1、Designation: D 3481 06Standard Test Method forManual Shelling Two-Piece Child-Resistant Closures ThatAre Activated by Two Simultaneous Dissimilar Motions1This standard is issued under the fixed designation D 3481; the number immediately following the designation indicates the year oforiginal adoptio
2、n 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 test method covers the measurement of the forcerequired to separate (
3、or “shell”) the snap-fitted outer cap fromthe inner cap of Type IA, IB, or IC child-resistant closures.1.2 This test method does not measure the force required toseparate parts of a child-resistant closure system that wereoriginally “screwed-on” instead of “snapped-on” (for example,pull a cap over o
4、r through continuous or multi-start threadswhen the cap was originally screwed on).1.3 The values stated in SI units are to be regarded as thestandard. The inch-pound units given in parentheses are forinformation only.1.4 This standard does not purport to address all of thesafety concerns, if any, a
5、ssociated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 3474 Practice for The Calibration and Use of TorqueM
6、eters Used in Packaging ApplicationsD 3475 Classification of Child-Resistant PackagesE 105 Practice for Probability Sampling Of MaterialsE 122 Practice for Calculating Sample Size to Estimate,With a Specified Tolerable Error, the Average for aCharacteristic of a Lot or Process2.2 Other Documents:ISO
7、 Bulletin 2233 PackagingComplete, Filled, TransportPackagesPart 2: Conditioning for Testing33. Terminology (see Classification D 3475)3.1 Definitions:3.1.1 Type IA child-resistant closurea two-piece continu-ous thread closure requiring a random push down whileturning; no orientation of the push down
8、 force is necessary.3.1.2 Type IB child-resistant closurea two-piece continu-ous thread closure requiring a localized squeeze force whileturning; the force must be applied to a designated location onthe closure skirt.3.1.3 Type IC child-resistant closurea two-piece continu-ous thread closure requiri
9、ng a random squeeze while turning;no orientation of the squeeze force is necessary.4. Summary of Test Method4.1 This test method measures the force required to pry theouter cap off the inner cap using a fixture having a contact pointunder the tip of the skirt of the outer cap and leverage beingplace
10、d on that point and the top of the cap. This procedure isused where a pivotal prying force can be successfully used toseparate the components of the closure system. Either a torquewrench or a torque meter can be used as a measuring device.5. Significance and Use5.1 This test method of applying force
11、 may be used as astandard test to compare the characteristics of a given design ofcontainer/child-resistant closure system with a standard or tocompare the characteristics of container/child-resistant closuresystems differing in construction.5.2 It may be used to simulate certain manipulations thatm
12、ay be expected to occur in protocol testing4(such as, pryingwith the teeth or objects in the room, biting, and pulling withthe teeth).5.3 This test method may be used to establish performancespecifications.6. Apparatus6.1 Testing Machine(s):6.1.1 Torque Meter5with a scale that will read with themaxi
13、mum point reading accuracy within the torque range1This test method is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.31 on Child-Resistant Packaging and Closure Systems.Current edition approved April 1, 2006. Published April 2006. Origi
14、nallyapproved in 1976. Last previous edition approved in 2002 as D 3481 97 (2002).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 pag
15、e onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.4Consumer Product Safety Commissions Poison Prevention Packaging Act,1970.5A digital torque instrument, if used, will have an appropriate design and scalecapacity for the c
16、ontainer/closure system to be evaluated. Torque results will beavailable in either electronic display or printout format.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.expected to be measured (for example, usea0to25T.I.P.torque mete
17、r for readings under 25 T.I.P., not a 0 to 100 T.I.P.torque meter).6.1.2 Torque Wrench, of accepted design and capacity.6.2 Attachments, Fixtures, etc. (see Fig. 1):6.2.1 Cap Holding Fixture with one contact point under thelip of the outer cap skirt and the other point contacting the topof the cap.
18、The distance between the two contact points shouldbe 34 mm or approximately 138 in. (in accordance with page 19of the Krogman study5) or to the farthest side of the cap if lessthan 34 mm.6.2.2 Device for attaching the above tool to a torque wrenchor torque meter.6.2.3 Bottle, standard size, with cor
19、responding finish to theclosure(s) being tested.7. Sampling7.1 The number of samples will depend on the desiredpurpose for which the test is being conducted. However, for agiven set of samples, sufficient measurements should be takenMetric Equivalentsin. mm3.00 76.21.00 25.41.70 43.20.50 12.70.22 5.
20、60.04 1.00.07 1.80.88 22.40.38 9.70.60 15.20.85 21.62.10 53.3Note A0.040 in. (1.0 mm) or outer shell thickness.Note BMaximum 134 in. (34 mm)Note CHeight adjusted with cap screw shown.Note 114 ,12 ,or34-in. square hole to fit a standard torquewrench post.Note 2Tool made of14-in. metal bar stock.FIG.
