Verkkokauppa
SFS-EN ISO 7405:2018:en
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
Tekninen komitea
Direktiivi
Vahvistuspäivä
07.12.2018
Julkaisupäivä
11.12.2018
Painos
3
Sivumäärä
48
Julkaisun kieli
englanti