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  • AAMI TIR65 : 2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    SUSTAINABILITY OF MEDICAL DEVICES - ELEMENTS OF A RESPONSIBLE PRODUCT LIFE CYCLE

    Available format(s):  Hardcopy, PDF

    Superseded date:  15-02-2023

    Language(s):  English

    Published date:  04-11-2015

    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
    Introduction
    1 Scope
    2 Normative references
    3 Informative references
    4 Definitions
    5 Social sustainability
    6 Economic sustainability
    7 Environmental sustainability
    8 Conclusions
    Annexes
    A - Chemicals of concern references
    B - Sustainable product development tools
    C - Appendix of acronyms
    D - Manufacturer life cycle case studies
    E - User life cycle case studies
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes sustainability considerations during the product design, supply chain, manufacturing, acquisition, use, and end of life of medical devices, taking into account the life cycle impacts of the product.

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

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

    OHSAS 18001:2007 Occupational health and safety management systems. Requirements
    AAMI ISO TIR 11139 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
    ISO 50001:2011 Energy management systems Requirements with guidance for use
    ISO Guide 82:2014 Guidelines for addressing sustainability in standards
    ISO 14044:2006 Environmental management Life cycle assessment Requirements and guidelines
    ISO 14001:2015 Environmental management systems — Requirements with guidance for use
    2012/19/EU : 2012 COR 1 2015 DIRECTIVE 2012/19/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 4 JULY 2012 ON WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE) (RECAST)
    AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
    ASTM D 6868 : 2017 : REDLINE Standard Specification for Labeling of End Items that Incorporate Plastics and Polymers as Coatings or Additives with Paper and Other Substrates Designed to be Aerobically Composted in Municipal or Industrial Facilities
    ANSI/AAMI EQ89:2015 GUIDANCE FOR THE USE OF MEDICAL EQUIPMENT MAINTENANCE STRATEGIES AND PROCEDURES
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    AAMI ST91 : 2015 FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES
    ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    IEC 62474:2012 Material declaration for products of and for the electrotechnical industry
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