BS EN ISO 22442-1:2020 - Medical Devices Utilizing Animal Tissues and Their Derivatives: Application of Risk Management

In the ever-evolving world of medical technology, ensuring the safety and efficacy of medical devices is paramount. The BS EN ISO 22442-1:2020 standard is a crucial document for professionals in the medical device industry, particularly those involved in the development and management of devices that utilize animal tissues and their derivatives. This standard provides comprehensive guidelines for the application of risk management, ensuring that these devices meet the highest safety standards.

Overview of BS EN ISO 22442-1:2020

Released on December 14, 2020, the BS EN ISO 22442-1:2020 standard is an essential resource for manufacturers, regulatory bodies, and healthcare professionals. With a total of 38 pages, this document offers detailed insights into the risk management processes necessary for medical devices that incorporate animal-derived materials. The standard is identified by the ISBN 978 0 539 00458 8, ensuring its authenticity and ease of reference.

Importance of Risk Management in Medical Devices

Medical devices that utilize animal tissues and their derivatives pose unique challenges and risks. These materials can be susceptible to contamination and may carry the risk of transmitting infectious agents. Therefore, implementing a robust risk management strategy is critical to mitigate these risks and ensure patient safety. The BS EN ISO 22442-1:2020 standard provides a structured approach to identifying, evaluating, and controlling risks associated with these devices.

Key Features of the Standard

• Comprehensive Guidelines: The standard offers a detailed framework for risk management, covering all aspects from initial risk assessment to ongoing monitoring and control.
• Focus on Safety: Emphasizes the importance of safety in the design and manufacturing processes of medical devices using animal tissues.
• Regulatory Compliance: Assists manufacturers in meeting regulatory requirements, ensuring that their products are safe for use in healthcare settings.
• International Applicability: As an ISO standard, it is recognized and applicable worldwide, facilitating international trade and collaboration.

Who Should Use This Standard?

The BS EN ISO 22442-1:2020 standard is designed for a wide range of stakeholders in the medical device industry, including:

• Manufacturers: To ensure their products meet safety and regulatory standards.
• Regulatory Authorities: To evaluate and approve medical devices for market entry.
• Healthcare Professionals: To understand the safety measures in place for devices they use or recommend.
• Quality Assurance Teams: To implement and maintain effective risk management systems.

Benefits of Implementing BS EN ISO 22442-1:2020

Adopting the guidelines set forth in this standard offers numerous benefits, including:

• Enhanced Patient Safety: By systematically managing risks, the likelihood of adverse events is significantly reduced.
• Improved Product Quality: A focus on risk management leads to higher quality products that meet stringent safety standards.
• Regulatory Confidence: Compliance with international standards builds trust with regulatory bodies and facilitates smoother approval processes.
• Market Competitiveness: Products that adhere to recognized standards are more competitive in the global market.

Conclusion

The BS EN ISO 22442-1:2020 standard is an indispensable tool for anyone involved in the development, regulation, or use of medical devices that incorporate animal tissues and their derivatives. By providing a clear and structured approach to risk management, this standard helps ensure that these devices are safe, effective, and compliant with international regulations. Whether you are a manufacturer, regulator, or healthcare professional, understanding and implementing the guidelines of this standard is crucial for the advancement of safe medical technologies.

BS EN ISO 22442-1:2020

This standard BS EN ISO 22442-1:2020 Medical devices utilizing animal tissues and their derivatives is classified in these ICS categories:

• 11.020.20 Medical science
• 11.100.20 Biological evaluation of medical devices

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:

1. contamination by bacteria, moulds or yeasts;

2. contamination by viruses;

3. contamination by agents causing transmissible spongiform encephalopathies (TSE);

4. material responsible for undesired pyrogenic, immunological or toxicological reactions.

For parasites and other unclassified pathogenic entities, similar principles can apply.

This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.

This document does not specify a quality management system for the control of all stages of production of medical devices.

This document does not cover the utilization of human tissues in medical devices.