BS EN ISO 11140-4:2007 - A Comprehensive Guide

The BS EN ISO 11140-4:2007 standard provides vital guidelines for the validation of biological indicators used in sterilization processes in healthcare settings. As a vital reference document for healthcare professionals, it outlines the requirements for the performance testing of biological indicators, ensuring that these tools effectively demonstrate the performance of sterilization processes.

By adhering to this standard, healthcare organizations can enhance the reliability of their sterilization practices, ultimately leading to improved patient safety and care outcomes. This document is crucial for manufacturers of biological indicators, sterilization service providers, and any institution involved in the validation of sterilization protocols.

Key Features of BS EN ISO 11140-4:2007

• Health Care Technology Focus: The standard is tailored specifically to the healthcare sector, addressing unique challenges faced in sterilization validation.
• Identical Conformance to ISO 11140-4:2007: This British Standard is identical to the international equivalent, ensuring global consistency in sterilization practices.
• Clear Specifications: Detailed requirements for testing methodologies, performance criteria, and evaluation protocols for biological indicators.
• Regulatory Compliance: Assists organizations in meeting statutory and regulatory requirements by providing a framework for compliance.
• Version Information: Published on 30th March 2007, the standard reflects the latest industry practices and scientific advancements pertinent to sterilization validation.

Who Should Use This Standard?

This standard is essential for a range of professionals in the healthcare sector, including:

• Quality Assurance Managers
• Sterilization Technologists
• Biomedical Engineers
• Regulatory Affairs Specialists
• Laboratory Technicians

The adoption of BS EN ISO 11140-4:2007 will enable organizations to establish robust protocols for the validation of biological indicators, ensuring that every sterilization process is evaluated with precision and accuracy.

Purchase Information

This invaluable resource is available for purchase in both PDF and hardcopy formats. At a price of £290.00, investing in BS EN ISO 11140-4:2007 is a necessary step for any organization committed to maintaining the highest standards in patient safety and healthcare technology.