Name: AAMI/ISO 10993-1:2018 PDF
Price: 82.5 USD
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Name:
AAMI/ISO 10993-1:2018 PDF

Published Date:
04/27/2020

Status:
Active

Description:

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

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

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.

ANSI :	ANSI Approved
File Size :	1 file , 840 KB
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	53
Published :	04/27/2020

AAMI/ISO 10993-1:2018 PDF