Dentistry. Medical devices for dentistry. Materials Ingestion-build-100580 in conjunction with IEC 61508-1

in conjunction with IEC 61508-1 and IEC 61508-2

Process and governance

Annex E (informative) General instructions labels

but the viability of businesses within the supply chain is also covered

Dentistry. Medical devices for dentistry. Materials Ingestion-build-100580 in conjunction with IEC 61508-1BS EN 1641: 2004 specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard includes requirements for intended performance, design attributes, components, sterilization,