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  • AAMI ISO 10993-1:2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS

    Available format(s): 

    Superseded date:  06-04-2024

    Language(s): 

    Published date:  01-01-2013

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption of ISO 10993-1:2009
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General principles applying to biological evaluation
      of medical devices
    5 Categorization of medical devices
    6 Biological evaluation process
    7 Interpretation of biological evaluation data and overall
      biological safety assessment
    Annex A (informative) - Biological evaluation tests
    Annex B (informative) - Guidance on the risk management process
    Annex C (informative) - Suggested procedure for literature review
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyze the biological safety of the medical device; - the assessment of the biological safety of the medical device.

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

    Committee WG 01
    Document Type Standard
    Product Note Reconfirmed 2009
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
    ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
    ISO 10993-13:2010 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    ISO 10993-14:2001 Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    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 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 9001:2015 Quality management systems — Requirements
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
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