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EVS-EN ISO 6717:2021

In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

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Kehtiv alates 16.09.2021
Alusdokumendid
ISO 6717:2021; EN ISO 6717:2021
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Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
16.09.2021
Põhitekst
12.10.2004
Põhitekst
This standard specifies requirements and test methods for single-use evacuated and non-evacuated receptacles, 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. NOTE 1 Requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers are specified in EN ISO 6710. NOTE 2 While it is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents, when being opened, this standard does not specify a test procedure for this because it has not been possible to devise an objective and reproducible test. This standard does not specify requirements for collection needles or needle holders or other accessories used in conjunction with specimen receptacles.
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EVS-EN ISO 4674-1:2016

Rubber- or plastics-coated fabrics - Determination of tear resistance - Part 1: Constant rate of tear methods (ISO 4674-1:2016)
Uusim versioon Kehtiv alates 06.12.2016