age 2 Of 4 List of Attachments (including a total number of pages in each attachment) Document No. Documents included / attached to this report (descr

Transcription

1 Test Report issued under the responsibility of: Brainvision Inc. (Self check and test) TEST REORT Safety requirements for electrical equipment for measurement, control, and laboratory use art 1: General requirements Report Number...: Date of issue...: 2016/10/19 Total number of pages...: 47 Applicant s name...: Address...: Brainvision Inc. 7F, UI-building, 2-2, kanda-ogawamachi, Chiyoda-city, Tokyo, japan Test specification: Standard... : Test procedure...: Non-standard test method... : :2010 (Third Edition) Test Report Form No...: Test Report Form(s) Originator... : IEC61010_1J Master TRF... : VDE Testing and Certification Institute Copyright 2013 Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components (IECEE), Geneva, Switzerland. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. If this Test Report Form is used by non-iecee members, the IECEE/IEC logo and the reference to the CB Scheme procedure shall be removed. This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. Test item description...: Trade Mark...: Manufacturer...: Model/Type reference...: Ratings... : MiCAM05 imaging system MiCAM Brainvision Inc. MiCAM05-RC V 50Hz/60Hz 150W(max)

2 age 2 Of 4 List of Attachments (including a total number of pages in each attachment) Document No. Documents included / attached to this report (description) Form A.1 Testing in SINGLE FAULT CONDITION 40 Form A.2 MAINS supply 41 Form A.3 Durability of markings 42 Form A.4 List of ACCESSIBLE parts 43 Form A.5 Values in NORMAL CONDITION 44 Form A.6 Values in SINGLE FAULT CONDITION 45 Form A.9 Bonding impedance of plug connected equipment 46 Form A.26A Temperature Measurements 47 age No. Documents referenced by this report (available on request): Document Name or No. REF1 REF2 REF3 REF4 REF5 REF6 REF7 REF8 Documents description Overview of MiCAM05 system Main power safety test report Temperature test report (normal condition) Temperature test report (single-fault condition: FAN STO) Routine Test Sheet age No.

3 age 3 Of 4 Summary of testing: Clause Comment

4 age 4 Of 4 Test Report History: This report may consist of more than one report and is valid only with additional or previous issued reports: Ref. No. Item Tests performed (name of test and test clause): Main power safety test Temperature test Testing location: Brainvision Inc. Kanda labo. Brainvision Inc. Kanda labo. Summary of compliance with National Differences List of countries addressed: The product fulfils the requirements of (insert standard number and edition and delete the text in parenthesis or delete the whole sentence if not applicable) Copy of marking plate: The artwork below may be only a draft. The use of certification marks on a product must be authorized by the respective NCBs that own these marks.

5 age 5 Of 4 Test item particulars: Type of item... : Description of equipment function...: Connection to MAINS supply... : Overvoltage category... : OLLUTION DEGREE... : 2 Means of protection... : Environmental conditions...: For use in wet locations...: Equipment mobility...: Operating conditions...: Overall size of equipment (W x D x H)... : Mass of equipment (kg)...: Marked degree of protection to IEC : ossible test case verdicts: Measurement / Control / Laboratory Imaging System Detachable cord set II Class II (isolated) Normal No ortable Continuous W430xD341xH75 7.0Kg - Test case does not apply to the test object...: (Not Applicable) - Test object does meet the requirement... : (ass) - Test object does not meet the requirement...: F (Fail) Testing: Date of receipt of test item...: Date (s) of performance of tests... : General remarks: The test results presented in this report relate only to the object tested. This report shall not be reproduced, except in full, without the written approval of the issuing testing laboratory. "(see ENCLOSURE #)" refers to additional information appended to the report. "(see Form A.xx)" refers to a table appended to the report. Bottom lines for measurement tables Form A.xx are optional if used as record. Throughout this report a point is used as the decimal separator. Manufacturer s Declaration per sub-clause of IECEE 02: The application for obtaining a CB Test Certificate includes more than one factory location and a declaration from the manufacturer stating that the sample(s) submitted for evaluation is (are) representative of the products from each factory has been provided...: Not applicable When differences exist; they shall be identified in the general product information section.

6 age 6 Of 4 General product information: Description of unit: The product is consisted from (1)processor unit, (2)camera units, one or four units and (3)cables. The processor unit includes single AC-DC converter which provides reinforced isolation between primary and secondary terminals. rimary means main input from commercial electricity, such as 220V 60Hz, and secondary means a power unit output, such as 12V DC. The report will be about the processor unit test mainly because other functional parts are supplied from isolated secondary power line. Description of model differences. MiCAM05-RC is consisted from a main unit and selectable installing I/F units and memory cards. The main unit with full mounted of I/F and memory is subject of this test, because of it is most consuming power, which means highest possibility of hazard. Description of special features. (HV circuits, high pressure systems etc.) none

