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1、Designation: D357805 (Reapproved 2010) Standard Specifi cation for Rubber Examination Gloves1 This standard is issued under the fi xed designation D3578; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A
2、 number in parentheses indicates the year of last reapproval. A superscript epsilon () indicates an editorial change since the last revision or reapproval. This standard has been approved for use by agencies of the U.S. Department of Defense. 1. Scope 1.1 This specifi cation covers certain requireme
3、nts for natu- ral rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material. 1.2 This specifi cation provides for natural rubber gloves that fi t either hand, paired gloves, and
4、 gloves by size. It also provides for packaged sterile natural rubber gloves and pack- aged or bulk nonsterile natural rubber gloves. 2. Referenced Documents 2.1 ASTM Standards:2 D412 Test Methods for Vulcanized Rubber and Thermoplas- tic ElastomersTension D573 Test Method for RubberDeterioration in
5、 an Air Oven D3767 Practice for RubberMeasurement of Dimensions D5151 Test Method for Detection of Holes in Medical Gloves D5712 Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Prod- ucts Using the Modifi ed Lowry Method D6124 Test Method for Residua
6、l Powder on Medical Gloves D6499 Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products 2.2 Other Documents: ISO 2859 Sampling Procedures and Tables for Inspection by Attributes3 U. S. Pharmacopeia4 3. Classifi cation 3.1 Type IGloves with a minimum ten
7、sile strength of 18 MPa and a maximum stress at 500 % elongation of 5.5 MPa. 3.2 Type IIGloves with a minimum tensile strength of 14 MPa and a maximum stress at 500 % elongation of 2.8 MPa. 4. Materials and Manufacture 4.1 Any natural rubber compound that permits the glove to meet the requirements o
8、f this specifi cation. 4.2 A lubricant that meets the current requirements of the U.S. Pharmacopeia for Absorbable Dusting Powder may be applied to the glove. Other lubricants may be used if their safety and efficacy have been previously established. 4.3 The inside and outside surface of the natural
9、 rubber examination gloves shall be free of talc. 5. Signifi cance and Use 5.1 The specifi cation is intended as a reference to the performance and safety of natural rubber examination gloves. The safe and proper use of natural rubber examination gloves is beyond the scope of this specifi cation. 6.
10、 Sampling 6.1 For referee purposes, gloves shall be sampled and inspected in accordance with ISO 2859. The inspection levels and acceptable quality levels (AQL) shall conform to those specifi ed in Table 1, or as agreed between the purchaser and the seller, if the latter is more comprehensive. 7. Pe
11、rformance Requirements 7.1 Gloves, sampled in accordance with Section 6, shall meet the following referee performance requirements: 7.1.1 Comply with requirements for sterility when tested in accordance with 8.2. 7.1.2 Be free from holes when tested in accordance with 8.3. 7.1.3 Have consistent phys
12、ical dimensions in accordance with 8.4. 7.1.4 Have acceptable physical property characteristics in accordance with 8.5. 7.1.5 Have a powder residue limit of 2.0 mg in accordance with 8.6. 1 This specifi cation is under the jurisdiction ofASTM Committee D11 on Rubber and is the direct responsibility
13、of Subcommittee D11.40 on Consumer Rubber Products. Current edition approved May 1, 2010. Published September 2010. Originally approved in 1977. Last previous edition approved in 2005 as D3578 051. DOI: 10.1520/D3578-05R10. 2For referenced ASTM standards, visit the ASTM website, www.astm.org, or con
14、tact ASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standards volume information, refer to the standards Document Summary page on the ASTM website. 3Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036. 4U.S. Pharmacopeia, late
15、st edition, Mack Publishing Co., Easton, PA, 19175. Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 1 7.1.6 Have a recommended aqueous soluble protein content limit of 200 g/dm2in accordance with 8.7 and Annex A1 or have a recommended
16、 antigenic protein content limit of 10 g/dm2in accordance with 8.9 and Annex A2. 7.1.7 Have a recommended maximum powder limit of 10 mg/dm2in accordance with 8.8. 8. Referee Test Methods 8.1 The following tests shall be conducted to ensure the requirements of Section 8, as prescribed in Table 1: 8.2
17、 Sterility TestTesting for sterility shall be conducted in accordance with the latest edition of The U.S. Pharmacopeia. 8.3 Freedom From HolesTesting for freedom from holes shall be conducted in accordance with Test Method D5151. 8.4 Physical Dimensions Test (Practice D3767): 8.4.1 The gloves shall
