What is it? Why is it important?
The International Organisation for Standardisation (ISO) is an independent, non-governmental international organisation.
The ISO 20916 defines ethical and scientific quality standards for the designing, conducting, recording, and reporting of studies evaluating clinical performance of In-Vitro-Diagnostic (IVD) Medical Devices (MD).
The aim is to provide principles supporting studies on clinical performances and provides requirements on:
What do I need to do?
When planning IVD MD studies, you are required to know and adhere to requirements defined in the ISO 20916:
- Obtain and file a copy of the ISO standard in the TMF/ISF of your study (access liable to costs; personalized licence)
- Familiarise yourself with the organization of the various chapters and sections
- Focus on the articles that are relevant to your study. Tag them in order to ensure compliance
- Based on the intervention know what risk-category applies to your study (e.g. category A with low risk and category C with high risk)
ISO standards are liable to costs; you must therefore purchase the ISO standards.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
ISO 20916:2019 In vitro diagnostic medical devices (access liable to costs)
SNV Standards that connect the world
- Shop for the purchasing of ISO standards