ASTM D3579-1977(2016) Standard Specification for Rubber Surgical Drainage Tubes Penrose-Type《彭罗斯型外科用橡胶引流管的标准规格》.pdf

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1、Designation: D3579 77 (Reapproved 2016)Standard Specification forRubber Surgical Drainage Tubes, Penrose-Type1This standard is issued under the fixed designation D3579; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of la

2、st 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 covers Penrose-type rubber tubesused in performing certain surgical drainage procedures.1.2 The speci

3、fication 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 theresponsibility of the user of this standard to establish appro-priate safety and health p

4、ractices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOven2.2 Other Documents:3ISO 2859 Sampling Procedu

5、res and Tables for Inspection byAttributes3. 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 surgical drainage tubes is beyondthe scope of this standard.4. Materials and Manufacture

6、4.1 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.4.3 X-ray opaque materials that permit the tube to meet therequirements of this specif

7、ication 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) shall conform to thosespecified in Table 1, or as agreed between the purchaser and these

8、ller, 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 Comply with requirements for sterility when tested inaccordance with 7.2.6.1.2 Comply wit

9、h 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 property characteristics inaccordance with 7.6.7. Referee Test Methods7.1 The following

10、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. Pharmacopoeia.7.3 Safety TestTesting for safety shall be conducted inaccordance with the lates

11、t 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 thick sheet lead under each tube. Superim-pose 240 6 10 mm of USP paraffin over the tu

12、bes. Use astandard make of cassette with screens, films, and processingsolutions. Expose at a setting of 85 kV, 10 mAs and from a1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edit

13、ion approved June 1, 2016. Published July 2016. Originally approvedin 1977. Last previous edition approved in 2010 as D3579 77 (2010). DOI:10.1520/D3579-77R16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of

14、ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2

15、959. United States1distance of 640 6 10 mm. The tubes shall show a definite,uniform shadow, and the degree of opaqueness shall show theshadow of the foreign body.7.5 Physical Dimensions Test:7.5.1 The tubes shall comply with the dimension require-ments specified in Table 2.7.5.2 The length shall be

16、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 measurements shall be taken and averaged. Theaverage dimension shall be withi

17、n 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 microm-eter described in Test Methods D412. Three random measure-ments shall be taken along the axis of the tube. Each measure-ment shall be ca

18、lculated 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 after accelerated aging, the tubes shallconform to the physical require

19、ments specified in Table 3.Tests shall be conducted as specified in Test Methods D412.7.6.2 Accelerated aging tests shall be conducted in accor-dance with Test Method D573. Test the tubes by either one ofthe following methods:7.6.2.1 After being subjected to a temperature of 70 6 2Cfor 166 6 2 h, th

20、e 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 strength and elongation shall not beless than the values specified in Tab

21、le 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 the U.S. Pharmacopoeia and ISO 2859.9. Packaging and Marking9.1 Sterile Pack

22、aging: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 closuresufficient to assure the sterility of the product until opened ordama

23、ged.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 besuch that prior opening will be detectable by the user.9.1.6 None of the

24、 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 during normal transportation and storage.9.2 Nonsterile and Bulk Packaging:

25、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 the cartons or shipping cases, or both.9.2.3 None of the packaging material

26、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 Marking:9.3.1 Sterile packages shall bear markings for the contentsto include

27、 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 The outermost case shall be labeled on one or moreend panels with the tube

28、 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 tubes; penrose; surgicalTABLE 1 Performance RequirementsCharacteristic Re

29、lated 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-2 4.0ASee U.S. Pharmacopoeia, latest edition, Mack Publishing Co., Easton

30、, PA19175.TABLE 2 Dimensions and TolerancesDescription All SizesTolerance,mmLength as labeled 10Width as labeled 1.0Single-wall thickness, mm 0.15 minTABLE 3 Physical RequirementsBefore Aging After Accelerated AgingTensileStrengthUltimateElongationTensileStrengthUltimateElongation21 MPa min 700 % mi

31、n 16 MPa min 500 % minD3579 77 (2016)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 advised that determination of the validity of any such patent rights, and the r

32、iskof 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, either reapproved or withdrawn. Your comments are invited either for revision of t

33、his 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. If you feel that your comments have not received a fair hearing you shouldmak

34、e 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 b

35、y 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 Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 77 (2016)3