18、comply with the dimension require- ments prescribed in Table 2. 8.4.2 The length shall be expressed in millimetres as mea- sured from the tip of the middle fi nger to the outside edge of the cuff as indicated in Fig. 1. 8.4.3 The width of the palm shall be expressed in millime- tres as measured at a
19、 level between the base of the index fi nger and the base of the thumb. Values of width per size other than listed shall meet the stated tolerance specifi ed in Table 2. 8.4.4 The minimum thickness shall be expressed in milli- metres as specifi ed in Table 2 when using a dial micrometer described in
20、 Test Methods D412 and in the locations indicated on Fig. 1. For referee tests, cutting the glove is necessary to obtain single-thickness measurements. 8.5 Physical Requirements Test: 8.5.1 Before and after accelerated aging, the gloves shall conform to the physical requirements specifi ed in Table
21、3. Tests shall be conducted as specifi ed in Test Methods D412. Die C is recommended. 8.5.2 Accelerated aging tests shall be conducted in accor- dance with Test Method D573. Test the gloves by either one of the following methods: 8.5.2.1 After being subjected to a temperature of 70 6 2C for 166 6 2
22、h, the tensile strength and ultimate elongation shall not be less than the values specifi ed in Table 3. This method shall be the condition for referee tests. 8.5.2.2 After being subjected to a temperature of 100 6 2C for 22 6 0.3 h, the tensile strength and ultimate elongation shall not be less tha
23、n the values specifi ed in Table 3. 8.6 Powder Free Gloves: 8.6.1 Determine the powder residue using Test Method D6124. 8.7 Aqueous Extractable Protein Content: 8.7.1 Determine the aqueous extractable protein (g/mL) using Test Method D5712 for each glove sample tested. 8.7.2 Determine the total micr
24、ograms of aqueous extract- able protein in each glove sample by multiplying the result from 8.7.1 by the total volume of extractant used for that specifi c glove sample. If the glove sample is less than a whole glove, then adjust the protein results to refl ect the amount of protein in the whole glo
25、ve. 8.7.3 Determine the square decimeters for the glove size. Multiply the minimum length and nominal width found in Table 2 and convert to dm2using (dm2/mm2) (mm2/10 000) (4). Four (4) is the factor for all inside and outside surface areas. 8.7.4 Determine the aqueous extractable protein content of
26、 a glove sample by dividing the result from 8.7.2 (total g of protein) by 8.7.3 (total surface area of glove). 8.7.5 If the sample is more than one (1) glove, use the average g/dm2of protein for the number of gloves tested in the sample. 8.8 Powdered Gloves: 8.8.1 Determine the recommended maximum p
27、owder limit using Test Method D6124 for powdered gloves. 8.8.2 Determine the square decimeters for the glove size as in 8.7.3. 8.9 Antigenic Protein Content: 8.9.1 Determine the extractable antigenic protein (g/mL) using Test Method D6499 for each glove sample tested. TABLE 1 Performance Requirement
28、s CharacteristicRelated Defects Inspection Level AQL Sterilityfails sterility A N/A Freedom from holesholes2.5 Dimensionswidth, length, and thickness S-24.0 Physical propertiesbefore aging, after accel- erated aging S-24.0 Powder Free ResidueExceeds Maximum LimitN=5N/A Protein ContentExceeds Recomme
29、nded Maximum Limit N=3N/A Powder AmountExceeds Recommended Maximum Limit N=2N/A Antigenic Protein Content Exceeds Recommended Maximum Limit N=1N/A ASee U.S. Pharmacopeia. TABLE 2 Dimensions and Tolerances Designation Size Tolerance, mm 6612771288129 Width by size, mm758389951021081146 Width byExtra
30、Small SmallUnisizeMediumLarge mm7080859511110 Length, mm220220220230230Min Thickness, mm:For All Sizes Finger Palm 0.08 0.08 Min Min D3578 05 (2010) 2 8.9.2 Determine the total microgram of extractable anti- genic protein in each glove sample by multiplying the result from 8.9.1 by the total volume
31、of extractant used for that specifi c glove sample. 8.9.3 Determine the square decimeter for the glove size as in 8.7.3. 8.9.4 Determine the extractable antigenic protein content of a glove sample by dividing the result from 8.9.2 (total microgram of antigenic protein) by 8.9.3 (total surface area o
32、f glove). 9. Acceptance 9.1 Gloves will be considered to meet the referee perfor- mance requirements when test results conform to the require- ments prescribed in Table 1. 9.2 Retests or reinspections are permissible under the pro- visions of the U.S. Pharmacopeia and ISO 2859. 10. Packaging and Mar
