BS EN ISO 7405:2008+A1:2013

Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

Published:

31 Jan 2009

•

Withdrawn:

28 Nov 2018

1 Scope

This International Standard 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 International Standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Product Details

Descriptors

Classification systems

Testing conditions

Control samples

Dental materials

Toxicity

Clinical testing

Culture techniques

Visual inspection (testing)

Tissue implantation tests

Biological hazards

Teeth

Dentistry

Biological analysis and testing

Cytotoxicity tests

Specimen preparation

Laboratory animals

ICS Codes

11.060.10 Dental materials

11.100.20 Biological evaluation of medical devices

11.100.99 Other standards related to laboratory medicine

Committee

CH/106

International relationships

Identical to:

EN ISO 7405:2008/A1:2013

ISO 7405:2008/Amd 1:2013

ISBN

978 0 580 77340 2

Publisher

BSI