BS EN ISO 11138-8:2021 - Sterilization of Health Care Products

Standard Number: BS EN ISO 11138-8:2021

Pages: 16

Released: 2021-07-28

ISBN: 978 0 580 91581 9

Status: Standard

Overview

The BS EN ISO 11138-8:2021 is a crucial standard for professionals in the healthcare industry, particularly those involved in the sterilization of healthcare products. This standard provides a comprehensive method for the validation of a reduced incubation time for biological indicators, which are essential tools in ensuring the effectiveness of sterilization processes.

Importance of Biological Indicators

Biological indicators are critical in the sterilization process as they provide a direct measure of the lethality of the sterilization process. They contain viable microorganisms with a known resistance to the sterilization process being monitored. The ability to validate a reduced incubation time for these indicators can significantly enhance the efficiency and speed of sterilization processes, allowing healthcare facilities to maintain high standards of hygiene and safety while optimizing operational workflows.

Key Features of the Standard

• Comprehensive Guidelines: The standard offers detailed guidelines on the methodology for validating reduced incubation times, ensuring that the biological indicators provide accurate and reliable results.
• Enhanced Efficiency: By reducing the incubation time, healthcare facilities can achieve faster turnaround times in their sterilization processes, which is crucial in high-demand environments.
• Global Applicability: As an ISO standard, it is recognized and applicable worldwide, making it a valuable resource for international healthcare facilities and organizations.
• Up-to-date Practices: Released in 2021, this standard reflects the latest advancements and best practices in the field of sterilization.

Who Should Use This Standard?

This standard is indispensable for:

• Healthcare Facilities: Hospitals, clinics, and laboratories that require stringent sterilization processes to ensure patient safety and compliance with health regulations.
• Manufacturers of Sterilization Equipment: Companies that design and produce sterilization equipment can use this standard to enhance the effectiveness and reliability of their products.
• Quality Assurance Professionals: Individuals responsible for maintaining and auditing sterilization processes within healthcare settings.
• Regulatory Bodies: Organizations that oversee healthcare standards and compliance can use this document to inform policy and regulatory frameworks.

Benefits of Implementing BS EN ISO 11138-8:2021

Implementing this standard offers numerous benefits, including:

• Improved Patient Safety: By ensuring that sterilization processes are effective, healthcare providers can significantly reduce the risk of infections and complications.
• Operational Efficiency: Reduced incubation times mean faster processing of sterilized items, which can lead to increased throughput and reduced downtime.
• Cost Savings: More efficient sterilization processes can lead to cost savings in terms of time, resources, and reduced waste.
• Compliance and Accreditation: Adhering to international standards helps healthcare facilities meet regulatory requirements and achieve accreditation, enhancing their reputation and trustworthiness.

Conclusion

The BS EN ISO 11138-8:2021 standard is an essential tool for any organization involved in the sterilization of healthcare products. By providing a validated method for reducing incubation times for biological indicators, it helps ensure that sterilization processes are both effective and efficient. This not only enhances patient safety but also optimizes operational workflows, making it a valuable asset for healthcare providers worldwide.

BS EN ISO 11138-8:2021

This standard BS EN ISO 11138-8:2021 Sterilization of health care products. Biological indicators is classified in these ICS categories:

• 11.080.01 Sterilization and disinfection in general

1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7 day reference incubation time specified in 7.3.22 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes. 1.2 This document is applicable to manufacturers of biological indicators and to end users of biological indicators who intend to, if required by their quality system, establish, validate or confirm an RIT. 1.3 This document is not applicable to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes. NOTE 1 The method described in this document to establish an RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish an RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes. NOTE 2 For EO as a sterilizing agent, the stated RIT will be applicable for any EO cycle type, i.e. 100% EO, EO blends, etc.