BS EN 14254:2004

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Nominal liquid capacity
6 Graduation and fill lines
   6.1 Graduation lines
   6.2 Minimum fill line
   6.3 Maximum fill line
7 Design
8 Construction
9 Sterility and special microbiological states
10 Additives
11 Information supplied by the manufacturer
Annex A (normative) Tests for nominal capacity, graduation
                    lines and minimum free space for
                    non-evacuated specimen receptacles up
                    to and including 30 ml nominal capacity
   A.1 Reagents and apparatus
   A.2 Test Conditions
   A.3 Test procedure
Annex B (normative) Tests for nominal capacity, graduation
                    lines and minimum free space, for
                    non-evacuated specimen receptacles of
                    greater than 30 ml nominal capacity
   B.1 Reagents and apparatus
   B.2 Test conditions
   B.3 Test procedures
Annex C (normative) Tests for draw volume and minimum free
                    space for evacuated receptacles
   C.1 Reagents and apparatus
   C.2 Test conditions
   C.3 Test procedure
Annex D (normative) Test for leakage from the closure of
                    a receptacle
   D.1 Reagents and apparatus
   D.2 Test procedure for non-evacuated receptacles intended
       for storage above 0 degree C
   D.3 Test procedure for non-evacuated receptacles intended
       for storage at 0 degree C or below
   D.4 Test procedure for evacuated receptacles
Annex E (normative) Test for the robustness of a receptacle
                    that is intended for centrifugation
   E.1 Reagents and apparatus
   E.2 Test conditions
   E.3 Test procedure
Annex ZA (informative) Relationship between this European
                       Standard and the Essential
                       Requirements of EU Directive 98/79/EC
Bibliography

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.

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.