ASTM D7161-2005 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions《在常规仓库条件下到期医用手套实时有效期测定的标准实施规程》.pdf

1、Designation: D 7161 05Standard Practice forDetermination of Real Time Expiration Dating of MatureMedical Gloves Stored Under Typical WarehouseConditions1This standard is issued under the fixed designation D 7161; the number immediately following the designation indicates the year oforiginal adoption

2、 or, in the case of revision, the year of last revision. 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 s

3、ynthetic or natural rubber latex,marketed at the time this practice is published, for which thereis no previous real time aging data available, and for whichthere are at least 12 months of storage as finished goods undertypical warehouse conditions. This practice describes how todevelop real time ag

4、ing data for gloves that are part of finishedgoods inventory (including gloves that may no longer bemanufactured) in order to verify the estimated expiration date(see Note 1). Manufacturers may use this data as a startingpoint for real time aging studies as described in PracticeD 7160.NOTE 1Accelera

5、ted aging for three-year shelf life is described inPractice D 7160.1.2 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 and health practices and determine the ap

6、plica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 3078 Test Method for Determination of Leaks in FlexiblePackaging by Bubble EmissionD 3577 Specification for Rubber Surgical Gl

7、ovesD 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 Specification for Nitrile Examination Gloves forMedical ApplicationD 7160 Practice for Determination of Ex

8、piration Dating forMedical GlovesF88 Test Method for Seal Strength of Flexible BarrierMaterialsF 1929 Test Method for Detecting Seal Leaks in PorousMedical Packaging by Dye Penetration2.2 ISO Standard:ISO 2859 Sampling Procedures for Inspection by At-tributes33. Terminology3.1 Definitions of Terms S

9、pecific to This Standard:3.1.1 date of manufacturethe date of the final processingstep. For sterile products, the last processing step would besterilization.3.1.2 mature medical glovesthose that have at least 12months of storage as finished goods under warehouse condi-tions.3.1.3 real time expiratio

10、n datecalculated by adding theshelf life to the date of manufacture3.1.4 shelf lifedetermined by the longest storage intervalof the mature gloves (from the date of manufacture) for whichthere is data demonstrating that the product meets the specifi-cations defined in this practice. The data should b

11、e generatedutilizing the test plan and methods defined in this practice.4. Significance and Use4.1 This practice provides a study design for determiningshelf life of medical gloves using product in its final packagingconfiguration that has been stored under typical warehouseconditions.5. General Inf

12、ormation5.1 For each glove type to be evaluated for expirationdating, select not less than three (3) lots from finished goods1This practice is under the jurisdiction of ASTM Committee D11 on Rubber andis the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition app

13、roved 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 Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from In

14、ternational Organization for Standardization (ISO), 1 rue deVaremb, Case postale 56, CH-1211, Geneva 20, Switzerland.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.inventory for which there are documented conditions ofstorage. The c

15、onditions to be documented are:5.1.1 Date of manufacture.5.1.2 Length of storage in warehouse.5.1.3 Location of warehouse.5.1.4 Temperature control at warehouse (controlled or un-controlled). If controlled, indicate the controlled temperatureand record the rationale why this temperature is represent

16、ativeof typical warehouse conditions. If uncontrolled, provide theaverage annual temperature for the warehouse location duringthe period of storage.NOTE 2May use data from http:/www.cdc.noaa.gov/Usclimate/states.fast.html.5.1.5 Humidity control at the warehouse (controlled oruncontrolled). If contro

17、lled, indicate the controlled relativehumidity.6. Materials and Equipment6.1 Refer to the individual procedures and standards refer-enced.7. Test Methods7.1 All GlovesEach of the three (3) lots of finishedproduct must be tested in accordance with Table 1.8. Acceptance Criteria8.1 Glove samples must

18、meet the requirements of theappropriate ASTM product specifications with respect to waterleak testing and “before aging” physical properties.8.2 Sterile product packaging must demonstrate predeter-mined requirements for seal strength and the ability to maintainpackage integrity.9. Real Time Stabilit

19、y Study9.1 If product test data meet the acceptance requirements in8.1, then the initial product shelf life, as determined by realtime aging, is that of the shortest storage period of the three (3)test lots. Assuming there are enough gloves in the test lots tocontinue testing on at least an annual b

20、asis, the mature glovestudy may be extended up to a maximum of five (5) years.However, no glove may be labeled with an expiration date ofmore than five (5) years from its date of manufacture.10. Keywords10.1 expiration date; medical gloves; shelf life; storageconditionsASTM International takes no po

21、sition respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this 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 responsibi

22、lity.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years 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 A

23、STM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, 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 addres

24、s shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,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), 61

25、0-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).TABLE 1 Tests RequiredGloves Sample Size and SpecificationTest Method D 5151 Sample Size: per ISO 2859, Inspection Level G-1AQL = 1.50 (Surgeons)AQL = 2.50 (Exam)Test Methods D 412 Sample Size: per ISO 2859, Ins

26、pection Level S-3, but not less than 32 gloves.Specified values for physical requirements per appropriate ASTM glove standard.(Specifications D 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 IS

27、O 2859, Inspection Level S-4, but not less than 50 packages.AQL = 0.65 (Surgeons)AQL = 1.50 (Exam)Permeable PackageTest Method F 1929 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)D7161052