Basic↦Ethics and Laws↦Guidelines↦ISO 14155
Was betrifft es? Warum ist das wichtig?
The International Organisation for Standardisation (ISO) is an independent, non-governmental international organisation.
The ISO 14155 defines ethical and scientific quality standards for the designing, conducting, recording and reporting of Medical Device (MD) studies (ClinO-MD).
The aim is to assess the safety and performance (e.g. quality assurance) of MDs in human studies.
General requirements include to:
- Protect the rights, safety and well-being of human study participants
- Ensure good scientific conduct and the credibility of study results (e.g. data quality)
- Define SP-INV responsibilities
ISO 14155 does not apply to In-Vitro Diagnostics (IVD). IDV studies are regulated in ISO 20916.
Was muss ich befolgen?
As a SP-INV planning a MD study, you are required to know and adhere to requirements defined in the ISO 14155:
- Obtain and file a copy of the ISO standard in the TMF/ISF of your study (e.g. access liable to costs)
- 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.
Wo kann ich Hilfe anfordern?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
HumRes: Coordination portal for human research in Switzerland
ISO 14155:2020 – Medical Device Clinical Studies (access liable to costs)
SNV Standards that connect the world
- Shop for the purchasing of ISO standards
MDCG – see in particular
- Main page that provides guidance and documents for EU medical device applications