DeutschIso 146443pdf 2021 ((top)) Instant
Yes. ISO 14644-8 addresses airborne chemical concentration (ACC), and ISO 14644-10 addresses chemical contamination on surfaces.
These revisions reflect a stronger emphasis on practical, risk-based testing that aligns with real-world applications. The standard now provides clearer differentiation between HEPA/ULPA filter integrity requirements based on filter efficiency, which was previously a point of ambiguity in the 2005 version.
The 2020 corrigendum fixed a critical error in Annex B’s formula for leak rate calculation. Ensure your PDF includes this correction. iso 146443pdf 2021
, though multi-part bundles may offer discounts. Corporate subscriptions may be cost-effective for organizations requiring access to multiple parts.
It also accounts for :
: The equipment is fully set up and running, but no personnel are on the production floor.
You're referring to the ISO 14644-1:2021 standard! , though multi-part bundles may offer discounts
| Aspect | ISO 14644-3:2005 (Old Version) | ISO 14644-3:2019 (New Version) | | :--- | :--- | :--- | | | Used term "optional tests" for many supporting procedures. | Renamed them "supporting tests" to emphasize their importance | | Airflow Visualization | Primarily focused on static airflow pattern testing. | Requires both static (basic pattern) and dynamic (simulating actual operations) testing | | Filter Leak Test – Upstream Concentration | Required upstream concentration of 10 mg/m³ to 100 mg/m³ for photometer testing. | Expanded to 1 mg/m³ to 100 mg/m³, acknowledging that not all photometers are suitable at the lower level | | Filter Leak Test – Acceptance Criteria | Uniform acceptance criteria of ≤0.01% for all HEPA filters. | Introduces differentiated criteria: ≤0.01% remains, but adds ≤0.1% for filters with MPPS efficiency 99.95% to 99.995% | | Filter Leak Test – Scan Speed | Scan speed not explicitly specified. | Specifies scan speed of 5 cm/s to improve detection efficiency and testing productivity | | Recovery Test | Did not specifically advise against testing in unidirectional flow rooms. | Explicitly advises against performing recovery tests in unidirectional airflow cleanrooms | | Segregation Test | Not included. | Added as a completely new test method to evaluate the effectiveness of segregation devices or barriers | | Electrostatic & Ion Generator Tests | Less detailed guidance. | Expanded and refined to support industries where electrostatic discharge (ESD) control is critical (e.g., electronics manufacturing) |
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