Hivatkozási szám

MSZ EN ISO 14644-18:2024

Dokumentumazonosító

183492

Cím

Tisztaterek és kapcsolódó szabályozott környezetek. 18. rész: A fogyóeszközök alkalmasságának értékelése (ISO 14644-18:2023)

Angol cím

Cleanrooms and associated controlled environments. Part 18: Assessment of suitability of consumables (ISO 14644-18:2023)

Alkalmazási terület

This document gives guidance for assessing personal and non-personal consumables for their appropriate use in cleanrooms, clean zones or controlled zones, based on product and process requirements, cleanliness attributes and functional performance properties. The cleanliness attributes addressed are particles or chemicals in air or on surfaces. Biocontamination (viable particles, microorganisms or pyrogens) is considered as a special property of consumables. Identification of associated risks are considered. This document complements cleanroom operation as outlined in ISO 14644-5. This document gives guidance concerning: - determination of cleanroom suitability of consumables in general; - specification of requirements for an intended use of a consumable by the customer with respect to functional performance, cleanliness attributes and special properties; - specification of properties for a designed use of a consumable by supplier; - assessment of a consumable for an appropriate use; - documentation. Informative annexes are used to list examples for personal and non-personal consumables, verification methods for cleanliness attributes testing and the potential impact of consumables on a cleanroom. Cleaning agents, disinfectants and lubricants are considered as consumables with respect to their packaging, as their packaging is likely to have cleanliness requirements in common with all consumables. This document does not apply to: - design details of consumables; - testing of functional performance of materials, e.g. barrier properties of gloves, wear and slip resistance of flooring; - health and safety requirements; legal requirements can apply in specific countries; - cleanability; - (raw) materials which are added within the production process as ingredients; - performance or function testing; - transport containers; - process media such as gases or liquids; - the functional performance of cleaning agents, disinfectants and lubricants.

ICS

13.040.35 Tiszta terek és a velük kapcsolatos szabályozott környezetek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2024-04-01

Forrás

idt EN ISO 14644-18:2023; idt ISO 14644-18:2023

Előd

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

kapható formátuma

Papír ,
PDF (letöltés) (a fájl mérete: 1994365) ,

oldalszáma

47 oldal; T kategória

ára

Nettó: 15850 Ft
Bruttó:
Papír formátum esetén (5% Áfával): 19971 Ft
PDF (letöltés) formátum esetén (27% Áfával): 20130 Ft