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DIN EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

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Organization: DIN
Publication Date: 1 March 2019
Status: active
Page Count: 53
ICS Code (Dental materials): 11.060.10
ICS Code (Other standards related to laboratory medicine): 11.100.99

Document History

DIN EN ISO 7405
March 1, 2019
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
A description is not available for this item.
DIN EN ISO 7405
April 1, 2017
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2017); German and English version prEN ISO 7405:2017
A description is not available for this item.
DIN EN ISO 7405
December 1, 2013
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008 + Amd. 1:2013) (includes Amendment :2013)
This International Standard 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...
DIN EN ISO 7405
June 1, 2009
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008)
A description is not available for this item.
DIN EN ISO 7405
January 1, 1998
Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials (ISO 7405:1997)
A description is not available for this item.

References

This document references:
ISO 10993-2 - Biological evaluation of medical devices Part 2: Animal welfare requirements
Published by ISO on July 15, 2006
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical...
This document references:
ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Published by ISO on June 1, 2009
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts...
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 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Published by ISO on October 15, 2008
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
This document references:
10993-10 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Published by ISO on November 1, 2021
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
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 references:
10993-17 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
Published by ISO on September 1, 2023
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is...
This document references:
ISO 6344-1 - Coated Abrasives - Grain Size Analysis - Part 1: Grain Size Distribution Test
Published by ISO on April 15, 1998
A description is not available for this item.
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.
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