BS EN ISO 10993-12:2021 - Essential Standards for Biological Evaluation

The BS EN ISO 10993-12:2021 is a pivotal standard in the field of health care technology, thoroughly addressing the biological evaluation of medical devices. Published on June 21, 2021, this standard is essential for manufacturers and regulatory bodies aiming to ensure the biocompatibility of medical devices that come into contact with the human body.

As part of the ISO 10993 series, which provides comprehensive guidelines on the biological evaluation of medical devices, BS EN ISO 10993-12:2021 focuses specifically on the sample preparation and reference materials necessary for such evaluations. Understanding and applying the principles outlined in this standard is crucial for manufacturers looking to bring compliant and safe products to market.

Key features of this standard include:

• Guidelines for sample preparation: The standard provides detailed instructions on how to prepare samples for biological testing, ensuring that results are reliable and reproducible.
• Reference Materials: Emphasizes the importance of using authenticated reference materials to validate test methods, which enhances consistency and credibility in biocompatibility assessments.
• Alignment with global standards: It is identically aligned with ISO 10993-12:2021, facilitating international compliance and market access for medical devices.

The implementation of BS EN ISO 10993-12:2021 enables organizations to perform rigorous risk assessments related to device interactions with biological systems. By following the outlined protocols, manufacturers can significantly improve their product safety profiles, ensuring that any adverse biological reactions are adequately assessed and addressed.

This standard is not only intended for manufacturers but also serves as a critical resource for testing laboratories and regulatory agencies involved in the evaluation of medical devices. By adhering to this standard, stakeholders can fulfill their obligations for compliance with relevant health regulations, ensuring that products are safe for human use.

Available for purchase in a hardcopy or PDF format, this comprehensive document is a necessary investment for organizations committed to delivering high-quality, biocompatible medical devices. With a price point of £362.00, the BS EN ISO 10993-12:2021 is an essential tool for fostering innovation and ensuring safety in the healthcare technology sector.