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ISO

ISO/TC 106/WG 10 - Biological evaluation

Évaluation biologique

General Information

Status
Active
Parent
ISO/TC 106 - Dentistry
Standardization Organization
ICS
Directive
Mandate
50
ISO
ISO 7405:2018(Main)
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 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.

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    43 pages
    English language
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    46 pages
    French language
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ISO
ISO 7405:2008/Amd 1:2013(Amendment)
Positive control material
  • Standard
    1 page
    English language
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  • Standard
    1 page
    French language
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ISO
ISO 7405:2008(Main)
Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry

ISO 7405:2008 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. ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

  • Standard
    34 pages
    English language
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    36 pages
    French language
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50