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ISO 6717:2021

In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood
26. 8. 2021.

Опште информације

60.60     26. 8. 2021.

ISO

ISO/TC 76

Međunarodni standard

11.100.10  

engleski   francuski  

Kupovina

Objavljen

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Apstrakt

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.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 6717:2021
60.60 Standard objavljen
26. 8. 2021.

Nacionalna preuzimanja

SRPS EN ISO 6717:2021  
ISS

In vitro dijagnostička medicinska sredstva – Posude za jednokratnu upotrebu za sakupljanje humanih uzoraka, izuzev krvi

60.60   Standard objavljen

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