NF EN ISO 6710
Single-use containers for human venous blood specimen collection
ISO 6710:2017 specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers.It does not specify requirements for blood collection needles, needle holders, blood culture receptacles or "arterial" blood gas collection devices that can be used for venous blood.
ISO 6710:2017 specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers.
It does not specify requirements for blood collection needles, needle holders, blood culture receptacles or "arterial" blood gas collection devices that can be used for venous blood.
Le présent document spécifie les exigences et méthodes d'essai relatives aux récipients à usage unique destinés par le fabricant aux prélèvements de sang veineux humain dans le but d'examens diagnostiques in vitro, ainsi qu'aux récipients contenant des milieux pour hémoculture.
- Avant-propos
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1 Domaine d'application
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2 Références normatives
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3 Termes et définitions
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4 Matériaux
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5 Volume prélevé
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6 Conception
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7 Fabrication
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8 Stérilité et états microbiologiques spéciaux
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9 Additifs
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10 Marquage et étiquetage
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11 Identification du récipient
- Annexe A Essai de détermination du volume prélevé pour les récipients autres que ceux sous vide
- Annexe B (normative) Essai de détermination du volume prélevé pour les récipients sous vide
- Annexe C (normative) Essai de fuite du récipient
- Annexe D (normative) Essai de robustesse du récipient
- Annexe E (normative) Concentrations des additifs et volume des additifs liquides
- Annexe F (informative) Codes couleurs recommandés pour l'identification des additifs et des accessoires
- Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive 98/79/CE [JO L 331]
- Bibliographie
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