<p><span lang="EN-GB">This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.</span></p>
<p><span lang="EN-GB">This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.</span></p>
<p><span lang="EN-GB">NOTE 1 In some countries, national or regional pharmacopoeias or other government regulations are legally binding, and these requirements take precedence over this document.</span></p>
<p><span lang="EN-GB">NOTE 2 </span>Annex E<span lang="EN-GB"> provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of the document.</span></p>
<p><span lang="EN-GB">NOTE 3 </span>Annex F<span lang="EN-GB"> provides recommendations regarding sustainability.</span></p>
<p><span lang="EN-GB">NOTE 4 </span>Annex G<span lang="EN-GB"> provides information on attributive and variable testing.</span></p>
Registration number (WIID)
89249
Scope
<p><span lang="EN-GB">This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.</span></p>
<p><span lang="EN-GB">This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.</span></p>
<p><span lang="EN-GB">NOTE 1 In some countries, national or regional pharmacopoeias or other government regulations are legally binding, and these requirements take precedence over this document.</span></p>
<p><span lang="EN-GB">NOTE 2 </span>Annex E<span lang="EN-GB"> provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of the document.</span></p>
<p><span lang="EN-GB">NOTE 3 </span>Annex F<span lang="EN-GB"> provides recommendations regarding sustainability.</span></p>
<p><span lang="EN-GB">NOTE 4 </span>Annex G<span lang="EN-GB"> provides information on attributive and variable testing.</span></p>
