ISO/TC 198

Projekta Nr.ISO/TS 5111:2022
Nosaukums<p class="MsoBodyText"><span lang="EN-GB">This document provides guidance on the quality of water for sterilizers, sterilization and washer-disinfectors (WDs) used to process health care products.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document covers the quality of water used directly for cleaning, thermal and chemical disinfection, rinsing and sterilization, as feedwater for the generation of steam, as a service to a sterilizer or WD, or as a cooling agent.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document provides specific guidance on:</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">water quality for different applications;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">water treatment systems;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">water distribution and storage;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">monitoring and control of water quality;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">investigating out of specification results.</span></p> <p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;">            </span>Guidance given in this document can also be applied to specifications for the quality of water required for manual cleaning or disinfection of medical devices (see the ISO 17664 series).</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not supersede or modify requirements or test methods of published standards applying to:</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">development, validation or routine control and monitoring of a sterilization process;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">sterilizers; </span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">WDs.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not specify requirements for water treatment systems (see, for example, standards for particular sterilizers or WDs).</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not specify the water quality for manufacturing pharmaceuticals, cell-based health care products or medical devices.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not provide guidance on the attributes of steam quality (see, for example, EN 285).</span></p>
Reģistrācijas numurs (WIID)80823
Darbības sfēra<p class="MsoBodyText"><span lang="EN-GB">This document provides guidance on the quality of water for sterilizers, sterilization and washer-disinfectors (WDs) used to process health care products.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document covers the quality of water used directly for cleaning, thermal and chemical disinfection, rinsing and sterilization, as feedwater for the generation of steam, as a service to a sterilizer or WD, or as a cooling agent.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document provides specific guidance on:</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">water quality for different applications;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">water treatment systems;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">water distribution and storage;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">monitoring and control of water quality;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">investigating out of specification results.</span></p> <p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;">            </span>Guidance given in this document can also be applied to specifications for the quality of water required for manual cleaning or disinfection of medical devices (see the ISO 17664 series).</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not supersede or modify requirements or test methods of published standards applying to:</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">development, validation or routine control and monitoring of a sterilization process;</span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">sterilizers; </span></p> <p class="ListContinue1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">WDs.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not specify requirements for water treatment systems (see, for example, standards for particular sterilizers or WDs).</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not specify the water quality for manufacturing pharmaceuticals, cell-based health care products or medical devices.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not provide guidance on the attributes of steam quality (see, for example, EN 285).</span></p>
StatussStandarts spēkā
ICS grupa11.080.01