IMO Classes

Class 6: Toxic and infectious substances

Subclass 6.1: Toxic, poison substances

輸送中に健康に害を及ぼすために人体に有害であることが知られているか、または実験動物で試験した場合には人体に有害であると推定されている

An irritating material such as tear gas that causes extreme irritation, especially in confined spaces

Subclass 6.2: Biohazard

6.2.1 Definitions

これらの規則の目的のために：

6.2.1.1 Infectious substances are substances which are known or are reasonably expected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in

人間や動物。

Note: Toxins from plant, animal or bacterial sources which do not contain any infectious substances or toxins that are not contained in substances which are infectious substances should be considered for classification in Division 6.1 and assigned to UN3172.

6.2.1.2 Biological products are those products derived from living organisms which are manufactured and distributed in accordance with the requirements of appropriate national authorities, which may have special licensing requirements, and are used either for prevention, treatment, or diagnosis of disease in humans or animals, or for development, experimental or investigational purposes related thereto. They include, but are not limited to, finished or unfinished products such as vaccines.

6.2.1.3 Cultures are the result of a process by which pathogens are intentionally. This definition does not include patient specimens as defined in 6.2.1.4.

6.2.1.4 Patient specimens are those collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention.

6.2.1.5 Medical or clinical wastes are wastes derived from the medical treatment of animals or humans or from bio-research.

6.2.2 Classification of Infectious Substances

6.2.2.1 Infectious substances must be classified in Division 6.2 and assigned to UN2814, UN2900, UN 3291 or UN3373, as appropriate.

6.2.2.2 Infectious substances are divided into the following categories.

6.2.2.2.1 Category A:

それにさらされたときに、それ以外の点では健康な人間または動物に恒久的な障害、生命を脅かす、または致命的な病気を引き起こすことがある形で輸送される感染性物質。これらの基準を満たす物質の代表例を表3.6.Dに示します。

注：感染性物質が保護包装の外側に放出され、その結果、人または動物と物理的に接触すると暴露が起こります。

（a）ヒトまたはヒトと動物の両方に病気を引き起こすこれらの基準を満たす感染性物質は、国連2814に割り当てられなければならない。動物だけに病気を引き起こす感染性物質は、国連2900に割り当てられなければならない。

（b）国連2814または国連2900への割り当ては、発生源のヒトまたは動物の既知の病歴および症状、流行の地域の状況、または発生源のヒトの個々の状況に関する専門的判断に基づくものでなければならない。

注意:

1.国連2814の正式な出荷名は感染性物質であり、人に影響を与えます。 UN 2900の正式な出荷名は感染性物質で、動物にのみ影響を及ぼします。

2.次の表は網羅的なものではありません。表には記載されていないが同じ基準を満たす新規または新興の病原体を含む感染性物質をカテゴリーAに割り当てる必要があります。カテゴリーAに含まれる

3.以下のリストで、イタリック体で書かれている微生物はバクテリア、マイコプラズマ、リケッチアまたは真菌です。

Bacillus anthracis (cultures only)
Infectious substance
Brucella abortus (cultures only)
Brucella melitensis (cultures only)
Brucella suis (cultures only)
Burkholderia mallei – Pseudomonas mallei – Glanders (cultures only)
Burkholderia pseudomallei – Pseudomonas pseudomallei (cultures only)
Chlamydia psittaci – avian strains (cultures only)
Clostridium botulinum (cultures only)
Coccidioides immitis (cultures only)
Coxiella burnetii (cultures only)
Crimean-Congo hemorrhagic fever virus
Dengue virus (cultures only)
Eastern equine encephalitis virus (cultures only)
Escherichia coli, verotoxigenic (cultures only)
Ebola virus
Flexal virus
Francisella tularensis (cultures only)
Guanarito virus
Hantaan virus
Hantavirus causing hemorragic fever with renal syndrome
Hendra virus
Hepatitis B virus (cultures only)
Herpes B virus (cultures only)
Human immunodeficiency virus (cultures only)
Highly pathogenic avian influenza virus (cultures only)
Japanese Encephalitis virus (cultures only)
Junin virus
Kyasanur Forest disease virus
Lassa virus
Machupo virus
Marburg virus
Monkeypox virus
Mycobacterium tuberculosis (cultures only)
Nipah virus
Omsk hemorrhagic fever virus
Poliovirus (cultures only)
Rabies virus
Rickettsia prowazekii (cultures only)
Rickettsia rickettsii (cultures only)
Rift Valley fever virus
Russian spring-summer encephalitis virus (cultures only)
Sabia virus
Shigella dysenteriae type 1 (cultures only)
Tick-borne encephalitis virus (cultures only)
Variola virus
Venezuelan equine encephalitis virus
West Nile virus (cultures only)
Yellow fever virus (cultures only)
Yersinia pestis (cultures only)
African swine fever virus (cultures only)
Avian paramyxovirus Type 1 – Velogenic Newcastle disease virus (cultures only)
Classical swine fever virus (cultures only)
Foot and mouth disease virus (cultures only)
Goatpox virus (cultures only)
Lumpy skin disease virus (cultures only)
Mycoplasma mycoides – Contagious bovine pleuropneumonia(cultures only)
Peste des petits ruminants virus (cultures only)
Rinderpest virus (cultures only)
Sheep-pox virus (cultures only)
Swine vesicular disease virus (cultures only)
Vesicular stomatitis virus (cultures only)

6.2.2.2.2 Category B:

カテゴリーAに含まれる基準を満たさない感染性物質。カテゴリーBの感染性物質は、国連3373に割り当てられなければならない。

Note: The proper shipping name of UN 3373 is Diagnostic specimens or Clinical specimens or Biological substance, category B. On 1 January 2007, it is anticipated that the use of the shipping names Diagnostic specimens and Clinical specimens will no longer be permitted.

