收藏 分享(赏)

ASTM_E_2314_-_03_2014.pdf

上传人:益****师 文档编号:169452 上传时间:2023-03-04 格式:PDF 页数:6 大小:101.06KB
下载 相关 举报
ASTM_E_2314_-_03_2014.pdf_第1页
第1页 / 共6页
ASTM_E_2314_-_03_2014.pdf_第2页
第2页 / 共6页
ASTM_E_2314_-_03_2014.pdf_第3页
第3页 / 共6页
ASTM_E_2314_-_03_2014.pdf_第4页
第4页 / 共6页
ASTM_E_2314_-_03_2014.pdf_第5页
第5页 / 共6页
ASTM_E_2314_-_03_2014.pdf_第6页
第6页 / 共6页
亲,该文档总共6页,全部预览完了,如果喜欢就下载吧!
资源描述

1、Designation:E231403(Reapproved 2014)Standard Test Method forDetermination of Effectiveness of Cleaning Processes forReusable Medical Instruments Using a MicrobiologicMethod(Simulated Use Test)1This standard is issued under the fixed designation E2314;the number immediately following the designation

2、indicates the year oforiginal adoption or,in the case of revision,the year 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.INTRODUCTIONCleaning is acknowledged as the critical fir

3、st step in the reprocessing of reusable medicalinstruments.A test method to examine the efficacy and reproducibility of cleaning procedures wouldbe valuable in optimizing decontamination of medical instruments,as well as increasing the marginof safety of subsequent disinfection and sterilization pro

4、cedures.This test method is a means ofdetermining the efficacy of the instrument manufacturers cleaning instructions.In this simulated usetest cleaning steps are performed with the instruments in a controlled laboratory environment.Withinthis environment,various parameters may be exaggerated to crea

5、te worst-case conditions for the test.Among these are the amount or type of organic soil or microorganisms contaminating the instruments.The test method was developed primarily for large medical instruments or instruments with internalchannels or recesses(for example,flexible endoscopes)but may be u

6、sed for any resuable medicalinstruments.It employs both direct inoculation and sampling methods for external surfaces andindirect inoculation and sampling methods for less accessible internal channels.Cleaning is defined as the removal of foreign materials,most often mixtures of organic soil(forexam

7、ple,protein)and microorganisms,from medical instruments.Bacterial endospores are thepreferred microorganisms in this simulated test because they would be more resistant to the potentialmicrobiocidal effects of the cleaning processes and solutions.This method examines the reduction inthe number of sp

8、ores as a tracer of foreign materials and not necessarily the reduction in organic soildirectly.This test may be designed to either examine the efficacy of a complete cleaning cycle consisting ofseveral integrated steps or individual cleaning step such as precleaning,manual cleaning,automatedcleanin

9、g or rinsing.1.Scope1.1 This test method is written principally for large medicalinstruments or instruments with internal channels or recesses(for example,flexible endoscopes)but may be used for anyresuable medical instruments.1.2 This test method describes a procedure for testing theefficacy of a c

10、leaning process for reusable medical instrumentsartificially contaminated with mixtures of microorganisms andsimulated soil.1.3 The test method utilizes bacterial spores as tracers forforeign materials and quantifies their removal as a means ofdetermining the efficacy of a cleaning process.1.4 The t

11、est method is designed for use by manufacturers ofmedical instruments and devices.However,it may also beemployed by other individuals who have a knowledge of theinstruments,techniques and access to appropriate facilities.1.5 Worst-case conditions can be represented by exaggerat-ing a specific test p

12、arameter or otherwise intentionally simu-lating an extreme condition such as performing the test withoutcleaning solutions or utilizing instruments which are not new.1.6 The test procedure is devised to determine the efficacyof a cleaning process as applied to a particular instrument orgroup of inst

13、ruments by simulating actual use situations.1.7 The test procedure may be performed on test instru-ments using a complete cleaning cycle or be limited to1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agentsand is the direct respo

14、n-sibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved Oct.1,2014.Published December 2014.Originallyapproved in 2003.Last previous edition approved in 2008 as E2314 03(2008).DOI:10.1520/E2314-03R14.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Consho

15、hocken,PA 19428-2959.United States1 particular phases of the cycle such as precleaning,manualcleaning,automated cleaning,or rinsing.1.8 The test procedure is normally performed on a numberof external and internal sites,but it may be restricted to oneparticular site on the instrument.1.9 A knowledge

16、of microbiological and aseptic techniquesand familiarity with the instruments is required to conductthese procedures.NOTE1Because contamination of the surfaces of instruments mayoccur as a result of rinsing with tap water,bacteria-free water should beused for all rinsing when a water rinse step is part of the cleaningdirections.NOTE2Test methods to determine the effectiveness of cleaningmedical instruments has only recently been actively debated,and researchefforts are in their infancy.Because p

展开阅读全文
相关资源
猜你喜欢
相关搜索

当前位置:首页 > 专业资料 > 国外标准

copyright@ 2008-2023 wnwk.com网站版权所有

经营许可证编号:浙ICP备2024059924号-2