AS IEC 60601.1.9:2017 – Medical electrical equipment Part 1.9: General requirements for basicsafety and essential performance— Collateral Standard: Requirements for environmentally conscious design.
substance or object which the holder disposes of, or is required to dispose of, pursuant to the provisions of national law in force
LIEC Guide 109:2003, definition 3.181
4 Protection of the ENVIRONMENT
4.1 • Identification of ENVIRONMENTAL ASPECTS
THE MANUFACTURER shall establish. implement and maintain a PROCESS to identify and document the relevant ENVIRONMENTAL ASPECTS of ME EQUIPMENT across all LIFE-CYCLE stages Examples of ENVIRONMENTAL ASPECTS are’
— emissions to air;
— releases to surface water and ground water;
— use of natural resource:, energy and raw materials.
— noise, vibration, odour, dust. electromagnetic fields etc.;
— transport (both for goods and services and employees):
— RISKS from environmental accidents and ENVIRONMENTAL IMPACTS arising, or likely to arise. as consequences of incidents, accidents and potential emergency situations: arid
— use and contamination of the biosphere.
Compliance is checked by ,nspection of the relevant destgn documents end PROCESS description
4.2 • Determination of significant ENVIRONMENTAL ASPECTS
The MANUFACTURER shall establish, implement and maintain a PROCESS to qualitatively or quantitatively determine and document the ENVIRONMENTAL ASPECTS that can have significant ENVIRONMENTAL IMPACTS (i.e. significant ENVIRONMENTAL ASPECTS) during all LIFECYCLE stages of the ME EQUIPMENT.
Compliance is checked by inspection of the relevant design documents end PROCESS description.
4.3 • Information from the SUPPLY CHAiN
The MANUFACTURER shall establish, implement and maintain PROCESSES to:
— identify those suppliers (including services) that are likely to contribute significant ENVIRONMENTAL ASPECTS to the ME EQUIPMENT: and
— obtain from those SUPPLIERS the information necessary to assist the MANUFACTURER in identifying and assessing the ENVIRONMENTAL ASPECTS of the ME EQUIPMENT as required in 4.1 and 4,2.
If, despite the MANUFACTURERS efforts. ORGANIZATIONS within the SUPPLY CHAIN fall to provide the information requested by the MANUFACTURER, the MANUFACTURER shall provide an estimation of the missing information and document the rationale,
4.4 • Reduction of adverse ENVIRONMENTAL IMPACTS
The MANUFACTURER shall establish and document targets for the significant ENVIRONMENTAL
ASPECTS of the ME EQUIPMENT to minimize as far as reasonable the adverse ENVIRONMENTAL
IMPACTS across all LIEC-CYCLE stages. The documented targets shall be based on functional as
well as environmental requirements, and, when available, previous product designs.
During the ME EQUIPMENT concept and specification setting stage, the UANUFACTURER shall consider, as tar as, novel emerging or alternative technologies and/or solutions for the ME EQUIPMENT that reduce significant adverse ENVIRONMENTAL IMPACTS.
The MANUFACTURER shall assess and document the actual significant ENVIRONMENTAL ASPECTS across all LIFE-CYCLE stages of a representative prototype of the final design of the ME EQuIPMENT, Any deviations from the targets shall be assessed and documented for consideration in future designs
Compliance is checked by inspection of the relevant design documents.
4.5 EnvIronmental Information
The MANUFACTURER shall make available Information on the type and mass of PACKAGING material(s).
Compliance is checked by verifying the availability of the information.
4.5.2 • Instructions for minimizing ENVIRONMENTAL IMPACT during NORMAL USE
The MANUFACTURER shall provide instructions for minimizing the ENVIRONMENTAL IMPACT of the ME EQUIPMENT during NORMAL USE in the ACCOMPANYING DOCUMENTS.
The instructions shall cover the following items where applicable:
— instructions on how to install the ME EQUIPMENT ifl order to minimize the ENVIRONMENTAL IMPACT during its EXPECTED SERVICE LIFE;
— instructions on how to use and maintain the ME EQUIPMENT in order to minImIze the ENVIRONMENTAL IMPACT during its EXPECTED SERVICE L1FE
— consumption during NORMAL USE (eg energy, consumable materialslparts, dlsposables. water, gasses, chemicals/reagents etc.).