7 age 7 Of 4 4 TESTS Testing in SINGLE FAULT CONDITIONS Fault tests (see Form A.1) Application of SINGLE FAULT CONDITIONS SINGLE FAULT CONDITIONS not covered by to (see Form A ROTECTIVE IMEDANCE Not installed ROTECTIVE CONDUCTOR (see Form A.6) Equipment or parts for short-term or intermittent operation Motors FAN unit stopped while fully energized Form A.26A prevented from starting Form A.26A, one phase interrupted (multi-phase) Not installed Capacitors Not installed MAINS transformers Not installed Short circuit Ref Overload Ref Outputs Not installed Equipment for more than one supply Not installed Cooling Form A.26A, Ref3 air holes closed Form A.26A fans stopped Form A.26A, Ref4 coolant stopped Not installed loss of cooling liquid Not installed Heating devices Not installed timer overridden temperature controller overridden Insulation between circuits and parts Checked by design Interlocks Not installed Voltage selectors Not installed Duration of tests (see Form A.1) Conformity after application of fault conditions (see Form A.1) 5 MARKING AND DOCUMENTATION Required equipment markings visible from the exterior; or yes visible after removing cover or opening door No cover and door

8 age 8 Of 4 visible after removal from a rack or panel No rack Not put on parts which can be removed by an operator Yes it on back-panel Letter symbols (IEC 60027) used Yes CE Graphic symbols (: Table 1) used Yes ~ 0/ Identification Equipment is identified by: a) Manufacturer s or supplier s name or trademark Brainvision b) Model number, name or other means MiCAM05 Manufacturing location identified By serial number MAINS supply - Equipment is marked as follows: ~ V a) Nature of supply: AC 1) a.c. RATED MAINS frequency or range of frequencies... : 50/60Hz 2) d.c. with symbol 1...: b) RATED supply voltage(s) or range... : 100V-230V C) Max. RATED power (W or VA) or input current... : 100W The marked value not less than 90 % of the maximum value (see Form A.2) tested If more than one voltage range: Separate values marked; or Values differ by less than 20 % (see Form A.2) d) OERATOR-set for different RATED supply voltages: Indicates the equipment set voltage ortable equipment indication is visible from the exterior Changing the setting changes the indication e) Accessory MAINS socket-outlets accepting standard MAINS plugs are marked: With the voltage if it is different from the MAINS supply voltage... : For use only with specific equipment If not marked for specific equipment it is marked with: The maximum rated current or power; or Symbol 14 with full details in the documentation Fuses - Operator replaceable fuse marking (see also 5.4.5)... : T2A L 250V

9 age 9 Of TERMINALS, connections and operating devices Only concern safety General Where necessary for safety, indication of purpose of TERMINALS, connectors, controls and indicators marked If insufficient space, symbol 14 used ush-buttons and actuators of emergency stop devices and indicators: No such function used only to indicate a warning of danger; or the need for urgent action coloured red coded as specified in IEC Supplementary means of coding provided, if meaning of colour relates (see IEC 60073): to safety of persons; or safety of the environment TERMINALS MAINS supply TERMINAL identified Inlet was used Other TERMINAL marking: a) FUNCTIONAL EARTH TERMINALS (symbol 5 used) No terminal b) ROTECTIVE CONDUCTOR TERMINALS: Symbol 6 is placed close to or on the TERMINAL; or art of appliance inlet c) TERMINALS of control circuits (symbol 7 used) d) HAZARDOUS LIVE TERMINALS supplied from the interior Standard MAINS socket outlet; or RATINGS marked; or Symbol 14 used Switches and circuit breakers - If disconnecting device, off position clearly marked 0/1 mark is used If push-button used as power supply switch: symbol 9 and 15 used for on-position symbol 10 and 16 used for off-position pair of symbols 9, 15 and 10, 16 close together Equipment protected by DOUBLE INSULATION or REINFORCED INSULATION rotected throughout (symbol 11 used) -

10 age 10 Of 4 Only partially protected (symbol 11 not used) artly (not use symbol11) Field-wiring TERMINAL boxes If TERMINAL or ENCLOSURE exceeds 60 C: (see Form A.26A) Cable temperature RATING marked...: Marking visible before and during connection or beside TERMINAL 5.2 Warning markings Visible when ready for NORMAL USE Are near or on applicable parts Symbols and text correct dimensions and colour: a) symbols min 2,75 mm and text 1,5 mm high and contrasting in colour with background b) symbols and text moulded, stamped or engraved in material min. 2,0 mm high and 0,5 mm depth or raised if not contrasting in colour If necessary marked with symbol 14 Statement to isolate or disconnect if access by using a tool to HAZARDOUS LIVE parts is permitted 5.3 Durability of markings The required markings remain clear and legible in NORMAL USE (see Form A.3) 5.4 Documentation General - Equipment is accompanied by documentation for safety purposes for OERATOR or RESONSIBLE BODY Safety documentation for service personnel authorized by the manufacturer Documentation necessary for safe operation is provided in printed media or files in electronic media if available at any time Documentation includes: a) intended use age 3 b) technical specification age54 c) name and address of manufacturer or supplier age57 d) information specified in to age8 e) information to mitigate residual RISK (see also subclause 17) f) accessories for safe operation of the equipment specified age2-3 age2-3

