Corrigendum - REACH24H Consulting Group
Corrigendum - REACH24H Consulting Group Corrigendum - REACH24H Consulting Group
2.6.3.3 Biological products 2.6.3.3.1 For the purposes of these Regulations, biological products are divided into the following groups: (a) those which are manufactured and packaged in accordance with the requirements of appropriate national authorities and transported for the purposes of final packaging or distribution, and use for personal health care by medical professionals or individuals. Substances in this group are not subject to these Regulations; (b) those which do not fall under paragraph (a) and are known or reasonably believed to contain infectious substances and which meet the criteria for inclusion in Category A or Category B. Substances in this group shall be assigned to UN 2814, UN 2900 or UN 3373, as appropriate. NOTE: Some licensed biological products may present a biohazard only in certain parts of the world. In that case, competent authorities may require these biological products to be in compliance with local requirements for infectious substances or may impose other restrictions. 2.6.3.4 Genetically modified microorganisms and organisms 2.6.3.4.1 Genetically modified microorganisms not meeting the definition of infectious substance shall be classified according to Chapter 2.9. 2.6.3.5 Medical or clinical wastes 2.6.3.5.1 Medical or clinical wastes containing Category A infectious substances shall be assigned to UN 2814 or UN 2900 as appropriate. Medical or clinical wastes containing infectious substances in Category B shall be assigned to UN 3291. 2.6.3.5.2 Medical or clinical wastes which are reasonably believed to have a low probability of containing infectious substances shall be assigned to UN 3291. For the assignment, international, regional or national waste catalogues may be taken into account. NOTE: The proper shipping name for UN 3291 is “CLINICAL WASTE, UNSPECIFIED, N.O.S.” or “(BIO) MEDICAL WASTE, N.O.S” or “REGULATED MEDICAL WASTE, N.O.S.”. 2.6.3.5.3 Decontaminated medical or clinical wastes which previously contained infectious substances are not subject to these Regulations unless they meet the criteria for inclusion in another class. 2.6.3.6 Infected animals Copyright@United Nations, 2011. All rights reserved. 2.6.3.6.1 Unless an infectious substance cannot be consigned by any other means, live animals shall not be used to consign such a substance. A live animal which has been intentionally infected and is known or suspected to contain an infectious substance shall only be transported under terms and conditions approved by the competent authority. 2.6.3.6.2 Animal material affected by pathogens of Category A or which would be assigned to Category A in cultures only, shall be assigned to UN 2814 or UN 2900 as appropriate. Animal material affected by pathogens of Category B other than those which would be assigned to Category A if they were in cultures shall be assigned to UN No. 3373. - 128 -
CHAPTER 2.7 CLASS 7 - RADIOACTIVE MATERIAL NOTE: For Class 7, the type of packaging may have a decisive effect on classification. 2.7.1 Definitions 2.7.1.1 Radioactive material means any material containing radionuclides where both the activity concentration and the total activity in the consignment exceed the values specified in 2.7.2.2.1 to 2.7.2.2.6. 2.7.1.2 Contamination Contamination means the presence of a radioactive substance on a surface in quantities in excess of 0.4 Bq/cm 2 for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm 2 for all other alpha emitters. Non-fixed contamination means contamination that can be removed from a surface during routine conditions of transport. Fixed contamination means contamination other than non-fixed contamination. 2.7.1.3 Definitions of specific terms A1 and A2 Copyright@United Nations, 2011. All rights reserved. A1 means the activity value of special form radioactive material which is listed in the Table in 2.7.2.2.1 or derived in 2.7.2.2.2 and is used to determine the activity limits for the requirements of these Regulations. A2 means the activity value of radioactive material, other than special form radioactive material, which is listed in the Table in 2.7.2.2.1 or derived in 2.7.2.2.2 and is used to determine the activity limits for the requirements of these Regulations. Fissile nuclides means uranium-233, uranium-235, plutonium-239 and plutonium-241. Fissile material means a material containing any of the fissile nuclides. Excluded from the definition of fissile material are: (a) Natural uranium or depleted uranium which is unirradiated; and (b) Natural uranium or depleted uranium which has been irradiated in thermal reactors only. Low dispersible radioactive material means either a solid radioactive material or a solid radioactive material in a sealed capsule, that has limited dispersibility and is not in powder form. Low specific activity (LSA) material means radioactive material which by its nature has a limited specific activity, or radioactive material for which limits of estimated average specific activity apply. External shielding materials surrounding the LSA material shall not be considered in determining the estimated average specific activity. Low toxicity alpha emitters are: natural uranium; depleted uranium; natural thorium; uranium-235 or uranium-238; thorium-232; thorium-228 and thorium-230 when contained in ores or physical and chemical concentrates; or alpha emitters with a half-life of less than 10 days. - 129 -
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2.6.3.3 Biological products<br />
2.6.3.3.1 For the purposes of these Regulations, biological products are divided into the following groups:<br />
(a) those which are manufactured and packaged in accordance with the requirements of<br />
appropriate national authorities and transported for the purposes of final packaging or<br />
distribution, and use for personal health care by medical professionals or individuals.<br />
Substances in this group are not subject to these Regulations;<br />
(b) those which do not fall under paragraph (a) and are known or reasonably believed to<br />
contain infectious substances and which meet the criteria for inclusion in Category A or<br />
Category B. Substances in this group shall be assigned to UN 2814, UN 2900 or UN 3373,<br />
as appropriate.<br />
NOTE: Some licensed biological products may present a biohazard only in certain parts of the world. In<br />
that case, competent authorities may require these biological products to be in compliance with local<br />
requirements for infectious substances or may impose other restrictions.<br />
2.6.3.4 Genetically modified microorganisms and organisms<br />
2.6.3.4.1 Genetically modified microorganisms not meeting the definition of infectious substance shall be<br />
classified according to Chapter 2.9.<br />
2.6.3.5 Medical or clinical wastes<br />
2.6.3.5.1 Medical or clinical wastes containing Category A infectious substances shall be assigned to<br />
UN 2814 or UN 2900 as appropriate. Medical or clinical wastes containing infectious substances in Category B<br />
shall be assigned to UN 3291.<br />
2.6.3.5.2 Medical or clinical wastes which are reasonably believed to have a low probability of containing<br />
infectious substances shall be assigned to UN 3291.<br />
For the assignment, international, regional or national waste catalogues may be taken into account.<br />
NOTE: The proper shipping name for UN 3291 is “CLINICAL WASTE, UNSPECIFIED, N.O.S.” or<br />
“(BIO) MEDICAL WASTE, N.O.S” or “REGULATED MEDICAL WASTE, N.O.S.”.<br />
2.6.3.5.3 Decontaminated medical or clinical wastes which previously contained infectious substances are<br />
not subject to these Regulations unless they meet the criteria for inclusion in another class.<br />
2.6.3.6 Infected animals<br />
Copyright@United Nations, 2011. All rights reserved.<br />
2.6.3.6.1 Unless an infectious substance cannot be consigned by any other means, live animals shall not be<br />
used to consign such a substance. A live animal which has been intentionally infected and is known or suspected<br />
to contain an infectious substance shall only be transported under terms and conditions approved by the competent<br />
authority.<br />
2.6.3.6.2 Animal material affected by pathogens of Category A or which would be assigned to Category A<br />
in cultures only, shall be assigned to UN 2814 or UN 2900 as appropriate. Animal material affected by pathogens<br />
of Category B other than those which would be assigned to Category A if they were in cultures shall be assigned<br />
to UN No. 3373.<br />
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