Will we see the new revision of ISO14644-3 Soon?

In this edition, we delve into ISO 14644-3:2019, the pivotal standard governing cleanroom test methods, and explore the feedback gathered during its systematic review, hinting at potential future revisions. Let’s explore the current standard’s scope, strengths, challenges and the way forward.

Understanding ISO 14644-3 "Cleanroom Test Methods"

ISO 14644-3:2019 is part of the ISO 14644 series, which focuses on cleanrooms and associated controlled environments. This specific part provides guidance on test methods for cleanroom performance and compliance, ensuring that controlled environments meet the required specifications.

Systematic Review Process of ISO 14644-3

A systematic review of ISO standards is a formal process undertaken by the International Organization for Standardization (ISO) to evaluate the relevance, effectiveness, and currency of existing ISO standards. This review process helps ensure that ISO standards remain technically valid, up to date, and aligned with current market and technological needs. ISO standards are generally reviewed every?five years. This periodicity ensures that standards are revisited regularly to address changes in industry practices, technologies, regulations, or user requirements.

Since the ISO 14644-3 revision was published in 2019, it was on a systematic review process in 2024. Even though it was supported by 12 member countries, emphasizing the standard’s robustness and continued relevance, revision or amendment was suggested by 9 countries, aiming for alignment with technological advances and addressing identified challenges. 6 countries' abstentions were also recorded, reflecting a neutral stance or lack of specific feedback.

What are the highlighted Areas for Improvement?

We can group feedback under 3 main subject

1. Testing Methodologies:

• Refinement of filter integrity tests for non-unidirectional systems.
• Enhanced clarity on HEPA filter tests using particle counters.

2. Technical and Structural Updates:

• Simplification of Annex B to address its perceived complexity.
• Improved definitions, such as harmonizing “final filter” with other terms.

3. Emerging Needs:

• Incorporating tests for new parameters, like room permeability.
• Periodic testing recommendations referencing ISO 14644-2.

What Happens Next?

The systematic review marks the starting point of the revision process. Here’s what to expect:

Formation of a Working Group (WG): ISO Technical Committee 209 will likely establish a working group to address the proposed revisions. Experts from member countries will be nominated to contribute their insights.

Draft Development: The working group will develop a Committee Draft (CD) based on the feedback. The draft will outline proposed changes, including technical updates and structural adjustments.

Review and Voting: The CD will be circulated among ISO member bodies for review and comments. After incorporating feedback, the draft will progress to the Draft International Standard (DIS) stage.

Finalization: Once the DIS is approved, a Final Draft International Standard (FDIS) will be prepared for final voting. Upon approval, the revised standard will be published.

Expected Timeline: Revisions typically take 2-3 years to complete, depending on the complexity of changes and consensus-building efforts. Stakeholders should monitor updates from ISO/TC 209 for key milestones.

Opportunities for Input: Industry professionals can participate in national mirror committees to influence the revision process. Feedback during the DIS stage is critical for refining the standard.

Would you like to be involved?

If you are a subject matter expert in this field and want to participate in this revision project, you can visit the ISO/TC209 Official Website,?find your country's regulatory body,?and contact them. I am sure this process will be easier than you expected.