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  • 16/30312836 DC : 0

    NA Status of Standard is Unknown

    BS ISO 19227 - CLEANING OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS

    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 General requirements
    5 Cleanliness requirements
    6 Continued process verification
    7 Documentation
    Annex A (informative) - Sources of harm in the
            cleaning process
    Annex B (informative) - Relation between cleaning
            design, validation and risk management
    Annex C (informative) - Relation between
            cleaning validation, biological evaluation
            and sterilization validation
    Bibliography

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

    Comment Closes On
    Committee 45
    Document Type Draft
    Publisher British Standards Institution
    Status NA

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 3951-1:2013 Sampling procedures for inspection by variables — Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL
    ISO 9377-2:2000 Water quality Determination of hydrocarbon oil index Part 2: Method using solvent extraction and gas chromatography
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 1484 : 1997 WATER ANALYSIS - GUIDELINES FOR THE DETERMINATION OF TOTAL ORGANIC CARBON (TOC) AND DISSOLVED ORGANIC CARBON (DOC)
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    NFS 94 091 : 2013 IMPLANTS CHIRURGICAUX - EXIGENCES DE VALIDATION POUR LE PROCEDE DE NETTOYAGE DES IMPLANTS ORTHOPEDIQUES AVANT CONDITIONNEMENT FINAL
    EN 13018:2016 NON-DESTRUCTIVE TESTING - VISUAL TESTING - GENERAL PRINCIPLES
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 3951-2:2013 Sampling procedures for inspection by variables — Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics
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