AAMI TIR65 2015

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AAMI TIR65:2015 – Technical Information Report Sustainability of medical devices – Elements of a responsible product life cycle

Published By	Publication Date	Number of Pages
AAMI	2015	44

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

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PDF Pages	PDF Title
1	AAMI TIR65:2015, Sustainability of medical devices—Elements of a responsible product life cycle
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents
6	Glossary of equivalent standards
7	Committee representation
8	Introduction
11	1 Scope 2 Normative references 3 Informative references
12	4 Definitions
15	5 Social sustainability 5.1 Corporate responsibility 5.2 Employee management 5.3 Supply chain
16	5.4 External engagement 6 Economic sustainability 6.1 Extended supply chain 6.2 Total cost of ownership (TCO)
17	6.3 Measurement and disclosure of material sustainability topics 7 Environmental sustainability 7.1 Manufacturer
18	7.1.1 Product design minimization/ simplicity 7.1.2 Raw materials and selection 7.1.2.1 Chemical assessment
19	7.1.2.2 Renewable and nonrenewable resources 7.1.2.3 Recycled materials 7.1.3 Manufacturing 7.1.3.1 Environmental, health, and safety management system
20	7.1.3.2 Energy management 7.1.3.3 Renewable energy 33F
21	7.1.3.4 Air quality and emissions management 34F 7.1.3.5 Water management
22	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
23	7.1.3.7 Waste management 7.1.4 Packaging system 7.1.4.1 Minimize packaging 7.1.4.2 Raw materials
24	7.1.4.3 Design for end of life 7.1.4.4 Distribution packaging 7.1.5 Distribution 7.1.5.1 Mode of transportation
25	Figure 1 – Transportation Emissions by Type 7.1.5.2 Distribution efficiency 7.1.6 Use 7.1.6.1 Disclosure of environmental attributes
26	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
27	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
28	7.1.7.1 Recyclability 7.1.7.2 Compostability 7.1.7.3 Hazardous waste 7.1.7.4 Take-back programs
29	7.2 User and/or purchaser 7.2.1 Procurement 7.2.1.1 Medical device selection and acquisition 7.2.1.2 Training 7.2.1.3 Warehouse, distribution center, and other transportation
30	7.2.2 Use of all medical devices 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
31	7.2.2.5 Water management, if applicable 7.2.2.6 Energy management, if applicable 7.2.3 Use of sterile medical devices 7.2.3.1 Single-use disposable medical devices
32	7.2.3.2 Reprocessing (multi-use medical devices) 7.2.3.3 Reprocessing single-use medical devices 7.2.4 End of life
33	7.2.4.1 Reuse, repair, refurbishment, and upgrades 7.2.4.2 Recycling, general 7.2.4.3 Recycling, electronic waste
34	7.2.4.4 Take-back programs 7.2.4.5 Donation and redeployment 8 Conclusions
35	Annex A: Chemicals of concern references
37	Annex B: Sustainable product development tools
39	Annex C: Appendix of acronyms
40	Annex D: Manufacturer life cycle case studies
41	Annex E: User life cycle case studies
42	Bibliography


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Standard Title	AAMI TIR65:2015 – Technical Information Report Sustainability of medical devices – Elements of a responsible product life cycle
Published Code	AAMI
Publication Date	2015
Pages Count	44

AAMI TIR65 2015

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