BS EN ISO 6717:2021 - TC

This standard BS EN ISO 6717:2021 - TC Tracked Changes. In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood is classified in these ICS categories:

• 11.100 Laboratory medicine
• 11.100.10 In vitro diagnostic test systems
• 11.100.10 In vitro diagnostic test systems

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.

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