International Organization of Standardization

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

Some ISO standards regarding implants:
Medical devices: ICS 11.100.20 and 11.040.01.
The quality and risk management regarding the topic for regulatory purposes: ISO 13485, ISO 14971.
Basis for regulatory compliance in most markets: ISO 13485:2003 (applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices).  Company engagement in new products: ISO 9001:2008 (approved process, quality standards, development records)
Electrical devices: IEC 60601-1.
Active implantable medical devices: EN 45502-1.
Medical software: IEC 62304.
Implants for surgery: ISO/TC 150 (f. i. materials, cardiovascular implants, bone and joint replacements, osteosynthesis and spinal devices, active implants, tissue-engineered medical products.
There are more under development and more subspecialties.

See more

Scroll to Top