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BSI BS EN ISO 6717:2021

In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
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BSI BS EN ISO 6717:2021

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

PUBLISH DATE 2021
PAGES 22
BSI BS EN ISO 6717:2021

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 ISO 6710 .

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

SDO BSI: British Standards Institution
Document Number ISO 6717
Publication Date Sept. 8, 2021
Language en - English
Page Count 22
Revision Level
Supercedes
Committee CH/212
Publish Date Document Id Type View
Sept. 8, 2021 BS EN ISO 6717:2021 Revision