PD ISO/TS 21387:2020 - Sterilization of Medical Devices

Ensure the highest standards of safety and efficacy in the sterilization of medical devices with the comprehensive guidance provided by the PD ISO/TS 21387:2020. This essential standard offers detailed instructions on the validation and routine processing of ethylene oxide sterilization processes, utilizing the innovative approach of parametric release.

Overview

Released on September 16, 2020, this standard is a crucial resource for professionals involved in the sterilization of medical devices. With its 26 pages of in-depth content, it provides a thorough understanding of the requirements necessary to ensure that sterilization processes are both effective and compliant with international standards.

Key Features

• Standard Number: PD ISO/TS 21387:2020
• ISBN: 978 0 539 02800 3
• Status: Standard

Why Choose PD ISO/TS 21387:2020?

The PD ISO/TS 21387:2020 standard is indispensable for ensuring that medical devices are sterilized to the highest possible standards. Here are some reasons why this standard is a must-have for your organization:

• Comprehensive Guidance: This standard provides detailed guidance on the validation and routine processing of ethylene oxide sterilization processes, ensuring that your procedures are both effective and compliant.
• Parametric Release: By utilizing parametric release, this standard allows for a more efficient and reliable sterilization process, reducing the need for extensive biological indicators and ensuring faster turnaround times.
• International Compliance: Adhering to this standard ensures that your sterilization processes meet international requirements, facilitating global trade and collaboration.

Who Should Use This Standard?

This standard is designed for a wide range of professionals involved in the sterilization of medical devices, including:

• Quality Assurance Managers
• Sterilization Engineers
• Regulatory Affairs Specialists
• Manufacturers of Medical Devices

Benefits of Ethylene Oxide Sterilization

Ethylene oxide (EO) sterilization is a widely used method for sterilizing medical devices due to its effectiveness in penetrating complex device geometries and its compatibility with a wide range of materials. The PD ISO/TS 21387:2020 standard ensures that your EO sterilization processes are optimized for safety and efficacy.

Advantages of EO Sterilization:

• Material Compatibility: EO sterilization is suitable for a variety of materials, including plastics, metals, and glass, making it ideal for complex medical devices.
• Effective Penetration: The gaseous nature of EO allows it to penetrate intricate device geometries, ensuring thorough sterilization.
• Low Temperature Process: EO sterilization is conducted at low temperatures, preserving the integrity of heat-sensitive materials.

Implementing PD ISO/TS 21387:2020

Implementing the guidelines provided in the PD ISO/TS 21387:2020 standard can significantly enhance the reliability and efficiency of your sterilization processes. By following the detailed instructions on validation and routine processing, you can ensure that your medical devices are consistently sterilized to the highest standards.

Steps to Implementation:

1. Understand the Requirements: Familiarize yourself with the detailed requirements outlined in the standard to ensure full compliance.
2. Validate Your Processes: Conduct thorough validation of your EO sterilization processes to confirm their effectiveness and reliability.
3. Implement Parametric Release: Utilize parametric release to streamline your sterilization processes, reducing reliance on biological indicators.
4. Regular Monitoring: Continuously monitor and review your sterilization processes to maintain compliance and optimize performance.

Conclusion

The PD ISO/TS 21387:2020 standard is an invaluable resource for any organization involved in the sterilization of medical devices. By providing comprehensive guidance on the validation and routine processing of ethylene oxide sterilization processes, this standard ensures that your procedures are both effective and compliant with international standards. Embrace the benefits of parametric release and enhance the safety and efficacy of your sterilization processes with this essential standard.

PD ISO/TS 21387:2020

This standard PD ISO/TS 21387:2020 Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release is classified in these ICS categories:

• 11.080.01 Sterilization and disinfection in general

This document provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Additionally, it highlights the importance and interrelationship of other process factors, i.e. load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process.

No additional guidance is offered for processes where the declaration of adequacy of the validated sterilization cycle includes a requirement for no growth in biological indicators (BIs) exposed to that process.