ࡱ>  mbjbjVV k<<9Ooo++/9/9:::$;:;:;:P:<;;:Q??( @ @ @}GG G+Q-Q-Q-Q-Q-Q-Q$TWQQ9:GF^G^GGQQ/9/9 @ @QHHHGR/9R @9R @+QHG+QHH6[N9"9"_P @J}p;:GRPQQ0QP@$XCHF$X8_P$X:_PGGHGGGGGQQQQHGGGQGGGG$XGGGGGGGGG+ 7:  STRATEGIC DEVICE COMPLIANCE SERVICES Global Safety, Regulatory and Standards Compliance ServicesIEC 60601 - 1- 11 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentReport Reference No. : FORMTEXT      Compiled by (+ signature) : Approved by (+ signature) : Date of issue :Applicant s name :Address : Test specification:Standard :IEC606011-11: 2010Test item description :Trade Mark :Manufacturer :Model/Type reference :Ratings :Possible test case verdicts:- test case does not apply to the test object :N/A- test object does meet the requirement :Pass (P)- test object does not meet the requirement :Fail (F) ClauseRequirement + TestResult - RemarkP/F/NA4.1For ME EQUIPMENT or ME SYSTEMS intended for the HOME HEALTHCARE ENVIRONMENT, the characteristics of the SUPPLY MAINS specified in 4.10.2 of the general standard apply, except for replacement of the fifth dash as follows: for non-LIFE-SUPPORTING ME EQUIPMENT or ME SYSTEMS, no voltage in excess of 110 % or lower than 85 % of the NOMINAL voltage between any of the conductors of the system or between any of these conductors and earth for LIFE-SUPPORTING ME EQUIPMENT or ME SYSTEMS, no voltage in excess of 110 % or lower than 80 % of the NOMINAL voltage between any of the conductors of the system or between any of these conductors and earth.4.2The instructions for use shall indicate the permissible environmental conditions of transport and storage of ME EQUIPMENT after the ME EQUIPMENT has been removed from its protective packaging and subsequently between uses.Unless otherwise indicated the transport and storage environment shall be: - 25 C without relative humidity control; and + 70 C at a relative humidity up to 93 %, non-condensing;4.2.2Unless otherwise indicated in the instructions for use, the ME EQUIPMENT shall comply with its specifications and all the requirements of this standard when operated in NORMAL USE under the following environmental operating conditions: a temperature range of + 5 C to + 40 C; a relative humidity range of 15 % to 93 %, non- condensing; and an atmospheric pressure range of 700 hPa to 1 060 hPa.Where a less extreme environment is defined it shall be justified in the Risk Management FileWhere a less extreme environment is defined it shall be marked on the equipment.Where a less extreme environment is defined it shall be marked on the carrying case.4.2.3If the instructions for use state a wider range of environmental operating conditions than those indicated in 4.2.2, the TRANSIT-OPERABLE ME EQUIPMENT 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.5Parts of ME EQUIPMENT that are to be regarded as ACCESSIBLE PARTS are identified by inspection and, where necessary, by testing. In case of doubt, a part of ME EQUIPMENT that is to be regarded as an ACCESSIBLE PART is determined by a test with the small finger probe shown in Figure 1, applied in a bent or straight position: for all positions of the ME EQUIPMENT when operated as in NORMAL USE, and after opening ACCESS COVERS and removal of parts, including lamps, fuses and fuse holders, when:6Equipment shall be classified as: shall be CLASS II or INTERNALLY POWERED; shall not have a FUNCTIONAL EARTH TERMINAL; if equipped with APPLIED PARTS, it shall have either TYPE BF APPLIED PARTS or TYPE CF APPLIED PARTS.7.1In addition to the requirements of 7.1.1 of the general standard, the USABILITY of the identification, marking and ACCOMPANYING DOCUMENTS intended for the LAY OPERATOR or LAY RESPONSIBLE ORGANIZATION shall be evaluated based on an OPERATOR PROFILE that includes a maximum of eight years of education.ME EQUIPMENT and ME SYSTEMS intended for the HOME