BS EN ISO 7405:2018 Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

BS EN ISO 7405:2018

Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

Status : Current   Published : November 2018



What is this standard about?

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 NumberBS EN ISO 7405:2018
TitleDentistry. Evaluation of biocompatibility of medical devices used in dentistry
Publication Date28 November 2018
Normative References(Required to achieve compliance to this standard)ISO/TS 10993-19, ISO 10993-2, ISO 10993-11, ISO 1942, ISO 16443, ISO 10993-10, ISO 10993-18, ISO 10993-3, ISO 10993-6, ISO 10993-1, ISO 6344-1, ISO 14971, ISO 10993-5, ISO 10993-12
Informative References(Provided for Information)ISO 14801, ISO 10993-9, ISO 10993-17, OECD 425, OECD 423, ISO 10993-14, ISO 10993-13, ISO 10993-15, ISO 10993-7, ISO 10993-16, ISO/IEC 17025, OECD 420
International RelationshipsEN ISO 7405:2018,ISO 7405:2018
Draft Superseded By17/30343686 DC
DescriptorsLaboratory animals, Culture techniques, Biological hazards, Clinical testing, Cytotoxicity tests, Tissue implantation tests, Dental materials, Visual inspection (testing), Toxicity, Specimen preparation, Control samples, Teeth, Dentistry, Testing conditions, Classification systems, Biological analysis and testing
Title in FrenchMédecine bucco-dentaire. Évaluation de la biocompatibilité des dispositifs médicaux utilisés en médecine bucco-dentaire
Title in GermanZahnheilkunde. Beurteilung der Biokompatibilität von in der Zahnheilkunde verwendeten Medizinprodukten
ISBN978 0 580 94712 4
File Size1.485 MB

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