ISO/TC 210

Projekta Nr.ISO/CD TS 5137
Nosaukums<p class="MsoNormal" style="margin-left: 36.0pt;"><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">This document provides guidance on the maintenance management of medical devices that are </span><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">under the supervision of healthcare delivery organizations.</span></p> <p class="MsoNormal" style="margin-left: 36.0pt;"><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">This document is not applicable to:</span></p> <p class="MsoNormal" style="margin-left: 36.0pt;"><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">a) modification, refurbishment or remanufacturing of medical devices;</span></p> <p class="MsoNormal" style="margin-left: 36.0pt;"><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">b) manufacturers that are responsible for installation, testing, maintenance, and servicing on </span><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">medical devices that they have placed on the market; or</span></p> <p class="MsoNormal" style="margin-left: 36.0pt;"><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">c) implantable or single-use medical devices.</span></p>
Reģistrācijas numurs (WIID)86275
Darbības sfēra<p class="MsoNormal" style="margin-left: 36.0pt;"><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">This document provides guidance on the maintenance management of medical devices that are </span><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">under the supervision of healthcare delivery organizations.</span></p> <p class="MsoNormal" style="margin-left: 36.0pt;"><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">This document is not applicable to:</span></p> <p class="MsoNormal" style="margin-left: 36.0pt;"><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">a) modification, refurbishment or remanufacturing of medical devices;</span></p> <p class="MsoNormal" style="margin-left: 36.0pt;"><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">b) manufacturers that are responsible for installation, testing, maintenance, and servicing on </span><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">medical devices that they have placed on the market; or</span></p> <p class="MsoNormal" style="margin-left: 36.0pt;"><span style="mso-ascii-font-family: Calibri; mso-ascii-theme-font: minor-latin; mso-hansi-font-family: Calibri; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi;">c) implantable or single-use medical devices.</span></p>
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