11 age 11 Of 4 g) guidance provided to check correct function of the equipment, if incorrect reading may cause a HAZARD from harmful or corrosive substances of HAZARDOUS live parts age2-3 h) instructions for lifting and carrying Warning statements and a clear explanation of warning symbols: provided in the documentation; or information is marked on the equipment Equipment ratings Documentation includes: a) Supply voltage or voltage range...: V AC Frequency or frequency range...: 50Hz/60Hz ower or current rating...: 150W max. b) Description of all input and output connections in accordance to a) c) RATING of insulation of external circuits in accordance to b) d) Statement of the range of environmental conditions (see 1.4) age 7-9 Class I for main supply Reinforced isolation age 4 * e) Degree of protection (IEC 60529) Class II f) If impact rating less than 5 J: IK code in accordance to IEC marked; or symbol 14 of table 1 marked, with RATED energy level and test method stated Equipment installation Documentation includes instructions for: a) assembly, location and mounting requirements age 57 b) protective earthing age 4 * c) connections to supply age 4 * d) ERMANENTLY CONNECTED EQUIMENT: Not such equipment 1) Supply wiring requirements 2) If external switch or circuit-breaker, requirements and location recommendation e) ventilation requirements age 4 f) special services (e. g. air, cooling liquid) No such service g) instructions relating to sound level No sound Equipment operation Instructions for use include: a) identification and description of operating controls age 10-49

12 age 12 Of 4 b) positioning for disconnection By switch symbol 1/0 c) instructions for interconnection age 9 d) specification of intermittent operation limits No limit e) explanation of symbols used age 3-4 f) replacement of consumable materials g) cleaning and decontamination h) listing of any poisonous or injurious gases and quantities i) RISK reduction procedures relating to flammable liquids (see 9.5) j) RISK reduction procedures relating burn from surfaces permitted to exceed limits of 10.1 Additional precautions for IEC conforming equipment in regard to moistures and liquids A statement about protection impairment if used in a manner not specified by the manufacturer Equipment maintenance and Service age 4 age 4 age 3 Instructions for RESONSIBLE BODY include: Instructions sufficient in detail permitting safe maintenance and inspection and continued safety: Instruction against the use of detachable MAINS supply cord with inadequate rating Specific battery type of user replaceable batteries Any manufacturer specified parts 3A 250V * Rating and characteristics of fuses T2A 250V * Instructions include following subjects permitting safe servicing and continued safety: a) product specific RISKS may affect service personal No such service b) protective measures for these RISKS c) verification of the safe state after repair Integration into systems or effects resulting from special conditions Aspects described in documentation 6 ROTECTION AGAINST ELECTRIC SHOCK General (see Form A.14 and A.15) Requirements - rotection against electric shock maintained in NORMAL CONDITION and SINGLE FAULT CONDITION Case of protect bonding removed ACCESSIBLE parts not HAZARDOUS LIVE Below 12V/2A

13 age 13 Of 4 Voltage, current, charge or energy below the limits in NORMAL CONDITION and in SINGLE FAULT CONDITION between: ACCESSIBLE parts and earth two ACCESSIBLE parts on same piece of the equipment within a distance of 1,8 m Conformity is checked by the determination of 6.2 and 6.3 followed by the tests of 6.4 to Exceptions Following HAZARDOUS LIVE parts may be ACCESSIBLE to an OERATOR: a) parts of lamps and lamp sockets after lamp removal b) parts to be replaced by OERATOR only by the use of tool and warning marking Those parts not HAZARDOUS LIVE 10 s after interruption of supply Capacitance test if charge is received from internal capacitor (see Form A.5 ) (see Form A.4 and A.5) 6.2 Determination of ACCESSIBLE parts (see Form A.4) General - Unless obviously determination of ACCESSIBLE parts as specified in to By (a) all parts are not hazardous except main inlet Examination with jointed test finger (as specified B.2) with rigid test finger (as specified B.1) and a force of 10 N Openings above parts that are HAZARDOUS LIVE test pin with length of 100 mm and 4 mm in diameter applied Openings for pre-set controls test pin with length of 100 mm and 3 mm in diameter applied 6.3 Limit values for ACCESSIBLE parts Levels in NORMAL CONDITION (see Form A.5) a) Voltage limits less than 33 V r.m.s. and 46,7 V peak or 70 V d.c. for WET LOCATIONS voltage limits less than 16 V r.m.s. and 22,6 V peak or 35 V d.c. Less than 12V No wet Voltages are not HAZARDOUS LIVE the levels of: b) Current less than 0,5 ma r.m.s. for sinusoidal, 0,7 ma peak non-sinusoidal or mixed frequencies or 2 ma d.c. when measured with measuring circuit A.1 or A.2 if less than 100 Hz By a) passed

14 age 14 Of 4 for WET LOCATIONS measuring circuit A.4 used 70 ma r.m.s. when measured with circuit A.3 for higher frequencies or c) Levels of capacitive charge or energy less: 1) 45 µc for voltages up to 15 kv peak or d.c. or line A of Figure 3 2) 350 mj stored energy for voltages above 15 kv peak or d.c Levels in SINGLE FAULT CONDITION (see Form A.6) a) Voltage limits less than 55 V r.m.s. and 78 V peak or 140 V d.c. for WET LOCATIONS voltage limits less than 33 V r.m.s. and 46,7 V peak or 70 V d.c. Case of protect bonding removed 77V peak (50Hz/230V Voltages are not HAZARDOUS LIVE the levels of: b) Current less than 3,5 ma r.m.s. for sinusoidal, 5 ma peak non-sinusoidal or mixed frequencies or 15 ma d.c. when measured with measuring circuit A.1 or A.2 if less than 100 Hz for WET LOCATIONS measuring circuit A.4 used 500 ma r.m.s. when measured with circuit A.3 for higher frequencies 0.005mA (50Hz/230V) or c) Levels of capacitive charge or energy less line B of Figure rimary means of protection ACCESSIBLE parts prevented from being HAZARDOUS LIVE by one or more of following means: a) ENCLOSURES or ROTECTIVE BARRIERS (see 6.4.2) b) BASIC INSULATION (see 6.4.3) c) Impedance (see 6.4.4) ENCLOSURES or ROTECTIVE BARRIERS (see Form A.15 and A.16) meet rigidity requirements of 8.1 Yes meet requirements for BASIC INSULATION, if protection is provided by insulation meet requirements of 6.7 for CREEAGE and CLEARANCES between ACCESSIBLE parts and HAZARDOUS live parts, if protection is provided by limited access BASIC INSULATION (see Form A.15 and A.16) meet CLEARANCE, CREEAGE DISTANCE and solid insulation requirements of 6.7 Used devices are fit for all requirements Impedance (see Form A.12 and A.15)

15 age 15 Of 4 Impedance used as primary means of protection meets all of following requirements: a) limits current or voltage to level of (see Form A.6) b) RATED for maximum WORKING VOLTAGE and the amount of power it will dissipate c) CLEARANCE, CREEAGE DISTANCE between terminations of the impedance meet requirements of BASIC INSULATION of Additional means of protection in case of SINGLE FAULT CONDITION ACCESSIBLE parts are prevented from becoming HAZARDOUS live by the primary means of protection and supplemented by one of: (see Form A.15) a) ROTECTIVE BONDING (see 6.5.2) 5mohm b) SULEMENTARY INSULATION (see 6.5.3) Reinforcement c) automatic disconnection of the supply (see 6.5.5) d) current- or voltage-limiting device (see 6.5.6) Alternatively one of the single means of protection is used: e) REINFORCED INSULATION (see 6.5.3) 4KV tested for AC-DC f) ROTECTIVE IMEDANCE (see 6.5.4) ROTECTIVE BONDING (see Form A.9) ACCESSIBLE conductive parts, may become HAZARDOUS LIVE in SINGLE FAULT CONDITION: Bonded to the ROTECTIVE CONDUCTOR TERMINAL; or Separated by conductive screen or barrier bonded to ROTECTIVE CONDUCTOR TERMINAL Integrity of ROTECTIVE BONDING A) ROTECTIVE BONDING consists of directly connected structural parts or discrete conductors or both; and withstands thermal and dynamic stresses Using short wire terminal contact between case and inlet, and using direct contact between SU and case. b) Soldered connections: Independently secured against loosening Not used for other purposes c) Screw connections are secured M4 D) ROTECTIVE BONDING not interrupted; or exempted as removable part carries MAINS SULY input connection e) Any movable ROTECTIVE BONDING connection specifically designed, and meets f) No external metal braid of cables used (not regarded as ROTECTIVE BONDING) Main switch disconnect AC only No move -

16 age 16 Of 4 G) IF MAINS SULY passes through: Means provided for passing protective conductor; Impedance meets H) rotective conductors bare or insulated, if insulated, green/yellow See Ref1 Exceptions: 1) earthing braids; 2) internal protective conductors etc.; Green/yellow not used for other purposes TERMINAL suitable for connection of a ROTECTIVE CONDUCTOR, and meets ROTECTIVE CONDUCTOR TERMINAL a) Contact surfaces are metal Steel b) Appliance inlet used TDK RE-2003F02L C) For rewirable cords and ERMANENTLY CONNECTED EQUIMENT, ROTECTIVE CONDUCTOR TERMINAL is close to MAINS supply TERMINALS d) If no MAINS supply is required, any ROTECTIVE CONDUCTOR TERMINAL: Is near terminals of circuit for which protective earthing is necessary External if other terminals external e) Equivalent current-carrying capacity to MAINS supply TERMINALS (see Form A.7) f) If plug-in, makes first and breaks last Yes, by structure g) If also used for other bonding purposes, ROTECTIVE CONDUCTOR: Applied first; Secured independently; Unlikely to be removed by servicing h) ROTECTIVE CONDUCTOR of measuring circuit: 1) Current RATING equivalent to measuring circuit TERMINAL; 2) ROTECTIVE BONDING: not interrupted by any switch or interrupting device i) FUNCTIONAL EARTH TERMINALS allow independent connection j) If a binding screw used for ROTECTIVE CONDUCTOR TERMINAL: Nichifu TMEDN FA 15A for 1.25mm2 wire yes Suitable size for bond wire AWG16 used Not smaller than M 4 M4

17 age 17 Of 4 At least 3 turns of screw engaged 6turns asses tightening torque test (see Form A.8) k) Contact pressure not capable being reduced by deformation of materials Impedance of ROTECTIVE BONDING of plug-connected equipment Impedance between ROTECTIVE CONDUCTOR TERMINAL and each ACCESSIBLE part where ROTECTIVE BONDING is specified, is: (see Form A.9) less than 0,1 Ohm; or 0.05ohm less than 0,2 Ohm if equipment is provided with non-detachable cord Bonding impedance of ERMANENTLY CONNECTED EQUIMENT (see Form A.10) Transformer ROTECTIVE BONDING screen (see Form A.11) Transformer provided with screen for ROTECTIVE BONDING: screen bonding consists of directly connected structural parts or discrete conductors or both; and withstands thermal and dynamic stresses (see a ) screen bonding with soldered connection (see b ) is: Independently secured against loosening Not used for other purposes SULEMENTARY and REINFORCED INSULATION Meet CLEARANCE, CREEAGE DISTANCE and solid insulation requirements of ROTECTIVE IMEDANCE (see Form A.12) Limits current or voltage to level of in NORMAL and to level of in SINGLE FAULT CONDITION CLEARANCE, CREEAGE DISTANCE between terminations of the impedance meet requirements of DOUBLE or REINFORCED INSULATION of 6.7 The ROTECTIVE IMEDANCE consists of one or more of the following: a) appropriate single component suitable for safety and reliability for protection, it is: (see Form A.15) (see TABLE 1 and Form A.12) 1) RATED twice the maximum WORKING VOLTAGE 2) resistor RATED for twice the power dissipation for maximum WORKING VOLTAGE b) combination of components Single electronic device not used as ROTECTIVE IMEDANCE

