How to document the suitability of rubber compounds in relation to consumer contact
As we see it, compliance in relation to consumer contact primarily concerns Medical Devices that come into direct or indirect contact with the consumer. The equipment – and with that the rubber component – is qualified in accordance with a carefully defined basis for acceptance, based on the use of the device as well as the marketing plan.
This is important, in terms of not only safety but also the high costs related to the development of the products. As owner of the equipment, you must define the basis of acceptance, but with our experience with rubber, we can help you in this process.
When a rubber compound is intended for human contact, it is necessary to consider any possible risks. Therefore, we send our rubber materials to an external lab for testing and approval in accordance with the relevant requirements. This process is followed by test and documentation of the total equipment – a task that lies with the equipment manufacturer.
A rubber formulation is tested either In Vitro or In Vivo. More specific extraction tests may also be carried out, e.g. when documenting the durability of a medical active substance that comes into contact with our rubber material.
There are several normative references. Most often, the test will be carried out in accordance with US Pharmacopeia, where USP <87> is the method for In vitro test and USP<88> is a group of methods for Vivo test. The latter is subdivided into classes, where Class VI is the method most commonly used.
Finally, it is also possible to test in accordance with ISO 10995. This method basically contains the same possibilities as the above-mentioned tests, but is not quite as popular in the market.
If you require further information on how the tests are carried out in practice, you are always welcome to contact us.
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