NF EN ISO 8536-11
Infusion equipment for medical use - Part 11 : infusion filters for use with pressure infusion equipment
ISO 8536-11:2004 applies to sterilized infusion filters for single use up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs.
ISO 8536-11:2004 applies to sterilized infusion filters for single use up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs.
<p>ISO 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536‑8. It does not include the effectiveness of filters for separation of particles or germs.</p>
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1 Domaine d'application1
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2 Références normatives1
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3 Désignation1
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4 Conception1
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5 Matériaux1
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6 Exigences physiques2
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6.1 Transparence2
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6.2 Contamination particulaire2
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6.3 Résistance à la rupture2
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6.4 Étanchéité2
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6.5 Adaptateurs à raccords coniques mâle et/ou femelle2
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6.6 Protecteurs2
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7 Exigences chimiques2
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8 Exigences biologiques2
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8.1 Stérilité2
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8.2 Recherche des pyrogènes2
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8.3 Hémolyse3
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9 Emballage3
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10 Étiquetage3
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10.1 Emballage primaire3
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10.2 Emballage secondaire3
- Annexe A (normative) Essais physiques5
- Annexe B (normative) Essais chimiques6
- Annexe C (normative) Essais biologiques7
- Bibliographie8
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