ISO 6717:2021

ISO 6717:2021

August 2021
International 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

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International ISO standards

Publication date

August 2021

Number of pages

14 p.

Reference

ISO 6717:2021

ICS Codes

11.100.10   In vitro diagnostic test systems

Print number

1
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.

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