ASTM E2335-2017 Standard Guide for Laboratory Monitors《实验室监测的标准指南》.pdf

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1、Designation: E2335 12E2335 17 An American National StandardStandard Guide forLaboratory Monitors1This standard is issued under the fixed designation E2335; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision.

2、A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONThis guide is for use by laboratory monitors who observe interlaboratory testing performed byparticipating organizations that validat

3、e the legitimacy of test methods and also establish a base of datafrom which precision and bias statements are to be written. Interlaboratory testing is done to determinethe validity of a test standard. Such testing requires diligence by adhering to the protocol establishedfor performing the test in

4、 order to minimize variability which often exists between laboratories.Because laboratories differ in size, organization, management, personnel, facilities and environmentthere is always a potential for introducing variability in test results.Laboratory monitors confirm that the participating facili

5、ties adhere to the test protocol as closely aspossible, thereby improving the chances of a successful interlaboratory study. The laboratory monitorobserves and assesses but does not perform the functions of an auditor or trainer; the laboratorymonitor does not provide accreditation of a laboratory.

6、Laboratory monitors should demonstrateexpertise in both the content and the intent of the test method. The laboratory monitor is responsibleto render a report to the appointing subcommittee. It is incumbent upon the laboratory monitor tomaintain objectivity when working with participating laboratori

7、es.Full-scale product fire tests are expensive, especially full-scale tests of bedding and homefurnishings. The development of this standard is intended to ensure that the precision and biasdeveloped for E05 standards demonstrates a high level of statistical validity.This guide does not contain proc

8、edures for analysis of the test data obtained from an interlaboratorystudy. The user is directed to Practice E691, if the laboratory study includes six laboratories or more,and to Practice E2653 if the number of laboratories in the interlaboratory study is at least three, butless than six.Using a la

9、boratory monitor as part of an interlaboratory test program is optional. However, if amonitor is used, all of the laboratories in the project are to be included.1. Scope1.1 This guide provides a general outline, for use by a laboratory monitor, to assess the qualifications of a laboratory whichthath

10、as requested to participate in a specific ASTM interlaboratory test.1.2 The preliminary assessment is based on observations made before initiation of any interlaboratory tests.1.3 The subcommittee, which appoints the laboratory monitor, specifies the minimum requirements whichthat an organizationsho

11、uld meet to qualify as a participant for the interlaboratory test. If a pretest laboratory qualification test (pretest) is to be included,see details in Section 13.1.4 This fire standard can not be used to provide quantitative measures.1.5 This standard does not purport to address all of the safety

12、concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatoryrequirements prior to use.1.6 This international standard was developed in accordance with internationally

13、 recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.1 This guide is under the jurisdiction of ASTM Committee E05

14、 on Fire Standards and is the direct responsibility of Subcommittee E05.31 on Terminology and Services/ Functions.Current edition approved Dec. 1, 2012July 1, 2017. Published December 2012July 2017. Originally approved in 2004. Last previous edition approved in 20082012 asE2335-08.-12. DOI: 10.1520/

15、E2335-12.10.1520/E2335-17.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends th

16、at users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12. Referenced Document

17、s2.1 ASTM Standards:2E176 Terminology of Fire StandardsE691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test MethodE1537 Test Method for Fire Testing of Upholstered FurnitureE1822 Test Method for Fire Testing of Stacked ChairsE2653 Practice for Conducting an Inte

18、rlaboratory Study to Determine Precision Estimates for a Fire Test Method with FewerThan Six Participating Laboratories2.2 ISO Standards:ISO 13943 Fire Safety-Vocabulary3ISO/IEC 17025 :2005 General Requirements for the Competence of Testing and Calibration Laboratories32.3 Other Standard:A2LA R101 -

19、General Requirements: Accreditation of ISO/IEC 17025 Laboratories (December 2011)2016)43. Terminology3.1 For definitions of terms used in this guide and associated with fire issues refer to the terminology contained in TerminologyE176 and ISO 13943. In case of conflict, the definition given in Termi

