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EN ISO 6717:2021

Current

Current

The latest, up-to-date edition.

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

Published date

08-09-2021

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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 ISO6710.This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.

Committee
CEN/TC 140
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

Standards Relationship
ISO 6717:2021 Identical
NS-EN ISO 6717:2021 Identical
ÖNORM EN ISO 6717:2021 12 15 Identical
BS EN ISO 6717:2021 Identical
I.S. EN ISO 6717:2021 Identical
SN EN ISO 6717:2021 Identical
PN-EN ISO 6717:2022-03 Identical
UNE-EN ISO 6717:2022 Identical

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