18 age 18 Of Automatic disconnection of the supply a) RATED to disconnect the load within time specified in Figure 2 b) RATED for the maximum load conditions of the equipment Current- or voltage-limiting devices (see Form A.12) Device complies with all of: a) RATED to limit the current or voltage to the level of (see Form A.6) b) RATED for the maximum WORKING VOLTAGE; and RATED for the maximum operational current if applicable c) CLEARANCE, CREEAGE DISTANCE between terminations of the impedance meet requirements of SULEMENTARY INSULATION of 6.7 (see Form A.14, A.15) 6.6 Connections to external circuits Connections do not cause ACCESSIBLE parts of the following to become HAZARDOUS LIVE in NORMAL CONDITION or SINGLE FAULT CONDITION: the external circuits the equipment rotection achieved by separation of circuits; or short circuit of separation does not cause a HAZARD Instructions or markings for each terminal include: A) RATED conditions for TERMINAL B) Required RATING of external circuit insulation TERMINALS for external circuits TERMINALS which receive a charge from an internal capacitor are not HAZARDOUS LIVE after 10 s of interrupting supply connection (see Form A.5) Circuits with terminals which are HAZARDOUS LIVE These circuits are: Not connected to ACCESSIBLE conductive parts; or Connected to ACCESSIBLE conductive parts, but are not MAINS CIRCUITS and have one TERMINAL contact at earth potential No ACCESSIBLE conductive parts are HAZARDOUS LIVE ACCESSIBLE terminals for stranded conductors No RISK of accidental contact because: Located or shielded Self-evident or marked whether or not connected to ACCESSIBLE conductive parts

19 age 19 Of 4 ACCESSIBLE TERMINALS will not work loose 6.7 Insulation requirements (see Form A.14) The nature of insulation Insulation between ACCESSIBLE parts or between separate circuits consist of CLEARANCES, CREEAGE DISTANCES and solid insulation if provided as protection against a HAZARD CLEARANCES Required CLEARANCES reflecting factors of (see Form A.14 and A.15) Equipment rated for operating altitude greater than 2000 m correction factor of Table 3 of applied CREEAGE DISTANCES Required CREEAGE DISTANCES reflecting factors of a) to d) CTI material group reflected by requirements CTI test performed (see Form A.14 and A.15) Solid insulation Required solid insulation reflecting factors of a) to d) Requirements for insulation according to type of circuit A) MAINS circuits of OVERVOLTAGE CATEGORY II up to nominal supply voltage of 300 V B) secondary circuits separated from circuits defined in a) by transformer C) K.1 MAINS circuits of OVERVOLTAGE CATEGORY III and IV or OVERVOLTAGE CATEGORY II over 300 V D) K.2 secondary circuits separated from circuits defined in c) by transformer (see Form A.14 and A.15) (see Form A.14 and A.15) 230V E) K.3 circuits having one or more of: 1) maximum TRANSIENT OVERVOLTAGE is limited to known level below the level of MAINS CIRCUIT 2) maximum TRANSIENT OVERVOLTAGE above the level of MAINS CIRCUIT 3) WORKING VOLTAGE is the sum of more than one circuit or a mixed voltage 4) WORKING VOLTAGE includes recurring peak voltage, may include non-sinusoidal or non-periodic waveform 5) WORKING VOLTAGE with a frequency above 30 khz

20 age 20 Of Insulation for MAINS CIRCUITS of OVERVOLTAGE CATEGORY II with a nominal supply voltage up to 300 V CLEARANCES and CREEAGE DISTANCES (see Form A.14 and A.15) Values for MAINS CIRCUITS of Table 4 are met Coatings to achieve reduction to OLLUTION DEGREE 1 comply with requirements of Annex H Solid insulation Withstands electrical and mechanical stresses in normal use and all RATED environmental conditions of 1.4 Equipment passed voltage tests of with values of Table 5 230V (see Form A.18) Complies as applicable: A) ENCLOSURE or ROTECTIVE BARRIER of Clause 8 b) moulded and potted parts requirements of C) inner layers of printed wiring boards requirements of D) thin-film insulation requirements of Moulded and potted parts Conductors between same two layers are separated by at least 0,4 mm after moulding is completed Inner insulating layers of printed wiring boards Separated by at least 0,4 mm between same two layers REINFORCED INSULATION have adequate electric strength; one of following methods used: a) thickness of insulation is at least 0,4 mm b) insulation is assembled of minimum two separate layers, each RATED for test voltage of Table 5 for BASIC INSULATION C) insulation is assembled of minimum two separate layers, where the combination is rated for test voltage of Table 5 for REINFORCED INSULATION Thin-film insulation Conductors between same two layers are separated by applicable CLEARANCES and CREEAGE DISTANCE of REINFORCED INSULATION have adequate electric strength; one of following methods used: a) thickness through the insulation at least 0,4 mm

