BS EN ISO 10993-7:2008+A1:2022 - TC

What is ISO 10993-7 - Biological evaluation of medical devices about?

This ISO 10993-7 is the seventh in an extensive series of international standards on conducting biological evaluations of medical devices so they can be used more safely.

ISO 10993-7 gives limits for ethylene oxide gas residues when used to sterilize medical devices that can’t withstand high temperatures or radiation.

Who is ISO 10993-7 - Biological evaluation of medical devices for?

ISO 10993-7 on the biological evaluations of medical devices can be adopted by:

• Test laboratories
• Medical device manufacturers
• Regulators
• Notified Bodies

Why should you use ISO 10993-7 - Biological evaluation of medical devices?

Ethylene oxide is used to sterilize medical devices because it’s highly toxic to microorganisms. It’s also highly toxic to humans making it essential that the exposure of patients and users to ethylene oxide is controlled to below a level that could cause harm to health.

ISO 10993-7, therefore, specifies the allowable limits for ethylene oxide exposure, calculated using the method of toxicological risk assessment specified in BS EN ISO 10993-17. It also specifies methods for the chemical analysis of ethylene oxide residues.

What’s new about ISO 10993-7:2008+A1:2022?

The French Competent Authority raised concerns that the standard didn’t contain limits that explicitly protect newborn babies, so ISO 10993-7:2008+A1:2020 the standard on the biological evaluations of medical devices has been revised to remedy this concern.

ISO 10993-7 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages since it underpins the safety of medical devices.