Overview of IEC 60601-1-11Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentAgenda1.Introduction IEC 60601-1-11 and Scope2.Other Definitions3.Use Conditions (tests required)4.Classification5.Additional Mechanical Requirements (tests required)6.Additional requirements for other hazards7.Documentation2Introduction IEC 60601-1-11 and ScopeIEC 60601-1 (3rd Edition) Series of Standards4General standard(Part 1 Standard)60601-160601-2-xx60601-2-0160601-2-0260601-2-0560601-2-0360601-2-0480601-2-xx60601-1-260601-1-1160601-1-1060601-1-960601-1-860601-1-660601-1-3Particulars, Vertical , Part 2 Standards, 60601-2-XXCollaterals, Horizontal Standards, 60601-1-XXEMCHome Healthcare EquipmentClosed-loop controllersEnvironmentAlarmsUsabilityX-Ray80000 series for standards issued by joint working groups of ISO/IECIEC 62366ISO 14971Risk ManagementClause 4.2IEC 62304Software life-cycle processesClause 14Previous60601-1-1Medical Electrical SystemsClause 16A MANUFACTURER MUST APPLY ALL APPLICABLE STANDARDS TO SHOW COMPLIANCE WITH 60601-1 and FULFILL WITH INDIVIDUAL REGULATION REQUIREMENTS !IEC60601-1-11:20105ScopeIncluding.MEE / SystemsHome Healthcare Environment (Clause 3.2)Lay operator (Clause 3.3) or Trained Professional6NOT Including.Solely for use by emergency medical servicesSolely for use in professional healthcare facilitiesHoweverIncludes MEE with intended uses for bothHome and Healthcare facilitiesOther DefinitionsTerms and definitionsBody worn (3.1)Life supporting (3.4)ex.呼吸器、氧氣筒、氧氣製造機Shelf life (3.5)Transit operable (3.6)8Use Conditions (tests required)Supply mains conditionsSupply mains more restrictive than general standard (clause 4.1)85 to 110% for non life support MEE80 to 110% for life support MEEAdd 85% (or 80%) test voltage condition when testing in general part.10Environmental conditions- Transport and storage (clause 4.2.1) 25 C without relative humidity control+ 70 C at a relative humidity up to 93 %, non-condensing1) Check instructions for use.2) Expose the MEE at its lowest specified environmental transport and storage conditions (ex. -25 C) until stable.3) Expose the MEE at its highest specified environmental transport andstorage conditions (ex. 70C/ 93 %RH) until stable.Evaluate BASIC SAFETY and ESSENTIAL PERFORMANCE.*Stable: at least 24h; or thermal stability for at least 2h11Environmental conditions- Operating (clause 4.2.2)Temperature: + 5 C to + 40 C;Relative humidity: 15 % to 93 %, non-condensingAtmospheric pressure: 700 hPa to 1 060 hPa.1) Check instructions for use.2) Evaluate the MEE at the lowest specified atmospheric pressure (ex. 700hPa)3) Evaluate the MEE at the highest specified atmospheric pressure (ex. 1060hPa)4) Expose the MEE at its lowest specified environmental operating conditions (ex. 5 C/ 15%RH) until stable.5) Expose the MEE at its highest specified environmental operating conditions (ex. 40C/ 93 %RH) until stable.Evaluate BASIC SAFETY and ESSENTIAL PERFORMANCE.*Stable: at least 6h; or thermal stability for at least 2h12Environmental shock- for Transit-Operable MEE (clause 4.2.3)If the instructions for use state a wider range of environmental operating conditions than those indicated in 4.2.2, TRANSIT-OPERABLE MEE shall maintain BASIC SAFETY and ESSENTIAL PERFORMANCE in the presence of condensation and thermal shock resulting from rapid changes in environmental temperature and humidity during INTENDED USE.13Lowestex. 0 C/ 15%RHHighestex. 50 C/ 95%RHIn 5 minsClassificationClassificationClass II or internally poweredShall NOT have a functional earth terminalIf equipped with applied parts, shall have either type BF or CF applied parts15Additional Mechanical Requirements (tests required)Mechanical strength test (clause 10)17Shock test18See 10.1.2a), 10.1.3a) and 10.1.3b) for details+X-X+Y-Y+Z-ZVibration testBroad-band random vibration test19See 10.1.2b) and 10.1.3c) for detailsXYZExample for shock/ vibration tests20Free fall testFree fall heightmass 1 kg0.25 mmass 1 kg and 10 kg0.1 mmass 10 kg and 50 kg0.05 mmass 50 kg0.01 m2 in each specified height.21Evaluate BASIC SAFETY and ESSENTIAL PERFORMANCE.According to IEC 60068-2-31:2008, PROCEDURE 1:The test facility surface shall be smooth, hard, rigid, unyielding, horizontal and, for example, made of concrete or steel.Additional requirements for other hazardsAccessible part inspectionIn IEC 60601-1-11, inspect by small finger probe (5,6 )Ingress of waterIP22 for Transit-operable, Hand-held, Body wormIP21 for other MEEIP Marking requirement: see clause 7.2 for detail24Ingress of water- IP code (IPXX)25IPX1IPX2IP1X and IP2XLoss of Power (Life-supporting MEE only)26At some time there will be a power loss to the homeAdded requirements in 8.4 applicable to both mains and internal power sourcesExpectation that there will be a “plan” in case of loss of powerThis is more critical for life-supporting ME equipmentStrangulation or AsphyxiationMeans shall be provided to control these risks (Clause 11)The risks apply to both patient and others, including children, in the equipment area Can be accomplished by: Routing wires and tubing, Use of retention devices, Use of multi-length accessories Not including small parts27DocumentationAccompanying DocumentsContact information (7.3.1)Lay Operator briefing information (7.3.2)Added warning/safety notices including strangulation requirements (7.4.1)Added detail for device internal power sources (7.4.2)Assembly, start-up and operating instructions (7.4.3, 7.4.4 and 7.4.5)Equipment message trouble shooting guide (7.4.6)Added requirements for cleaning/disinfecting/sterilization and maintenance (7.4.7, 7.5.2, 7.4.8, 8.1 and 8.2).etc.29Usability Engineering FileSet of RECORDS and other documents that are produced by USABILITY ENGINEERING activities (Clause 3.8)USABILITY ENGINEERING (可用性工程): application of knowledge about human behavior, abilities, limitations, and other characteristics to the design of tools, machines, ME EQUIPMENT, devices, systems, tasks, jobs, and environments to achieve adequateUSABILITY 30What need to be checked in Usability report according to -1-11Usability requirement for Accompanying Documents (7.1)Cleaning/ disinfecting/ sterilization of MEE (8.1 and 8.2)Accuracy of controls (9)Relevant standards: IEC60601-1-6; ISO 62366THANK YOU.