Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2025); German and English version prEN ISO 10993-11:2025
Abstract
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
Begin
2023-04-25
WI
00206098
Planned document number
DIN EN ISO 10993-11
Project number
02703398
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 7 - Systemic toxicity
draft standard
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2025); German and English version prEN ISO 10993-11:2025
2025-05
Order from DIN Media