HEALTHCARE ENVIRONMENT should be designed to be simple to use and not require reference to complex ACCOMPANYING DOCUMENTS.7.2Notwithstanding the requirements of 7.2.9 of the general standard, the ENCLOSURE of ME EQUIPMENT shall be marked with the IP classification required by 8.3.1. If some or all of the protection is provided by the carrying case they shall be identified separately.7.3.1The ACCOMPANYING DOCUMENTS shall indicate that the LAY OPERATOR or LAY RESPONSIBLE ORGANIZATION should contact the MANUFACTURER or the MANUFACTURER'S representative: for assistance, if needed, in setting up, using or maintaining the ME EQUIPMENT or ME SYSTEM; or to report unexpected operation or events.The ACCOMPANYING DOCUMENTS shall include a postal address and either a telephone number or web address through which the LAY OPERATOR or LAY RESPONSIBLE ORGANIZATION can contact the MANUFACTURER or the MANUFACTURER'S representative.7.3.2When appropriate in addition to the requirements of 7.9.1 and 16.2 of the general standard, the ACCOMPANYING DOCUMENTS shall include the details necessary for the healthcare professional to brief the LAY OPERATOR or LAY RESPONSIBLE ORGANIZATION on any known contraindication(s) to the use of the ME EQUIPMENT or ME SYSTEM and any precautions to be taken such as: precautions to be taken in the event of changes in the performance of the ME EQUIPMENT or ME SYSTEM; precautions to be taken regarding the exposure of the ME EQUIPMENT or ME SYSTEM to reasonably foreseeable environmental conditions (e.g. to magnetic fields, electromagnetic fields, external electrical influences, atmospheric pressure or variations in pressure, acceleration, thermal ignition sources); adequate information regarding any medicinal substances that the ME EQUIPMENT is designed to administer; information on any medicinal substances or human blood derivatives incorporated into the ME EQUIPMENT or ACCESSORIES as an integral part; and the degree of accuracy claimed for measuring FUNCTIONs.7.4.1For each warning and safety sign, the instructions for use shall describe the nature of the HAZARD, likely consequences that could occur if the advice is not followed, and the precautions for reducing the RISK. These shall include as appropriate strangling hazards, choking from small parts, possible allergic hazards interconnection with other equipment, use of all or part for other than the specified use, modifying the equipment.7.4.2If ME EQUIPMENT is equipped with an INTERNAL ELECTRICAL POWER SOURCE and the BASIC SAFETY or ESSENTIAL PERFORMANCE is dependent on the INTERNAL ELECTRICAL POWER SOURCE, the instructions for use shall describe: the typical operation time or number of procedures; the typical service life; and for a rechargeable INTERNAL ELECTRICAL POWER SOURCE, the behavior of the ME EQUIPMENT while the rechargeable INTERNAL ELECTRICAL POWER SOURCE is charging.7.4.3The instructions for use shall include easily understood diagrams, illustrations, or photographs of the fully assembled and ready-to-operate ME EQUIPMENT including all controls, visual INFORMATION SIGNALS, and indicators provided with the ME EQUIPMENT.7.4.4The instructions for use shall include easily understood diagrams, illustrations, or photographs showing proper connection and set-up of the PATIENT to the ME EQUIPMENT, ACCESSORIES and other equipment and the time from switching ON until the ME EQUIPMENT is ready for NORMAL USE, if that time exceeds 15 s.7.4.5the instructions for use shall include a description of generally known conditions in the HOME HEALTHCARE ENVIRONMENT that can unacceptably affect the BASIC SAFETY and ESSENTIAL PERFORMANCE of the ME EQUIPMENT and the steps that can be taken by the LAY OPERATOR to identify and resolve these conditions, and shall include, where applicable, at least the following issues: the effects of lint, dust, light ht), etc.; a list of known devices or other sources that can potentially cause interference problems; the effects of degraded sensors and electrodes, or loosened electrodes; the effects caused by pets, pests or children.The instructions for use shall explain the meaning of the IP classification marked on the ME EQUIPMENT and, if applicable, on any carrying case provided with the ME EQUIPMENT.7.4.6The instructions for use shall include a trouble shooting guide for use when there are indications of a ME EQUIPMENT malfunction during start-up or operation. The troubleshooting guide shall disclose the necessary steps to be taken in the event of an ALARM CONDITION.7.4.7ME EQUIPMENT, ME SYSTEMS, their parts or ACCESSORIES that are intended for other than single use and that can become contaminated through contact with the PATIENT or with body fluids or expired gases during INTENDED USE, the instructions for use shall either provide detailed instructions for cleaning, disinfection, sterilization OR direct the user that professional cleaning, disinfection, sterilization.7.4.8The instructions for use shall include: the EXPECTED SERVICE LIFE of the ME EQUIPMENT; the EXPECTED SERVICE LIFE of parts or ACCESSORIES shipped with the ME EQUIPMENT; and where the SHELF LIFE is less than the EXPECTED SERVICE LIFE, the SHELF LIFE of parts or ACCESSORIES shipped with the ME EQUIPMENT.7.4.9The instructions for use shall indicate: information concerning the proper disposal of the ME EQUIPMENT, its parts or ACCESSORIES; and where applicable, a statement to the effect that the LAY RESPONSIBLE ORGANIZATION must contact its local authorities to determine the proper method of disposal of potentially biohazardous parts and ACCESSORIES.7.4.10For ME EQUIPMENT or an ME SYSTEM utilizing a DISTRIBUTED ALARM SYSTEM, the instructions for use shall include the recommended placement of the remote parts of the DISTRIBUTED ALARM SYSTEM to ensure that an OPERATOR can be notified at all times by an appropriate element of the DISTRIBUTED ALARM SYSTEM within its specified range.7.5.1To ensure that PERMANENTLY INSTALLED CLASS I ME EQUIPMENT is PROPERLY INSTALLED, the technical description shall include: a warning to the effect that the ME EQUIPMENT installation, including a correct PROTECTIVE EARTH CONNECTION, must only be carried out by qualified SERVICE PERSONNEL; the specifications of the PERMANENTLY INSTALLED PROTECTIVE EARTH CONDUCTOR; a warning to verify the integrity of the external protective earthing system; a warning to connect and verify that the PROTECTIVE EARTH TERMINAL of the PERMANENTLY INSTALLED ME EQUIPMENT is connected to the external protective earthing system.7.5.2For ME EQUIPMENT or ACCESSORIES that require professional hygienic maintenance prior to reuse (see 7.4.7), the technical description shall include methods for cleaning and disinfection or cleaning and sterilization: before and after any type of service PROCEDURE; when the ME EQUIPMENT is transferred to another PATIENT.8.1The cleaning or cleaning and disinfection PROCESSES intended to be performed in the HOME HEALTHCARE ENVIRONMENT by a LAY OPERATOR shall be capable of being performed by a LAY OPERATOR in the HOME HEALTHCARE ENVIRONMENT. The USABILITY of each such PROCESS as it pertains to a LAY OPERATOR shall be investigated by the USABILITY ENGINEERING PROCESS.8.2Each step of the cleaning and sterilization processes intended to be performed by a LAY OPERATOR shall be evaluated for adequate usability through application of the Usability Engineering Process as defined in 6060-1-6. 8.3.1TRANSIT-OPERABLE, HAND-HELD, and BODY-WORN ME EQUIPMENT shall maintain BASIC SAFETY and ESSENTIAL PERFORMANCE after undergoing the test of IEC 60529:1989 for IP22. All other types of EQUIPMENT shall maintain BASIC SAFETY and ESSENTIAL PERFORMANCE after undergoing the test of IEC 60529:1989 for IP21.8.3.2The ENCLOSURES of the non-ME EQUIPMENT parts of the ME SYSTEMS shall provide the degree of protection against harmful ingress of water or particulate matter equivalent to equipment complying with their respective IEC or ISO safety standards.8.4LIFE-SUPPORTING ME EQUIPMENT or ME SYSTEM shall maintain its ESSENTIAL PERFORMANCE for a sufficient time or for a sufficient number of PROCEDURES after loss or failure of the SUPPLY MAINS or INTERNAL ELECTRICAL POWER SOURCE occurs to allow alternative methods to be employed. 9In applying Usability Engineering according to 60601-1-6, the following shall be considered/evaluated: changes of controls; unexpected movement; potential for misconnection; potential for improper operation, or unsafe use; potential for confusion as to current operational mode; change in the transfer of energy or substance; exposure to biological materials; and small parts being inhaled or swallowed. limited skills/training of the operator in restoring essential performance or avoiding harm.10.1.1Non-TRANSIT-OPERABLE and HAND-HELD, Non-TRANSIT-OPERABLE and BODY-WORN, Non-TRANSIT-OPERABLE and PORTABLE, Non-TRANSIT-OPERABLE and MOBILE ME EQUIPMENT shall withstand the following without loss of BASIC SAFETY and ESSENTIAL PERFORMANCE in addition to the tests identified in 60601-1: 2005 Table 28:Shock test in accordance with IEC 60068-2-27:2008, using the following conditions: peak acceleration: 150 m/s2 (15 g); duration: 11 ms; pulse shape: half-sine; number of shocks: 3 shocks per direction per axis (18 total).Broad-band random vibration test in accordance with IEC 60068-2-64:2008, using the following conditions: acceleration amplitude: 10 Hz to 100 Hz: 1,0 (m/s2)2/Hz; 100 Hz to 200 Hz: 3 db per octave; 200 Hz to 2 000 Hz: 0,5 (m/s2)2/Hz; duration: 30 min per perpendicular axis (3 total).TRANSIT-OPERABLE and HAND-HELD ME EQUIPMENT shall withstand the following without loss of BASIC SAFETY and ESSENTIAL PERFORMANCE in addition to the tests identified in 60601-1: 2005 Table 28:For HAND-HELD ME EQUIPMENT and its parts, including mounting ACCESSORIES, shock test in accordance with IEC 60068-2-27:2008, using the following conditions: 1) test type: Type 1; peak acceleration: 300 m/s2 (30 g), duration: 11 ms, pulse shape: half-sine, number of shocks: 3 shocks per direction per axis (18 total); OR 2) test type: Type 2; peak acceleration: 1 000 m/s2 (100 g), duration: 6 ms, pulse shape: half-sine, number of shocks: 3 shocks per direction per axis (18 total).Test Type Performed: For ME EQUIPMENT and its parts, including mounting ACCESSORIES, broad-band random vibration test in accordance with IEC 60068-2-64:2008, using the following conditions: acceleration amplitude: 10 Hz to 100 Hz: 1,0 (m/s2)2 /Hz, 100 Hz to 200 Hz: 3 db per octave, 200 Hz to 2 000 Hz: 0,5 (m/s2)2 /Hz, duration: 30 min per perpendicular axis (3 total).TRANSIT-OPERABLE and BODY-WORN ME EQUIPMENT shall withstand the following without loss of BASIC SAFETY and ESSENTIAL PERFORMANCE in addition to the tests identified in 60601-1: 2005 Table 28:For other than HAND-HELD ME EQUIPMENT and its parts, including mounting ACCESSORIES, shock test in accordance with IEC 60068-2-27:2008, using the following conditions: 1) test type: Type 1; peak acceleration: 150 m/s2 (15 g), duration: 11 ms, pulse shape: half-sine, number of shocks: 3 shocks per direction per axis (18 total); or 2) test type: Type 2; peak acceleration: 300 m/s2 (30 g), duration: 6 ms, pulse shape: half-sine, number of shocks: 3 shocks per direction per axis (18 total).Test Type Performed:For ME EQUIPMENT and its parts, including mounting ACCESSORIES, broad-band random vibration test in accordance with IEC 60068-2-64:2008, using the following conditions: acceleration