ASTM D8179-2018 6250 Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices.pdf

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1、Designation: D8179 18Standard Guide forCharacterizing Detergents for the Cleaning of Clinically-used Medical Devices1This standard is issued under the fixed designation D8179; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the yea

2、r of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 Detergents play a critical role in the cleaning ofclinically-used medical devices, but there are few consensusmet

3、hods for describing the key characteristics of these deter-gents. This guide identifies consensus standards, ASTM andothers, used to characterize detergents in other applications,which can also be used to characterize detergents used to cleanclinically-used medical devices.1.2 In identifying these t

4、est methods, manufacturers ofdetergents can reference this guide to characterize their deter-gents.1.3 By identifying applicable test methods, gaps may beidentified where development of new standardized test meth-ods need to be developed to characterize detergents intended toclean medical devices.1.

5、4 By identifying applicable test methods that are used andresults reported by detergent manufacturers, test results can beshared and may lead in the future to development of perfor-mance criteria for the key characteristics of detergent.1.5 The values stated in SI units are to be regarded asstandard

6、. No other units of measurement are included in thisstandard.1.6 Exclusions:1.6.1 This guide is not intended for detergents formulated toremove residues as a result of the manufacturing process.1.6.2 This guide does not provide information related todisinfection or disinfecting agents that might be

7、part of adetergent formulation.1.7 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regu

8、latory limitations prior to use.1.8 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade O

9、rganization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D459 Terminology Relating to Soaps and Other DetergentsD471 Test Method for Rubber PropertyEffect of LiquidsD543 Practices for Evaluating the Resistance of Plastics toChemical ReagentsD820 Test Methods

10、for Chemical Analysis of Soaps Con-taining Synthetic DetergentsD1172 Guide for pH of Aqueous Solutions of Soaps andDetergentsD2024 Test Method for Cloud Point of Nonionic SurfactantsD3048 Test Method of Assay for Alkaline ProteaseD3519 Test Method for Foam in Aqueous Media (BlenderTest) (Withdrawn 2

11、013)3D3601 Test Method for Foam In Aqueous Media (BottleTest) (Withdrawn 2013)3D7225 Guide for Blood Cleaning Efficiency of Detergentsand Washer-DisinfectorsE2454 Guide for Sensory Evaluation Methods to Determinethe Sensory Shelf Life of Consumer ProductsF2809 Terminology Relating to Medical and Sur

12、gical Mate-rials and DevicesF2847 Practice for Reporting and Assessment of Residueson Single-Use Implants and Single-Use Sterile Instru-mentsF3208 Guide for Selecting Test Soils for Validation ofCleaning Methods for Reusable Medical DevicesF3293 Guide for Application of Test Soils for the Validation

13、of Cleaning Methods for Reusable Medical DevicesG31 Guide for Laboratory Immersion Corrosion Testing ofMetals1This test method is under the jurisdiction of ASTM Committee D12 on Soapsand Other Detergents and is the direct responsibility of Subcommittee D12.15 onPhysical Testing.Current edition appro

14、ved Sept. 1, 2018. Published September 2018. DOI:10.1520/D8179-18.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM web

15、site.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles

16、 on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1G122 Test Method for Evaluating the Effectiveness ofCleaning Agents2.2 AAMI Docu

17、ments:4AAMI TIR12:2010 Designing, testing, and labeling reusablemedical devices for reprocessing in health care facilities:A guide for medical device manufacturersAAMI TIR30:2011 A compendium of processes, materials,test methods, and acceptance criteria for cleaning reusablemedical devicesAAMI TIR34

18、:2014 Water for the processing of medicaldevicesAAMI ST79:2017 Comprehensive guide to steam steriliza-tion and sterility assurance in health care facilities2.3 ISO Standards:5ISO 7827:2010 Water quality Evaluation of the “ready”,“ultimate” aerobic biodegradability of organic compoundsin aqueous medi

