DIN Standards Committee Optics and Precision Mechanics
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025); German version EN ISO 10993-1:2025
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
Order from DIN Media
