nsBAS EN ISO 10993-15:2024
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
General information
Status:Project
Number of pages:25
Adoption method:Proglašavanje
Language:engleski
Edition:3.
Realization date:28.03.2024
Forseen date for next stage code:27.05.2024
Technical committee:BAS/TC 25, Healthcare
Directives:
2017/745, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
ICS:
11.100.20, Biological evaluation of medical devices
Abstract
Lifecycle
...
Original document and degree of correspondence
EN ISO 10993-15:2023, identical
ISO 10993-15:2019, identical
Relation to BAS standards
Work material
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