BS EN ISO 11138-7:2019

Comprehensive Standard for Sterilization of Health Care Products

BS EN ISO 11138-7:2019 is the essential standard for the sterilization of health care products. This British Standard, which is identical to ISO 11138-7:2019, provides comprehensive guidelines and requirements for the development, validation, and routine control of sterilization processes. Compliance with this standard ensures that health care facilities and manufacturers can implement effective and safe sterilization procedures, safeguarding patient safety and product quality.

Key Features and Benefits:

• Comprehensive Guidance: The standard covers all aspects of the sterilization process, including process development, validation, routine monitoring, and process control.
• Compliance with ISO Standards: BS EN ISO 11138-7:2019 is identical to ISO 11138-7:2019, ensuring alignment with international best practices and facilitating global harmonization.
• Ensures Effective Sterilization: The standard provides detailed requirements for validating sterilization processes, ensuring that they consistently achieve the desired level of sterility assurance.
• Supports Patient Safety: Adherence to this standard helps health care facilities and manufacturers minimize the risk of product contamination, protecting patients from potential infections.
• Facilitates Regulatory Compliance: Compliance with BS EN ISO 11138-7:2019 demonstrates conformity with relevant regulations and guidelines, such as the EU Medical Device Regulation (MDR) and the US FDA's Quality System Regulation.

Comprehensive Guidance for Sterilization Processes

BS EN ISO 11138-7:2019 covers the development, validation, and routine control of sterilization processes for health care products. The standard provides detailed requirements and recommendations for each stage of the sterilization process, ensuring that it is carried out effectively and safely.

Process Development:

• Identification of critical process parameters and their control
• Selection of appropriate sterilization methods and equipment
• Determination of the minimum acceptable sterilization dose or time

Process Validation:

• Validation of the sterilization process, including biological and chemical indicators
• Establishment of the maximum acceptable sterilization dose or time
• Verification of the sterilization process's ability to achieve the desired sterility assurance level

Routine Monitoring and Control:

• Continuous monitoring of critical process parameters
• Periodic revalidation of the sterilization process
• Appropriate record-keeping and documentation

By following the guidance provided in BS EN ISO 11138-7:2019, health care facilities and manufacturers can ensure that their sterilization processes are effective, reliable, and compliant with the latest international standards.