What is ISO 6717 about?
ISO 6717 addresses In Vitro diagnostic medical devices and 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 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 from ISO 6717 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.
Note: ISO 6717 does not specify requirements for auxiliary devices used in conjunction with specimen containers.
Who is ISO 6717 for?
ISO 6717 on In Vitro diagnostic medical devices, is applicable to-
- Manufacturers of In Vitro diagnostic medical devices
- Medical laboratories
- Research facilities
- Diagnostic labs
Why should you use ISO 6717?
In Vitro, diagnostic medical devices are tests used on biological samples to determine the status of a person’s health.
Using ISO 6717 guidelines will help you understand the general requirements and test methods for specialized single-use evacuated and non-evacuated containers which will help in proper assessments and improvement in quality of In Vitro diagnostic medical devices.