sdram控制器Designation:D3578−05(Reapproved2010)
Standard Specification for
液压矫平机Rubber Examination Gloves1 This standard is issued under thefixed 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 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
1.1This specification covers certain requirements 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.
1.2This specification provides for natural rubber gloves that fit either hand,paired gloves,and gloves by size.It also provides for packaged sterile natural rubber gloves and pack-aged or bulk nonsterile natural rubber gloves.
2.Referenced Documents
2.1ASTM Standards:2
D412Test Methods for Vulcanized Rubber and Thermoplas-tic Elastomers—Tension
D573Test Method for Rubber—Deterioration in an Air Oven
D3767Practice for Rubber—Measurement of Dimensions D5151Test Method for Detection of Holes in Medical Gloves
D5712Test Method for Analysis of Aqueous Extractable Protein in Latex,Natural Rubber,and Elastomeric Prod-ucts Using the Modified Lowry Method
D6124Test Method for Residual Powder on Medical Gloves D6499Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products 2.2Other Documents:
ISO2859Sampling Procedures and Tables for Inspection by Attributes3
U.S.Pharmacopeia43.Classification
3.1Type I—Gloves with a minimum tensile strength of18 MPa and a maximum stress at500%elongation of5.5MPa.
3.2Type II—Gloves with a minimum tensile strength of14 MPa and a maximum stress at500%elongation of2.8MPa.
4.Materials and Manufacture
4.1Any natural rubber compound that permits the glove to meet the requirements of this specification.
4.2A 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.
4.3The inside and outside surface of the natural rubber examination gloves shall be free of talc.
5.Significance and Use
5.1The specification 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 specification.
6.Sampling
6.1For referee purposes,gloves shall be sampled and inspected in accordance with ISO2859.The inspection levels and acceptable quality levels(AQL)shall conform to those specified in Table1,or as agreed between the purchaser and the seller,if the latter is more comprehensive.
7.Performance Requirements
7.1Gloves,sampled in accordance with Section6,shall meet the following referee performance requirements:
7.1.1Comply with requirements for sterility when tested in accordance with8.2.
7.1.2Be free from holes when tested in accordance with8.3.
7.1.3Have consistent physical dimensions in accordance with8.4.
7.1.4Have acceptable physical property characteristics in accordance with8.5.
7.1.5Have a powder residue limit of2.0mg in accordance with8.6.
1This specification is under the jurisdiction of ASTM Committee D11on Rubber
and is the direct responsibility of Subcommittee D11.40on Consumer Rubber
Products.
Current edition approved May1,2010.Published September2010.Originally
approved in1977.Last previous edition approved in2005as D3578–05ε1.DOI:
10.1520/D3578-05R10.
2For referenced ASTM standards,visit the ASTM website,,or
contact ASTM Customer Service at For Annual Book of ASTM
Standards volume information,refer to the standard’s Document Summary page on
the ASTM website.
3Available from American National Standards Institute(ANSI),25W.43rd St.,
4th Floor,New York,NY10036.
4U.S.Pharmacopeia,latest edition,Mack Publishing Co.,Easton,PA,19175.
Copyright©ASTM International,100Barr Harbor Drive,PO Box C700,West Conshohocken,PA19428-2959.United States
7.1.6Have a recommended aqueous soluble protein content limit of200µg/dm2in accordance with8.7and Annex A1or have a recommended antigenic protein content limit of10µg/dm2in accordan
ce with8.9and Annex A2.
7.1.7Have a recommended maximum powder limit of10 mg/dm2in accordance with8.8.
8.Referee Test Methods
8.1The following tests shall be conducted to ensure the requirements of Section8,as prescribed in Table1:年龄
识别 8.2Sterility Test—Testing for sterility shall be conducted in accordance with the latest edition of The U.S.Pharmacopeia.
8.3Freedom From Holes—Testing for freedom from holes shall be conducted in accordance with Test Method D5151.
8.4Physical Dimensions Test(Practice D3767):
8.4.1The gloves shall comply with the dimension require-ments prescribed in Table2.
8.4.2The length shall be expressed in millimetres as mea-sured from the tip of the middlefinger to the outside edge of the cuff as indicated in Fig.1.地龙多肽
8.4.3The width of the palm shall be expressed in millime-tres as measured at a level between the base of the indexfinger and the base of the thumb.Values of width per size other than listed shall meet the stated tolerance specified in Table2. 8.4.4The minimum thickness shall be expressed in milli-metres as specified in Table2when using a dial micrometer described in Test Methods D412and in the locations indicated on Fig.1.For referee tests,cutting the glove is necessary to obtain single-thickness measurements.
8.5Physical Requirements Test:
8.5.1Before and after accelerated aging,the gloves shall conform to the physical requirements specified in Table3. Tests shall be conducted as specified in Test Methods D412. Die C is recommended.
8.5.2Accelerated aging tests shall be conducted in accor-dance with Test Method D573.Test the gloves by either one of the following methods:
8.5.2.1After being subjected to a temperature of7062°C for16662h,the tensile strength and ultimate elongation shall not be less than the values specified in Table3.This method shall be the condition for referee tests.
8.5.2.2After being subjected to a temperature of10062°C for2260.3h,the tensile strength and ultimate elongation shall not be less than the values specified in Table3.
8.6Powder Free Gloves:
8.6.1Determine the powder residue using Test Method D6124.
8.7Aqueous Extractable Protein Content:
8.7.1Determine the aqueous extractable protein(µg/mL) using Test Method D5712for each glove sample tested.
