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1、 AS 48342007 Australian Standard Packaging for surface transport of biological material that may cause disease in humans, animals and plants AS 48342007 This Australian Standard was prepared by Committee HE-007, Packaging of Infectious Materials. It was approved on behalf of the Council of Standards
2、 Australia on 19 January 2007. This Standard was published on 23 February 2007. The following are represented on Committee HE-007: Australasian Association of Clinical Biochemists Australian and New Zealand Clinical Waste Management Industry Group Australian Association of Pathology Practices Inc Au
3、stralian Society for Microbiology Incorporated Australia Quarantine and Inspection Services Commonwealth Department of Health and Ageing Commonwealth Department of Transport and Regional Services CSIRO Australian Animal Health Laboratory Department for Environment and Heritage, SA Department of Envi
4、ronment and Conservation, NSW National Pathology Accreditation Advisory Council Public Health Laboratory Network Queensland Health Royal College of Pathologists of Australasia Transport Workers Union of Australia University of Melbourne University of Queensland This Standard was issued in draft form
5、 for comment as DR 05023. Standards Australia wishes to acknowledge the participation of the expert individuals that contributed to the development of this Standard through their representation on the Committee and through public comment period. Keeping Standards upKeeping Standards upKeeping Standa
6、rds upKeeping Standards up- - - -totototo- - - -datedatedatedate Australian Standards are living documents that reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, amendments may b
7、e issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments that may have been published since the Standard was published. Detailed information about Australian Standards, drafts, amendments and new
8、projects can be found by visiting www.standards.org.auwww.standards.org.auwww.standards.org.auwww.standards.org.au Standards Australia welcomes suggestions for improvements, and encourages readers to notify us immediately of any apparent inaccuracies or ambiguities. Contact us via email at mailstand
9、ards.org.aumailstandards.org.aumailstandards.org.aumailstandards.org.au, or write to Standards Australia, GPO Box 476, Sydney, NSW 2001. AS 48342007 Australian Standard Packaging for surface transport of biological material that may cause disease in humans, animals and plants First published as AS 4
10、8342007. COPYRIGHT Standards Australia All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher. Published by Standards Australia, GPO Box 476, Sydney, NSW
11、2001, Australia ISBN 0 7337 8059 8 AS 48342007 2 PREFACE This Standard was prepared by the Standards Australia Committee HE-007, Packaging of Infectious Materials. It stems from a need, expressed by the Commonwealth Department of Transport and Regional Services and the Australian Society for Microbi
12、ology Incorporated, for a Standard on packaging of biological material for surface transport. The objectives of this Standard are as follows: (a) To responsibly manage risks to ensure that (i) the workforce is properly protected when they handle the packaged biological material without the necessity
13、 of personal protective equipment (PPE) or specialist training; and (ii) the community is provided with a level of assurance that appropriate measures have been taken for safe transportation and containment of biological material. (b) To establish a national Standard for the packaging and surface tr
14、ansport of biological material including those for investigation and research. Appendix A is essentially based on United Nations Recommendations on the Transport of Dangerous Goods, Model Regulations, 14th edition 2005, currently under review for inclusion in the 7th edition of the Australian Danger
15、ous Goods Code (ADG Code). Further assistance from this UN publication on packaging definitions, classification of infectious substances into categories and packaging instructions has been taken while preparing this Standard. The term informative has been used in this Standard to define the applicat
16、ion of the appendix to which it applies. An informative appendix is only for information and guidance. 3 AS 48342007 CONTENTS Page FOREWORD4 1 SCOPE5 2 REFERENCED DOCUMENTS5 3 DEFINITIONS6 4 CATEGORIES OF BIOLOGICAL MATERIAL7 5 PACKAGING REQUIREMENTS8 6 MARKING AND DOCUMENTATION. 10 7 TRANSPORT. 10
17、8 REFRIGERANTS. 10 9 PACKAGING AWARENESS 11 APPENDICES A INDICATIVE EXAMPLES OF INFECTIOUS SUBSTANCES INCLUDED IN CATEGORY A IN ANY FORM UNLESS OTHERWISE INDICATED 12 B INDICATIVE EXAMPLES OF QUARANTINABLE PLANT DISEASES INCLUDED IN CATEGORY A IN ANY FORM 14 C SOURCE DETAILS FOR REFERENCE DOCUMENTS.
