I have a supplier whose IVD equipment has in their Labeling (User Guide and Shipping Label):
Transport and storage conditions −30 to +60 °C
Minimum 20% relative humidity, maximum
85% (non-condensing)
There are no Time or Temperature Sensitive material in the equipment.
Based on 5.4.102 Transport and storage
The manufacturer shall specify the conditions for transport and storage of the equipment. The documentation shall contain a specification of the permissible environmental conditions for transport and storage. Essential information shall be repeated on the outside of the package using appropriate symbols (see 5.1.101). When the manufacturer assumes responsibility for delivery and installation the above is not required in the documentation.
The supplier isn't temperature monitoring the instrument. The temperature and humidity range is not a requirement of their design during transportation or storage, but feels they need to provide temperature and humidity ranges in order to satisfy the environmental conditions of Clause 5.4.102.
I don't see a need for the temperature and humidity to be on the shipping label or user guide for storage and transport since it's not a design requirement, and I see the temperature and humidity being a compliance issue since it's not being monitored from distribution to arrival at the customer's site.
Thoughts about having temperature and humidity ranges on shipping labels for IVD instruments?
Transport and storage conditions −30 to +60 °C
Minimum 20% relative humidity, maximum
85% (non-condensing)
There are no Time or Temperature Sensitive material in the equipment.
Based on 5.4.102 Transport and storage
The manufacturer shall specify the conditions for transport and storage of the equipment. The documentation shall contain a specification of the permissible environmental conditions for transport and storage. Essential information shall be repeated on the outside of the package using appropriate symbols (see 5.1.101). When the manufacturer assumes responsibility for delivery and installation the above is not required in the documentation.
The supplier isn't temperature monitoring the instrument. The temperature and humidity range is not a requirement of their design during transportation or storage, but feels they need to provide temperature and humidity ranges in order to satisfy the environmental conditions of Clause 5.4.102.
I don't see a need for the temperature and humidity to be on the shipping label or user guide for storage and transport since it's not a design requirement, and I see the temperature and humidity being a compliance issue since it's not being monitored from distribution to arrival at the customer's site.
Thoughts about having temperature and humidity ranges on shipping labels for IVD instruments?
