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COCIR Self Regulatory Initiative (SRI) under EuP Directive
EuP Consultation Forum Meeting 1 7 th Novem ber 2 0 0 9
Nicole Denjoy, COCIR Constantin Herrmann, PE I nternational
EuP Steering Committee – CF 17 Nov. 2009
EDD-CF-2009-11-17-Doc02
COCIR Self Regulatory Initiative (SRI) under EuP Directive EuP - - PowerPoint PPT Presentation
EDD-CF-2009-11-17-Doc02 COCIR Self Regulatory Initiative (SRI) under EuP Directive EuP Consultation Forum Meeting 1 7 th Novem ber 2 0 0 9 Nicole Denjoy, COCIR Constantin Herrmann, PE I nternational page 1 EuP Steering Committee CF 17
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Nicole Denjoy, COCIR Constantin Herrmann, PE I nternational
EuP Steering Committee – CF 17 Nov. 2009
EDD-CF-2009-11-17-Doc02
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EuP Steering Committee – CF 17 Nov. 2009
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I ntroduction to COCI R
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COCIR leadership in environmental matters
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EuP Initiative
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What has been done
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Concept of Self Regulative Initiative (SRI )
§ Scope § Participants § Method of the concept § Compliance with Annex VIII of EuP Directive § Conclusion §
Next Steps
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Q&A
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( 1 of 2 )
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( 2 of 2 )
HUNGARY EuP Steering Committee – CF 17 Nov. 2009
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Medical I maging
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Electromedical
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Healthcare I T
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Market Statistics (Medical Imaging and Healthcare I T Intelligence Centre)
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eHealth
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Contribution to sustainable healthcare with Institutions and other stakeholders (Europe)
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Regulatory Activities and Standardisation (EU and Global)
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Environment (EU and Global)
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Hosting EuP Steering Committee EuP Steering Committee – CF 17 Nov. 2009
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§ Saving lives and contributing to quality of life
§ Covering the complete care cycle § Capital investment goods § High technology and highly innovative § Safety conscious and highly regulated § Sustainability
§ Better management of chronic diseases § More efficient data exchange & work flow § Prevention § Early diagnostic § Therapy § Quality of care
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Dem and and necessity of:
patient safety (e.g. optimized radiation dose) or product reliability/ optimal performance
Consequence is:
approaches as information baseline
environmental protection
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§
I ntroduction to COCI R
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COCI R leadership in environm ental m atters
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EuP Initiative
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What has been done
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Concept of Self Regulative Initiative (SRI )
§ Scope § Participants § Method of the concept § Compliance with Annex VIII of EuP Directive § Conclusion §
Next Steps
§
Q&A
EuP Steering Committee – CF 17 Nov. 2009
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design – Thinking in life cycles
product standard IEC 60601-1-9, Requirements for environmentally conscious design
from Hamburg project
REACH compliance, RoHS substances, …
§ Guide for manufacturers § BOMcheck I nitiative (involvement of supply chain)
version 2 of GRP
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I EC 6 0 6 0 1-1 -9 (First edition 2007-07) “Requirements for environmentally conscious design (ECD) to become harmonized standard”
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EuP Steering Committee – CF 17 Nov. 2009 Source: http: / / www.cocir.org/ uploads/ documents/ -560-cocir_industry_standard1806.pdf
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I ntroduction to COCI R
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COCIR leadership in environmental matters
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EuP I nitiative
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What has been done
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Concept of Self Regulative Initiative (SRI )
§ Scope § Participants § Method of the concept § Compliance with Annex VIII of EuP Directive § Conclusion §
Next Steps
§
Q&A
EuP Steering Committee – CF 17 Nov. 2009
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December 2007: Start of development of the general SRI Concept
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May 2008: First announcement about SRI at CF meeting
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During 2008: Development of the detail SRI Concept
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January 2009: Commitment on participation from 11 companies (equals 100% COCIR members on electrical medical equipment)
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March 2009: Creation of EuP Steering Committee
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May 2009: First product group (ultrasound) investigated
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November 2009: Presentation on methodology and preliminary achievements to the Consultation Forum (gathering new input for improvements )
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§ Ultrasound (already investigated) § X-ray § Computed Tomography § Magnetic Resonance § Nuclear Medicine
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2 0 0 8 Market Value Estim ated EU Market Coverage Participating com panies Other targeted com panies Com puter Tom ography ( CT) 6 3 0 M€ 1 0 0 % GEHC, Philips, Siemens, Toshiba None Ultrasound 8 3 9 M€ 8 0 % Aloka, GEHC, Medison, Philips, Siemens, Toshiba Esaote Medical, Sonosite, Mindray, Ultrasonix, Zonare X-ray Cardio ( 4 5 % ) 3 8 1 M€ 1 0 0 % GEHC, Philips, Siemens, Toshiba None Others ( 5 5 % ) 4 9 0 M€ 8 2 % GEHC, Philips, Siemens, Toshiba, Agfa, Shimadzu, Canon
companies incl. Hologic, Konica, Mindray Magnetic Resonance I m aging ( MRI ) 7 6 9 M€ 1 0 0 % GEHC, Philips, Siemens, Toshiba None Nuclear Medicine ( SPECT, PET) 2 2 4 M€ 1 0 0 % GEHC, Philips, Siemens None
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well understandable and communicable
I mprovements:
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use phase (LCA result)
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Energy consumption in use, 81% Manufacturing, 3% Distribution, 2% Materials procurement, 14% Energy consumption in use, 86% Materials procurement, 10% Distribution, 2% Manufacturing, 2%
LCA results: Ultrasound product 1 Ultrasound product 2
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for data collection
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for comparability
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for completeness
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for transparency
