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ISO 6877:2021

Dentistry — Endodontic obturating materials

Üldinfo
Kehtiv alates 08.09.2021
Tegevusala (ICS grupid)
11.060.10 Hambaravimaterjalid
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
08.09.2021
Põhitekst
22.03.2006
Põhitekst
This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a colour-coding system for designating the sizes of preformed endodontic obturating points. Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied. Sterility is not included in this document, and any claim that the product is sterile is the responsibility of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for use. This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that deform with heat). This document is not applicable to materials for support of a coronal restoration.
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EVS-EN ISO 13485:2016+A11:2021

Meditsiiniseadmed. Kvaliteedijuhtimissüsteemid. Normatiivsed nõuded
Uusim versioon Kehtiv alates 16.09.2021