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BS EN ISO 6717:2021 – TC

BS EN ISO 6717:2021 – TC

$134.27

Tracked Changes. 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 58
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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
1 30447115_New
37 A-30424658
38 undefined
41 European foreword
Endorsement notice
43 Foreword
44 1 Scope
2 Normative references
3 Terms and definitions
46 4 Materials
47 5 Filling capacity/draw volume
6 Graduation lines
7 Design
48 8 Construction
9 Sterility and special microbiological states
10 Additives
49 11 Marking and labelling
51 Annex A (normative) Tests for filling capacity and/or graduation lines for non-evacuated specimen container
52 Annex B (normative) Draw volume test for evacuated containers
54 Annex C (normative) Test for leakage from the closure of a container
56 Annex D (normative) Test for the robustness of a container that is intended for centrifugation
57 Bibliography

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BS EN ISO 6717:2021 - TC
$134.27