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SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION
Publisher: National Standards Authority of Ireland
Published: 01-01-2004
Available Formats: PDF - English, Hardcopy - English More Info on product formats
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.
ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 Materials5 Nominal liquid capacity6 Graduation and fill lines7 Design8 Construction9 Sterility and special microbiological states10 Additives11 Information supplied by the manufacturer12 Receptacle and additive identificationAnnex A (normative) Test for nominal liquid capacity and graduation marks, for non-evacuated blood specimen receptacles A.1 Reagents and apparatus A.2 Test conditions A.3 Test procedureAnnex B (normative) Tests for draw volume for evacuated receptacles B.1 Reagents and apparatus B.2 Test conditions B.3 Test procedureAnnex C (normative) Test for leakage from the closure of a receptacle C.1 Reagents and apparatus C.2 Test procedure for non-evacuated container C.3 Test procedure for evacuated receptaclesAnnex D (normative) Test for the robustness of a receptacle that is intended for centrifugations D.1 Reagents and apparatus D.2 Test conditions D.3 Test procedureAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/ECBibliography
Provides requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination.
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