<p class="p2" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level2 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.1<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="font-size: 11.0pt; font-weight: normal;">This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>Although the scope is limited to medical devices, this document can be applicable to other products and equipment.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document covers radiation processes employing irradiators using:</span></p>
<p class="ListNumber1" style="mso-list: l0 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">a)<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the radionuclide <sup>60</sup>Co or <sup>137</sup>Cs;</span></p>
<p class="ListNumber1" style="mso-list: l0 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">b)<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">a beam from an electron generator; or</span></p>
<p class="ListNumber1" style="mso-list: l0 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">c)<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">a beam from an X-ray generator.</span></p>
<p class="p2" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level2 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="font-size: 11.0pt; font-weight: normal;">This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. </span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.</span></p>
<p class="p3" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level3 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2.1<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="mso-bidi-font-size: 11.0pt; font-weight: normal;">This document does not specify requirements for designating a medical device as sterile.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.</span></p>
<p class="p3" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level3 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2.2<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="mso-bidi-font-size: 11.0pt; font-weight: normal;">This document does not specify a quality management system for the control of all stages of production of medical devices.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, <!-- [if supportFields]><span style='color:#0070C0'><span
style='mso-element:field-begin'></span><span
style='mso-spacerun:yes'> </span>REF Section_sec_4 \r \h <span
style='mso-element:field-separator'></span></span><![endif]--><span style="color: #0070c0;">Clause 4<!-- [if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0034000000</w:data>
</xml><![endif]--></span><!-- [if supportFields]><span style='color:#0070C0'><span
style='mso-element:field-end'></span></span><![endif]-->). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.</span></p>
<p class="p3" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level3 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2.3<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="mso-bidi-font-size: 11.0pt; font-weight: normal;">This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.</span></p>
<p class="p3" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level3 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2.4<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="mso-bidi-font-size: 11.0pt; font-weight: normal;">This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>Regulations on safety requirements for occupational safety related to radiation can exist in some countries.</span></p>
<p class="p3" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level3 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2.5<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="mso-bidi-font-size: 11.0pt; font-weight: normal;">This document does not specify requirements for the sterilization of used or reprocessed devices.</span></p>
Registration number (WIID)
81721
Scope
<p class="p2" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level2 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.1<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="font-size: 11.0pt; font-weight: normal;">This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>Although the scope is limited to medical devices, this document can be applicable to other products and equipment.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document covers radiation processes employing irradiators using:</span></p>
<p class="ListNumber1" style="mso-list: l0 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">a)<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">the radionuclide <sup>60</sup>Co or <sup>137</sup>Cs;</span></p>
<p class="ListNumber1" style="mso-list: l0 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">b)<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">a beam from an electron generator; or</span></p>
<p class="ListNumber1" style="mso-list: l0 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">c)<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="EN-GB">a beam from an X-ray generator.</span></p>
<p class="p2" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level2 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="font-size: 11.0pt; font-weight: normal;">This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. </span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.</span></p>
<p class="p3" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level3 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2.1<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="mso-bidi-font-size: 11.0pt; font-weight: normal;">This document does not specify requirements for designating a medical device as sterile.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.</span></p>
<p class="p3" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level3 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2.2<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="mso-bidi-font-size: 11.0pt; font-weight: normal;">This document does not specify a quality management system for the control of all stages of production of medical devices.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, <!-- [if supportFields]><span style='color:#0070C0'><span
style='mso-element:field-begin'></span><span
style='mso-spacerun:yes'> </span>REF Section_sec_4 \r \h <span
style='mso-element:field-separator'></span></span><![endif]--><span style="color: #0070c0;">Clause 4<!-- [if gte mso 9]><xml>
<w:data>08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0034000000</w:data>
</xml><![endif]--></span><!-- [if supportFields]><span style='color:#0070C0'><span
style='mso-element:field-end'></span></span><![endif]-->). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.</span></p>
<p class="p3" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level3 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2.3<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="mso-bidi-font-size: 11.0pt; font-weight: normal;">This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.</span></p>
<p class="p3" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level3 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2.4<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="mso-bidi-font-size: 11.0pt; font-weight: normal;">This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>Regulations on safety requirements for occupational safety related to radiation can exist in some countries.</span></p>
<p class="p3" style="margin-left: 0cm; text-indent: 0cm; mso-list: l1 level3 lfo1;"><!-- [if !supportLists]--><span lang="NL" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-bidi-font-weight: bold;"><span style="mso-list: Ignore;">1.2.5<span style="font: 7.0pt 'Times New Roman';"> </span></span></span><!--[endif]--><span lang="NL" style="mso-bidi-font-size: 11.0pt; font-weight: normal;">This document does not specify requirements for the sterilization of used or reprocessed devices.</span></p>
