ISO 14644-10:2022
Cleanrooms and associated controlled environments — Part 10: Assessment of surface cleanliness for chemical contamination
Cleanrooms and associated controlled environments — Part 10: Assessment of surface cleanliness for chemical contamination
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 31
- Дата публикации:
- 4 мая 2022 г.
- Издание:
- ISO IS 14644 edition 2 version 1
- ICS:
- 13.040.35
This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices. NOTE 1 For the purpose of this document, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this document does not cover the interaction between the contamination and the surface. NOTE 2 This document does not include the contamination generation process or any time-dependent influences (e.g. deposition, sedimentation, ageing) or process-dependent activities such as transportation and handling. Neither does it include guidance on statistical quality-control techniques to ensure compliance.
Abstract
Overview - ISO 14644-10:2022 (surface chemical cleanliness)
ISO 14644-10:2022 is an international standard for assessing the chemical cleanliness of solid surfaces in cleanrooms and associated controlled environments. It defines appropriate testing processes, a uniform descriptor format (ISO‑SCC), and grading levels to report surface chemical contamination expressed as surface mass concentration (g/m²). The standard applies to walls, ceilings, floors, worksurfaces, tools, equipment and devices, but excludes particle physical properties, contamination generation processes and time‑dependent effects (deposition, ageing) and does not prescribe statistical quality‑control techniques.
Key topics and technical requirements
- ISO‑SCC descriptor and grading: Surface cleanliness by chemical concentration (SCC) is reported as ISO‑SCC Level N (X) where N is the common‑logarithm index of concentration and X is the chemical species or group. Thirteen grading levels from 0 to −12 correspond to C = 10^N g/m².
- Unit conversion: Surface number concentrations (molecules/atoms per area) can be converted to mass concentration using Avogadro’s number and the molar mass of the species (formula provided in the standard).
- Testing principles: Testing must use suitable measurement methods and calibrated instruments in environments where airborne contaminants do not bias results. Repeated measurements and agreed test conditions between customer and supplier are recommended.
- Documentation and reporting: Test reports must include minimum items such as testing organization, tester, measurement environment, sampling dates/times, measurement results and the SCC grade statement. The standard lists required report content and examples.
- Annexes and guidance: Informative annexes cover unit conversions, parameters influencing testing and interpretation, essential considerations for a good assessment, typical measurement methods and example test record formats.
Applications and who uses it
ISO 14644-10 is used by:
- Cleanroom operators and facility managers (pharmaceutical, biotech, semiconductor, medical device, aerospace, precision manufacturing)
- Quality and contamination control engineers
- Validation and compliance teams
- Test laboratories and suppliers of materials, tools and equipment for controlled environments
Practical applications include validating cleaning procedures, qualifying surfaces for sensitive processes, supplier acceptance testing and documenting compliance to customer‑specified SCC grade levels.
Related standards
- Other parts of the ISO 14644 series (e.g., ISO 14644‑1 for airborne particle classification) provide complementary guidance for cleanroom classification and control.
- Users should agree test environments, methods and acceptance criteria between customer and supplier as recommended by ISO 14644‑10.
Keywords: ISO 14644-10, cleanrooms, surface cleanliness, chemical contamination, ISO‑SCC, SCC grade, surface chemical concentration, cleanroom testing.
Технические детали
- Технический комитет
- ISO/TC 209 - Cleanrooms and associated controlled environments
- SKU
- ISO 14644-10:2022
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