20、nology E176 shall prevail.3.2 Definitions of Terms Specific to This Standard:3.2.1 laboratory monitor, na representative of a subcommittee who is appointed to determine if the qualifications, equipment,personnel, and level of skill at a test facility meet the criteria necessary to participate in an

21、interlaboratory test protocol.4. Significance and Use4.1 These guidelines are intended to enable a laboratory monitor to perform onsite assessments of laboratory facilities.Acceptedfacilities will then participate in an interlaboratory test protocol to establish precision and bias for a particular A

22、STM standard.4.2 This assessment is intended to determine that all of the participants have the necessary equipment, an understanding of thetest method, and the minimum level of skill necessary to gather data whichthat are to be used to establish precision and bias forthe particular standard.4.3 Thi

23、s guide is not intended to be used as a tool to qualify or accredit laboratories to perform any tests. Refer to ISO/IEC17025 and to the A2LA R101 Document for further guidance on accreditation requirements.5. Qualifications of a Laboratory Monitor5.1 The laboratory monitor should demonstrate a level

24、 of expertise about the test method for which the interlaboratory test willbe done.5.2 Technical understanding of the test method is imperative in order to understand the principles of the measurements to bemade during the test procedure.5.3 The laboratory monitor should demonstrate objectivity. Thi

25、s includes not deriving any profit, commissions, or dividendsfrom any commercial entity whichthat performs the same or similar type of test evaluations.6. Responsibilities of a Laboratory Monitor6.1 Develop a checklist specific to the subject test method.6.1.1 This checklist is to serve as a guide f

26、or the inspection of the laboratory during the initial qualification phase.6.2 The laboratory monitor performs an inspection of the test laboratories to determine if the equipment conforms with thatrequired to perform the test method, and if adequate training of the operators has been done.6.3 Verif

27、y that the data acquisition system used by the laboratory is compatible with the data to be acquired; and that analysisof the data will provide results whichthat are reliable and comparable to data obtained from other participants.6.4 Following completion of every laboratory inspection, an assessmen

28、t report, based on the Checklist described in Section 7,shall be completed and forwarded, with recommendations, to the sponsoring ASTM Subcommittee.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standar

29、dsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from International Organization for Standardization (ISO), 1 rue de Varemb, Case postale 56, CH-1211, Geneva 20, Switzerland.4 Available from American Association for Laboratory Accreditation, 5301 Buc

30、keytown Pike, 5202 Presidents Court, Suite 220, Frederick, MD 21704;www.a21a.org21703; www.a21a.org.E2335 1727. Checklist7.1 The laboratory monitors checklist is to be made available to participating laboratories, in advance of the preliminaryassessment visit so that a self-evaluation is an option f

31、or the participating laboratory.7.1.1 The checklist is a one-time, test specific document used as a guide by the laboratory monitor in assessing the following:7.1.1.1 Management of the laboratory,7.1.1.2 Test operator skill level,7.1.1.3 Condition and calibration of the laboratory facilities and equ

32、ipment,7.1.1.4 Environmental conditions and facilities for conditioning specimens,7.1.1.5 Handling and storage of the test materials and any reference materials, and7.1.1.6 Appropriate handling of data to ensure that the validity of the data is not compromised.7.2 Each test method and associated int

33、erlaboratory test requires development of a specific checklist. See Appendix X1 for anexample of a checklist used in an ASTM E5.15 Interlaboratory Study.8. Management, Supervisor, and Operators8.1 The environment established by management of the laboratory is expected to demonstrate support for the

34、objectives of theinterlaboratory test. The following demonstrate this type of support:8.1.1 Have managerial staff that understands the purpose of the test, are supportive of the testing, and also have the authorityand resources needed to see that the interlaboratory test is conducted as agreed, and

35、in accordance with the established timetable.8.1.2 Specify and document the responsibility, authority, and interrelations of all personnel who manage, perform or verify workaffecting the quality of tests (chain of management).8.1.3 Provide supervision by persons who have a functional knowledge of th

