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<p>This document specifies essential requirements and related test methods for non-electrically driven portable infusion devices, thereafter called "device".</p>
<p>It is applicable to devices designed for continuous (fixed or adjustable) flow and/or for bolus neuraxial and intravascular or hypodermic applications.</p>
<p>NOTE Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain and the epi-, extra- or peri-dural space. Neuraxial application anaesthetics can be administered regionally, affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.</p>
<p>These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient.</p>
<p>These devices can be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient.</p>
<p>This document does not apply to</p>
<p>— electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24,</p>
<p>— devices for single patient use intended to deliver discrete volumes (bolus) of medicinal product that are covered by the ISO 11608 series,</p>
<p>— implantable devices,</p>
<p>— enteral devices,</p>
<p>— transdermal delivery devices, and</p>
<p>— devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity).</p>
Reģistrācijas numurs (WIID)
74736
Darbības sfēra
<p>This document specifies essential requirements and related test methods for non-electrically driven portable infusion devices, thereafter called "device".</p>
<p>It is applicable to devices designed for continuous (fixed or adjustable) flow and/or for bolus neuraxial and intravascular or hypodermic applications.</p>
<p>NOTE Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain and the epi-, extra- or peri-dural space. Neuraxial application anaesthetics can be administered regionally, affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.</p>
<p>These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient.</p>
<p>These devices can be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient.</p>
<p>This document does not apply to</p>
<p>— electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24,</p>
<p>— devices for single patient use intended to deliver discrete volumes (bolus) of medicinal product that are covered by the ISO 11608 series,</p>
<p>— implantable devices,</p>
<p>— enteral devices,</p>
<p>— transdermal delivery devices, and</p>
<p>— devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity).</p>