21 age 21 Of 4 b) insulation is assembled of min two separate layers, each RATED for test voltage of Table 5 for BASIC INSULATION C) insulation is assembled of min three separate layers, where the combination of two layers passed voltage tests of with values of Table 5 for REINFORCED INSULATION Insulation for secondary circuits derived from MAINS CIRCUITS of OVERVOLTAGE CATEGORY II up to 300 V Secondary circuits where separation from MAINS CIRCUITS is achieved by a transformer providing: (see Form A.18) 230V REINFORCED INSULATION COSEL BA150F-12V DOUBLE INSULATION screen connected to the ROTECTIVE CONDUCTOR TERMINAL CLEARANCES a) meet the values of Table 6 for BASIC INSULATION and SULEMENTARY INSULATION; or twice the values of Table 6 for REINFORCED INSULATION or B) pass the voltage tests of 6.8 with values of Table 6; (see Form A.18) with following adjustments: 1) values for reinforced insulation are 1,6 times the values for basic insulation 2) if operating altitude is greater than 2000 m values of CLEARANCES multiplied with factor of Table 3 3) minimum CLEARANCE is 0,2 mm for OLLUTION DEGREE 2 and 0,8 mm for OLLUTION DEGREE CREEAGE DISTANCES Based on WORKING VOLTAGE meets the values of Table 7 for BASIC and SULEMENTARY INSULATION Values for REINFORCED INSULATION are twice the values of BASIC INSULATION Coatings to achieve reduction to OLLUTION DEGREE 1 comply with requirements of Annex H Solid insulation Withstands electrical and mechanical stresses in normal use and all RATED environmental conditions of 1.4 a) Equipment passed voltage test of for 5 s with VALUES of Table 6 for BASIC and SULEMENTARY INSULATION (see Form A.18)

22 age 22 Of 4 values for REINFORCED INSULATION are 1,6 times the values of BASIC INSULATION b) if WORKING VOLTAGE exceeds 300 V, equipment passed voltage test of for 1 min with a test voltage of 1,5 times working voltage for BASIC or SULEMENTARY INSULATION value for REINFORCED INSULATION are twice the WORKING VOLTAGE (see Form A.18) Complies as applicable: 1) ENCLOSURE or ROTECTIVE BARRIER of Clause 8 2) moulded and potted parts requirements of ) inner layers of printed wiring boards requirements of ) thin-film insulation requirements of Moulded and potted parts Conductors between same two layers are separated by applicable distances of Table Inner insulation layers of printed wiring boards Separated by at least by applicable distances of Table 8 between same two layers REINFORCED INSULATION have adequate electric strength; one of following methods used: a) thickness at least applicable distance of Table 8 b) insulation is assembled of minimum two separate layers, each RATED for test voltage of Table 6 for BASIC INSULATION C) insulation is assembled of min two separate layers, where the combination is RATED for 1,6 times the test voltage of Table Thin-film insulation Conductors between same two layers are separated by applicable CLEARANCES and CREEAGE DISTANCE of and REINFORCED INSULATION have adequate electric strength; one of following methods used: a) thickness at least applicable distance of Table 8 b) insulation is assembled of min. two separate layers, each RATED for test voltage of Table 6 for BASIC INSULATION C) insulation is assembled of min. three separate layers, where the combination of two layers passed voltage tests with 1,6 time values of Table 6: a.c. test of ; or (see Form A.18)

23 age 23 Of 4 d.c. test of for circuits stressed only by d.c. voltages 6.8 rocedure for dielectric strength tests (see Form A.14 and A.18) 6.9 Constructional requirements for protection against electric shock If a failure could cause a HAZARD: a) security of wiring connections b) screws securing removable covers c) accidental loosening d) CLEARANCES and CREEAGE DISTANCES not reduced below the values of basic insulation by loosening of parts or wires Insulating materials - Material not to be used for safety relevant insulation: a) easily damaged materials not used b) non-impregnated hygroscopic materials not used Colour coding - Green-and-yellow insulation shall not be used except: a) protective earth conductors; b) ROTECTIVE BONDING conductors; c) potential equalization conductors; d) functional earth conductors 6.10 Connection to MAINS supply source and connections between parts of equipment MAINS supply cords RATED for maximum equipment current (see c) Cable complies with IEC or IEC Heat-resistant if likely to contact hot parts Temperature RATING (cord and inlet)...: Green/yellow used only for connection to ROTECTIVE CONDUCTOR TERMINALS Detachable cords with IEC MAINS connectors: Conform to IEC 60799; or Have the current RATING of the MAINS connector Fitting of non-detachable MAINS supply cords Cord entry a) inlet or bushing with a smoothly rounded opening; or b) insulated cord guard protruding >5 D (diameter) Cord anchorage

