ISO
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.
ISO develops International Standards, such as ISO 9001, but is not involved in their certification, and does not issue certificates. Certificates are performed by external certification bodies, thus a company or organization cannot be certified by ISO.
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.