33、king 10.1 Sterile Packaging: 10.1.1 The unit of packaging shall normally be one glove or one pair of gloves. 10.1.2 Aglove or pair of gloves, normally, shall be enclosed in an inner wallet or wrapper. The wrapper shall be of sufficient size when opened to provide a fi eld for glove-donning pur- pose
34、s. 10.1.3 The glove or pair, and accompanying wrapper if utilized, shall be totally enclosed in an outer package that shall allow sterilization of the product. 10.1.4 The outer package shall have a method of closure sufficient to assure the sterility of the product until opened or damaged. 10.1.5 Th
35、e outer package shall have sufficient strength and integrity to withstand normal transportation and storage within the intermediate or shipping cartons, or both. 10.1.6 The method of closure of the outer package shall be such that prior opening will be detectable by the user. 10.1.7 None of the pack
36、aging material shall contain any material likely to impair the quality and use of the gloves. 10.1.8 Intermediate cartons and shipping cases shall be of sufficient strength to maintain the quality and sterility of the product during normal transportation and storage. 10.2 Nonsterile and Bulk Packagi
37、ng: 10.2.1 The unit of packaging shall normally be more than one glove and of a specifi c amount. 10.2.2 The gloves shall be enclosed in an outer package that has sufficient strength to withstand normal transportation and storage within the cartons or shipping cases, or both. FIG. 1 Location of Thic
38、kness and Length Measurements TABLE 3 Physical Requirements Before AgingAfter Accelerated Aging Tensile Strength Stress at 500 % Elongation Ultimate Elongation Tensile Strength Ultimate Elongation Type I18 MPa min 5.5 MPa max650 % min14 MPa min500 % min Type II14 MPa min 2.8 MPa max650 % min14 MPa m
39、in500 % min D3578 05 (2010) 3 10.2.3 None of the packaging material shall contain any material likely to impair the quality and use of the gloves. 10.2.4 Cartons and shipping cases shall be of sufficient strength to maintain the quality of the product during normal transportation and storage. 10.3 M
40、arking: 10.3.1 Sterile packages shall bear markings for the contents to include the glove size, instructions for opening, the legend “sterile,” and a manufacturing lot number. 10.3.2 Nonsterile and bulk packages shall bear markings for the contents to include the glove size and a manufacturing lot n
41、umber. 10.3.3 The outermost case shall be labeled with the glove size and a manufacturing lot number. Sterile product cases shall also be marked with the legend “sterile.” 10.3.4 All levels of packaging shall conform to all appro- priate government labeling regulations. 11. Keywords 11.1 examination
42、; gloves; rubber ANNEXES Mandatory Information A1.PROTEIN CONTENT A1.1 The current assay precision is large enough that only a recommended limit can be considered. A1.2 Consideration should be given to the relative repeat- ability and reproducibility when reporting test method results. A1.3 Reasonab
43、le allowance should be given for test results in excess of the recommended limit until greater precision of the method can be attained. A2. ANTIGENIC PROTEIN CONTENT A2.1 The current assay precision is large enough that only a recommended limit can be considered. A2.2 Consideration should be given t
44、o the relative repeat- ability and reproducibility when reporting test methods. A2.3 A pooled sample from three individual NR specimens or products as extracted in accordance with Test Method D5712 is permitted for use as the extraction sample. APPENDIX (Nonmandatory Information) X1. Rationale X1.1
45、At a meeting of the Glove Task Force of ASTM D11.40, it was determined to expand the physical requirement values allowing consumers more choice in fi t, feel, and comfort by having two types of examination gloves. D3578 05 (2010) 4 ASTM International takes no position respecting the validity of any
46、patent rights asserted in connection with any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility. This standard is subject to re
47、vision at any time by the responsible technical committee and must be reviewed every fi ve years and if not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters.
48、Your comments will receive careful consideration at a meeting of the responsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards, at the address shown below. This standard i
49、s 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 above address 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 Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; D3578 05 (2010) 5