently show growth. d) Take a 14 cm Petri dish with agar. The Petri dish shall have a label fixed to the bottom with traceability information (date, time of start, te

43、st site address, code, etc). Indicate the starting position and the direction of rotation. e) Ensure that the air inlet and level indicator of the slit-sampler are turned up. Lift the lid of the slit-sampler and ensure that the plate holder is placed correctly in relation to the micro-switch. Wipe t

44、he internal sides of the slit-sampler with a disinfecting pad. f) Insert the Petri dish in the slit-sampler, which should be exposed so that the radial line is situated directly under the air inlet slit. Remove the lid and store it in a sterile plastic bag. BSISO85737:2003IS-3758 O7:(3002E) 6 g) Qui

45、ckly replace the lid of the slit-sampler immediately after removing the Petri dish lid. h) Loosen the level indicator and lower it carefully onto the surface of the agar. Lower the air inlet so the indicator arrow points directly at the inferior edge of the groove track. Raise the level indicator ag

46、ain to its upper position and fasten it. i) Start the automatic sampling by pressing the start button. Make a note of the starting time, sampling time, test premises and other conditions or observations that could influence the measurements. j) When the pilot lamp is switched off, the sampling is fi

47、nished. With the start/stop button in the off-position, raise the air inlet. k) Loosen the lid of the slit-sampler and carefully lift it, at the same time removing the lid of the Petri dish from the sterile plastic bag and replacing it on the Petri dish. Due care and attention shall be observed in t

48、his process so as not to disturb the agar and sample. l) Remove the Petri dish from the sampling equipment and replace the lid of the slit-sampler. Seal the Petri dish with tape and replace it in the sterile bag, then seal the bag with tape. m) Petri dishes are incubated at a convenient temperature

49、and read after a suitable time. See B.3. At the centre and outer edge, the agar surface shall be free from colonies. NOTE The start/end line could contain “extra” colonies. n) Move the activation arm of the dish holder past the micro-switch to a new start position. o) Wipe the inside of the slit-sampler with a disinfecting pad. Replace the lid on the slit-sampler. p) Restart this procedure from the beginning when perform