18、 15 D EXAMPLES OF PACKAGING PREPARATION, ASSEMBLY, CLOSING AND MARKING 17 E SAMPLE DECLARATION FORM FOR CATEGORY B AND C BIOLOGICAL MATERIALS FOR SURFACE TRANSPORT . 18 AS 48342007 4 FOREWORD This Standard is based on the premise that the inherent risks to the community associated with the transport
19、ation of potentially infectious and infectious biological material are minimized by adequate packaging. The requirements for these packaging types are set out in the content of this Australian Standard. It is the responsibility of the organization, management and the individual to safely package bio
20、logical material for surface transport. World Health Organization (WHO)Transport of Infectious Substances WHO/CDS/CSR/LYO/2004.9, recognizes that diagnostic specimens resulting from medical practice are considered a negligible threat to public health. Australian Government, Department of Health and
21、AgeingInfection Control Guidelines for the Prevention of Transmission of Infectious Diseases in the Health Care Setting presumes that all bodily fluids are infectious and require standard and additional precautions. Although there is only a low probability that such biological material will be infec
22、tious, these precautions should be used when packaging such biological materials. The management of clinical waste is covered by AS/NZS 3816, Management of clinical and related wastes, and a range of state and territory regulations. 5 AS 48342007 www.standards.org.au Standards Australia STANDARDS AU
23、STRALIA Australian Standard Packaging for surface transport of biological material that may cause disease in humans, animals and plants 1 SCOPE This Standard defines the categories of biological material and specifies requirements for packaging and marking for the surface transport of biological mat
24、erial which may be hazardous to the community and environment. This Standard defines three categories of biological material (see Clause 4) and specifies packaging requirements for surface transport of Category B and Category C material (see Note 1). This Standard does not apply to the following: (a
25、) Blood for transfusion, blood products, and tissues and organs for transplantation. (b) Blood or blood components that health professionals have determined are acceptable for transfusion or transplantation or for the preparation of blood products. (c) Genetically modified organisms (see Note 3), li
26、ve animals and hospital laundry. The Standard acknowledges packaging of these biological materials is subject to the requirements of their relevant authorities. (d) Substances such as smears on absorbent paper, hair, nails, paraffin embedded blocks of processed tissue and fixed slides. NOTES: 1 Biol
27、ogical material being transported by air, sea or post is subject to other packaging requirements such as The International Air Transport Association (IATA), International Civil Aviation Organisation (ICAO), The International Maritime Dangerous Goods Code (IMDG) or Australia Post Dangerous and Prohib
28、ited Goods Postal Guide. 2 Where the transport is likely to be multi-modal, the packaging requirements of ALL modes must be met. For example, if a package is to go by both air and road, the packaging requirements for air will satisfy both requirements. 3 Requirements for the packaging of genetically
29、 modified organisms (GMOs) are detailed in the Guidelines for the Transport of GMOs issued by the Office of the Gene Technology Regulator (OGTR). 2 REFERENCED DOCUMENTS The following documents are referred to in this Standard: AS/NZS 2243 Safety in laboratories 2243.3 Part 3: Microbiological aspects
30、 and containment facilities 2243.10 Part 10: Storage of chemicals NTC (National Transport Commission) Australian Code for the Transport of Dangerous Goods by Road and Rail (ADG Code) Australia Post Australia Post Dangerous and Prohibited Goods and Packaging Post Guide AS 48342007 6 Standards Austral
31、ia www.standards.org.au IATA (International Air Transport Association) Packaging instructionsClass 6Toxic and infectious substances. International Maritime Dangerous Goods Code (IMDG Code) OGTR (Office of the Gene Technology Regulator) Guidelines for the Transport of GMOs UN (United Nations) Recomme
32、ndations on the Transport of Dangerous Goods. Model RegulationsDivision 6.2 Infectious Substances NOTE: Source details of these documents are given in Appendix C. 3 DEFINITIONS For the purpose of this Standard, the definitions below apply. 3.1 Biological material Human, animal or plant material. (Se
33、e Clause 4 for categories of biological material). 3.2 Combination packagings A combination of packagings for transport purposes, consisting of one or more inner packagings secured in an outer packaging. 3.3 Consignment Any package or packages presented by a consignor for transport. 3.4 Cultures (la
34、boratory stocks) The result of a process by which pathogens are intentionally propagated, thereby increasing the risk of disease when exposure to them occurs. This definition does not include specimens for clinical purposes in growth or non-growth promoting media. 3.5 Dry shipper An insulated packag
35、e containing liquid nitrogen refrigerant that is fully absorbed into a porous material. When properly prepared, no liquid nitrogen can leak regardless of the orientation of the insulated package but nitrogen vapour is generated and must be vented. The shipper may be considered only an outer packagin
36、g. 3.6 Genetically modified organism (GMO) An organism that has been modified by gene technology or the progeny of a GMO that has inherited GM traits. Genetically modified organism (GMO) is defined in the Gene Technology Act 2000, the Gene Technology Regulations 2001 and the corresponding state law.
