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AAMI TIR65:2015 - Sustainability of medical devices-Elements of a responsible product life cycle, 2015
- AAMI TIR65:2015, Sustainability of medical devices—Elements of a responsible product life cycle
- Title page
- AAMI Technical Information Report
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Introduction
- 1 Scope
- 2 Normative references
- 3 Informative references
- 4 Definitions
- 5 Social sustainability [Go to Page]
- 5.1 Corporate responsibility
- 5.2 Employee management
- 5.3 Supply chain
- 5.4 External engagement
- 6 Economic sustainability [Go to Page]
- 6.1 Extended supply chain
- 6.2 Total cost of ownership (TCO)
- 6.3 Measurement and disclosure of material sustainability topics
- 7 Environmental sustainability [Go to Page]
- 7.1 Manufacturer [Go to Page]
- 7.1.1 Product design minimization/ simplicity
- 7.1.2 Raw materials and selection [Go to Page]
- 7.1.2.1 Chemical assessment
- 7.1.2.2 Renewable and nonrenewable resources
- 7.1.2.3 Recycled materials
- 7.1.3 Manufacturing [Go to Page]
- 7.1.3.1 Environmental, health, and safety management system
- 7.1.3.2 Energy management
- 7.1.3.3 Renewable energy 33F
- 7.1.3.4 Air quality and emissions management 34F
- 7.1.3.5 Water management [Go to Page]
- 7.1.3.5.1 Water usage
- 7.1.3.5.2 Water reuse and recycling
- 7.1.3.5.3 Pollution to water37F
- 7.1.3.6 Chemical/ resource management
- 7.1.3.7 Waste management
- 7.1.4 Packaging system [Go to Page]
- 7.1.4.1 Minimize packaging
- 7.1.4.2 Raw materials
- 7.1.4.3 Design for end of life
- 7.1.4.4 Distribution packaging
- 7.1.5 Distribution [Go to Page]
- 7.1.5.1 Mode of transportation [Go to Page]
- Figure 1 – Transportation Emissions by Type
- 7.1.5.2 Distribution efficiency
- 7.1.6 Use [Go to Page]
- 7.1.6.1 Disclosure of environmental attributes
- 7.1.6.2 User guide
- 7.1.6.3 Manufacturer recommended cleaning chemicals
- 7.1.6.4 Energy intensity, for electrical medical devices only
- 7.1.6.5 Consumables including accessories
- 7.1.6.6 Water usage
- 7.1.6.7 Medical gas usage
- 7.1.6.8 Waste generation during use
- 7.1.6.9 Storage required, physical or electronic
- 7.1.7 End of life [Go to Page]
- 7.1.7.1 Recyclability
- 7.1.7.2 Compostability
- 7.1.7.3 Hazardous waste
- 7.1.7.4 Take-back programs
- 7.2 User and/or purchaser [Go to Page]
- 7.2.1 Procurement [Go to Page]
- 7.2.1.1 Medical device selection and acquisition
- 7.2.1.2 Training
- 7.2.1.3 Warehouse, distribution center, and other transportation
- 7.2.2 Use of all medical devices [Go to Page]
- 7.2.2.1 Routine maintenance, if applicable
- 7.2.2.2 Repair, if applicable
- 7.2.2.3 Consumables, if applicable
- 7.2.2.4 Medical gas usage, if applicable
- 7.2.2.5 Water management, if applicable
- 7.2.2.6 Energy management, if applicable
- 7.2.3 Use of sterile medical devices [Go to Page]
- 7.2.3.1 Single-use disposable medical devices
- 7.2.3.2 Reprocessing (multi-use medical devices)
- 7.2.3.3 Reprocessing single-use medical devices
- 7.2.4 End of life [Go to Page]
- 7.2.4.1 Reuse, repair, refurbishment, and upgrades
- 7.2.4.2 Recycling, general
- 7.2.4.3 Recycling, electronic waste
- 7.2.4.4 Take-back programs
- 7.2.4.5 Donation and redeployment
- 8 Conclusions
- Annex A: Chemicals of concern references
- Annex B: Sustainable product development tools
- Annex C: Appendix of acronyms
- Annex D: Manufacturer life cycle case studies
- Annex E: User life cycle case studies
- Bibliography [Go to Page]