Neonatal and paediatric transport is an essential link in the chain of care. To guarantee the safety of the most fragile patients, it is essential to rely on a solid normative environment. But what is a standard? How are they articulated? And what are the obligations for medical devices used during transport?
What is a standard?
A standard is a collaboratively developed technical reference document that sets minimum safety, performance, or interface specifications. It can be international (ISO, IEC), European (EN) or national (NF, DIN) and is only mandatory if it is incorporated into a law or regulation[1].
Standards and CE
markingTo be marketed in France and Europe, a medical device must comply with the European Directive 93/42/EEC and bear the CE marking. Compliance with so-called “harmonised” standards gives a presumption of conformity, but it is also possible to justify compliance by other equivalent methods[1].
Multiplicity and evolution of standards
There are a multitude of applicable standards: EN 60601 (safety of electro-medical devices), EN 13976 (incubator transport systems), EN 1789 (road ambulances), EN 13718 (air ambulances), RTCA-DO160G (environmental tests for on-board equipment), etc. These standards evolve regularly, making regulatory monitoring essential for biomedical and healthcare teams[1].
Tips for caregivers
- Check the CE marking and compliance with the basic standards (EN 60601, EN 60601-2-20).
- Ensure that the documentation specifies the scope of certification (incubator only, structure, complete system).
- Consider the version of the standard claimed and the exact configuration tested.
Conclusion
Understanding the normative environment is a guarantee of safety for patients and serenity for teams. Informing yourself and checking the conformity of the equipment is an essential step in the choice of transport equipment.