NF EN ISO 6717

NF EN ISO 6717

September 2021
Standard Current

In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood

This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations.Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples.Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs.NOTE       Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710.This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2021

Number of pages

23 p.

Reference

NF EN ISO 6717

ICS Codes

11.040.55   Diagnostic equipment
11.100.10   In vitro diagnostic test systems

Classification index

S92-036

Print number

1

International kinship

ISO 6717:2021

European kinship

EN ISO 6717:2021
Sumary
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood

This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations.

Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples.

Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs.

NOTE       Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710.

This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.

Replaced standards (1)
NF EN 14254
October 2004
Standard Cancelled
In vitro diagnostic medical devices - Single-use receptables for the collection of specimens, other than blood, from humans

Le présent document spécifie les exigences et les méthodes d'essai relatives aux récipients à usage unique sous vide et autres que sous vide destinés par le fabricant au prélèvement sur les humains et à la conservation d'échantillons autres que le sang dans le but d'examens diagnostiques in vitro.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Matériaux
  • 5 Capacité de remplissage/volume prélevé
  • 6 Traits de graduation
  • 7 Conception
  • 8 Fabrication
  • 9 Stérilité et états microbiologiques spéciaux
  • 10 Additifs
  • 11 Marquage et étiquetage
  • Annexe A (normative) Essais de détermination de la capacité de remplissage et/ou des traits de graduation des récipients pour échantillons autres que ceux sous vide
  • Annexe C (normative) Essai de fuite du bouchon d'un récipient
  • Annexe D (normative) Essai de robustesse d'un récipient destiné à être centrifugé
  • Annexe B (normative) Essai de détermination du volume prélevé pour les récipients sous vide
  • Bibliographie
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