What are the updates on sterilisation by steam in EN ISO 17665?

The transition from ISO 17665-1:2006 to the updated ISO 17665:2024 marks a significant shift in how we approach moist heat sterilization. It isn't just a minor update; it’s a total structural overhaul designed to align with the modern "Quality Management System" (QMS) philosophy seen in ISO 13485.

Here is a breakdown of the critical changes you need to know.

1. Structural Consolidation

The most immediate change is the "merging" of concepts. Previously, the standard was split into distinct parts (Part 1 for requirements, Part 2 for guidance).

• The Shift: ISO 17665:2024 integrates these elements to provide a more cohesive flow from process development to routine control.

• The Goal: To reduce ambiguity between "what" must be done and "how" it should be achieved.

2. Risk-Based Approach

While the 2006 version touched on risk, the 2024 edition places Risk Management at the center of the sterilization lifecycle.

• It requires explicit documentation of risks associated with the specific moist heat process being used (e.g., saturated steam vs. air-steam mixtures).

• Emphasis is placed on the impact of non-condensable gases (NCGs) and steam quality on the lethality of the cycle.

Image of cogs interaction to describes the elements for the risk management process

3. Equipment & Characterization in sterilisation by steam

The new standard tightens the requirements for the equipment used to deliver the process.

• Installation Qualification (IQ): More rigorous requirements for verifying that the utilities (water, steam, compressed air) meet the specifications required for the medical device's safety.

• Operational Qualification (OQ): Enhanced focus on "worst-case" scenarios during empty chamber studies.

4. Process Definition and Validation

Validation is no longer a "one and done" event. The 2024 update emphasizes Product Family Grouping.

• Master Products: Provides clearer criteria for selecting a "Master Product" to represent a family of devices, ensuring that validation covers the most challenging items to sterilize.

• Lethality Calculations: Refined guidance on calculating F0 values and ensuring that the physical measurements correlate accurately with biological indicator (BI) lethality.

Person checking an equipment and completing a checklist

5. Why This Matters

If you are operating under the old 2006 standard, your technical files may soon be considered non-compliant during your next notified body audit. Transitioning requires a gap analysis of your current Sterilization Validation Reports and potentially updated Software Validation for your sterilizer control systems.

Are you up to date with the new requirements? We provide a training on the validation of sterilisation by steam that incorporate the new requirements and our experts can help you to be in compliance.