AS IEC 60601.1.9 pdf download – Medical electrical equipment Part 1.9: General requirements for basic safety and essential performance— Collateral Standard: Requirements for environmentally conscious design
4Protection of the ENVIRONMENT
4.1 * ldentification of ENVIRONMENTAL ASPECTs
THE MANUFACTURER shall establish，implement and maintain a PROCESs to identify anddocument the relevant ENVIRONMENTAL ASPECTs of ME EQUIPMENT across all LIFE-CYCLE stages.Examples of ENVIRONMENTAL ASPECTs are:
-use of HAZARDOus suBSTANCES;
emissions to air;
releases to surface water and ground water;wASTE,especially HAZARDOus suBSTANCES;
use of natural resources, 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; and
-use and contamination of the biosphere.
Compliance is checked by inspection of the relevant design documents and pRocESsdescription.
4.2* Determination of significant ENVIRONMENTAL ASPECTs
The MANUFACTURER shall establish,implement and maintain a PRocEss to qualitatively orquantitatively determine and document the ENVIRONMENTAL ASPECTs that can have significantENVIRONMENTALIMPACTS (i.e. significant ENVIRONMENTAL ASPECTs)during all LIFE-cYcLE stagesof the ME EQUIPMENT.
Compliance is checked by inspection of the relevant design documents and PROcESsdescription.
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 inidentifying and assessing the ENVIRONMENTAL ASPECTs of the ME EQUIPMENT as required in4.1 and 4.2.
lf, despite the MANUFACTURER’s efforts,ORGANIZATIONS within the suPPLY CHAlN fail to providethe information requested by the MANUFACTURER,the MANUFACTURER shall provide anestimation of the missing information and document the rationale.
NOTE To fully assess the ENVIRONMENTALASPECTS across the entire life of the ME EQUIPMENT it is necessary forthe MANUFACTURER to gather information and involve the environmentally significant suPPLIERs during the conceptand design stage.
Compliance is checked by inspection of the relevant design documents and PRocESsdescription.
4.4* Reduction of adverse ENVIRONMENTAL IMPACTS
The MANUFACTURER shall establish and document targets for the significant ENVIRONMENTALASPECTs of the ME EQUIPMENT to minimize as far as reasonable the adverse ENVIRONMENTALIMPACTS across all LIFE-CYCLE stages.The documented targets shall be based on functional aswell as environmental requirements,and, when available,previous product designs.
During the ME EQUIPMENT concept and specification setting stage，the MANUFACTURER shallconsider, as far as reasonable, novel emerging or alternative technologies and/or solutions forthe ME EQUIPMENT that reduce significant adverse ENVIRONMENTAL IMPACTs.
The MANUFACTURER shall assess and document the actual significant ENVIRONMENTAL ASPECTSacross all LIFE-CYcLE stages of a representative prototype of the final design of the MEEQUIPMENT. Any deviations from the targets shall be assessed and documented forconsideration in future designs.
Compliance is checked by inspection of the relevant design documents.
4.5.1 * PACKAGING of ME EQUIPMENT
The MANUFACTURER shall make available information on the type and mass of PACKAGINGmaterial(s).
NOTE‘Type’of PACKAGING refers,as a minimum, to the generic description (e.g. cardboard, plastic, wood, glassetc)-
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 theME 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 in order to minimize the ENVIRONMENTALIMPACT during its EXPECTED SERVICE LIFE;
instructions on how to use and maintain the ME EQUIPMENT in order to minimize theENVIRONMENTAL IMPACT during its EXPECTED SERVICE LIFE;
consumption during NORMAL USE (e.g. energy,consumable materials/parts，disposables,water, gasses, chemicals/reagents etc.);
emissions during NORMAL USE (e.g. WASTE water，WASTE consumable materials，acousticenergy,heat,gasses，vapours，particulates，HAZARDOUS sUBSTANCEs and other wASTE);and
information on the location within the ME EQUIPMENT of HAZARDOUS sUBSTANCES,radioactive sources and induced radioactive materials.
Compliance is checked by inspection of the AccOMPANYING DOCUMENTs.