1、CAN/CGSB-43.125-2016Supersedes CAN/CGSB-43.125-2003National Standard of CanadaCanadian General Standards BoardPackaging of Category A and Category B infectious substances (Class 6.2) and clinical, (bio) medical or regulated medical wasteThe CANADIAN GENERAL STANDARDS BOARD (CGSB), under whose auspic
2、es this standard has been developed, is a government agency within Public Services and Procurement Canada. CGSB is engaged in the production of voluntary standards in a wide range of subject areas through the media of standards committees and the consensus process. The standards committees are compo
3、sed of representatives of relevant interests including producers, consumers and other users, retailers, governments, educational institutions, technical, professional and trade societies, and research and testing organizations. Any given standard is developed on the consensus of views expressed by s
4、uch representatives.CGSB has been accredited by the Standards Council of Canada as a national standards-development organization. The standards that it develops and offers as National Standards of Canada conform to the criteria and procedures established for this purpose by the Standards Council of
5、Canada. In addition to standards it publishes as National Standards of Canada, CGSB produces standards to meet particular needs, in response to requests from a variety of sources in both the public and private sectors. Both CGSB standards and CGSB national standards are developed in conformance with
6、 the policies described in the CGSB Policy and Procedures Manual for the Development and Maintenance of Standards.CGSB standards are subject to review and revision to ensure that they keep abreast of technological progress. CGSB will initiate the review of this standard within five years of the date
7、 of publication. Suggestions for their improvement, which are always welcome, should be brought to the notice of the standards committees concerned. Changes to standards are issued either as separate amendment sheets or in new editions of standards.An up-to-date listing of CGSB standards, including
8、details on latest issues and amendments, and ordering instructions, is found in the CGSB Catalogue at our Web site www.tpsgc-pwgsc.gc.ca/ongc-cgsb/index-eng.html along with more information about CGSB products and services.Although the intended primary application of this standard is stated in its S
9、cope, it is important to note that it remains the responsibility of the users of the standard to judge its suitability for their particular purpose.The testing and evaluation of a product against this standard may require the use of materials and/or equipment that could be hazardous. This document d
10、oes not purport to address all the safety aspects associated with its use. Anyone using this standard has the responsibility to consult the appropriate authorities and to establish appropriate health and safety practices in conjunction with any applicable regulatory requirements prior to its use. CG
11、SB neither assumes nor accepts any responsibility for any injury or damage that may occur during or as the result of tests, wherever performed.Attention is drawn to the possibility that some of the elements of this Canadian standard may be the subject of patent rights. CGSB shall not be held respons
12、ible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any such patent rights is entirely their own responsibility.LanguageIn this Standard, “shall” states a mandatory requirement, “should” expresses a recommendation and
13、 “may” is used to express an option or that which is permissible within the limits of this Standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Annex
14、es are designated normative (mandatory) or informative (non-mandatory) to define their application.Further information on CGSB and its services and standards may be obtained from:The Manager Standards Division Canadian General Standards Board Gatineau, Canada K1A 1G6A National Standard of Canada is
15、a standard developed by an SCC- accredited Standards Development Organization (SDO), and approved by the Standards Council of Canada (SCC), in accordance with SCCs: Requirements and Guidance-Accreditation for Standards Development Organizations, and Requirements and Guidance-Approval of National Sta
16、ndards of Canada Designation. More information on National Standard requirements can be found at www.scc.ca. An SCC-approved standard reflects the consensus of a number of experts whose collective interests provide, to the greatest practicable extent, a balance of representation of affected stakehol
17、ders. National Standards of Canada are intended to make a significant and timely contribution to the Canadian interest. SCC is a Crown corporation within the portfolio of Industry Canada. With the goal of enhancing Canadas economic competitiveness and social well-being, SCC leads and facilitates the
