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BS EN ISO 6717:2021

BS EN ISO 6717:2021

$102.76

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

Published By Publication Date Number of Pages
BSI 2021 22
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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 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.

PDF Catalog

PDF Pages PDF Title
2 undefined
5 European foreword
Endorsement notice
7 Foreword
8 1 Scope
2 Normative references
3 Terms and definitions
10 4 Materials
11 5 Filling capacity/draw volume
6 Graduation lines
7 Design
12 8 Construction
9 Sterility and special microbiological states
10 Additives
13 11 Marking and labelling
15 Annex A (normative) Tests for filling capacity and/or graduation lines for non-evacuated specimen container
16 Annex B (normative) Draw volume test for evacuated containers
18 Annex C (normative) Test for leakage from the closure of a container
20 Annex D (normative) Test for the robustness of a container that is intended for centrifugation
21 Bibliography

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BS EN ISO 6717:2021
$102.76