24 age 24 Of 4 rotective earth conductor is the last to take the strain a) cord is not clamped by direct pressure from a screw b) knots are not used c) cannot push the cord into the equipment to cause a HAZARD d) no failure of cord insulation in anchorage with metal parts e) not to be loosened without a tool f) cord replacement does not cause a HAZARD and method of strain relief is clear ush-pull and or torque test (see Form A.19) lugs and connectors - MAINS supply plugs, connectors etc., conform with relevant specifications If equipment supplied at voltages below a) or from a sole source: lugs of supply cords do not fit MAINS sockets above rated SULY voltage MAINS type plugs used only for connection to MAINS supply lug pins which receive a charge from an internal capacitor (see Form A.5) Accessory MAINS socket outlets: a) marking if accepts a standard MAINS supply plug (see 5.1.3e) b) input has a protective earth conductor if outlet has EARTH TERMINAL CONTACT 6.11 Disconnection from supply source Disconnects all current-carrying conductors Exceptions Requirements according to type of equipment ERMANENTLY CONNECTED EQUIMENT and multi-phase equipment Employs switch or circuit-breaker If switch or circuit-breaker is not part of the equipment, documentation requires: a) switch or circuit-breaker to be included in building installation b) suitable location easily reached c) marking as disconnecting for the equipment Single-phase cord-connected equipment

25 age 25 Of 4 Equipment is provided with one of the following: a) switch or circuit-breaker b) appliance coupler (disconnectable without tool) c) separable plug (without locking device) Disconnecting devices Disconnecting device part of equipment - Electrically close to the SULY ower-consuming components not electrically located between the supply source and the disconnecting device Except electromagnetic interference suppression circuits permitted to be located on the supply side of the disconnecting device Switches and circuit-breakers - When used as disconnection device: Meets IEC and IEC Marked to indicate function...: Not incorporated in MAINS cord Does not interrupt ROTECTIVE EARTH CONDUCTOR Appliance couplers and plugs Where an appliance coupler or separable plug is used as the disconnecting device (see ): Readily identifiable and easily reached by the operator Single-phase portable equipment cord length not more than 3 m ROTECTIVE EARTH CONDUCTOR connected first and disconnected last 7 ROTECTION AGAINST MECHANICAL HAZARDS Equipment does not cause a mechanical HAZARD in NORMAL nor in SINGLE FAULT CONDITION Conformity is checked by 7.2 to Sharp edges Easily touched parts are smooth and rounded Do not cause injury during NORMAL USE and Do not cause injury during SINGLE FAULT CONDITION 7.3 Moving parts HAZARDS from moving parts limited to a tolerable level with the conditions specified in and RISK assessment in accordance with carried out

26 age 26 Of Exceptions Access to HAZARDOUS moving parts permitted under following circumstances: a) obviously intended to operate on parts or materials external of the equipment inadvertent touching of moving parts minimized by equipment design (e.g. guards or handles) b) If OERATOR access is unavoidable outside NORMAL USE following precautions have been taken: 1) access requires TOOL 2) statement about training in the instructions 3) warning markings on covers prohibiting access by untrained OERATORS or symbol 14 with full details in documentation RISK assessment for mechanical HAZARDS to body parts RISK is reduced to a tolerable level by protective measures as specified in table 12 Minimum protective measures: A. Low level measures B. Moderate measures C. Stringent measures Limitation of force and pressure (see Form A.20) Following levels are met in NORMAL and SINGLE FAULT CONDITION: Continuous contact pressure below 50 N / cm² with force below 150 N Temporary force below 250 N for an area at least of 3 cm² for a maximum duration of 0,75 s Gap limitations between moving parts (see Form A.20) Access normally allowed If levels of exceeded and body part may be inserted minimum gap as specified in table 13 assured in NORMAL and in SINGLE FAULT CONDITION Access normally prevented Maximum gap as specified in table 14 assured in NORMAL and in SINGLE FAULT CONDITION 7.4 Stability Equipment not secured to building structure is physical stable Stability maintained after opening of drawers etc. by automatic means, or

27 age 27 Of 4 warning marking requires the application of means Compliance checked by following tests as applicable: a) 10 tilt test for other than handheld equipment b) multi-directional force test for equipment exceeds height of 1 m and mass of 25 kg c) downward force test for floor-standing equipment d) overload test with 4 times maximum load for castor or support that supports greatest load e) castor or support that supports greatest load removed from equipment 7.5 rovisions for lifting and carrying Equipment more than 18 kg : Has means for lifting or carrying; or Directions in documentation Handles and grips Handles or grips withstand four times weight Lifting devices and supporting parts RATED for maximum load; or tested with four times maximum static load 7.6 Wall mounting Mounting brackets withstand four times weight 7.7 Expelled parts Equipment contains or limits the energy rotection not removable without the aid of a tool 8 RESISTANCE TO MECHANICAL STRESSES Equipment does not cause a HAZARD when subjected to mechanical stresses in NORMAL USE Normal protection level is 5 J Levels below 5 J but not less than 1 J are acceptable if all of following criteria are met: a) lower level justified by RISK assessment of manufacturer b) equipment installed in its intended application is not easily touched A enclosure is made from steel plate. It is enough robust to clear following test. c) only occasional access during NORMAL USE d) IK code in accordance to IEC marked or symbol 14 used with full information in the documentation

