ASTM D3579-1977(2004) Standard Specification for Rubber Surgical Drainage Tubes Penrose-Type《彭罗斯型外科用橡胶引流管标准规范》.pdf

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1、Designation: D 3579 77 (Reapproved 2004)Standard Specification forRubber Surgical Drainage Tubes, Penrose-Type1This standard is issued under the fixed designation D 3579; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of

2、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.This standard has been approved for use by agencies of the Department of Defense.1. Scope1.1 This specification covers Penrose-ty

3、pe rubber tubesused in performing certain surgical drainage procedures.1.2 The specification provides for packaged sterile rubbertubes and packaged or bulk nonsterile rubber tubes.1.3 This standard does not purport to address all of thesafety problems, if any, associated with its use. It is therespo

4、nsibility 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 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 573 Test Meth

5、od for RubberDeterioration in an AirOven2.2 Other Documents:3ISO 2859 Sampling Procedures and Tables for Inspectionby Attributes3. Significance and Use3.1 This specification is intended as a reference to theperformance and safety of rubber surgical drainage tubes. Thesafe and proper use of rubber su

6、rgical drainage tubes is beyondthe scope of this standard.4. Materials and Manufacture4.1 Any rubber polymer compound that permits the tube tomeet the requirements of this standard.4.2 Absorbable dusting powder that meets the current re-quirements of the U.S. Pharmacopoeia may be applied to thetube.

7、4.3 X-ray opaque materials that permit the tube to meet therequirements of this specification may be added to the rubberpolymer compound.5. Sampling5.1 For referee purposes, tubes shall be sampled and in-spected in accordance with ISO 2859. The inspection levelsand acceptable quality levels (AQL) sh

8、all conform to thosespecified in Table 1, or as agreed between the purchaser and theseller, if the latter is more comprehensive.6. Performance6.1 As necessary, tubes sampled according to Section 5 shallbe subject to inspection and tests to meet the following refereeperformance requirements:6.1.1 Com

9、ply with requirements for sterility when tested inaccordance with 7.2.6.1.2 Comply with requirements for safety when tested inaccordance with 7.3.6.1.3 Be X-ray opaque when tested in accordance with 7.4.6.1.4 Have consistent physical dimensions in accordancewith 7.5.6.1.5 Have acceptable physical pr

10、operty characteristics inaccordance with 7.6.7. Referee Test Methods7.1 The following tests shall be conducted to assure thenecessary requirements of Section 6 as specified in Table 1.7.2 Sterility TestTesting for sterility shall be conducted inaccordance with the latest edition of the U.S. Pharmaco

11、poeia.7.3 Safety TestTesting for safety shall be conducted inaccordance with the latest revision of the U.S. Pharmacopoeia,for transfusion and infusion assemblies.7.4 X-ray Opaque TestSelect at least two tubes from eachlot and radiograph as follows: Place a small foreign body of notless than 0.5-mm

12、thick sheet lead under each tube. Superim-pose 240 6 10 mm of USP paraffin over the tubes. Use astandard make of cassette with screens, films, and processingsolutions. Expose at a setting of 85 kV, 10 mAs and from adistance of 640 6 10 mm. The tubes shall show a definite,uniform shadow, and the degr

13、ee of opaqueness shall show theshadow of the foreign body.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Dec. 1, 2004. Published December 2004. Originallyapproved

14、in 1977. Last previous edition approved in 1999 as D 3579 - 77 (1999)e1.2For 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 AS

15、TM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.7.5 Physical Dimensions Test:7.5.1 The tubes shall comply with the

16、dimension require-ments specified in Table 2.7.5.2 The length shall be expressed in millimetres as mea-sured from end to end and parallel to the axis of the tube.7.5.3 The flat width of the tube shall be expressed inmillimetres as measured at a right angle to the axis of the tube.Three random measur

17、ements shall be taken and averaged. Theaverage dimension shall be within the tolerance requirementsspecified in Table 2.7.5.4 The minimum wall thickness shall be expressed inmillimetres as specified in Table 2 when using a dial microme-ter described in Test Methods D 412. Three random measure-ments

18、shall be taken along the axis of the tube. Each measure-ment shall be calculated for single thickness and shall meet theminimum dimension requirement. For referee tests, cutting thetube along the axis is necessary to obtain single-thicknessmeasurements.7.6 Physical Requirements Test:7.6.1 Before and

19、 after accelerated aging, the tubes shallconform to the physical requirements specified in Table 3.Tests shall be conducted as specified in Test Methods D 412.7.6.2 Accelerated aging tests shall be conducted in accor-dance with Test Method D 573. Test the tubes by either one ofthe following methods:

20、7.6.2.1 After being subjected to a temperature of 70 6 2Cfor 166 6 2 h, the tensile strength and elongation shall not beless than the values specified in Table 3. This method shall bethe condition for referee tests.7.6.2.2 After being subjected to a temperature of 100 6 2Cfor 22 6 0.3 h, the tensile

21、 strength and elongation shall not beless than the values specified in Table 3.8. Acceptance8.1 Tubes will be considered to meet the referee perfor-mance requirements when test results do not exceed the AQLprescribed in Table 1.8.2 Retests or reinspections are permissible under the pro-visions of th

22、e U.S. Pharmacopoeia and ISO 2859.9. Packaging and Marking9.1 Sterile Packaging:9.1.1 The unit of packaging shall normally be one tube perpackage.9.1.2 The tube shall be totally enclosed in an outer packagethat will allow sterilization of the product.9.1.3 The outer package shall have a method of cl

23、osuresufficient to assure the sterility of the product until opened ordamaged.9.1.4 The outer package shall have sufficient strength andintegrity to withstand normal transportation and storage withinthe intermediate or shipping cartons, or both.9.1.5 The method of closure of the outer package shall

24、besuch that prior opening will be detectable by the user.9.1.6 None of the packaging material shall contain anymaterial likely to impair the quality and use of the tubes.9.1.7 Intermediate cartons and shipping cases shall be ofsufficient strength to maintain the quality and sterility of theproduct d

25、uring normal transportation and storage.9.2 Nonsterile and Bulk Packaging:9.2.1 The unit of packaging shall normally be more than onetube and of a specific amount.9.2.2 The tubes shall be enclosed in an outer package thathas sufficient strength to withstand normal transportation andstorage within th

26、e cartons or shipping cases, or both.9.2.3 None of the packaging material shall contain anymaterial likely to impair the quality and use of the tubes.9.2.4 Cartons and shipping cases shall be of sufficientstrength to maintain the quality of the product during normaltransportation and storage.9.3 Mar

27、king:9.3.1 Sterile packages shall bear markings for the contentsto include the tube size, instructions for opening, the legend“sterile,” and a manufacturing lot number.9.3.2 Nonsterile and bulk packages shall bear markings forthe contents to include the tube size and a manufacturing lotnumber.9.3.3

28、The outermost case shall be labeled on one or moreend panels with the tube size and a manufacturing lot number.Sterile product cases shall also be marked with the legend“sterile.”9.3.4 All levels of packaging shall conform to all appropri-ate government labeling regulations.10. Keywords10.1 drainage

29、 tubes; penrose; surgicalTABLE 1 Performance RequirementsCharacteristic Related Defects Inspection Level AQLSterility fails sterilityAN/ASafety toxicAN/AX-ray opaque not opaque two units per lot N/ADimensions length, width, andthicknessS-2 2.5Physical properties before aging, afteraccelerated agingS

30、-2 4.0ASee U.S. Pharmacopoeia, latest edition, Mack Publishing Co., Easton, PA19175.TABLE 2 Dimensions and TolerancesDescription All SizesTolerance,mmLength as labeled 610Width as labeled 61.0Single-wall thickness, mm 0.15 minTABLE 3 Physical RequirementsBefore Aging After Accelerated AgingTensileSt

31、rengthUltimateElongationTensileStrengthUltimateElongation21 MPa min 700 % min 16 MPa min 500 % minD 3579 77 (2004)2ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly ad

32、vised 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 any time by the responsible technical committee and must be reviewed every five years andif not revised, eithe

33、r 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 will receive careful consideration at a meeting of theresponsible technical committee, which you may attend.

34、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 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).D 3579 77 (2004)3