amplitude: 10 Hz to 100 Hz: 1,0 (m/s2)2 /Hz, 100 Hz to 200 Hz: 3 db per octave, 200 Hz to 2 000 Hz: 0,5 (m/s2)2 /Hz, duration: 30 min per perpendicular axis (3 total).TRANSIT-OPERABLE and PORTABLE or TRANSIT-OPERABLE and MOBILE ME EQUIPMENT shall withstand the following without loss of BASIC SAFETY and ESSENTIAL PERFORMANCE in addition to the tests identified in 60601-1: 2005 Table 28:For other than HAND-HELD ME EQUIPMENT and its parts, including mounting ACCESSORIES, shock test in accordance with IEC 60068-2-27:2008, using the following conditions: 1) test type: Type 1; peak acceleration: 150 m/s2 (15 g), duration: 11 ms, pulse shape: half-sine, number of shocks: 3 shocks per direction per axis (18 total); or 2) test type: Type 2; peak acceleration: 300 m/s2 (30 g), duration: 6 ms, pulse shape: half-sine, number of shocks: 3 shocks per direction per axis (18 total).Test Type Performed:For ME EQUIPMENT and its parts, including mounting ACCESSORIES, broad-band random vibration test in accordance with IEC 60068-2-64:2008, using the following conditions: acceleration amplitude: 10 Hz to 100 Hz: 1,0 (m/s2)2 /Hz, 100 Hz to 200 Hz: 3 db per octave, 200 Hz to 2 000 Hz: 0,5 (m/s2)2 /Hz, duration: 30 min per perpendicular axis (3 total).For PORTABLE and MOBILE ME EQUIPMENT and its parts, including mounting ACCESSORIES, free fall to IEC 60068-2-31:2008, using PROCEDURE 1 and the following conditions: fall height: for mass = 1 kg, 0,25 m, for mass > 1 kg and = 10 kg, 0,1 m, for mass > 10 kg and = 50 kg, 0,05 m, for mass > 50 kg, 0,01 m, number of falls: 2 in each specified attitude. For PORTABLE ME EQUIPMENT that is intended to be used only with a carrying case, that case may be applied to the equipment during this test.10.2If the INTERNAL ELECTRICAL POWER SOURCE is essential to maintain BASIC SAFETY or maintain ESSENTIAL PERFORMANCE or control the RISKS associated with the loss of ESSENTIAL PERFORMANCE, the ME EQUIPMENT shall be equipped with a means for the OPERATOR to determine the state of the INTERNAL ELECTRICAL POWER SOURCE.10.3Controls of ME EQUIPMENT that can affect BASIC SAFETY or ESSENTIAL PERFORMANCE shall be protected from accidental or unauthorized changes or adjustments.11Means must be provided to reduce the risk of strangulation or asphyxiation from cables, tubing, removable small parts.12.1ME EQUIPMENT and ME SYSTEMS intended for the HOME HEALTHCARE ENVIRONMENT shall be classified as Class B according to CISPR 11:2009 during emissions testing according to 60601-1-2.12.3The TECHNICAL DESCRIPTION of ME EQUIPMENT and ME SYSTEMS intended for the HOME HEALTHCARE ENVIRONMENT shall include the following:a statement to the effect that this equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;a statement to the effect that wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 800 MHz to 2,5 GHz column of Table 5 or Table 6 of IEC 60601-1-2:2007, as appropriate.13.1for the ALARM SYSTEM of ME EQUIPMENT and ME SYSTEMS intended for the HOME HEALTHCARE ENVIRONMENT, unless they are connected to a DISTRIBUTED ALARM SYSTEM that includes the generation of auditory ALARM SIGNALS as specified in IEC 60601-1-8:2006, each HIGH PRIORITY and MEDIUM PRIORITY ALARM CONDITION shall cause the generation of auditory ALARM SIGNALS as specified in IEC 60601-1- 8:2006.13.2for the ALARM SYSTEM of ME EQUIPMENT and ME SYSTEMS intended for the HOME HEALTHCARE ENVIRONMENT reducing the auditory ALARM SIGNAL volume below audible levels shall: activate the indication of ALARM OFF or AUDIO OFF as specified in IEC 60601-1-8:2006. for LIFE-SUPPORTING ME EQUIPMENT or ME SYSTEM not be possible unless the ALARM SYSTEM is connected to a DISTRIBUTED ALARM SYSTEM that includes the generation of auditory ALARM SIGNALS as specified in IEC 60601-1-8:2006.   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