ASTM D7160-2016 6103 Standard Practice for Determination of Expiration Dating for Medical Gloves《医用手套有效期测定的标准实施规程》.pdf

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1、Designation: D7160 16Standard 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 revision. A

2、 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 practic

3、e 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 thelabel claims and safety concerns, if any, associated with its use.It is the responsibility of the user of this standard to establishappropri

4、ate safety and health practices and determine theapplicability 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 Det

5、ermination 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 Specifica

6、tion for Nitrile 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 Porous

7、Medical Packaging 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 Methods2.3 Other:ICH Q1D Bracketing and Matrixing

8、 designs for StabilityTesting of Drug Substances and Drug Products43. Terminology3.1 Definitions of Terms Specific to This 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 m

9、anufacturedate of the final processing step.For sterile products, the last processing step is sterilization.3.1.3 real time agingthe storage of samples under condi-tions that the product is expected to experience over its shelflife. Storage conditions should include exposure to elevatedtemperatures

10、that product may experience during shipping.3.1.4 real time expiration datecalculated by adding theshelf life to the date of 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 i

11、n this practice. Thedata should be generated utilizing the test plan and methodsdefined in this practice.3.1.6 time zerothe date 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

12、 aspect of the product to deteriorate,1This practice is under the jurisdiction ofASTM Committee D11 on Rubber andRubber-like Materials and is the direct responsibility of Subcommittee D11.40 onConsumer Rubber Products.Current edition approved June 1, 2016. Published December 2016. Originallyapproved

13、 in 2005. Last previous edition approved in 2010 as D7160 05 (2010).DOI: 10.1520/D7160-16.2For 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 Sum

14、mary page onthe ASTM website.3Available from International Organization for Standardization (ISO), 1, ch. dela Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http:/www.iso.ch.4Available from International Conference on Harmonisation of TechnicalRequirements for Registration of Pharma

15、ceuticals for Human Use (ICH), ICHSecretariat, 9, chemin des Mines, P.O. Box 195, 1211 Geneva 20, Switzerland,http:/www.ich.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1resulting in a patient/user safety risk. The potential for

16、 productdeterioration is determined 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,the

17、 Arrhenius equation found in Guide F1980 is an acceptablepredictor of real time aging.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 procedu

18、res 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 is one in which th

19、ere have beensignificant changes to the formulation, manufacturing process,or individual sealed containers. Before a new or modified glovedesign is placed on the market, the following requirementsshall be met:6.2.1 The glove shall be tested for the minimum stabilityrequirements as described in 6.4.6

20、.2.2 Areal time study as described in 6.5 to determine shelflife must be initiated.6.2.3 Pending completion of the real time study, a provi-sional shelf life claim shall be substantiated as described in 6.4.6.3 The product to be considered for storage stability testingis categorized into family grou

21、pings that represent a worst orlimit case for a given set of common characteristics to thegloves within that family group of gloves. These groupings areformed with consideration to the type of latex formulationsused, types of processing such as chlorination or coatings,packing methods, sterilization

22、, and the products intended use.Typical groups or product family categories are summarized inAnnex A1.6.4 Accelerated Stability Test:6.4.1 A minimum of three discrete finished product lotsmust be tested. ICH Q1D may be used for bracketing andmatrixing designs. Only lots meeting the requirements of t

23、heapplicableASTM standard at time zero shall be included in thistest. Data from formal stability studies should be provided onlots manufactured by using the actual method of manufactureand procedure used for production lots.6.4.2 A sufficient number of samples shall be incubated atthe applicable con

24、ditions listed in Table 1. Samples must beincubated in the final packaging configuration. Alternativemethods for accelerated aging studies are described in 9.1.3.6.4.3 At the end of the incubation periods, test the glovesper Section 7. Note that the measurement of physical propertiesshould be perfor

25、med no earlier than 16 h and no later than 96h from the time of removal from the oven in accordance withTest Method D573. During this period, the oven-aged glovesshould be conditioned at room temperature.6.5 Real Time Stability Studies:6.5.1 Real time studies of gloves sampled from the samethree lot

26、s should be initiated at the same time as the acceleratedstudies.6.5.2 Sufficient samples shall be stored under conditionsthat are representative of the actual storage conditions theproduct is expected to experience over its shelf life. Storageconditions should be monitored and recorded. Testing sha

27、ll beperformed no sooner than 24 h from date of manufacturing atthe initiation of the study and, at a minimum, tested at yearlyintervals up to five years. Testing may occur at more frequentintervals if desired. The samples must be incubated in the finalpackaging configuration and be representative o

28、f the finishedproduct.6.5.3 Testing shall be performed at each interval on each ofthree lots per Section 7.6.5.4 If the real time data indicates a shorter shelf life thanthat established by accelerated aging, the manufacturer shallchange the shelf life for the product to that which is supportedby th

29、e real time study. The shelf life shall not exceed five yearsregardless of supporting data.7. Test Program for Accelerated and Real Time Aging7.1 All GlovesEach of the three (3) lots of finishedproduct must be tested in accordance with Table 2 anddocumented according to appropriate procedures.8. Acc

30、eptance Criteria for Real Time and AcceleratedAged Gloves8.1 Glove samples aged at less than 50 C must meet therequirements of the appropriate ASTM product type specifica-tion with respect to water leak testing and “before aging”physical properties.8.2 Glove samples aged at 50 6 2 C or greater must

31、meetthe requirements of the appropriate ASTM product typespecification with respect to water leak testing and “afteraccelerated aging” physical properties.8.3 If a 25 % or greater change in physical properties fromthe initial value is observed, an investigation should beinitiated to determine if the

