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  • 10/30233840 DC : 0

    Current The latest, up-to-date edition.

    BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Dimensions and designation
    5 Design
    6 Requirements
    7 Packaging
    8 Labelling
    9 Anticoagulant and/or preservative solution
    Annex A (normative) - Chemical tests
    Annex B (normative) - Physical tests
    Annex C (normative) - Biological tests
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU Directive
             93/42/EEC on Medical devices

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

    Comment Closes On
    Committee CH/212
    Document Type Draft
    Publisher British Standards Institution
    Status Current

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

    PREN 15986 : DRAFT 2009 SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 1135-4:2015 Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 1135-3:2016 Transfusion equipment for medical use Part 3: Blood-taking sets for single use
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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