19、um Method by analysis of dissolvedorganic carbon (DOC)ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicityISO 10993-12:2009 Biological evaluation of medical de-vices Part 12: Sample preparation and reference mate-rialsISO/TS 15883-5:2005 Washer-disinfecto

20、rs Part 5: Testsoils and methods for demonstrating cleaning efficacy2.4 Other Documents:CSPA: DCC-15:2011 Cleaning Test Method DCC-15 Guide-lines for Measuring Degree of Surface Abrasion6EN 285:2015 Sterilization Steam Sterilizers Large Ster-ilizers7EPA Test Guidelines for Pesticide Data Requirement

21、s “sixpack tox testing”8FDA Reprocessing Medical Devices in Health Care Set-tings: Validation Methods and Labeling/Guidance forIndustry and Food and Drug Administration Staff (Docu-ment updated on June 9, 2017)9OECD 105:1995 Water Solubility10OECD 301:1992 Test No 301: Ready Biodegradability10OECD 3

22、10:2006 Test No. 310: Ready Biodegradability -CO2in sealed vessels (Headspace Test)103. Terminology3.1 Definitions:3.1.1 cleaning , nremoval of contamination from a medi-cal device to the extent necessary for further processing of orfor intended use.3.1.2 detergents, na composition that removes soil

23、. D4593.1.3 disinfection, ndestruction or reduction of patho-genic and other kinds of microorganisms by thermal orchemical means.3.1.4 medical device, nany instrument, apparatus,implement, machine, appliance, implant, in vitro reagent orcalibrator, software, material, or other similar or related art

24、icleintended by the manufacturer to be used, alone or incombination, for human beings for one or more of the specificpurpose(s) of: (1) diagnosis, prevention, monitoring, treatment,or alleviation of disease, (2) diagnosis, monitoring, treatment,alleviation of, or compensation for an injury, (3) inve

25、stigation,replacement, modification, or support of the anatomy or of aphysiological process, (4) supporting or sustaining life, (5)control of conception, (6) disinfection of medical devices, and(7) providing information for medical purposes by means of invitro examination of specimens derived from t

26、he human bodyand which does not achieve its primary intended action in or onthe human body by pharmacological, immunological, or meta-bolic means, but which may be assisted in its function by suchmeans. F28093.1.5 shelf-life, nthe length of time recommended by themanufacturer, based upon testing, th

27、at a detergent may be fitfor use after the date of manufacture.4. Summary of Guide4.1 General ConsiderationsThis guide identifies ASTMand other consensus test methods to assess the characteristicsof detergent cleaning agents intended for use when cleaningclinically used medical instruments and devic

28、es. Detergents aredefined in 3.1.2 consistent with the ASTM D12 TerminologyGuide. Detergents are made up of a system of cleaning agentswith no one component solely responsible for its performance.Appropriate test methods may address components or thefinished product, or both.4.1.1 As a starting poin

29、t this guide identifies useful testmethods based on the list of characteristics for “ideal cleaningagents” identified in AAMI TIR 12 (Section 4.2.4.3, CleaningAgents) and in AAMI ST79 (Section 7.6.3, Cleaning): non-abrasive; compatible with the medical device or containersystem to be cleaned as well

30、 as the materials used in thecleaning equipment itself; low-foaming; free-rinsing (that is,easily removed from the medical device); biodegradable;provides for soil dispersion or suspension; rapidly dissolve(s)/disperse(s) soil; is effective on clinically relevant soils underspecified use conditions;

31、 is non-toxic in the specified usedilution; has a shelf life and use-life consistent with theanticipated clinical use; is cost-effective.4.2 The following factors are a framework for identifyingtest methods that will be helpful to characterize detergentcleaning agents intended for use when cleaning

32、clinically-usedmedical instruments and devices.4Available from Association for the Advancement of Medical Instrumentation(AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633,http:/www.aami.org.5Available from International Organization for Standardization (ISO), ISOCentral Secretariat, B

33、IBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.6Available from Household detergent; medical deviceASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of th

34、is standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five ye

35、ars andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical commi

36、ttee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 194

37、28-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 185