BS EN ISO 10993-23:2021 - Biological Evaluation of Medical Devices: Tests for Irritation

Ensure the safety and reliability of your medical devices with the comprehensive standard BS EN ISO 10993-23:2021. This essential document provides detailed guidelines for conducting irritation tests, a critical component in the biological evaluation of medical devices. Released on April 9, 2021, this standard is a must-have for manufacturers, researchers, and quality assurance professionals in the medical device industry.

Key Features

• Standard Number: BS EN ISO 10993-23:2021
• Pages: 80
• Release Date: April 9, 2021
• ISBN: 978 0 580 99743 3
• Status: Standard

Comprehensive Guidance for Irritation Testing

The BS EN ISO 10993-23:2021 standard is meticulously designed to guide you through the process of irritation testing, ensuring that your medical devices meet the highest safety standards. This document provides a structured approach to evaluating the potential irritation effects of medical devices on human tissues, which is crucial for patient safety and regulatory compliance.

Why Choose BS EN ISO 10993-23:2021?

In the rapidly evolving field of medical technology, staying ahead of regulatory requirements is essential. The BS EN ISO 10993-23:2021 standard offers:

• Up-to-Date Information: Released in 2021, this standard reflects the latest advancements and regulatory expectations in the field of medical device evaluation.
• Comprehensive Coverage: With 80 pages of detailed guidelines, this document covers all aspects of irritation testing, from test design to interpretation of results.
• Global Recognition: As part of the ISO 10993 series, this standard is recognized and respected worldwide, facilitating international market access for your products.

Who Should Use This Standard?

The BS EN ISO 10993-23:2021 standard is indispensable for a wide range of professionals, including:

• Medical Device Manufacturers: Ensure your products meet safety standards and gain regulatory approval.
• Quality Assurance Teams: Implement robust testing protocols to maintain product quality and safety.
• Regulatory Affairs Specialists: Stay informed about the latest requirements and ensure compliance with international standards.
• Research and Development Teams: Develop innovative products with confidence, knowing they meet rigorous safety criteria.

Enhance Patient Safety and Product Reliability

By adhering to the BS EN ISO 10993-23:2021 standard, you are taking a proactive step towards enhancing patient safety and ensuring the reliability of your medical devices. This standard provides the framework needed to conduct thorough irritation tests, helping you identify and mitigate potential risks before they reach the market.

Invest in Quality and Compliance

Investing in the BS EN ISO 10993-23:2021 standard is an investment in the quality and compliance of your medical devices. By following the guidelines outlined in this document, you can confidently navigate the complex landscape of medical device regulation and deliver products that meet the highest standards of safety and efficacy.

Conclusion

In the competitive and highly regulated medical device industry, ensuring the safety and effectiveness of your products is paramount. The BS EN ISO 10993-23:2021 standard provides the essential guidance needed to conduct irritation tests, a critical component of the biological evaluation process. With its comprehensive coverage and global recognition, this standard is an invaluable resource for anyone involved in the development, manufacturing, or regulation of medical devices.

Equip yourself with the knowledge and tools necessary to succeed in the medical device industry by incorporating the BS EN ISO 10993-23:2021 standard into your testing and evaluation processes. Your commitment to quality and safety will not only benefit your organization but also the patients who rely on your products for their health and well-being.

BS EN ISO 10993-23:2021

This standard BS EN ISO 10993-23:2021 Biological evaluation of medical devices is classified in these ICS categories:

• 11.100.20 Biological evaluation of medical devices

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-2.

This document includes:

• pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;

• details of in vitro and in vivo irritation test procedures;

• key factors for the interpretation of the results.