ASTM D6977-2004(2010) 2500 Standard Specification for Polychloroprene Examination Gloves for Medical Application《医用氯丁橡胶检查手套的标准规范》.pdf

1、Designation: D6977 04 (Reapproved 2010)Standard Specification forPolychloroprene Examination Gloves for MedicalApplication1This standard is issued under the fixed designation D6977; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, t

2、he 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.1. Scope1.1 This specification provides certain requirements forpolychloroprene rubber gloves used in conducting medica

3、lexaminations and diagnostic and therapeutic procedures.1.2 This specification covers polychloroprene rubber exami-nation gloves that fit either hand, paired gloves, and gloves bysize. It also provides for packaged sterile or non-sterile or bulknon-sterile polychloroprene rubber examination gloves.1

4、.3 This specification is similar to that of D3578 StandardSpecification for Rubber Examination Gloves, and D6319Standard Specification for Nitrile Examination Gloves forMedical Applications.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermo-plastic Elastome

5、rsTensionD573 Test Method for RubberDeterioration in an AirOvenD3578 Specification for Rubber Examination GlovesD3767 Practice for RubberMeasurement of DimensionsD5151 Test Method for Detection of Holes in MedicalGlovesD6124 Test Method for Residual Powder on MedicalGlovesD6319 Specification for Nit

6、rile Examination Gloves forMedical ApplicationD6355 Test Method for Human Repeat Insult Patch Testingof Medical Gloves2.2 ISO Standard:ISO 2859 Sampling Procedures and Tables for Inspectionby Attributes32.3 Other Document:U.S. Pharmacopeia43. Significance and Use3.1 This specification is intended as

7、 a referee procedure forevaluating the performance and safety of polychloroprenerubber examination gloves. It is not intended for testing prior toroutine lot release. The safe and proper use of polychloroprenerubber examination gloves is beyond the scope of this speci-fication.4. Material4.1 Any pol

8、ychloroprene rubber compound that producesexamination gloves that meet the requirements of this specifi-cation are allowed.4.2 A lubricant that meets the current requirements of theU.S. Pharmacopoeia for absorbable dusting powder may beapplied to the glove. Other lubricants may be used if theirsafet

9、y and efficacy have been previously established.4.3 The inside and outside surface of the polychloroprenerubber examination gloves shall be free of talc.5. Performance Requirements5.1 Gloves, sampled in accordance with Section 6, shallmeet the following referee performance requirements:5.1.1 Product

10、s comply with requirements for sterility whentested in accordance with 7.2 when labeled sterile,5.1.2 Shall comply with freedom from holes when tested inaccordance with 7.3,5.1.3 Have consistent physical dimensions in accordancewith 7.4,5.1.4 Have acceptable physical property characteristics inaccor

11、dance with 7.5,5.1.5 Have a powder residue limit in accordance with 7.6,and5.1.6 Have a recommended maximum powder limit inaccordance with 7.7.6. Sampling6.1 For referee purposes, gloves shall be sampled fromfinished product, after sterilization when labeled sterile, and1This specification is under

12、the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved May 1, 2010. Published September 2010. Originallyapproved in 2004. Last previous edition approved in 2004 as D6977 041. DOI:10.1520/D6977-04R10.2

13、For 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 American National Standards Institute (ANSI),

14、25 W. 43rd St.,4th Floor, New York, NY 10036.4U.S. Pharmacopeia, latest edition, Mack Publishing Co., Easton, PA 19175.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.inspected in accordance with ISO 2859. The inspection levelsand ac

15、ceptable quality levels (AQL) shall conform to thosespecified in Table 1, or as agreed upon between the purchaserand the seller, if the latter is more comprehensive.7. Referee Test Methods7.1 The following tests shall be conducted to ensure therequirements of Section 8, as prescribed in Table 1.7.2

16、Sterility TestTesting for sterility shall be conducted inaccordance with the latest edition of the U.S. Pharmacopeia.7.3 Freedom from HolesTesting for freedom from holesshall be conducted in accordance with Test Method D5151.7.4 Physical Dimensions Test:7.4.1 The gloves shall comply with the dimensi

17、on require-ments prescribed in Table 2.7.4.2 The length shall be expressed in millimeters as mea-sured from the outside tip of the middle finger to the outsideedge of the cuff.7.4.3 The width of the palm shall be expressed in millime-ters as measured at a level between the base of the index fingeran

18、d the base of the thumb. Values of width per size other thanlisted shall meet the stated tolerance specified in Table 2.7.4.4 The minimum thickness shall be expressed in milli-meters as specified in Table 2 when using a dial or digitalmicrometer that meets requirements described in Test MethodsD412

19、and Practice D3767, and in the locations indicated in Fig.1. For referee tests, cutting the glove is necessary to obtainsingle-thickness measurements. (See Practice D3767 for moreinformation.)7.5 Physical Requirements Test:7.5.1 Before and after accelerated aging, the gloves shallconform to the phys

20、ical requirements specified in Table 3.Tests shall be conducted in accordance with Test MethodsD412. Die C is recommended.7.5.2 Accelerated AgingThe gloves shall be aged inaccordance with Test Method D573. Test the gloves by eitherone of the following methods:7.5.2.1 After being subjected to a tempe

