Testing of Medical Devices
The
term ‘medical device’ covers a vast range of products, from highly
sophisticated medical equipment and systems to simple spirometers
Medical devices are heavily regulated due to the type of environment in which they are used and the potential severity of product failure. They must not compromise the clinical condition or safety of users or patients.
Our EMC and safety laboratories can support you in achieving compliance for the medical standards BS EN / IEC 60601-1, BS EN / IEC 60601-1-2 and BS EN / IEC 61010-2-101, which are used in countries around the world. Cranage specialises in the assessment of Class 1, 2a and 2b medical electrical equipment with type B, BF and CF applied parts.
We have experience of evaluating electrical equipment
intended to be used in the diagnosis, treatment or monitoring of a patient, or
for compensation or alleviation of disease, injury or disability. Our engineers work with customers to get their medical devices compliant for the country in which they will be used, whether this is CE marking in Europe, UKCA in Britain, or the global equivalent.
We have a vast portfolio of medical items previously tested, some examples of which are listed below:
- hospital beds
- lifting devices
- prosthetic limbs
- blood pressure monitors
- ultrasound devices
- anesthetic machines and ventilators
- patient monitors
- imaging system displays
- pulse oximetry
- TENS machines
MEDICAL DEVICE STANDARDS
