The Canadian General Standards Board updated the CAN/CGSB-43.125 standard. The CAN/CGSB-43.125-2021 is based on the 21st edition of the Recommendations on the Transport of Dangerous Goods, published by the United Nations (UN).
This document summarizes the most significant changes to the standard that are applicable to manufacturers of packagings for Category A and Category B infectious substances and users of these packagings. Not all changes to the standard are covered here.
It is the responsibility of the manufacturer of Type P620 and/or Type P650 packagings or a user of packagings for Category A and Category B, or clinical or (bio)medical waste to read and understand the sections of the standard that are applicable to their respective activities, to ensure that they are aware of all the changes.
General
- Alignment with the 21st edition of the United Nations Recommendations on the Transport of Dangerous Goods - Model Regulations (Orange Book) (eg. updated definitions, packing instruction for UN3549 – see bullet below)
Part I - Design, test and manufacture of type P620 and P650 packagings
- Modification of packaging information requirements when infectious substance packaging is made available as a kit
- New requirement for the periodic retest of registered Type P620 packaging designs every five years
- Clarification of the requirements for the preparation of a Type P650 packaging design report (Note: this report must be prepared in accordance with the requirements of Annex A but submission to Transport Canada is not required)
Part II - Selection and use of packagings for infectious substances of Category A and Category B
- Clarification improvements to the selection and use requirements outlined in Part II and Part III (eg. removal of any classification-related requirements from this packaging standard)
- Introduction of new clause outlining the reuse provisions for infectious substances packaging. Clause 11.3 specifies that the primary receptacle(s) of a Type P620 or Type P650 packaging must not be reused, but that the secondary inner packaging or the outer packaging of Type P620 or Type P650 may be reused if they do not show any signs of contamination, damage or defects
Part III - Selection and use of packagings for the transport of clinical, (bio) medical or regulated medical waste
- Clarification improvements to the selection and use requirements outlined in Part II and Part III (eg. removal of any classification-related requirements from this packaging standard)
- Introduction of new packing instructions for the transport of the new classification UN3549, MEDICAL WASTE, CATEGORY A, AFFECTING HUMANS, solid or MEDICAL WASTE, CATEGORY A, AFFECTING ANIMALS only, solid. Stakeholders who intend to transport solid medical waste assigned to UN3549 must package it in accordance with the requirements of 12.2 which requires an inner packaging, an intermediate packaging and UN outer packaging
- Incorporation of UN Large Packaging Codes permitted for transport in Part III, pursuant to the publication of the CAN/CGSB-43.145 Standard (published but not yet in force under the TDG regulations)
- Introduction of new clause outlining the reuse provisions for infectious substances packaging. Packagings must not be reused unless they are in accordance with clause 11.3 for Type P620 and P650 packaging, or for other packagings, they shall not be reused unless each are inspected and are found to be free from contamination or infectious substances hazard, damage or defects
- Introduction of new general use clauses introduced into Part III for consistency with Part II