36、e test method, the apparatus, the objective of thetest and the assessment of the results.8.1.4 Have a quality system describing its commitment to good laboratory practices and quality of testing.8.1.5 Have procedures for control and maintenance of documentation.8.1.6 Have supervisors and personnel i

37、nvolved in testing who are trained and capable of performing the test.8.1.7 Have sufficient personnel for backups.8.1.8 Practice laboratory safety and good housekeeping.9. Laboratory Physical Facilities and Environment9.1 Laboratory facilities shall demonstrate adherence to recognized laboratory pro

38、tocols and procedures. See documentsreferenced in Section 2 for guidance.9.2 Laboratory accommodations, test areas, energy sources, lighting, heating and ventilation shall be such as to facilitate properperformance of the test and safety of operators.9.3 The environment in which testing is undertake

39、n shall not invalidate the results or adversely affect the required accuracy ofmeasurements.9.4 The laboratory is to have facilities for the effective monitoring, control and recording of environmental conditions asspecified in the test method.9.5 There shall be effective separation between neighbor

40、ing areas when the activities therein are incompatible.9.6 Access to and use of all areas affecting the quality of testing shall be defined and controlled.10. Laboratory Equipment and Reference Materials10.1 Equipment shall meet the specifications of the test method.10.2 Equipment shall be properly

41、maintained with documentation, as appropriate.10.3 Each item of equipment shall have calibration records, as appropriate.10.4 Reference materials, if available, shall meet standards specified for the test.10.5 Reference materials are to be properly stored and conditioned.11. Test Materials11.1 The l

42、aboratory system for identifying the items to be tested shall ensure that there is no confusion regarding the identityof such items at any time.11.2 Upon receipt, the condition of the test items, including any abnormalities or departures from standard conditions asprescribed in the test method, are

43、to be recorded.11.3 The laboratory shall have procedures and appropriate facilities to avoid deterioration or damage to test items, duringstorage, prior to test specimen preparation and testing.E2335 17311.4 Where items have to be stored, or conditioned under specific environmental conditions, these

44、 conditions are to bemaintained, monitored and recorded.11.5 There shall be a procedure for receipt, retention and safe disposal of test items. Confidentiality of the sources of test itemsis to be maintained.12. Records12.1 The laboratory shall have a system for:12.1.1 Maintaining clear and concise

45、records.12.1.2 If test results are to be transmitted by telephone, facsimile, or other electronic/electromagnetic means (for example, CDor DVD), follow a documented procedure that ensures the quality of the transmission.13. Observation of Laboratory Qualification Testing (Pretest)13.1 Verify the tes

46、t specimen preparation protocol is followed, that is, randomization of samples and test specimen preparation.13.2 Verify the test protocol is being followed in performing the test.13.3 Document observations and report findings to the managing Subcommittee or Task Group. Recommend whether thelaborato

47、ry is adequately qualified to proceed with the interlaboratory test program.APPENDIX(Nonmandatory Information)X1. EXAMPLE OF A CHECKLISTX1.1 An example of a checklist that has been used for interlaboratory testing is shown below. The test method for which this listwas prepared is Test Method E1537,

48、a full-scale fire test for upholstered furniture. Test Method E1822 is a very similar test forstacking chairs. This interlaboratory test has been completed and the results included in a Research Report on file with ASTM.Interlaboratory Test ProgramE1537Laboratory Name: Date:Conditioning: Temp. 21 3C

49、 (70 5F) RH Less 55 5 %Calibrations:Heat Release: Calibration burner: Sand PipeGas: Methane PropaneCalibration points: kW kWGas Flow Rates:Difference in test to calculated HRR not 5 %Time Delay for Sample Line and Instruments:Duct Air Flow: Type of Sensor:Accuracy:Have Gas Analyzers been calibrated? Y/N DailyOxygen Measurement AccuracyCarbon Dioxide MeasurementCarbon Monoxide MeasurementGas Burner: Gas Type: Flow Rate: 13 L/minMass Loss: Was the load platform calibrated? Y/NWhat method:Smoke Obscuration: Type of System: White Light LaserWas the smoke system calibrated?