ISO 9693-1 First edition 2012-02-15

Standard Organization:

ISO 9693-1 First edition 2012-02-15 Dentistry -- Compatibility testing - Part 1: Metal-ceramic systems

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This part of ISO 9693 specifies test methods for determining the compatibility of metallic and ceramic materials used for dental restorations by testing the composite structure.

The requirements given in this part of ISO 9693 are applicable to metallic materials and ceramics when used in combination, and are not applicable to either metallic materials or ceramics when used alone.

NOTE Requirements for metallic materials are given in ISO 22674; requirements for ceramic materials are given in ISO 6872.

Code of Federal Regulations:

FDA Guidance:

Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Dental Nobel Metal Alloys Document issued on: August 23, 2004 Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Dental Base Metal Alloys Document issued on: August 23, 2004 Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments Document issued on: May 12, 2004