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JSA - JIS T 6001

Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials

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Organization: JSA
Publication Date: 25 March 2005
Status: inactive
ICS Code (Dental materials): 11.060.10
ICS Code (Other standards related to laboratory medicine): 11.100.99

Document History

JIS T 6001
March 1, 2021
Evaluation of biocompatibility of medical devices used in dentistry
A description is not available for this item.
JIS T 6001
October 1, 2016
Evaluation of biocompatibility of medical devices used in dentistry (Amendment 1)
A description is not available for this item.
JIS T 6001
March 1, 2012
Evaluation of biocompatibility of medical devices used in dentistry
A description is not available for this item.
JIS T 6001
March 25, 2005
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:
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 10993-13 - 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 10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Published by ISO on May 1, 2017
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the...
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 10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Published by ISO on October 1, 2014
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially...
This document is referenced by:
JIS T 6520 - Long-term soft lining materials for removable dentures
Published by JSA on October 1, 2019
A description is not available for this item.
This document is referenced by:
JIS T 6525-1 - Denture adhesives - Part 1: Glue type denture adhesives
Published by JSA on September 1, 2013
A description is not available for this item.
This document is referenced by:
JIS T 6107 - Dental gold-silver-palladium alloy solders
Published by JSA on July 29, 2011
A description is not available for this item.
This document is referenced by:
JIS T 6609-2 - Dental water-based cements - Part 2: Resin-modified cements
Published by JSA on March 1, 2014
A description is not available for this item.
This document is referenced by:
JIS T 6525-2 - Denture adhesives - Part 2: Liner type denture adhesives
Published by JSA on September 1, 2013
A description is not available for this item.
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