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Proposed standards and technical reports available for review

July 30, 2015

By Michelle Manchir

The ADA Standards Committee on Dental Products seeks professionals from all areas of interest to contribute their expertise on two new draft standards on biocompatibility of medical devices and dental patient chairs approved for circulation, review and comment.

The ADA has played a key role in the development of standards since 1928 and is an American National Standards Institute accredited standards developer.

Here are summaries of the two new draft standards:

Proposed ANSI/ADA Standard No. 41 Evaluation of Biocompatibility of Medical Devices used in Dentistry will revise and replace the current ANSI/ADA Standard No. 41:2005 Recommended Standard Practices for Biological Evaluation of Dental Materials. The revision covers standard practices for the biological evaluation of the safety of medical devices used in dentistry. In addition, this document covers biological evaluation of the device component of combination products, including those with a pharmacological agent or biologic component as an integral part of the device. This standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Proposed ANSI/ADA Standard No. 46 Dental Patient Chair will be an identical adoption of ISO 6875:2011 Dentistry – Patient Chair and will revise and replace the current ANSI/ADA Standard No.46:2004 of the same name. This standard is applicable to all patient chairs, regardless of their construction and regardless of whether they are operated manually, electrically or by other means – or as a combination of these. This standard specifies requirements, test methods, manufacturer's information, marking and packaging.

Copies of the draft standards and technical reports are available by calling the ADA toll-free number, ext. 2506, or sending an e-mail request to