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  • ANSI/AAMI/ISO 16142-1:2016

    Current The latest, up-to-date edition.

    MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  07-07-2016

    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 16142-1:2016
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Essential principles of safety and performance
      of medical devices
    5 Use of standards and guides in support of the
      essential principles
    6 Essential principles and references to relevant
      standards and guides
    Annex A (informative) - Rationale and guidance
    Annex B (normative) - Table relating essential principles
            to standards
    Annex C (informative) - Website listings of other standards
            suitable for the medical device sector and for
            assessment purposes
    Annex D (informative) - Reference to the essential principles
            by International Standards
    Annex E (informative) - Terminology - alphabetized index
            of defined terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended.

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

    Development Note Supersedes AAMI ISO TIR 16142. (08/2017)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes

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

    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    ISO 5364:2016 Anaesthetic and respiratory equipment — Oropharyngeal airways
    ISO 5360:2016 Anaesthetic vaporizers Agent-specific filling systems
    ISO 7376:2009 Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation
    ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 5362:2006 Anaesthetic reservoir bags
    ISO 6474-1:2010 Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina
    ISO 3107:2011 Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
    ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 7153-1:2016 Surgical instruments Materials Part 1: Metals
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    ISO 7197:2006 Neurosurgical implants Sterile, single-use hydrocephalus shunts and components
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    View more information

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