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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.10 In vitro diagnostic test systems>20/30424657 DC BS EN ISO 6717. In vitro diagnostic medical devices. Single-use containers for the collection of specimens, other than blood, from humans
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20/30424657 DC BS EN ISO 6717. In vitro diagnostic medical devices. Single-use containers for the collection of specimens, other than blood, from humans

20/30424657 DC

BS EN ISO 6717. In vitro diagnostic medical devices. Single-use containers for the collection of specimens, other than blood, from humans

CURRENCY
LANGUAGE
English
Standard number:20/30424657 DC
Pages:20
Released:2020-09-08
Status:Draft for Comment
DESCRIPTION
This standard 20/30424657 DC BS EN ISO 6717. In vitro diagnostic medical devices. Single-use containers for the collection of specimens, other than blood, from humans is classified in these ICS categories:
  • 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.

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.


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