CGSB 43 125-2003-CAN CGSB-2003 Conception Et Fabrication Des Emballages Destines Au Transport Des Materes Infectieuses Des Echantillons De Diagnostic Des Produits Biologieques Et D.pdf

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1、Governmentof CanadaCanadian GeneralStandards BoardExperience and excellenceExprience et excellenceGouvernementdu CanadaOffice des normesgnrales du Canada CAN/CGSB-43.125-2003Supersedes CAN/CGSB-43.125-99Design and Manufacture of Packagingfor the Transportation of InfectiousSubstances, Diagnostic Spe

2、cimens,Biological Products or (Bio)Medical WasteICS 13.300National Standard of CanadaCopyright Canadian General Standards Board Provided by IHS under license with CGSBNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-The CANADIAN GENERAL STANDARDS BOARD (CGSB), The S

3、TANDARDS COUNCIL OF CANADA is the co-ordinatingunder whose auspices this National Standard of Canada has been body of the National Standards System, a federation ofdeveloped is a government agency within Public Works and independent, autonomous organizations working towards theGovernment Services Ca

4、nada. CGSB is engaged in the production further development and improvement of voluntaryof voluntary standards in a wide range of subject areas through the standardization in the national interest.media of standards committees and the consensus process. TheThe principal objectives of the Council are

5、 to foster and promotestandards committees are composed of representatives of relevantvoluntary standardization as a means of advancing the nationalinterests including producers, consumers and other users, retailers,economy, benefiting the health, safety and welfare of the public,governments, educat

6、ional institutions, technical, professional andassisting and protecting the consumer, facilitating domestic andtrade societies, and research and testing organizations. Any giveninternational trade, and furthering international co-operation in thestandard is developed on the consensus of views expres

7、sed byfield of standards.such representatives.A National Standard of Canada is a standard which has beenCGSB has been accredited by the Standards Council of Canada asapproved by the Standards Council of Canada and one whicha national standards-development organization. The standards thatreflects a r

8、easonable agreement among the views of a number ofit develops and offers as National Standards of Canada conform tocapable individuals whose collective interests provide, to thethe criteria and procedures established for this purpose by thegreatest practicable extent, a balance of representation ofS

9、tandards Council of Canada. In addition to standards it publishesproducers, users, consumers and others with relevant interests, asas national standards, CGSB produces standards to meet particularmay be appropriate to the subject in hand. It normally is aneeds, in response to requests from a variety

10、 of sources in both thestandard that is capable of making a significant and timelypublic and private sectors. Both CGSB standards and CGSBcontribution to the national interest.national standards are developed in conformance with the policiesApproval of a standard as a National Standard of Canada ind

11、icatesdescribed in the CGSB Policy Manual for the Development andthat a standard conforms to the criteria and procedures establishedMaintenance of Standards.by the Standards Council of Canada. Approval does not refer toCGSB standards are subject to review and revision to ensure thatthe technical con

12、tent of the standard; this remains the continuingthey keep abreast of technological progress. Suggestions for theirresponsibility of the accredited standards-developmentimprovement, which are always welcome, should be brought toorganization.the notice of the standards committees concerned. Changes t

13、oThose who have a need to apply standards are encouraged to usestandards are issued either as separate amendment sheets or inNational Standards of Canada whenever practicable. Thesenew editions of standards.standards are subject to periodic review; therefore, users areAn up-to-date listing of CGSB s

14、tandards, including details oncautioned to obtain the latest edition from the organizationlatest issues and amendments, and ordering instructions, is foundpreparing the standard.in the CGSB Catalogue, which is published annually and isThe responsibility for approving National Standards of Canadaavai

15、lable without charge upon request. An electronic version,rests with the:ECAT, is also available. More information is available aboutCGSB products and services at our Web site Standards Council of Canadahttp:/www.pwgsc.gc.ca/cgsb.270 Albert StreetSuite 200Although the intended primary application of

16、this standard isOttawa, Ontariostated in its Scope, it is important to note that it remains theK1P 6N7responsibility of the users of the standard to judge its suitabilityfor their particular purpose.The testing and evaluation of a product against this standard mayrequire the use of materials and/or

17、equipment that could behazardous. This document does not purport to address all thesafety aspects associated with its use. Anyone using this standardhas the responsibility to consult the appropriate authorities and toHow to order Publications:establish appropriate health and safety practices in conj

18、unctionwith any applicable regulatory requirements prior to its use.CGSB neither assumes nor accepts any responsibility for any by telephone (819) 956-0425 orinjury or damage that may occur during or as the result of tests, 1-800-665-CGSBwherever performed. (Canada only)Attention is drawn to the pos

19、sibility that some of the elements ofby fax (819) 956-5644this Canadian standard may be the subject of patent rights. CGSBby mail CGSB Sales Centreshall not be held responsible for identifying any or all such patentOttawa, Canadarights. Users of this standard are expressly advised thatK1A 1G6determi