6.2.2.3 Exemptions

6.2.2.3.1 Substances which do not contain infectious substances or substances which are unlikely to cause disease in humans or animals are not subject to these Regulations unless they meet the criteria for inclusion in another class.

6.2.2.3.2 Substances containing microorganisms which are non-pathogenic to humans or animals are not subject to these Regulations unless they meet the criteria for inclusion in another class.

6.2.2.3.3 Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk are not subject to these Regulations unless they meet the criteria for inclusion in another class.

6.2.2.3.4 Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection are not subject to these Regulations unless they meet the criteria for inclusion in another class.

6.2.2.3.5 Dried blood spots, collected by applying a drop of blood onto absorbent material, or faecal occult blood screening tests and blood or blood components which have been collected for the purposes of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation are not subject to these Regulations.

6.2.2.3.6 Patient specimens for which there is minimal likelihood that pathogens are present are not subject to these Regulations if the specimen is packed in a packaging which will prevent any leakage and which is marked with the words "Exempt human specimen" or "Exempt animal specimen", as appropriate. The packaging must meet the following conditions:

（a）包装は3つの要素から構成されていなければなりません。

1. A leak-proof primary receptacle(s);

2. A leak-proof secondary packaging; and

3. An outer packaging of adequate strength for its capacity, mass and intended use, and with at least one surface having minimum dimensions of 100 mm × 100 mm;

（b）液体の場合、内容物全体を吸収するのに十分な量の吸収性材料は

一次容器と二次包装との間に配置され、輸送中に液体物質の放出または漏れが外包装に到達せず、緩衝材料の完全性を損なわないようにする。

（c）複数の壊れやすい一次容器を単一の二次包装に入れるときは、それらが接触しないように個々に包装するか分離する必要があります。

NOTE: In determining whether a patient specimen has a minimum likelihood that pathogens are present, an element of professional judgment is required to determine if a substance is exempt under this paragraph. That judgment should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions.

この段落の下で輸送される可能性のある検体の例には、コレステロール値、血糖値、ホルモン値、または前立腺特異抗原（PSA）を監視するための血液または尿検査が含まれます。ヒトまたは非感染性疾患を有する動物の心臓、肝臓または腎臓機能などの臓器機能を監視するために必要なもの、または治療薬の監視。保険または雇用目的で行われ、薬物またはアルコールの存在を判断することを目的としたもの。妊娠検査癌を検出するための生検ヒトまたは動物における抗体検出。

6.2.3 Biological Products

6.2.3.1 For the purposes of these Regulations, biological products are divided into the following groups:

（a）適切な国内当局の要件に従って製造および包装され、最終包装または配給の目的で輸送され、医療専門家または個人による個人の健康管理に使用されるものこのグループの物質はこれらの規制の対象ではありません。

（b）パラグラフ（a）に該当せず、感染性物質を含むと知られているか合理的に考えられ、カテゴリーAまたはカテゴリーBに含まれる基準を満たすもの、 適切に。

注：認可された生物学的製品の中には、世界の特定の地域でのみバイオハザードを示すものがあります。その場合、管轄当局は、これらの生物学的製品を感染性物質に関する現地の要求事項に準拠させることを要求したり、他の制限を課すことがあります。

6.2.4 Genetically Modified Micro-organisms and Organisms

6.2.4.1 Genetically modified micro-organisms not meeting the definition of an infectious substance must be classified according to Subsection 3.9.

6.2.5 Medical or Clinical Wastes

6.2.5.1 Medical or clinical wastes containing Category A infectious substances must be assigned to UN2814 or UN2900, as appropriate. Medical or clinical wastes containing infectious substances in Category B, must be assigned to UN3291.

6.2.5.2 Medical or clinical wastes which are reasonably believed to have a low probability of containing infectious substances must be assigned to UN3291. Note: The proper shipping name for UN3291 is Clinical waste, unspecified, n.o.s. or (Bio) Medical waste, n.o.s. or Regulated medical waste, n.o.s..

6.2.5.3

6.2.6 Infected Animals

6.2.6.1 A live animal that has been intentionally infected and is known or suspected to contain an infectious substance must not be transported by air unless the infectious substance contained cannot be consigned by any other means. Infected animals may only be transported under terms and conditions approved by the appropriate national authority.

6.2.6.2 Unless an infectious substance cannot be consigned by any other means, live animals must not be used to consign such a substance.

6.2.6.3 Animal carcasses affected by pathogens of category A or which would be assigned to category A in cultures only, must be assigned to UN 2814 or UN 2900 as appropriate. Other animal carcasses affected by pathogens included in Category B must be transported in accordance with provisions determined by the competent authority.

6.2.7 Patient Specimens Patient specimens must be assigned to UN 2814, UN 2900 or UN 3373 as appropriate except if they comply with 6.2.2.3