18、 development and use of national and international standards. SCC also coordinates Canadian participation in standards development, and identifies strategies to advance Canadian standardization efforts. Accreditation services are provided by SCC to various customers, including product certifiers, te
19、sting laboratories, and standards development organizations. A list of SCC programs and accredited bodies is publicly available at www.scc.ca. Users should always obtain the latest edition of a National Standard of Canada from the standards development organization responsible for its publication, a
20、s these documents are subject to periodic review.The responsibility for approving standards as NSCs rests with:Standards Council of Canada 55 Metcalfe Street, Suite 600 Ottawa, Ontario K1P 6L5, CANADAby telephone 819-956-0425 or 1-800-665-2472by fax 819-956-5740by mail CGSB Sales Centre Gatineau, Ca
21、nada K1A 1G6in person Place du Portage Phase III, 6B1 11 Laurier Street Gatineau, Quebecby email ncr.cgsb-ongctpsgc-pwgsc.gc.caon the Web www.tpsgc-pwgsc.gc.ca/ongc-cgsb/index-eng.htmlHow to order Publications:Published April 2016 by the Canadian General Standards Board Gatineau, Canada K1A 1G6 HER
22、MAJESTY THE QUEEN IN RIGHT OF CANADA, as represented by the Minister of Public Services and Procurement, the Minister responsible for the Canadian General Standards Board (2016).No part of this publication may be reproduced in any form without the prior permission of the publisher.Packaging of Categ
23、ory A and Category B infectious substances (Class 6.2) and clinical, (bio) medical or regulated medical wasteCETTE NORME NATIONALE DU CANADA EST DISPONIBLE EN VERSIONS FRANAISE ET ANGLAISE.ICS 13.300NATIONAL STANDARD OF CANADA CAN/CGSB-43.125-2016Supersedes CAN/CGSB-43.125-2003CAN/CGSB-43.125-2016 C
24、GSB 2016 All rights reservedCANADIAN GENERAL STANDARDS BOARDCommittee on Packaging of Infectious Substances(Voting membership at date of approval)ChairHeisz, M. Public Health Agency of Canada (General Interest)Producer categoryBell, K. Saf-T-Pak Inc.Foster, B. ICC The Compliance CentrePauw, J. Mitch
25、el-Lincoln Packaging Ltd.User categoryTilak, S.K. Hospitals In-Common Laboratory Inc.Ppin, J-P. Stericycle Inc.Ash, J. Ontario Association of Medical Laboratories (Vice-Chair)Gill-Savoie, L. Dynacare - A Health Solutions CompanyNagy, L. LifeLabs Medical Laboratory ServicesGeneral interest categoryLa
26、ngan, P. Canadian Food Inspection AgencyKendall, K. Kendall and b) exceeds 400 kg net mass or 450 litres capacity but has a volume of not more than 3 m3.3.10leakproof impermeable to liquid contents or to solid contents that may become liquids under normal condition of transport.3.11outer packaging o
27、uter protection of a combination packaging (excluding an overpack) together with any absorbent materials, cushioning and any other components necessary to contain and protect primary receptacles or secondary inner packagings.3.12packaging receptacle and any other components or materials necessary fo
28、r the receptacle to perform its containment function.3.13package design type design specification for the prototype packaging successfully tested in accordance with this standard and as described in Annex A Design report for type P620 packagings.3.14primary receptacle receptacle in direct contact wi
29、th the regulated good.3.15 secondary inner packaging inner packaging, including absorbent material as required, that provides additional protection for the primary receptacle(s).3.16sift-proof impermeable to dry contents, including any fine solid material produced during transport.3.17type P620 pack
30、aging packaging intended to transport an infectious substance of Category A in a form of culture or infectious substance of Category A meeting the requirements of 2.36 (3) in the TDG Regulations.3.18type P650 packaging packaging intended to transport an infectious substance of Category B or an infec
31、tious substance of Category A that does not meet 11.1.1 of the standard.3.19UN packaging symbol 6CAN/CGSB-43.125-2016 CGSB 2016 All rights reservedPart I Design and manufacture of packagings for infectious substances of Category A and Category B4 General requirements4.1 Design, test and manufacture
32、A packaging intended for the transportation of infectious substances of Category A or Category B shall be designed, tested and manufactured in accordance with Part I of this standard.4.2 Standardized packaging 4.2.1 To be considered as a type P620 packaging, the following requirements shall be met:a
33、) the compliance marks conform to the requirements of 5.1;b) the packaging was designed in accordance with 4.3.1.1 and 6.1;c) a representative prototype of the packaging has been successfully tested in accordance with the requirements of section 7 and Table 2A;d) the packaging was manufactured under