8.7.2Determine the total micrograms of aqueous extract-able protein in each glove sample by multiplying the result from8.7.1by the total volume of extractant used for that specific glove sample.If the glove sample is less than a whole glove,then adjust the protein results to reflect the amount of protein in the whole glove.
8.7.3Determine the square decimeters for the glove size. Multiply the minimum length and nominal width found in Table2and convert to dm2using(dm2/mm2)(mm2/10000) (4).Four(4)is the factor for all inside and outside surface areas.
8.7.4Determine the aqueous extractable protein content of a glove sample by dividing the result from8.7.2(totalµg of protein)by8.7.3(total surface area of glove).
8.7.5If the sample is more than one(1)glove,use the averageµg/dm2of protein for the number of gloves tested in the sample.
8.8Powdered Gloves:
8.8.1Determine the recommended maximum powder limit using Test Method D6124for powdered gloves.
8.8.2Determine the square decimeters for the glove size as in8.7.3.
8.9Antigenic Protein Content:
8.9.1Determine the extractable antigenic protein(µg/mL) using Test Method D6499for each glove sample tested.
TABLE1Performance Requirements
Characteristic Related Defects Inspection
Level
AQL
Sterility fails sterility A N/A Freedom from holes holesΙ 2.5 Dimensions width,length,and
S-2 4.0
远程运维服务
Physical properties before aging,after accel-
erated aging
S-2 4.0 Powder Free Residue Exceeds Maximum Limit N=5N/A Protein Content Exceeds Recommended
Maximum Limit
N=3N/A
Powder Amount Exceeds Recommended
Maximum Limit
N=2N/A
Antigenic Protein Content Exceeds Recommended
Maximum Limit
N=1N/A
A See U.S.Pharmacopeia.
TABLE2Dimensions and Tolerances
Designation
Size Tolerance,
mm 661⁄2771⁄2881⁄29
Width by size,mm75838995102108114±6 Width by Extra
Small
Small Unisize Medium Large
mm70808595111±10 Length,mm220220*********Min Thickness,mm:For All Sizes
Finger Palm 0.08
0.08
Min
Min
8.9.2Determine the total microgram of extractable anti-genic protein in each glove sample by multiplying the result from 8.9.1by the total volume of extractant used for that specific glove sample.
8.9.3Determine the square decimeter for the glove size as in 8.7.3.
8.9.4Determine 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 of glove).9.Acceptance
9.1Gloves will be considered to meet the referee perfor-mance requirements when test results conform to the require-ments prescribed in Table 1.
9.2Retests or reinspections are permissible under the pro-visions of the U.S.Pharmacopeia and ISO 2859.10.Packaging and Marking 10.1Sterile Packaging:
10.1.1The unit of packaging shall normally be one glove or one pair of gloves.
10.1.2A glove 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 field for glove-donning pur-poses.
10.1.3The glove or pair,and accompanying wrapper if utilized,shall be totally enclosed in an outer package that shall allow sterilization of the product.
10.1.4The outer package shall have a method of closure sufficient to assure the sterility of the product until opened or damaged.
10.1.5The outer package shall have sufficient strength and integrity to withstand normal transportation and storage within the intermediate or shipping cartons,or both.
10.1.6The method of closure of the outer package shall be such that prior opening will be detectable by the user.
10.1.7None of the packaging material shall contain any material likely to impair the quality and use of the gloves.10.1.8Intermediate cartons and shipping cases shall be of sufficient strength to maintain the quality and sterility of the product during normal transportation and storage.
10.2Nonsterile and Bulk Packaging:
10.2.1The unit of packaging shall normally be more than one glove and of a specific amount.
10.2.2The 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.1Location of Thickness and Length Measurements
TABLE 3Physical Requirements
Before Aging After Accelerated Aging Tensile Strength Stress at 500%Elongation
Ultimate Elongation
Tensile Strength Ultimate Elongation Type I 18MPa min 5.5MPa max 650%min 14MPa min 500%min Type II
14MPa min 2.8MPa max 650%min
14MPa min
500%
min
10.2.3None of the packaging material shall contain any material likely to impair the quality and use of the gloves. 10.2.4Cartons and shipping cases shall be of sufficient strength to maintain the quality of the product during normal transportation and storage.
10.3Marking:
10.3.1Sterile packages shall bear markings for the contents to include the glove size,instructions for opening,the legend “sterile,”and a manufacturing lot number.
10.3.2Nonsterile and bulk packages shall bear markings for the contents to include the glove size and a manufacturing lot number.
10.3.3The 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.”
10.3.4All levels of packaging shall conform to all appro-priate government labeling regulations.
11.Keywords
11.1examination;gloves;rubber
ANNEXES
Mandatory Information A1.PROTEIN CONTENT
A1.1The current assay precision is large enough that only a recommended limit can be considered.
A1.2Consideration should be given to the relative repeat-ability and reproducibility when reporting test method results.
A1.3Reasonable 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
A2.1The current assay precision is large enough that only a recommended limit can be considered.
A2.2Consideration should be given to the relative repeat-ability and reproducibility when reporting test methods.
A2.3A pooled sample from three individual NR specimens or products as extracted in accordance with Test Method D5712is permitted for use as the extraction sample.
APPENDIX (Nonmandatory Information)
X1.Rationale
X1.1At a meeting of the Glove Task Force of ASTM D11.40,it was determined to expand the physical requirement values allowing consumers more choice infit,feel,and comfort by having two types of examination
gloves.
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