ISO 10993-3:2026
ISO 10993-3:2026 Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity
CDN $347.00
This publication was last reviewed and confirmed in 2026.
Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity
Description
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 which are covered by regulations.
NOTE Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.
Edition
4
Published Date
2026-09-16
Status
PUBLISHED
Pages
41
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
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 which are covered by regulations.
NOTE Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 15223:2025 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements – Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
CDN $35.00 Add to cart -
ISO 21531:2009 Dentistry – Graphical symbols for dental instruments
CDN $192.00 Add to cart -
ISO 20537:2025 Footwear – Identification of defects during visual inspection – Vocabulary
CDN $305.00 Add to cart -
ISO 16840:2006 Wheelchair seating – Part 1: Vocabulary, reference axis convention and measures for body segments, posture and postural support surfaces
CDN $391.00 Add to cart
