ISO/TC 209

Project No.ISO 14644-4:2022
Title<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">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.</span></p> <p class="Note" style="line-height: 12.0pt; tab-stops: 19.85pt 39.7pt 42.55pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 198.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE<span style="mso-tab-count: 1;">       </span>Further guidance is given in <span class="citeapp"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Annexes A to D</span></span></span>. <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">8</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">9</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">10</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">12</span></span></span> and <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">17</span></span></span> provide complementary information. <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">7</span></span></span> offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments).</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">The following subjects are mentioned but not addressed in this document:</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 198.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>specific operational activities, processes to be accommodated and process equipment in the cleanroom installation;</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 198.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>fire and safety regulations;</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 198.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>ongoing operation, cleaning and maintenance activities, which are covered by <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">5</span></span></span>.</span></p>
Registration number (WIID)72379
Scope<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">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.</span></p> <p class="Note" style="line-height: 12.0pt; tab-stops: 19.85pt 39.7pt 42.55pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 198.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">NOTE<span style="mso-tab-count: 1;">       </span>Further guidance is given in <span class="citeapp"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">Annexes A to D</span></span></span>. <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">1</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">2</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">8</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">9</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">10</span></span></span>, <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">12</span></span></span> and <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">17</span></span></span> provide complementary information. <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">7</span></span></span> offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments).</span></p> <p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">The following subjects are mentioned but not addressed in this document:</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 198.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>specific operational activities, processes to be accommodated and process equipment in the cleanroom installation;</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 198.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>fire and safety regulations;</span></p> <p class="ListContinue1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 198.45pt; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;">    </span>ongoing operation, cleaning and maintenance activities, which are covered by <span class="stdpublisher"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">ISO</span></span></span> <span class="stddocNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">14644</span></span></span>-<span class="stddocPartNumber"><span style="color: black; mso-color-alt: windowtext; border: none;"><span style="border: none;">5</span></span></span>.</span></p>
StatusStandarts spēkā
ICS group13.040.35