ISO 6717:2021
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
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
French, English
26-08-2021
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.
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.