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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
    Edition: 2021
    $313.97
    / user per year

Description of BS EN ISO 6717:2021 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.



Standard NumberBS EN ISO 6717:2021
TitleIn vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
StatusDefinitive
Publication Date2021-09-08
ReplacesBS EN 14254:2004
Identical National Standard OfEN ISO 6717, ISO 6717:2021, EN ISO 6717:2021, ISO 6717:2021
DescriptorsMedical inspection, Medical equipment, Diagnosis (medical), Disposable, Clinical laboratory equipment, Patients, Clinical investigation instruments, Medical specimens, Containers, Performance testing
ICS11.100 Laboratory medicine, 11.100.10 In vitro diagnostic test systems, 11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 539 14717 9
PublisherBSI
Pages22

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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