28 age 28 Of 4 for non-metallic ENCLOSURES rated below 2 C ambient temperature value chosen for minimum RATED temperature impact energies between IK values, the IK code marked for nearest lower value Conformity is checked by performing following tests: 1) static test of ) impact test of with 5 J except for HAND-HELD EQUIMENT if impact energy not selected to 5 J alternate method of IEC used 3) drop test of or except for FIXED EQUIMENT and equipment with mass over 100 kg Equipment RATED with an impact rating of IK 08 that obviously meets the criteria After the tests inspection with following results: HAZARDOUS LIVE parts above the limits of not ACCESSIBLE checked insulation pass the voltage tests of 6.8 checked i) no leaks of corrosive and harmful substances checked ii) ENCLOSURE shows no cracks resulting in a HAZARD checked iii) CLEARANCES not less than their permitted values checked iv) insulation of internal wiring remains undamaged checked v) ROTECTIVE BARRIERS not damaged or loosened checked vi) No moving parts exposed, except permitted by 7.3 vii) no damage which could cause spread of fire checked 8.2 ENCLOSURE rigidity test Static test By design, it is cleared 30 N with 12 mm rod to each part of ENCLOSURE checked in case of doubt test conducted at maximum RATED ambient temperature checked Impact test By design, it is cleared Impact applied to any part of ENCLOSURE causing a HAZARD if damaged checked Impact energy level and corresponding IK code...: Non-metallic ENCLOSURES cooled to minimum RATED ambient temperature if below 2 C 8.3 Drop test Other than HAND-HELD and DIRECT-LUG-IN EQUIMENT Tests conducted with a drop height or angle of... : -

29 age 29 Of HAND-HELD and DIRECT-LUG-IN EQUIMENT Non-metallic ENCLOSURES cooled to minimum RATED ambient temperature if below 2 C Drop test conducted with an height of 1 m 9 ROTECTION AGAINST THE SREAD OF FIRE 9.1 No spread of fire in NORMAL and SINGLE FAULT CONDITION MAINS supplied equipment meets requirements of 9.6 additionally Conformity is checked by minimum one or a combination of the following (see Figure 11): (see Form A.22) a) SINGLE FAULT test of 4.4; or (see Form A.1) b) Application of 9.2 (eliminating or reducing the sources of ignition); or c) Application of 9.3 (containment of fire within the equipment) 9.2 Eliminating or reducing the sources of ignition within the equipment a) 1) Limited-energy circuit (see 9.4); or - b) 2) BASIC INSULATION provided for parts of different potential; or (see Form A.14 and A.18) - Bridging the insulation does not cause ignition (see Form A.1) - c) Surface temperature of liquids and parts (see 9.5) d) No ignition in circuits designed to produce heat (see Form A.1) 9.3 Containment of the fire within the equipment, should it occur Spread of fire outside equipment reduced to a tolerable level if: a) Energizing of the equipment is controlled by an OERATOR held switch b) ENCLOSURE is conform with constructional requirements of 9.3.2; and Requirements of 9.5 are met Constructional requirements a) Connectors and insulating material have flammability classification V-2 or better b) Insulated wires and cables are flame retardant (VW-1 or equivalent) (see TABLE 1 or Form A.23) (see TABLE 1 or Form A.23) c) ENCLOSURE meets following requirements: (see Form A.22) 1) Bottom and sides in arc of 5 (see Figure 13) to non-limited circuits (9.4) meets: - - -

30 age 30 Of 4 i) no openings; or ii) perforated as specified in table 16; or - iii) metal screen with a mesh; or - iv) baffles as specified in Figure 12-2) Material of ENCLOSURE and any baffle or flame barrier is made of: Metal (except magnesium); or - Non-metallic materials have flammability classification V-1 or better 3) ENCLOSURE and any baffle or flame barrier have adequate rigidity (see TABLE 1 or Form A.22) Limited-energy circuit (see Form A.24) - a) otential not more than 30 r.m.s. and 42,4 V peak, or 60 V dc 12V or less b) Current limited by one of following means: 1) Inherently or by impedance (see table 17); or 2) Overcurrent protective device (see table 18); or 3) A regulating network limits also in SINGLE FAULT CONDITION (see table 17) Fuse on CB is 5A c) Is separated by at least BASIC INSULATION - Fuse or a nonadjustable electromechanical device is used 9.5 Requirements for equipment containing or using flammable liquids Flammable liquids contained in or specified for use with equipment do not cause spread of fire (see Form A.25) RISK is reduced to a tolerable level: a) The temperature of surface or parts in contact with flammable liquids is 25 C below fire point b) The quantity of liquid is limited c) Flames are contained within the equipment Detailed instructions for RISK-reduction provided 9.6 Overcurrent protection MAINS supplied equipment protected BASIC INSULATION between MAINS parts of opposite polarity provided Devices not in the protective conductor Fuses or single-pole circuit-breakers not fitted in neutral (multi-phase) (see Form A.14 and A.15) ERMANENTLY CONNECTED EQUIMENT - - -

31 age 31 Of 4 Overcurrent protection device: Fitted within the equipment; or Specified in manufacturer's instructions Other equipment rotection within the equipment 10 EQUIMENT TEMERATURE LIMITS AND RESISTANCE TO HEAT 10.1 Surface temperature limits for protection against burns Easily touched surfaces within the limits in NORMAL and in SINGLE FAULT CONDITION: (see Form A.26A) at an specified ambient temperature of 40 C Ref3, Ref4 for equipment rated above 40 C ambient temperature limits not exceeded raised by the difference to 40 C Heated surfaces necessary for functional reasons exceeding specified values: Are recognizable as such by appearance or function; or Are marked with symbol 13 Guards are not removable without tool 10.2 Temperatures of windings Limits not exceeded in: (see Form A.26B) NORMAL CONDITION SINGLE FAULT CONDITION 10.3 Other temperature measurements IR Thermo camera Following measurements conducted if applicable: (see Form A.26A) a) Value of 60 C of field-wiring terminal box not exceeded b) Surface of flammable liquids and parts in contact with this liquids c) