ASTM D7160-2005 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: D 7160 05Standard Practice forDetermination of Expiration Dating for Medical Gloves1This standard is issued under the fixed designation D 7160; 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 (e) 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 prac

3、tice 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:2D 412 Test Method for Vulcanized Rubbers and Thermo-plastic ElastomersTensionD 573 Test Method for RubberDeterioration in an AirOvenD 3078 Test Method for Determinat

5、ion of Leaks in FlexiblePackaging by Bubble EmulsionD 3577 Specification for Rubber Surgical GlovesD 3578 Specification for Rubber Examination GlovesD 5151 Test Method for Detection of Holes in MedicalGlovesD 5250 Specification for Poly(vinyl chloride) Gloves forMedical ApplicationD 6319 Specificati

6、on for Nitrile Examination Gloves forMedical ApplicationD 7161 Practice for Determination of Real Time ExpirationDating of Mature Medical Gloves Stored Under TypicalWarehouse ConditionsF88 Test Method for Seal Strength of Flexible BarrierMaterialsF 1929 Test Method for Detecting Seal Leaks in Porous

7、Medical Packaging by Dye PenetrationF 1980 Guide for Accelerated Aging of Sterile MedicalDevice Packages2.2 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 tim

9、e 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

10、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 in this practice. Thedata should be generated utilizing the test plan and methodsdefined in this practice.3.1.6 time zeroth

11、e 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 aspect of the product to deteriorate,resulting in a patient/user safety risk. The potential for productdeterioration is d

12、etermined 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 Arrhenius equation found

13、in Guide F 1980 is an acceptablepredictor of real time aging; however, other aging models canbe 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 D 7160.1This practice is under the jurisdiction of A

14、STM Committee D11 on Rubber andis the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved June 15, 2005. Published August 2005.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For A

15、nnual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from International Organization for Standardization (ISO), 1 rue deVaremb, Case postale 56, CH-1211, Geneva 20, Switzerland.1Copyright ASTM International, 100 Barr Harbor Drive,

16、 PO Box C700, West Conshohocken, PA 19428-2959, United States.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 t

17、he end ofthe labeled shelf life. Shelf life claims shall not exceed fiveyears.6.2 Amodified glove design is one in which there have beensignificant changes to the formulation, manufacturing process,or individual sealed containers. Before a new or modified glovedesign is placed on the market, the fol

18、lowing requirementsshall be met:6.2.1 The glove shall be tested for the minimum stabilityrequirements as described in 6.4.6.2.2 Areal time study as described in 6.5 to determine shelflife must be initiated.6.2.3 Pending completion of the real time study, shelf lifeshall be estimated as described in

19、6.4.6.3 The product to be considered for storage stability testingis categorized into family groupings 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 form

20、ulationsused, types of processing such as chlorination or coatings,packing methods, sterilization, 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.

21、 Only lots meeting the requirements of theapplicableASTM standard at time zero shall be included in thistest. Control group testing of unaged product should beginwithin 96 h of the start of the oven aging.6.4.2 A sufficient number of samples shall be incubated atthe applicable conditions listed in T

22、able 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 performed no earlier than

23、 16 h and no later than 96h from the time of removal from the oven in accordance withTest Method D 573. During this period, the oven-aged glovesshould be conditions at room temperature.6.5 Real Time Stability Studies:6.5.1 Real time studies of gloves sampled from the samethree lots should be initiat

24、ed 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. Thestorage temperature should not be below 25C. Storage con-ditions should be moni

25、tored and recorded. Testing shall beperformed no sooner than 24 h from date of manufacturing atthe initiation of the study and, at a minimum, at yearly intervalsup to five years. Testing may occur at more frequent intervalsif desired. The samples must be incubated in the final packag-ing configurati

26、on and be representative of the finished product.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 t

27、hat which is supportedby the 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 ap

28、propriate procedures.8. Acceptance Criteria for Real Time and AcceleratedAged Gloves8.1 Glove samples aged at less than 50C 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

29、 50 6 2C or greater must 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 beinit

30、iated to determine if the 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 twoint

31、ervals is based on the average 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).9. Expiration Date Determination9.1 Accelerated Stability:9.1.1 Pending the completion of

32、real time studies, acceler-ated stability studies shall be used to estimate shelf life.9.1.2 A maximum shelf life of three (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 methodo

