• DIN EN 14820 E : 2004

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-12-2017

    Language(s):  English

    Published date:  01-01-2004

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Materials
    5 Nominal liquid capacity
    6 Graduation and fill lines
    7 Design
    8 Construction
    9 Sterility and special microbiological states
    10 Additives
    11 Information supplied by the manufacturer
    12 Receptacle and additive identification
    Annex 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 procedure
    Annex B (normative) Tests for draw volume for evacuated
             receptacles
             B.1 Reagents and apparatus
             B.2 Test conditions
             B.3 Test procedure
    Annex 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 receptacles
    Annex 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 procedure
    Annex ZA (informative) Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 98/79/EC
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides requirements and test methods for single-use receptacles, intended by their manufacture, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
    EN 829 : 1996 IN VITRO DIAGNOSTIC SYSTEMS - TRANSPORT PACKAGES FOR MEDICAL AND BIOLOGICAL SPECIMENS - REQUIREMENTS, TESTS
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
    EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
    EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective