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ANSI/AAMI/ISO 10993-1:2018

Current

Current

The latest, up-to-date edition.

Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

27-04-2020

€238.69
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
ISBN
978-1-57020-755-6
Pages
53
ProductNote
THIS STANDARD IS ALSO REFERS TO ISO/TR 10993-19
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 10993-1:2018 Identical

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