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CEN - EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

inactive
Organization: CEN
Publication Date: 1 December 2008
Status: inactive
Page Count: 44
ICS Code (Dental materials): 11.060.10
ICS Code (Laboratory medicine): 11.100
scope:

This International Standard specifies test methods for the evaluation of biological effects of medical devices used in d entistry. I t includes testing of pharmacological agents that are a n integral part of the device under test.

This I nternational S tandard does n ot cover t esting of materials a nd d evices that d o not come i nto direct or indirect contact with the patient's body.

Document History

EN ISO 7405
November 1, 2018
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the...
EN ISO 7405
December 1, 2008
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
A description is not available for this item.
EN ISO 7405
December 1, 2008
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
This International Standard specifies test methods for the evaluation of biological effects of medical devices used in d entistry. I t includes testing of pharmacological agents that are a n integral...
EN ISO 7405
August 1, 1997
Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental Materials
A description is not available for this item.

References

This document references:
41 - Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Published by ADA on January 1, 2020
This document covers standard practices for the biological evaluation of the safety of dental materials, including those with pharmacological agents as an integral part of the material.
This document references:
ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Published by ISO on September 1, 2017
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
This document references:
ISO 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Published by ISO on January 1, 2021
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
This document references:
ISO 10993-13 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
Published by ISO on June 15, 2010
This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices...
This document references:
ISO 10993-14 - Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics
Published by ISO on November 15, 2001
This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the...
This document is referenced by:
BS EN 1642 - Dentistry - Medical devices for dentistry - Dental implants
Published by BSI on October 31, 2011
A description is not available for this item.
This document is referenced by:
BS PD CEN/TR 12401 - Dentistry - Guidance on the classification of dental devices and accessories
Published by BSI on June 30, 2009
A description is not available for this item.
This document is referenced by:
VDI 5701 - Biomaterials in medicine - Classification, requirements, and applications
Published by VDI on May 1, 2018
The standard pertains to biomaterials and their use in the production of medical devices (e.g. implants) for use in the living organism, in particular, in humans and animals. Biomaterials belonging...
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