ISO 14644-18:2023 洁净室及相关受控环境 第18部分：耗材适用性的评估

标准编号：ISO 14644-18:2023

中文名称：洁净室及相关受控环境 第18部分：耗材适用性的评估

英文名称：Cleanrooms and associated controlled environments — Part 18: Assessment of suitability of consumables

发布日期：2023-10

标准范围

本文件根据产品和工艺要求、清洁属性和功能性能特性，为评估个人和非个人耗材在洁净室、洁净区或受控区的适当使用提供了指导。清洁度属性是空气中或表面上的颗粒或化学物质。生物污染（活颗粒、微生物或热原）被认为是耗材的一种特殊特性。考虑相关风险的识别。本文件补充了ISO？中概述的洁净室操作？14644-5.本文件提供了以下方面的指导:—？一般耗材洁净室适用性的确定；—？客户对消耗品的预期用途在功能性能、清洁属性和特殊特性方面的要求规范；—？供应商对消耗品设计用途的特性说明；—？评估消耗品的适当用途；—？文件。信息性附件用于列出个人和非个人耗材的示例、洁净度属性测试的验证方法以及耗材对洁净室的潜在影响。清洁剂、消毒剂和润滑剂就其包装而言被视为消耗品，因为它们的包装可能具有与所有消耗品相同的清洁度要求。本文件不适用于:—？耗材的设计细节；—？测试材料的功能性能，例如手套的阻隔性能、地板的耐磨性和防滑性；—？健康和安全要求；法律要求可能适用于特定国家/地区；—？可清洁性；—？（原料）在生产过程中作为配料添加的材料；—？性能或功能测试；—？运输集装箱；—？工艺介质，例如气体或液体；—？清洗剂、消毒剂和润滑剂的功能性能。

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.

标准预览图