CEN/TC 55/WG 4 - Preclinical biological evaluation and testing
To review standards prepared by CEN/TC 206 (ISO/TC 194) and to assess thier suitability for dental needs.
Preclinical biological evaluation and testing
To review standards prepared by CEN/TC 206 (ISO/TC 194) and to assess thier suitability for dental needs.
General Information
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.
- Standard52 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard52 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard42 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day