37、 3.7 Infectious substances Substances which are known or reasonably expected to contain pathogens. Pathogens are micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans, animals or plants. 3.8 May Indicates the e
38、xistence of an option. 3.9 Outer packaging The outer protection of a combination packaging (excluding an overpack) together with any absorbent materials, cushioning and any other components necessary to contain and protect the primary container and secondary packaging and make it capable of withstan
39、ding the rigours of transport (e.g. heavy braking and rough handling). 7 AS 48342007 www.standards.org.au Standards Australia 3.10 Overpack An enclosure used by a single consignor to contain one or more packages and to form one unit for convenience of handling and stowage during transport. For examp
40、le, a number of packages secured by shrink wrapping or stretch wrapping, or placed in a protective box or crate. 3.11 Package The complete product of the packing operation, consisting of the packaging and its contents prepared for transport. 3.12 Primary container or receptacle A container or recept
41、acle in contact with the biological material to be transported. 3.13 Secondary packaging Provides additional protection for the primary container(s), is leak proof and may include absorbent material. 3.14 Secured Fastened so as not to be displaced or to yield under strain; firmly fixed. 3.15 Shall I
42、ndicates that a statement is mandatory. 3.16 Should Indicates a recommendation. 3.17 Stowed To put in a place or receptacle for storage. 3.18 Surface transport Any form of surface transport within the public domain. NOTES: 1 Includes vehicles or packages transported on water. 2 Regulation of sea tra
43、nsport is the responsibility of the Australian Maritime Safety Authority. 4 CATEGORIES OF BIOLOGICAL MATERIAL 4.1 General This Clause outlines three categories of biological matter. The categories are based on the level of infectivity of the biological material and the mode(s) of transportation used
44、, while acknowledging the regulatory requirements where applicable. Category A and Category B material are dangerous goods for the purposes of the Australian Dangerous Goods Code. AS 48342007 8 Standards Australia www.standards.org.au 4.2 Category A Category A biological material comprises infectiou
45、s substances which are transported in a form that, when exposure to them occurs, are capable of causing permanent disability, or a life-threatening or fatal disease to otherwise healthy humans or animals. Infectious agents of plants that could cause significant damage to the environment or agricultu
46、re are included in this category. NOTES: 1 An exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans, animals or plants (environment). 2 Indicative examples of infectious substances that meet these criteria for humans a
47、nd animals are given in Appendix A. 3 Indicative examples of infectious substances that meet these criteria for plants are given in Appendix B. This category of biological material requires a high integrity package. 4.3 Category B Category B biological material comprises infectious substances that d
48、o not meet the criteria for inclusion under Category A. 4.4 Category C Category C biological material comprises substances with a low probability of causing disease in humans, animals or plants. This covers human, animal or plant samples, including excreta, secreta, blood and its components, tissues
49、 and tissue fluids, not belonging to Category A or B biological material. 5 PACKAGING REQUIREMENTS 5.1 Category A biological material High integrity packaging is required. Packaging such as IATAPackaging Instructions 602 or Packaging Instructions 650 as used for air transport is adequate for surface transport of Category A biological material. 5.2 Category B and C biological material 5.2.1 General The packaging requirements for the surface transport of Category B and Categ