33、utlined in 6.4.2, there are several accelerated aging modelsthat may be used. A model using Arrhenius shift factors isincluded in ISO 4074, Annex K “Guidance on Conducting andAnalyzing Accelerated Aging Studies.” Alternatively, the shiftfactor can be verified and the shelf life estimated using theme

34、thod described in this practice in Annex A2. Anothermethod based on activation energy is included in this practiceTABLE 1 Incubation ConditionsTime Interval TemperatureTime Zero (control group, no aging, all materials) Ambient72 6 2 h (vinyl only) 70 6 2C166 6 2 h (except vinyl) 70 6 2C90 6 1 day (a

35、ll materials) 50 6 2CD7160052as Annex A3. Manufacturers may chose other acceleratedaging models that can be validated with real-time data. Asmanufacturers, standard developing groups, and regulatoryagencies accumulate data, a consensus method will be devel-oped.9.2 Real Time AgingThe maximum shelf l

36、ife for medicalgloves is five years. The 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 sh

37、elf life obtained for the three test lots.10. Keywords10.1 expiration date; medical gloves; shelf lifeANNEXESA1. POSSIBLE GROUPINGS FOR TYPICAL MEDICAL GLOVE PRODUCT FAMILIESA2. VERIFICATION OF THE ACTIVATION ENERGY AND ESTIMATING SHELF LIFE USING SHIFT FACTORSA2.1 IntroductionA2.1.1 An accelerated

38、aging guidance for natural rubberlatex condoms that is based on the Arrhenius equation suggeststhat a constant activation energy of 83 kJ/mol will provide aconservative estimate of shelf life for that product (seeISO 4074, Annex K, Guidance on Conducting and AnalyzingAccelerated Ageing Studies). Whi

39、le there are similaritiesbetween 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 o

40、ver a large temperature range. 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

41、 of the shelf life can be 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 nonconsecutive production lots. (See 7.1 forrecommended sample sizes.) Gloves, in their original

42、 packag-ing, should be aged at a minimum of four elevated tempera-tures, including 50C and 70C. The maximum temperatureshould be 80C or less. Testing of the properties of interestshould be performed at multiple time intervals for eachTABLE 2 Tests RequiredGloves Sample Size and SpecificationTest Met

43、hod D 5151 Sample Size: per ISO 2859, Inspection Level S-3, but not less than 32 gloves.AQL = 1.50 (Surgeons)AQL = 2.50 (Exam)Test Methods D 412 Sample Size: per ISO 2859, Inspection Level S-3, but not less than 32 gloves.Specified values for physical requirements per appropriate ASTM standard. (Spe

44、cificationsD 3577, D 3578, D 5250, D 6319, and so forth.)AQL=4.00Sterile Packaging Sample Size and SpecificationImpermeable PackageTest Method D 3078 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 F 19

45、29 Sample Size: per ISO 2859, Inspection Level S-4, but not less than 50 packages.AQL = 0.65 (Surgeons)AQL = 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)NOTEFactors to consider include

46、 glove thickness, chlorination levels, and coatings or surface treatments.Material Type Chlorinated Coating Packaging Type SterileNRL Latex CompoundNeopreneNitrileVinylOtherFIG. A1.1 Possible Groupings for Typical Medical Glove Product FamiliesD7160053elevated temperature, until a predetermined thre

47、shold value isreached. At least 5 time points will be needed for eachtemperature.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 A expFEaRTG(A2.1)where:k = rate constant,A = a constan

48、t related to the property of interest,Ea= activation energy,R = the universal gas constant (8.314 3 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 c

49、onstant at T1, andk2= that at T2(T1T2).A2.2.3 Combining Eq A2.1 and Eq A2.2 yields:aT5 expFEaRS1T11T2DG(A2.3)A2.2.4 Experimentally, aTcan be determined byaT5t1t2(A2.4)where:t1= time the product dwells at T1until the propertythreshold is reached, andt2= that at T2(T1T2).A2.3 Verification of the Activation EnergyA2.3.1 Calculate the actual shift factor, aT, for at least 3pairs of accelerated aging temperatures (for example, 50C and60C, 60C and 70C, 70C and 80C) using the experimentaldata and Eq A2.4.A2.3.2 Calculate the actual activation energy, E