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

Status : Current, Draft for public comment   Published : September 2020

Format
PDF

Format
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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.




Standard Number20/30424657 DC
TitleBS EN ISO 6717. In vitro diagnostic medical devices. Single-use containers for the collection of specimens, other than blood, from humans
StatusCurrent, Draft for public comment
Publication Date08 September 2020
Normative References(Required to achieve compliance to this standard)ISO 3696, ISO 4788, ISO 15223-1
Informative References(Provided for Information)ISO 11137-1, ISO 11137-3, EN 556-2, ISO 6710, ISO/TS 17665-2, ISO 17665-1, EN 556-1, ISO 11135, ISO 11137-2, ISO 18113-2
International RelationshipsISO/DIS 6717
Draft Expiry Date25 October 2020
DescriptorsMedical technology, Diagnosis (medical), Medical equipment, Medical treatment, Diagnostic equipment (medical), Electrical medical equipment, Electronic medical equipment
ICS11.100.10
Title in FrenchTitre manque
CommitteeCH/212
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size548 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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