Podaci o nacrtu

Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO/FDIS 14644-15:2025)
Oznaka:prEN ISO 14644-15
Odbor:HZN/TO 555
Ime odbora:Medicinski proizvodi
Nacrt objavljen za komentiranje:2025-12-11
Rok za komentiranje:2026-01-06
Broj komentara:0
Contact email:nacrti(at)hzn.hr
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Područje primjene nacrta:

ISO 14644-15:2017 provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644‑8).
The following are outside the scope of ISO 14644-15:2017:
- health and safety requirements;
- compatibility with cleaning agents and techniques;
- cleanability;
- biocontamination;
- specific requirements of equipment and materials for processes and products;
- design details of equipment.

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