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CEN

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

Status
Inactive
Parent
CEN/TC 55 - Dentistry
Standardization Organization
ICS
Directive
Mandate
50
CEN
EN ISO 7405:2018(Main)
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
SIST EN ISO 7405:2019

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.

  • Standard
    52 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 7405:2008/A1:2013(Amendment)
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405:2008/Amd 1:2013)
SIST EN ISO 7405:2009/A1:2013

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.

  • Amendment
    7 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 7405:2008(Main)
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008)
SIST EN ISO 7405:2009

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
    42 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 7405:1997(Main)
Dentistry - Preclinical evaluation of biocompatability of medical devices used in dentistry - Test methods for dental materials (ISO 7405:1997)
SIST EN ISO 7405:2000
  • Standard
    22 pages
    English language
    e-Library read for
    1 day
50

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.