• 15/30329923 DC : 0

    NA Status of Standard is Unknown

    BS EN ISO 22610 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - TEST METHOD TO DETERMINE THE RESISTANCE TO WET BACTERIAL PENETRATION

    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 Principle
    5 Equipment, reagents and materials
    6 Apparatus
    7 Preparation of the Agar Plates
    8 Bacterial inoculum
    9 Procedure
    10 Evaluation
    11 Expression of the results
    12 Report
    Annex A (normative) - Apparatus for testing resistance
            to wet bacterial penetration
    Annex B (normative) - Nutrient media
    Annex C (normative) - Equipment and laboratory
            performance monitoring
    Annex ZA (informative) - Relationship between
             this European Standard and the Essential
             Requirements of EU Directive (Add the reference
             and title of the Directive)

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

    Comment Closes On
    Committee CH/205/1
    Document Type Draft
    Publisher British Standards Institution
    Status NA

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

    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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