I.S. EN ISO 6717:2021
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
Hardcopy , PDF
English
26-09-2021
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Filling capacity/draw volume
6 Graduation lines
7 Design
8 Construction
9 Sterility and special microbiological states
10 Additives
11 Marking and labelling
Annex A (normative) Tests for filling capacity and/or graduation lines for non-evacuated specimen container
Annex B (normative) Draw volume test for evacuated containers
Annex C (normative) Test for leakage from the closure of a container
Annex D (normative) Test for the robustness of a container that is intended for centrifugation
Bibliography
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