BS EN ISO 14160:2021 - Sterilization of Health Care Products

In the ever-evolving world of healthcare, ensuring the safety and efficacy of medical devices is paramount. The BS EN ISO 14160:2021 standard is a critical resource for professionals involved in the sterilization of single-use medical devices that utilize animal tissues and their derivatives. This comprehensive standard provides detailed requirements for the characterization, development, validation, and routine control of sterilization processes, ensuring that medical devices meet the highest safety standards.

Key Features of BS EN ISO 14160:2021

• Standard Number: BS EN ISO 14160:2021
• Pages: 54
• Release Date: July 5, 2021
• ISBN: 978 0 580 99381 7
• Status: Standard

Comprehensive Guidance for Sterilization Processes

This standard is an essential tool for manufacturers and healthcare professionals who are responsible for the sterilization of medical devices. It provides a framework for the use of liquid chemical sterilizing agents, specifically tailored for single-use devices that incorporate animal tissues. The guidance ensures that these devices are safe for use, minimizing the risk of infection and contamination.

Characterization and Development

The BS EN ISO 14160:2021 standard outlines the necessary steps for the characterization and development of sterilization processes. It emphasizes the importance of understanding the properties of both the sterilizing agents and the materials used in medical devices. This knowledge is crucial for developing effective sterilization methods that maintain the integrity and functionality of the devices.

Validation and Routine Control

Validation is a critical component of the sterilization process, ensuring that the methods used are effective and reliable. The standard provides detailed requirements for the validation of sterilization processes, including the use of biological indicators and other testing methods. Additionally, it outlines the procedures for routine control, ensuring that the sterilization process remains consistent and effective over time.

Why Choose BS EN ISO 14160:2021?

Adhering to the BS EN ISO 14160:2021 standard is not just about compliance; it's about ensuring the highest level of safety for patients and healthcare providers. By following this standard, manufacturers can demonstrate their commitment to quality and safety, gaining the trust of healthcare professionals and patients alike.

Global Recognition

The BS EN ISO 14160:2021 standard is recognized internationally, making it a valuable asset for companies operating in the global market. Compliance with this standard can facilitate market access and acceptance, providing a competitive edge in the healthcare industry.

Enhanced Safety and Efficacy

By following the guidelines set forth in this standard, manufacturers can ensure that their sterilization processes are both safe and effective. This not only protects patients from potential harm but also enhances the overall efficacy of medical devices, leading to better health outcomes.

Conclusion

The BS EN ISO 14160:2021 standard is an indispensable resource for anyone involved in the sterilization of medical devices. Its comprehensive guidelines ensure that devices are safe, effective, and compliant with international standards. By investing in this standard, manufacturers can enhance their reputation, improve patient safety, and gain a competitive advantage in the healthcare market.

For those committed to excellence in healthcare, the BS EN ISO 14160:2021 standard is a must-have tool, providing the knowledge and guidance needed to navigate the complex world of medical device sterilization.

BS EN ISO 14160:2021

This standard BS EN ISO 14160:2021 Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices is classified in these ICS categories:

• 11.080.01 Sterilization and disinfection in general

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.

This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1).

This document is not applicable to material of human origin.

This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3).

This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites.

The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4).

This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5).

This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6).

Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A.