BS EN ISO 10993-10:2023

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

NOTE: Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

Why should you use BS EN ISO 10993-10 - Tests for skin sensitization?

• It contributes to the development of safe medical devices
• It presents a step-wise approach and includes updated content on non-animal testing for skin sensitization, both of which are designed to reduce the number of animals used in testing and therefore the cost
• It provides one means of conformance with the relevant EU Directive
• It can strengthen organizational risk management
• It can increase market confidence in products

BS EN ISO 10993-10 contributes to UN Sustainable Development Goal 3 on good health and well-being, and Goal 12 on responsible consumption and production.

What’s new about BS EN ISO 10993-10:2022?

This is a technical revision of BS EN ISO 10993-10:2010, which it cancels and replaces. The major changes in BS EN ISO 10993-10:2023 are:

1. The document now contains a description of skin sensitization testing only
2. Annex C (formerly Annex D) on alternative test methods for skin sensitization has been updated
3. Testing for irritation is now described in BS EN ISO 10993-23