PD ISO/TS 22456:2021 - Sterilization of Healthcare Products

Standard Number: PD ISO/TS 22456:2021

Pages: 22

Released: March 22, 2021

ISBN: 978 0 539 02803 4

Status: Standard

Overview

The PD ISO/TS 22456:2021 is a comprehensive standard that provides essential guidance on the sterilization of healthcare products, specifically focusing on microbiological methods. This standard is crucial for professionals involved in the production and quality assurance of biologics and tissue-based products. It offers detailed instructions on conducting bioburden determinations and tests of sterility, ensuring that healthcare products meet the highest safety and efficacy standards.

Key Features

• Comprehensive Guidance: This standard offers in-depth guidance on microbiological methods, ensuring that healthcare products are free from harmful microorganisms.
• Focus on Biologics and Tissue-Based Products: Special attention is given to biologics and tissue-based products, which require stringent sterilization processes due to their nature and use in sensitive medical applications.
• Up-to-Date Practices: Released in 2021, this standard reflects the latest advancements and best practices in the field of healthcare product sterilization.
• Internationally Recognized: As part of the ISO standards, it is recognized and respected globally, making it a valuable resource for international compliance and quality assurance.

Importance of Sterilization in Healthcare

Sterilization is a critical process in the healthcare industry, aimed at eliminating all forms of microbial life, including bacteria, viruses, fungi, and spores. This process is vital for ensuring the safety and effectiveness of healthcare products, particularly those that come into direct contact with patients. The PD ISO/TS 22456:2021 standard plays a pivotal role in guiding manufacturers and healthcare providers in implementing effective sterilization methods, thereby reducing the risk of infections and ensuring patient safety.

Bioburden Determinations

Bioburden determination is a crucial step in the sterilization process, involving the assessment of the number and types of microorganisms present on a product before sterilization. This standard provides detailed methodologies for accurately determining bioburden levels, which is essential for validating the effectiveness of sterilization processes. By following the guidelines outlined in this standard, manufacturers can ensure that their products meet the required sterility assurance levels.

Tests of Sterility

Testing for sterility is a fundamental requirement for healthcare products, particularly those used in invasive procedures or implanted into the body. The PD ISO/TS 22456:2021 standard offers comprehensive guidance on conducting sterility tests, ensuring that products are free from viable microorganisms. This is crucial for preventing infections and ensuring the safety and efficacy of medical treatments.

Who Should Use This Standard?

This standard is an invaluable resource for a wide range of professionals in the healthcare and medical device industries, including:

• Quality Assurance Professionals: Ensuring that products meet the highest standards of sterility and safety.
• Regulatory Affairs Specialists: Navigating the complex landscape of international regulations and standards.
• Manufacturers of Biologics and Tissue-Based Products: Implementing effective sterilization processes to ensure product safety.
• Healthcare Providers: Understanding the importance of sterilization in patient care and safety.

Conclusion

The PD ISO/TS 22456:2021 standard is an essential tool for anyone involved in the production, regulation, or use of healthcare products. By providing detailed guidance on microbiological methods for sterilization, it helps ensure that products are safe, effective, and compliant with international standards. Whether you are a manufacturer, quality assurance professional, or healthcare provider, this standard is a critical resource for maintaining the highest levels of product safety and patient care.

PD ISO/TS 22456:2021

This standard PD ISO/TS 22456:2021 Sterilization of healthcare products. Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products is classified in these ICS categories:

• 07.100.10 Medical microbiology
• 11.080.01 Sterilization and disinfection in general

1.1 Inclusions

1.1.1

This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization.

NOTE This document is intended to be used in conjunction with ISO 11737‑1 and ISO 11737‑2.

1.1.2

Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.

1.2 Exclusions

1.2.1

This document does not include guidance for validation requirements for testing, eliminating and/or inactivating viruses and prions or sterilization of tissue-based products.

NOTE Guidance on inactivating viruses and prions can be found in ISO 22442‑3.

1.2.2

This document does not include guidance for containment or biosafety issues for biologics and tissue-based products.

1.2.3

This document does not include guidance for testing biologics and tissue-based products for specific infectious agents as listed in relevant national or international guidance (e.g. viruses/protozoa/parasites, intracellular microorganisms or mycoplasma screening).

1.2.4

This document does not include guidance for the acceptance criteria for biologics and tissue-based products during procurement or tissue to be processed and/or released for use.

1.2.5

This document does not include guidance for the testing associated with procurement and screening of biologics and tissue-based products.