21、1 Cap Holding FixtureD3481062in accordance with established statistical sampling proceduresin order to obtain consistent results.67.1.1 Refer to Practices E 105 and E 122 for more specificinformation.7.2 Performance normally should be based on a test of notless than ten representative specimens of a
22、 given type selectedat random.8. Test Specimens8.1 Use child-resistant closures and corresponding contain-ers that are within their respective specifications.9. Calibration9.1 Follow Practice D 3474 for calibrating the torquemeter.710. Conditioning10.1 Preconditioning is not necessary unless it is r
23、equired tosimulate a particular storage environment.10.2 If special conditions are not required, components maybe stored for a minimum of 24 h at 23 6 2C (73.4 6 3.4F)and 50 6 5 % relative humidity.10.3 The atmosphere conditions in Table 1 may be usedwhen special conditioning is appropriate. Other a
24、tmosphereconditions may be used as appropriate.11. Procedure11.1 Apply all closures to be tested to the appropriatecontainers at a specified and uniform torque.NOTE 1Specifying the application torque level is necessary for testconsistency as the physical relationship/interlocking between the inneran
25、d outer closure can change at different application torque levels.11.2 Attach the cap holding fixture to the torque meter ortorque tester and slide fixture over the widest part of the cap(the diameter).11.3 Apply torque in the following manner:11.3.1 When a table model torque meter is used, the test
26、container should be parallel to the table (that is, it should be ina horizontal position and not canted). Grasp the test containerat the base with the thumb and forefingers (not with the entirehand) to avoid the application of “english” or twisting forceswhile applying torque.11.3.2 When a torque wr
27、ench is used, grasp the test con-tainer firmly in the hand or in a holding fixture in a verticalposition (perpendicular to the floor). Apply direct upwardpressure with the torque wrench. Do not cant or cock thewrench when pressure is applied.11.4 Apply torque at a slow, steady rate that allows the t
28、otaltesting time to range between 15 and 30 s for each closure.11.5 The end point of the test should be the lifting of theouter cap to a position where the plane of the top surface of theouter cap forms a 45 angle with the bottom plane of the bottle.11.6 Record test results and procedures used to ob
29、tainresults.12. Report12.1 The report shall include the following:12.1.1 Name, number, and date of procedure used,12.1.2 Gross description of container/child-resistant closuresystem under test; its complete structural specifications; kind ofmaterial; size and style of closure and bottle finish inclu
30、dingthread type; manufacturer and lot number; date of receipt orother identification of the specific batch being evaluated,12.1.3 Description of the exact test equipment and proce-dures that were used to obtain the test results,12.1.4 Detailed record of the test on each container/child-resistant clo
31、sure system, including damage, together with anyobservations that may assist in correctly interpreting the resultsor aid in improving the design of the system,12.1.5 Table showing the maximum torque and lifting forcefor each test, and12.1.6 Statement that the test was made in accordance withASTM Tes
32、t Method D 3481.13. Precision and Bias13.1 PrecisionThe repeatability standard deviation hasbeen estimated for three packages based on testing conductedin one laboratory. One package had a within-laboratory stan-dard deviation of 1.6 lb or 11.1 % of the average. The secondpackage was 1.4 lb or 7.8 %
33、 of the average. The third packagewas 5.1 lb or 24.3 % of the average. A log-normal distributionmight also be considered for evaluation of data from this testmethod. Other packages may have different repeatability val-ues. The reproducibility of this test method is being deter-mined.13.2 BiasNo just
34、ifiable statement can be made on the biasof this test method since a true value cannot be established byan accepted referee method.14. Keywords14.1 shelling; two simultaneous dissimilar motions; TypeIAchild-resistant closure; Type IB child-resistant closure; TypeIC child-resistant closure6Krogman, W
35、 M., The Manual and Oral Strengths of American White andNegro Children, Ages 3 to 6 Years, School of Medicine, University of Pennsylvania,1971.7Follow calibration procedure of manufacturer if a digital torque instrument is tobe used.TABLE 1 Special AtmospheresEnvironment Temperature, C (F)RelativeH
36、umidity, %Cryogenic 55 6 3 (67 6 6) .Frozen food storage 18 6 2(06 4) .Refrigerated storage 5 6 2(416 4) 856 5Temperature high humidity 20 6 2(686 4) 856 5Tropical 40 6 2 (104 6 6) 85 6 5Desert 60 6 3 (140 6 6) 15 6 2D3481063ASTM International takes no position respecting the validity of any patent
37、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 revision at
38、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 comments
39、 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 copyrighted by
40、 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).D3481064
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