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ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

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Organization: ISO
Publication Date: 1 October 2018
Status: inactive
Page Count: 50
ICS Code (Dental materials): 11.060.10
ICS Code (Other standards related to laboratory medicine): 11.100.99
scope:

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 device under test.

This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Document History

ISO 7405
October 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...
ISO 7405
October 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...
ISO 7405
July 15, 2013
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry AMENDMENT 1: Positive control material
A description is not available for this item.
ISO 7405
December 15, 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 dentistry. It includes testing of pharmacological agents that are an integral...
ISO 7405
August 15, 1997
Dentistry - Preclinical Evaluation of Biocompatability of Medical Devices Used in Dentistry - Test Methods for Dental Materials
A description is not available for this item.
7405
August 15, 1997
Dentistry - Preclinical Evaluation of Biocompatability of Medical Devices Used in Dentistry - Test Methods for Dental Materials
A description is not available for this item.
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References

This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
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 10993-11 - 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 is referenced by:
DIN ISO/TS 16506 - Dentistry - Polymer-based luting materials containing adhesive components (ISO/TS 16506:2017)
Published by DIN on October 1, 2018
A description is not available for this item.
This document is referenced by:
EN ISO 20749 - Dentistry - Pre-capsulated dental amalgam
Published by CEN on July 1, 2023
This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy powder and dental mercury in quantities...
This document is referenced by:
DIN EN ISO 20749 - Dentistry - Pre-capsulated dental amalgam (ISO 20749:2023)
Published by DIN on October 1, 2023
A description is not available for this item.
This document is referenced by:
EN ISO 28158 - Dentistry - Integrated dental floss and handles
Published by CEN on October 1, 2018
This document specifies the requirements and test methods for integrated dental floss and handles used for home care, community care, professional care of oral health or a part of dental treatment....
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