Abstract

The most important concern of this document is the protection of humans from possible biological risks arising from the use of medical devices. The document has been compiled from numerous international and national standards and guidelines relating to the biological evaluation of medical devices. It is intended as a description of the biological evaluation of medical devices within a risk management process, as part of the comprehensive evaluation and development of medical devices. This approach combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests, allowing a complete assessment to be made of the biological response to each medical device according to its safety in use.

Begin

2022-02-03

WI

00206092

Planned document number

DIN EN ISO 10993-1

Project number

02703358

Responsible national committee

NA 027-07-12 AA - Biological evaluation of medical devices  

Responsible european committee

CEN/TC 206 - Biological and clinical evaluation of medical devices  

Responsible international committee

ISO/TC 194/WG 1 - Systematic approach to biological evaluation and terminology  

draft standard

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024
2024-07
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previous edition(s)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020
2021-05

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