21、rature of 70 6 2Cfor 166 6 2 h, the tensile strength and ultimate elongation shallnot be less than the values specified in Table 3. This methodshall be the conditions for referee tests.7.5.2.2 After being subjected to a temperature of 100 6 2Cfor 22 6 0.3 h, the tensile strength and ultimate elongat

22、ionshall not be less than the values specified in Table 3.7.6 Powder Free GlovesThe powder residue shall notexceed the average powder mass in A1.1 when tested inaccordance with Test Method D6124.7.7 Powdered Gloves:7.7.1 The amount of powder shall not exceed the recom-mended average powder mass limi

23、t in A1.2 when tested inaccordance with Test Method D6124 for powdered gloves.7.7.2 Determine the square decimeters for the glove size asin section 8.7.3 of Specification D3578.8. Acceptance8.1 Gloves will be considered to meet the referee perfor-mance requirements when test results conform to the r

24、equire-ments prescribed in Table 1.8.2 Retests or reinspections are permissible under the pro-vision of the U.S. Pharmacopeia and ISO 2859.9. Package Marking9.1 Sterile Packaging:9.1.1 The unit of packaging shall normally be one glove orone pair of gloves.9.1.2 A glove or pair of gloves, normally, s

25、hall be enclosedin an inner wallet or wrapper. The wrapper shall be of sufficientsize when opened to provide a field for glove-donning pur-poses.9.1.3 The glove or pair of gloves, and accompanyingwrapper if utilized, shall be totally enclosed in an outerpackage that will allow sterilization of the p

26、roduct.9.1.4 The outer package shall have a method of closuresufficient to ensure the sterility of the product until opened ordamaged.9.1.5 The outer package shall have sufficient strength andintegrity to withstand normal transportation and storage withinthe intermediate or shipping cartons, or both

27、.9.1.6 The method of closure of the outer package shall besuch that prior opening will be detectable by the user.9.1.7 None of the packaging material shall contain anymaterial likely to impair the quality and use of the gloves.9.1.8 Intermediate cartons and shipping cases shall be ofsufficient stren

28、gth to maintain the quality and sterility of theproduct during normal transportation and storage.9.2 Non-sterile and Bulk Packaging:9.2.1 The gloves shall be enclosed in an outer package thathas sufficient strength to withstand normal transportation andstorage within the cartons or shipping cases, o

29、r both.9.2.2 None of the packaging material shall contain anymaterial likely to impair the quality and use of the gloves.9.2.3 Cartons and shipping cases shall be of sufficientstrength to maintain the quality of the product during normaltransportation and storage.9.3 Package Marking:9.3.1 Sterile pa

30、ckages shall bear markings for the contentsto include the glove size, instructions for opening, the legend“sterile” and a manufacturing lot number.9.3.2 Non-sterile and bulk packages shall bear markings forthe contents to include the glove size and manufacturing lotnumber.9.3.3 The outermost case sh

31、all be labeled with the glove sizeand a manufacturing lot number. Sterile product cases shallalso be marked with the legend “sterile.”9.3.4 All levels of packaging shall conform to all appropri-ate government labeling regulations.TABLE 1 Performance RequirementsCharacteristic Related DefectsInspecti

32、onLevelAQLSterility fails sterilityAN/AFreedom from holes holes G-1 2.5Dimensions width, length, thickness S-2 4.0Physical properties before aging, afteraccelerated agingS-2 4.0Powder-free Residue exceeds maximum limit N=5 N/APowder Amount exceeds recommendedmaximum limitN=2 N/AASee U.S. Pharmacopei

33、a.D6977 04 (2010)210. Keywords10.1 examination gloves; polychloroprene; rubber; syn-thetic rubber; single-useTABLE 2 Dimensions and TolerancesDesignationSize6612 7712 8812 9 Tolerance, mmWidth by size 75 83 89 95 102 108 114 6 6Width by X-Small Small Unisize Medium Large X-large XX-large 6 1070 80 8

34、5 95 110 120 130Length 220 220 230 230 230 230 230 minimumThickness, mm:Finger, 0.05 minPalm, 0.05 minCuff, 0.05 minNOTESizing that falls within the tolerance overlaps between two sizes may be labeled as a size range including both sizes; for example, small/mediumand medium/large.FIG. 1 Location of

35、Thickness and Length MeasurementsTABLE 3 Physical RequirementsBefore Aging After Accelerated AgingTensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation14 MPa min 500 % min 14 MPa min 400 %minD6977 04 (2010)3ANNEX(Mandatory Information)A1.A1.1 Powder Residue Limit for Powder-free

36、GlovesA1.1.1 Average Powder Mass LimitThe recommendedlimit is not more than 2 mg per glove.A1.2 Powder Amount Limit for Powdered GlovesA1.2.1 Average Powder Mass LimitThe recommendedlimit is not more than 10 mg per square decimeter.ASTM International takes no position respecting the validity of any

37、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 responsibility.This standard is subject to revis

38、ion 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 ASTM International Headquarters. Your c

39、omments 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 address shown below.This standard is copyrig

40、hted 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), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).D6977 04 (2010)4