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
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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
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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
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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