20、nation of the validity of any such patent rights are entirelytheir own responsibility.in person Place du PortageFurther information on CGSB and its services and standards may Phase III, 6B1be obtained from: 11 Laurier StreetHull, QuebecThe ManagerStrategic Standardization Groupby email ncr.cgsb-ongc

21、pwgsc.gc.caCanadian General Standards BoardOttawa, Canada on the Web http:/www.pwgsc.gc.ca/cgsbK1A 1G6Copyright Canadian General Standards Board Provided by IHS under license with CGSBNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-NATIONAL STANDARD OF CANADA CAN/C

22、GSB-43.125-2003Supersedes CAN/CGSB-43.125-99DESIGN AND MANUFACTURE OF PACKAGINGFOR THE TRANSPORTATION OF INFECTIOUSSUBSTANCES, DIAGNOSTIC SPECIMENS, BIOLOGICALPRODUCTS OR (BIO) MEDICAL WASTEPrepared by the Approved by theCanadian General Standards Board Standards Council of CanadaPublished May 2003

23、by theCanadian General Standards BoardOttawa, Canada K1A 1G6 HER MAJESTY THE QUEEN IN RIGHT OF CANADA,as represented by the Minister of Public Works and Government Services,the Minister responsible for the Canadian General Standards Board, (2003).No part of this publication may be reproduced in any

24、form without the prior permission of the publisher.Copyright Canadian General Standards Board Provided by IHS under license with CGSBNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-CANADIAN GENERAL STANDARDS BOARDCOMMITTEE ON PACKAGING OF INFECTIOUS SUBSTANCES(Memb

25、ership at date of approval)Noble, M. Chairperson Cacmid UBCBangay, P. Terra Marine Environmental Ltd.Bowden, K. Health CanadaCook, D. Saf-T-PakDavis, K. Canadian Society for Medical Laboratory ScienceDickey, C. Canadian Healthcare AssociationEmond, C. Ministry of Transportation, QuebecEvans, D. Puro

26、lator CourierHansmann, A. Bodycote ORTECHHeisz, M. Health CanadaKennedy, D. Medical Waste Management Inc.Leblanc, J. ConsultantLessard, R. Canadian Food Inspection AgencyLi, A. International Compliance Centre Ltd.Lopez Pietravalle, L. Smurfit-MBIMcCartan, S. Western Concord Mfg.Ozanne, M. Laboratoir

27、e de sante publique du QuebecPittman, B. CovanceRichter, N. InnovacorpRuiz, F. Heritage Bag Co.Sibley, B. Environmental Packaging Systems Ltd.Tamburri, A. Ministry of Health and Long-Term Care, OntarioTurner, V. Ontario Association of Medical LaboratoriesWestman, D. Transport CanadaZahavich, A. Uni-

28、Plast IndustriesKnox, J. Secretary Canadian General Standards BoardAcknowledgment is made for the translation of this National Standard of Canada by the Translation Bureau of Public Works andGovernment Services Canada.CAN/CGSB-43.125-2003Copyright Canadian General Standards Board Provided by IHS und

29、er license with CGSBNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-CAN/CGSB-43.125-2003Supersedes CAN/CGSB-43.125-99FOREWORDThis standard sets out requirements for the design and manufacture of packaging that is to be used for the transportationof infectious subst

30、ances, diagnostic specimens, biological products or (bio) medical waste.Conformity assessment requirements are contained in this standard. There are three categories of packaging in thisstandard: Type 1A (UN Standard Infectious Substance Packaging), Type 1B and Type 1C. UN Standard InfectiousSubstan

31、ce Packaging is based on Chapter 6.3 of the Recommendations on the Transport of Dangerous Goods, ModelRegulations, 11th edition, published by the United Nations. Type 1B packaging is based on par. 2.6.3.3.2 of thatdocument. Type 1C packaging consists of a number of packaging options for the transpor

32、tation of (bio) medical waste.This standard has been incorporated by reference into the Transportation of Dangerous Goods (TDG) Regulations.Where there are differences between the requirements of the TDG Regulations and this standard, the TDG Regulationsprevail.Copyright Canadian General Standards B

33、oard Provided by IHS under license with CGSBNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-CAN/CGSB-43.125-2003Supersedes CAN/CGSB-43.125-99TABLE OF CONTENTSPage1. SCOPE 12. REFERENCED PUBLICATIONS 13. DEFINITIONS . 2PART 1 TYPE 1A: UN STANDARD INFECTIOUS SUBSTANC

34、E PACKAGING 34. GENERAL REQUIREMENTS . 34.1 General 34.2 Packaging Code. 34.3 Components 34.4 Primary Receptacle . 44.5 Refrigerants 44.6 Packaging Design Report. 44.7 Notice to the User 45. MARKING . 45.1 Location and Content. 46. TESTING 56.1 General Requirements. 56.2 Internal Pressure Test. 56.3

