洁净室和相关受控环境.第4部分:设计、施工和启动

[中文适用范围]： 本文件规定了从需求到洁净室的设计、建造和运行启动的全过程。它适用于新的、翻新和改造的洁净室安装。它不指定实现这些要求的具体技术和合同手段。它供洁净室安装的用户、规范制定者、设计者、购买者、供应商、建筑商和性能验证者使用。主要的清洁度考虑是空气中的颗粒浓度。本文件提供了需求、设计、建设和启动的详细检查表，其中包括要考虑的重要性能参数。为支持节能型洁净室设计，指定了能源管理设计方法。提供了建设指导，包括启动和验证的要求。本文件的一个基本要素是考虑到维护等方面，以帮助确保在整个生命周期内实现持续满意的运行。 [外文原描述]： This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom. NOTE Further guidance is given in Annexes A to D . ISO 14644 - 1 , ISO 14644 - 2 , ISO 14644 - 8 , ISO 14644 - 9 , ISO 14644 - 10 , ISO 14644 - 12 and ISO 14644 - 17 provide complementary information. ISO 14644 - 7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments). The following subjects are mentioned but not addressed in this document: — specific operational activities, processes to be accommodated and process equipment in the cleanroom installation; — fire and safety regulations; — ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644 - 5 .