32、 change is an indication of anincreased rate of degradation. If an increase in the rate ofdegradation of physical properties is confirmed, then theprevious test interval should be used to determine the shelf life.NOTE 1The percent change of physical properties between twointervals is based on the av

33、erage values of the samples tested.8.4 Sterile product packaging must demonstrate predeter-mined requirements for seal strength and the ability to maintainsterility (package integrity).TABLE 1 Incubation ConditionsTime Interval TemperatureTime Zero (control group, no aging, all materials) Ambient72

34、2 h (vinyl only) 70 2C166 2 h (except vinyl) 70 2C90 1 day (all materials) 50 2CD7160 1629. Expiration Date Determination9.1 Accelerated Stability:9.1.1 Pending the completion of real time studies, acceler-ated stability studies shall be used to estimate shelf life.9.1.2 A maximum shelf life of thre

35、e (3) years shall beassigned based on accelerated studies. The shelf life may beextended as real time data is generated.9.1.3 In addition to the Accelerated Stability Test methodoutlined in 6.4, there are several accelerated aging models thatmay be used.Amodel usingArrhenius shift factors is include

36、din ISO 4074, Annex L “Guidance on Conducting and Analyz-ing Accelerated Aging Studies.” Alternatively, the shift factorcan be verified and the shelf life estimated using the methoddescribed in this practice in Annex A2. Another method basedon activation energy is included in this practice as Annex

37、A3.Manufacturers may chose other accelerated aging models thatcan be validated with real-time data. As manufacturers, stan-dard developing groups, and regulatory agencies accumulatedata, a consensus method will be developed.9.2 Real Time AgingThe maximum shelf life for medicalgloves is five years. T

38、he shelf life of a test lot is determined byselecting the longest test interval from time zero for which allrequirements are met at the end of the entire test interval aswell as for each intermediate test interval. The shelf life of theproduct is the shortest shelf life obtained for the three test l

39、ots.10. Keywords10.1 expiration date; medical gloves; shelf lifeANNEXESA1. POSSIBLE GROUPINGS FOR TYPICAL MEDICAL GLOVE PRODUCT FAMILIESTABLE 2 Tests RequiredGloves Sample Size and SpecificationTest Method D5151 Sample Size: per ISO 2859, Inspection Level S-3, but not less than 32 gloves.AQL = 1.50

40、(Surgeons)AQL = 2.50 (Exam)Test Methods D412 Sample Size: per ISO 2859, Inspection Level S-3, but not less than 32 gloves.Specified values for physical requirements per appropriate ASTM standard. (Specifications D3577,D3578, D5250, D6319, and so forth.)AQL=4.00Sterile Packaging Sample Size and Speci

41、ficationImpermeable PackageTest Method D3078 Sample Size: per ISO 2859, Inspection Level S-4, but not less than 50 packages.AQL = 0.65 (Surgeons)AQL = 1.50 (Exam)Permeable PackageTest Method F1929 Sample Size: per ISO 2859, Inspection Level S-4, but not less than 50 packages.AQL = 0.65 (Surgeons)AQL

42、 = 1.50 (Exam)All Package TypesTest Method F88 Sample Size: per ISO 2859, Inspection Level S-4,but not less than 50 packages.AQL = 0.65 (Surgeons)AQL = 1.50 (Exam)NOTE 1Factors to consider include glove thickness, chlorination levels, and coatings or surface treatments.Material Type Chlorinated Coat

43、ing Packaging Type SterileNRL Latex CompoundNeopreneNitrileVinylOtherFIG. A1.1 Possible Groupings for Typical Medical Glove Product FamiliesD7160 163A2. VERIFICATION OF THE ACTIVATION ENERGY AND ESTIMATING SHELF LIFE USING SHIFT FACTORSA2.1 IntroductionA2.1.1 An accelerated aging guidance for natura

44、l rubberlatex condoms that is based on theArrhenius equation suggeststhat a constant activation energy of 83 kJ/mol will provide aconservative estimate of shelf life for that product (see ISO4074, Annex L, Guidance on Conducting and AnalyzingAccelerated Ageing Studies). While there are similaritiesb

45、etween natural rubber latex gloves and condoms, an activa-tion energy of 83 kJ/mol may not be appropriate for all gloves,whether made from latex or synthetic materials. In fact, it islikely that the activation energy necessary to cause degradationof the product may change over a large temperature ra

46、nge. Thefollowing method, also based on the Arrhenius equation, maybe used to determine the actual activation energy for eachproduct family (including each latex formulation) and for eachpair of temperatures in the accelerated aging study. Once this iscompleted, an estimate of the shelf life can be

47、made based onthe actual shift factors.A2.1.2 In order to use this approach, a statistically appro-priate sample of finished product should be randomly selectedfrom each of three production lots. (See 7.1 for recommendedsample sizes.) Gloves, in their original packaging, should beaged at a minimum of

48、 four elevated temperatures, including 50C and 70 C. The maximum temperature should be 80 C orless. Testing of the properties of interest should be performedat multiple time intervals for each elevated temperature, until apredetermined threshold value is reached.At least 5 time pointswill be needed

49、for each temperature.NOTE A2.1For tensile strength, the recommended threshold value is75 % of the original tensile strength.A2.2 BackgroundA2.2.1 According to the Arrhenius equation,k 5 AexpF2EaRTG(A2.1)where:k = rate constant,A = a constant related to the property of interest,Ea= activation energy,R = the universal gas constant (8.314 10-3kJ mol-1K-1),andT = temperature of interest (in degrees Kelvin).A2.2.2 The shift factor, aT, is the ratio of two different ratesof reaction. It can be expressed asaT5k2k1(A2.2)where:k1= the rate con