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ÖNORM EN ISO 10993-1:2021 04 15

Current

Current

The latest, up-to-date edition.

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

Available format(s)

Hardcopy

Language(s)

German - English

Published date

15-04-2021

€174.70
Excluding VAT

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the medical device; — the assessment of the biological safety of the medical device.

Committee
TC 194
DocumentType
Standard
Pages
0
PublisherName
Osterreichisches Normungsinstitut/Austrian Standards
Status
Current
Supersedes

Standards Relationship
ISO 10993-1:2018 Identical
EN ISO 10993-1:2020 Identical

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