SRPS EN 14254:2008

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

Scope

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 prEN 14820.
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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.