35、 Drop Test 56.4 Impact Test. 67. SPECIAL PACKAGING 78. MODIFICATIONS TO A PACKAGING 79. QUALITY SYSTEM . 810. TRANSPORT CANADA REGISTRATION 8PART 2 TYPE 1B PACKAGING. 911. GENERAL REQUIREMENTS . 911.1 General 911.2 Components 912. MARKING . 912.1 Location and Content. 912.2 Registration of a Manufac

36、turers Symbol. 9PART 3 TYPE 1C PACKAGING 913. GENERAL REQUIREMENTS . 913.1 General 914. DETAILED REQUIREMENTS 914.1 Packaging Types 914.2 Plastic Film Bag. 1015. NOTES 11APPENDIX A UN STANDARD INFECTIOUS SUBSTANCES PACKAGING DESIGN REPORT . A1APPENDIX B TYPE 1C PACKAGING: SPECIFICATION MARKS B1iCopy

37、right Canadian General Standards Board Provided by IHS under license with CGSBNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-CAN/CGSB-43.125-2003Supersedes CAN/CGSB-43.125-99CANADIAN GENERAL STANDARDS BOARDDESIGN AND MANUFACTURE OF PACKAGING FOR THETRANSPORTATION

38、OF INFECTIOUS SUBSTANCES, DIAGNOSTICSPECIMENS, BIOLOGICAL PRODUCTS OR (BIO) MEDICAL WASTE1. SCOPE1.1 Organization and Content This standard sets out requirements for the design and manufacture of packagingused for the transportation of infectious substances, diagnostic specimens, biological products

39、 or (bio) medicalwaste. There are three categories of packaging: Type 1A (UN Standard Infectious Substance Packaging), Type 1Band Type 1C. UN Standard Infectious Substance Packaging is based on Chapter 6.3 of the Recommendations on theTransport of Dangerous Goods, Model Regulations, 11th edition, pu

40、blished by the United Nations. Type 1Bpackaging is based on par. 2.6.3.3.2 of that document. Type 1C packaging consists of a number of packagingoptions for the transportation of (bio) medical waste.1.2 Application This standard does not address the use of the packaging. The Transportation of Dangero

41、us GoodsRegulations (TDG Regulations) specify which packaging type is to be used for the transportation of infectioussubstances, diagnostic specimens, biological products or (bio) medical waste.1.3 The testing and evaluation of a product against this standard may require the use of materials and/or

42、equipment thatcould be hazardous. This document does not purport to address all the safety aspects associated with its use. Anyoneusing this standard has the responsibility to consult the appropriate authorities and to establish appropriate healthand safety practices in conjunction with any requirem

43、ents prior to its use.2. REFERENCED PUBLICATIONS2.1 The following publications are referenced in this standard:2.1.1 Canadian General Standards Board (CGSB)CAN/CGSB-43.150-97 Performance Packagings for Transportation of Dangerous Goods.2.1.2 Canadian Standards Association (CSA)CAN/CSA-ISO 9001-94 Qu

44、ality Systems Model for Quality Assurance in Design, Development, Production,Installation and ServicingCAN/CSA-ISO 9001-00 Quality Management Systems RequirementsCSA Z316.6-95 Evaluation of Single Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste.2.1.3 Transport CanadaTransportation

45、 of Dangerous Goods Act, 1992Transportation of Dangerous Goods Regulations.2.1.4 Railway Association of Canada (RAC)RAC 6000-A Railway Packaging Standards of Canada.2.1.5 ASTM InternationalD 882-00 Standard Test Method for Tensile Properties of Thin Plastic SheetingD 1709-98 Standard Test Methods fo

46、r Impact Resistance of Plastic Film by the Free-Falling Dart MethodD 1922-00 Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting byPendulum Method1Copyright Canadian General Standards Board Provided by IHS under license with CGSBNot for ResaleNo reproduction or net

47、working permitted without license from IHS-,-,-D 4991-99 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum MethodD 5276-98 Standard Test Method for Drop Test of Loaded Containers by Free Fall.2.1.6 Technical Association of the Pulp and Paper Industry (TAPPI)T810 om-98 Burs

48、ting Strength of Corrugated and Solid FiberboardT811 om-95 Edgewise Compressive Strength of Corrugated Fiberboard (Short Column Test).2.1.7 United Nations (UN)Recommendations on the Transport of Dangerous Goods, Model Regulations, 11th edition.2.1.8 U.S. Department of DefenseMIL-D-6055C-1970 Drums,

49、Metal, Reusable Shipping and Storage (Capacity from 88 to 510 Cubic Inches).2.2 A dated reference in this standard is to the issue specified. An undated reference in this standard is to the latest issue,unless otherwise specified by the authority applying this standard. The sources are given in the Notes section.3. DEFINITIONS3.1 In addition to the definitions, terms and abbreviations