DIN Standards Committee Optics and Precision Mechanics
Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025); German and English version prEN ISO 10993-3:2025
Abstract
This document specifies strategies for risk estimation and evaluation of biological harms with respect to: — genotoxicity; — carcinogenicity; — reproductive toxicity; and — developmental toxicity. This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity has been established. This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products as additional regulatory considerations can apply. NOTE Guidance on selection of relevant effects is provided in ISO 10993-1.
Begin
2023-11-14
WI
00206101
Planned document number
DIN EN ISO 10993-3
Project number
02703417
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 6 - Mutagenicity, carcinogenicity and reproductive toxicity
draft standard
Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025); German and English version prEN ISO 10993-3:2025
2025-05
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