1、Designation:D716005(Reapproved 2010)Standard Practice forDetermination of Expiration Dating for Medical Gloves1This standard is issued under the fixed designation D7160;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last
2、 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 This practice covers all surgeons and examinationgloves made from either synthetic or natural rubber latex.Thepurpose of this p
3、ractice is to establish methods for testingmedical gloves and analyzing the data to determine their shelflife.1.2 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 a
4、nd health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD3078 Test Method for Determination
5、of Leaks in FlexiblePackaging by Bubble EmissionD3577 Specification for Rubber Surgical GlovesD3578 Specification for Rubber Examination GlovesD5151 Test Method for Detection of Holes in MedicalGlovesD5250 Specification for Poly(vinyl chloride)Gloves forMedical ApplicationD6319 Specification for Nit
6、rile Examination Gloves forMedical ApplicationD7161 Practice for Determination of Real Time ExpirationDating of Mature Medical Gloves Stored Under TypicalWarehouse ConditionsF88 Test Method for Seal Strength of Flexible BarrierMaterialsF1929 Test Method for Detecting Seal Leaks in PorousMedical Pack
7、aging by Dye PenetrationF1980 Guide for Accelerated Aging of Sterile Barrier Sys-tems for Medical Devices2.2 ISO Standards:3ISO 2859 Sampling Procedures for Inspection by AttributesISO 4074 Natural Latex Rubber CondomsRequirementsand Test Methods3.Terminology3.1 Definitions of Terms Specific to This
8、 Standard:3.1.1 accelerated agingconducted by storing samples atan elevated temperature for a reduced amount of time tosimulate a longer period of real time aging.3.1.2 date of manufacturedate of the final processing step.For sterile products,the last processing step is sterilization.3.1.3 real time
9、 agingthe storage of samples under condi-tions that the product is expected to experience over its shelflife.Storage conditions should include exposure to elevatedtemperatures that product may experience during shipping.3.1.4 real time expiration datecalculated by adding theshelf life to the date of
10、 manufacture.3.1.5 shelf lifedetermined by the longest storage interval(from time zero)for which there is data demonstrating that theproduct meets the specifications defined in this practice.Thedata should be generated utilizing the test plan and methodsdefined in this practice.3.1.6 time zerothe da
11、te of manufacture and the startingpoint for the shelf life studies.4.General Information4.1 The need for an expiration date is primarily based on thepotential for a critical aspect of the product to deteriorate,resulting in a patient/user safety risk.The potential for productdeterioration is determi
12、ned from exposure to the actual orsimulated handling and environmental conditions the productwould most likely encounter after release for sale.4.2 Because real time testing is often impractical,acceler-ated aging techniques must be used.For some medical devices,1This practice is under the jurisdict
13、ion ofASTM Committee D11 on Rubber andis the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved June 15,2010.Published September 2010.Originallyapproved in 2005.Last previous edition approved in 2005 as D7160 05.DOI:10.1520/D7160-05R10.2For referenced A
14、STM 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 website.3Available from International Organization for Standardization(ISO),1,ch.dela Voie-
15、Creuse,Case postale 56,CH-1211,Geneva 20,Switzerland,http:/www.iso.ch.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 the Arrhenius equation found in Guide F1980 is an acceptablepredictor of real time aging;however,other aging models canb
16、e used.4.3 Real time aging of medical gloves that have beenmarketed prior to the publication of this practice may beperformed in accordance with Practice D7161.5.Materials and Equipment5.1 Refer to the individual procedures and standards refer-enced.6.Tests for Stability and Shelf Life6.1 Manufacturers shall verify that gloves comply with therequirements of the applicable ASTM standard until the end ofthe labeled shelf life.Shelf life claims shall not exceed fiveyears.6.2 Amodified glove design