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for a meaningful and feasible reference (functional unit)
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for significant environmental aspects
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Total annual sales Tot al annual sales as a percent age of 2005 annual sales Total annual energy consum ption in kWh for new product s Tot al annual energy consumpt ion for new products as a percent age of 2005 annual energy consumpt ion Average annual en ergy consumpt ion for new products in kWh Average annual energy consum ption for new products com pared to 2005 2005 14 ,475 100% 13,6 28,343 kWh/ year 100% 942 kWh / unit/ year 100% 2006 17 ,088 118% 14,8 64,054 kWh/ year 109% 870 kWh / unit/ year 92% 2007 19 ,604 135% 15,1 21,116 kWh/ year 111% 771 kWh / unit/ year 82% 2008 20 ,791 144% 15,8 51,000 kWh/ year 116% 762 kWh / unit/ year 81% 2009 20 ,800 144% 15,8 51,000 116% 762 kWh / unit/ year 81% 2010 20 ,800 144% 15,8 51,000 116% 762 kWh / unit/ year 81%
Historical data Ø Prediction Œ
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Current situation:
power consumption of single ultrasound product per time
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6 hours operation per day
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6 hours standby per day
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5 days usage per week, for 52 weeks per year
Challenge:
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More functions per unit
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Better images/ better diagnosis (quality)
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Faster throughput of patients/ more diagnoses per day (time)
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Energy efficiency depends on:
Proposals/ options ( need for further developed) :
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standard examination challenge: loss of additional functions
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examinations per day challenge: depending on work conditions
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individual function (modular) challenge: needs dividing of possibly integrated functions
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individual use mode challenge: difficult to define time per mode per day
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market value challenge: not necessarily reflects product quality sufficiently; market and cost aspects overlay environmental improvements
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products
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Mobile/ remote products means less energy
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Smaller, better, easier products means higher market penetration
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Standard PC applied in products means using all benefits in regard
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More information channels in same time
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Better quality, more information, more energy in total but less energy per single function
per channel
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Better, more efficient I T means less energy
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collection
top of the BAU
Group; Target is trade off between:
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Collected company expectations
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BAU prediction
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Considered existing technologies and level of their application to all products sold in future
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Reduction potentials beyond BAU
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creates awareness and
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ensures success of meeting the targets
the companies
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Sales data are extracted from financial management systems
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Externally audited to comply with financial regulations
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Power consumption measurements are required by I EC 60601
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Typically externally audited (Quality Management System to maintain certification to I SO 13485)
it will/ has become day to day (year to year) business
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To develop a atmosphere of openness, transparency and trust for this COCI R SRI
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Establish a regular platform to align expectations, discuss chances challenges and risks
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I nitiated by SRI members
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SRI will present status, highlights and challenges
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Open for all interested stakeholders
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I nteractive process
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To address relevant aspects and improvements to the COCIR EuP SC
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Annually during the phase (2) - identification of the most significant product aspects
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Ultrasound (already investigated)
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X-ray
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Computed Tomography
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Magnetic Resonance
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Nuclear Medicine
increased environmental reduction on yearly base
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1: Openness to participation
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I maging, Electromedical and Healthcare I T I ndustry. Companies who do not wish to become members of COCIR can still participate in this EuP Self-Regulatory Initiative. I n this case, COCI R will charge the company a fee to reflect the reasonable costs for the company to participate in the I nitiative.
Fujifilm (Japan), GEHC (US), Hitachi (Japan) and Toshiba (Japan). All
implementation phases of this self-regulatory initiative. For example, representatives from these companies attend the Steering Committee meetings held at COCIR offices in Brussels and actively contribute towards the development of the methodology and approach.
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2: Added Value
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energy consumption for new products would stay the same in 2008, 2009 and 2010 at 762 kWh per year.
energy consumption of new ultrasound products placed on the market by 6% between 2010 and 2012. Using 2005 as a baseline, this is equivalent to reducing the average energy consumption of new ultrasound products placed on the market in 2012 by 25% compared to 2005. This target is based on total energy consumption of new products only.
placed on the market by 6% between 2010 and 2012 translates to a reduction in average energy consumption from 762 kWh per year down to 706 kWh per year in 2010. Based on predicted EU annual sales in 2012 by COCIR companies
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group 3: Representativeness
least 80% of units sold in the EU for the medical imaging equipment sector.
large majority of the relevant economic sector”.
