ISO 6717:2021

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

Standard Details

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.

General Information

Status : Published

Standard Type: Main

Document No: ISO 6717:2021

Document Year: 2021

Pages: 14

Edition: 1

Section Volume:
ISO/TC 76. Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

ICS:
11.100.10 In vitro diagnostic test systems

Preview Document

Life Cycle

Currently Viewing

Published

ISO 6717:2021

ISO 6717:2021

Standard Details

General Information

Life Cycle

Add Standards To Trackedge

Enquiry Form