Medical devices and in-vitro-diagnostics are out of scope of theif they are expected to be infectious before the end of their life cycle. The same applies to active, implantable medical equipment (§ 2 paragraph 2 number 10 ElektroG).
When an equipment is to be considered infectious and therefore is out of scope must in principle be decided individually. The following guidelines apply though:
- A b2c equipment generally counts as infectious if the equipment is determined to be in contact with blood and
- fluid can collect inside the electrical or electronic equipment and can be retained for more than a few days (with b2c equipment that are meant for single use it cannot be expected that there will be a longer period between utilisation and transfer to disposal, so that the fluid could lose its pathogenic agents)
- or the equipment can lead to the danger of injuring employees handling the equipment due to its properties/construction on dismantling.
A b2c equipment that only incidentally has contact with blood is generally not to be regarded as infectious.
Infectivity can generally be excluded for re-usable b2b electrical and electronic equipment due to the existing legal or subordinate obligations to decontaminate prior to re-use or respectively prior to transfer to disposal.
This does not apply to medical products for single use, as the above-named obligations to decontaminate do not exist to the same extent. With this electrical and electronic equipment, the infectivity must be checked in each case individually.