34、 a quality management system in accordance with 9.1.1; ande) the packaging design is registered with the Director in accordance with the requirements of section 10.4.2.2 To be considered as a type P650 packaging, the following requirements shall be met:a) the compliance marks conform to the requirem
35、ents of 5.2;b) the packaging was designed in accordance with 4.3.1.2 and 6.2;c) a representative prototype of the packaging has been successfully tested in accordance with the requirements of section 7 and Table 2B;d) the packaging was manufactured under a quality management system in accordance wit
36、h 9.2.4.3 Packaging design4.3.1 Performance4.3.1.1 Type P620 packaging The packaging shall conform to a registered design for which a representative prototype has been tested and found to meet the applicable performance requirements set out in section 7 and Table 2A of this standard, except for desi
37、gn variations permitted in section 8 or Part II of this standard.4.3.1.2 Type P650 packaging The packaging shall conform to a representative prototype that has been tested and found to meet the applicable performance requirements set out in section 7 and Table 2B of this standard, except for design
38、variations permitted in section 8 or Part II of this standard.CAN/CGSB-43.125-20167 CGSB 2016 All rights reserved4.3.2 Internal Pressure 4.3.2.1 Type P620 packaging The primary receptacle or the secondary inner packaging shall be capable of withstanding without leakage a pressure differential of not
39、 less than 95 kPa in accordance with 7.5.4.3.2.2 Type P650 packaging For shipment by aircraft, the primary receptacle or the secondary inner packaging for liquid substances shall be capable of withstanding without leakage a pressure differential of not less than 95 kPa in accordance with 7.5.4.3.3 T
40、emperature resistance Whatever the intended temperature of the consignment, the primary receptacle or the secondary inner packaging of a type P620 packaging shall be capable of withstanding temperatures in the range of -40 to +55C.4.3.4 Refrigerants The primary receptacle and the secondary inner pac
41、kaging of packagings intended to contain a refrigerant shall maintain their integrity at the temperature of the refrigerant used as well as at the temperatures and the pressures which could result if refrigeration were lost.4.4 Packaging information4.4.1 When made available as a kit, the packaging m
42、anufacturer and subsequent distributor shall provide the following information to the customer in relation to each packaging design:a) a procedure and a list of components with sufficient information to allow the user to assemble, fill and close the packaging in the same fashion as it was tested;b)
43、the maximum capacity of the tested primary receptacles; andc) the tare weight, maximum gross mass and maximum capacity based on the packaging and capacities used for the drop test.4.4.2 The packaging manufacturer and distributor shall provide the packaging information to a packaging purchaser at eac
44、h initial purchase of the corresponding packaging.4.4.3 The packaging manufacturer and distributor shall provide the packaging information to a packaging user upon request.5 Compliance mark5.1 Marking on a type P620 packaging5.1.1 General5.1.1.1 Required marking The marking shall be durable, legible
45、, placed in a location and of such a size as to be readily visible.5.1.1.2 Location of marking 8CAN/CGSB-43.125-2016 CGSB 2016 All rights reserved5.1.1.2.1 For packagings with a gross mass of more than 30 kg, the marking (or a duplicate thereof) shall appear on the top or side of the packaging. For
46、drums and jerricans with a removable head, the markings shall appear on the side.5.1.1.2.2 For packagings with a gross mass of 30 kg or less, the marking (or a duplicate thereof) shall appear on the top, side or bottom. For drums and jerricans with a removable head, the markings shall appear on the
47、side or bottom.5.1.1.3 Size of marking Letters, numerals and symbols comprising the markings shall be at least 12 mm high, except that:a) the markings on packagings of 30 L maximum capacity or 30 kg gross mass or less shall be at least 6 mm high; andb) the markings on packagings of 5 L maximum capac
48、ity or 5 kg gross mass or less shall be at least 3 mm high.5.1.2 Content and sequence of marking The following markings are required and shall be displayed in the following sequence with each of the elements clearly separated from one another:a) the UN packaging symbol;b) the packaging code listed i
49、n Table 1 and, when applicable, the letter “U” or “W” assigned to the packaging code in accordance with 5.1.4;c) the text: “CLASS 6.2”;d) the last two digits of the year of manufacture of the package;e) the three-letter country code “CAN”;f) the name or symbol of the manufacturer; and g) the Design Registration Number.5.1.3 Examples of marking5.1.3.1 Solid plastic box:4H2/CLASS6.2/15 CAN/ABC 8-9999as in 5.1.2 a), b), c), d) and e) as in 5.1.2 f) and g)For a packaging with solid plastic box outer packaging, for infectious substances of Category A and
