BS EN ISO 10993-10:2023
Biological evaluation of medical devices. Tests for skin sensitization

Standard No.

BS EN ISO 10993-10:2023

Release Date

2023

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 10993-10:2023

Scope

What is BS EN ISO 10993-10 - Tests for skin sensitization about? This is the tenth in an international series of standards on how to conduct biological evaluations of medical devices. Relevant to the safety of medical materials and devices, BS EN ISO 10993-10:2023 covers the selection and conduct of tests for evaluating dermal sensitization responses. Who is BS EN ISO 10993-10 – Tests for skin sensitization for? Manufacturers and suppliers of medical devices Medical laboratories Regulatory authorities Notified bodies What does BS EN ISO 10993-10 - Tests for skin sensitization cover? BS EN ISO 10993-10 specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. BS EN ISO 10993-10 includes: Details of in vivo skin sensitization test procedures Key factors for the interpretation of the results

BS EN ISO 10993-10:2023 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements

BS EN ISO 10993-10:2023 history

• 2023 BS EN ISO 10993-10:2023 Biological evaluation of medical devices. Tests for skin sensitization
• 2014 BS EN ISO 10993-10:2013 Biological evaluation of medical devices. Tests for irritation and skin sensitization
• 2010 BS EN ISO 10993-10:2010 Biological evaluation of medical devices. Tests for irritation and skin sensitization
• 0000 BS EN ISO 10993-10:2009
• 2002 BS EN ISO 10993-10:2002 Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity
• 0000 BS EN ISO 10993-10:1996