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
Frequently Asked Questions
CEN/TC 55/WG 4 is a Working Group within the European Committee for Standardization (CEN). It is named "Preclinical biological evaluation and testing" and is responsible for: To review standards prepared by CEN/TC 206 (ISO/TC 194) and to assess thier suitability for dental needs. This committee has published 4 standards.
CEN/TC 55/WG 4 develops CEN standards. The scope of work includes: To review standards prepared by CEN/TC 206 (ISO/TC 194) and to assess thier suitability for dental needs. Currently, there are 4 published standards from this working group.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.
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 languagee-Library read for1 day
- Standard52 pagesEnglish languagee-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 languagee-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 languagee-Library read for1 day
- Standard22 pagesEnglish languagee-Library read for1 day