BS EN ISO 6717. In vitro diagnostic medical devices. Single-use containers for the collection of specimens, other than blood, from humans
|Standard number:||20/30424657 DC|
|Status:||Draft for Comment|
- 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 are, but not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, sperm, sputum, urine, tissue samples.
Specimens and types of devices specifically excluded include specialized containers for cryo-preservation, samples for nucleic acid testing and swabs.
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.