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4: Quantified and staged
EuP Steering Committee – CF 17 Nov. 2009
energy consumption for new products would stay the same in 2008, 2009 and 2010 at 762 kWh per year.
energy consumption of new ultrasound products placed on the market by 6% between 2010 and 2012. Using 2005 as a baseline, this is equivalent to reducing the average energy consumption of new ultrasound products placed on the market in 2012 by 25% compared to 2005.
units, this is equivalent to a total annual energy saving of 1,165,000 kWhrs. This is equivalent to 624,000 kg of CO2 per year.
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5: Involvement of Civil Society
website (www.cocir.org). COCIR will also publish the annual performance reporting tables each year on its website.
as this includes wide representation from Member States, industry, environmental NGOs and consumer associations. In addition to comments during the meeting, COCIR would also welcome any follow-up comm ents after the meeting by e-mail to secretariat@cocir.org.
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6: Monitoring and Reporting
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Appendix 8 to gather confidential sales data and power consum ption data from companies for each model of ultrasound equipment they put on the EU market in 2009, 2010, 2011 and 2012.
and so these data do not require additional auditing for this self-regulatory initiative.
company into a single master Excel spreadsheet for analysis.
total annual sales and total annual energy consumption of new ultrasound products that participants put on the market in EU Member States in 2009, 2010, 2011 and 2012. These data will be used to calculate the average annual energy consumption for new products put on the market in each of these years. The EuP Steering Committee will use these data to assess whether participants are achieving the targets.
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7: Cost-effectiveness of administering SRI
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Members States to ensure that the costs and administrative burden that medical imaging equipment manufacturers incurs through the Self-Regulatory Initiative is not disproportionate compared to other policy instruments.
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8: Sustainability
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which are set under the Initiative are environmentally sound with regard to
has verified that the target to reduce average energy consumption of new ultrasound products placed on the market by 6% between 2010 and 2012 will not result in an increase in other environmental aspects of ultrasound products.
technology which have been achieved in recent years. As a result, ultrasound equipment has become an even more powerful tool for healthcare professionals, to enable better and earlier diagnosis of patient symptoms and therefore more successful patient treatment and outcomes.
imaging technology and whether this is essential to delivering improved consumers’ health and quality of life.
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9: Incentive com patibility
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COM(2008) 400- entitled: Public procurement for a better environment. A building block of the ‘Action Plan on Sustainable Consumption and Production and Sustainable Industrial Policy (SCP/ SIP)’ aiming at improving the energy and environmental performances of products.
is an initiative addressing all key industries including “Equipment used in the health sector” and should serve as policy instrument for member states guiding their procurement decisions addressing current energy and health concerns. Although the Communication does not in particular cover energy consumption, it states that “the "core" GPP criteria would be set at the level of the energy efficiency requirements”. For the time being, the GPP and developed Training Toolkit with 3 modules are expected to have no effect on the COCIR EuP self- regulatory initiative. Inasmuch as the EuP Steering Committee hopes that the GPP criteria will reflect the findings and proposal of the EuP self-regulatory
incentives that could affect the Self-Regulatory Initiative.
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COCIR Environmental Focus Group
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AXIOM Iconos R200
100 200 300 400 500 600 700 Lebensphasen KEA / MWh 38 MWh
Supply of Substances
37 MWh
28,2 MWh/a
564 MWh
20 Years
Disposal
14 MWh
Take Back Prozess 9 MWh Supply of Substances 21,4 MWh Thermal Recycling 1,5 MWh
Usage
(20 Years)
Life Cycle Manufacturing CED / MWh
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EuP Steering Committee – CF 17 Nov. 2009
0% 20% 40% 60% 80% 100% Carcinogens
Climate change Ecotoxicity Acid.-Eutroph. Minerals Fossil fuels Relative contribution of the life cycle stages (%) Film p ro du ction C o m po sition eq u ip m ent A ssem blin g equ ip m ent P ackag in g o f p rinter Tran spo rt to clien t E n ergy co nsu m p tio n of p rinter at clien t (R 1) P ackag in g w aste at clien t S ervice scenario at client Tran spo rt to en d-of-life treatm ent E n d -of life scen ario
Environmental profile Medical imaging equipment
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EuP Steering Committee – CF 17 Nov. 2009 Source: http: / / www.healthcare.philips.com/ main/ about/ Sustainabi lity/ GreenProducts/ 2008.wpd
Results by simple LCA tool EcoScan for X-Ray tube Green Product Logo EcoVision Program w ith
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Ecodesign procedure based on I EC60601-1-9 considering whole life cycle
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Green product sales target of 30% in 2012
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Specific green focal areas for improvement:
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Achieved improvements for Medical Devices ranging from 10-60% on all green focal areas and LCA
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EuP Steering Committee – CF 17 Nov. 2009 Source: http: / / www.ipp- medizintechnik.hamburg.de/ en/ index.php?NID= 33
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System reuse
+ +
Component reuse Reuse for spare parts Recycling
Spare parts Recycling
Reuse rate 0 % 100 %
Recycling
Refurbishing
Reuse
IPP Project, supported by Bavarian State Ministry of the Environment, Public Health and Consumer Protection, Munich, Germany
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