What is BS EN ISO 17665:2024 – Moist heat sterilization of health care products about?
Sterilization plays a critical role in health care.
BS EN ISO 17665:2024 is the international standard on how to develop, validate and routinely monitor moist heat sterilization processes used on medical devices and health care products.
Who is BS EN ISO 17665:2024 – Moist heat sterilization of health care products for?
Anyone who conducts moist heat sterilization, whether as saturated steam sterilization processes or contained product sterilization processes, specifically:
- Medical device manufacturers.
- Pharmaceutical manufacturers.
- Health care facilities where steam sterilization is carried out including hospitals, dental surgeries and GP service providers.
- Laboratories and non-medical device manufacturers where steam sterilization is done.
What does BS EN ISO 17665:2024 – Moist heat sterilization of health care products cover?
It provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices.
The annexes in BS EN ISO 17665:2024 contain guidance to explain the requirements and promote good practice related to moist heat sterilization processes. They include:
- Basic principles.
- Microbiological approaches to process development and validation.
- Physical approaches to process development validation and routine monitoring.
- Examples of moist heat sterilization processes.
- Application of steam tables to moist heat sterilization.
- The pitfalls of using temperature pressure correlation to confirm the presence of saturated steam.
- The specific application of the standard to health care facilities and industrial settings.
- The assignment of medical devices to product families and load configurations.
Why should you use BS EN ISO 17665:2024 – Moist heat sterilization of health care products?
- Patient safety. Proper sterilization processes help maintain the safety and efficacy of medical devices, protecting patient health.
- Comprehensive coverage. BS EN ISO 17665:2024 encompasses the content formerly spread across three international standards, covering moist heat sterilization from beginning to end. It contains both core normative requirements and comprehensive informative annexes.
- It’s up to date. The new standard supplies up to date thinking and state of the art moist heat sterilization principles.
- Regulatory compliance. Once harmonized to EU medical device regulations, BS EN ISO 17665:2024 will support regulatory submission and compliance with the requirements of the EU’s Medical Devices Regulation (MDR) as well as supporting the content of the UK’s Health Technical Memoranda.
- Trust and confidence. BS EN ISO 17665:2024 helps preserve the integrity of sterilized medical devices as well as supporting consistent and reproducible results, reducing the risk of errors, reducing the risk of over- or under-sterilization and ensuring reliable outcomes batch after batch – all of which build user confidence in sterilization processes.
- Risk mitigation. By validating and monitoring moist heat sterilization processes, BS EN ISO 17665:2024 helps identify and mitigate potential risks associated with inadequate sterilization. Also, by documenting processes and maintaining records, manufacturers can demonstrate compliance, track process changes and maintain traceability in case of any quality or safety concerns.
What’s new about BS EN ISO 17665:2024?
BS EN ISO 17665:2024 is the second edition of BS EN ISO 17665. This revision combines BS EN ISO 17665-1:2006, DD CEN ISO/TS 17665-2:2009 and PD ISO/TS 17665-3:2013 into a single document, replacing those standards with BS EN ISO 17665:2024. Considerable changes have been made in light of newer innovations and global changes in health care and industrial practice.
