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B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

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ISO 10993-3:2026

ISO 10993-3:2026 Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity

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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

SKU: 1960c7108253 Categories: ,

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 Detail Icon

English

Format Secure Icon

Secure PDF

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

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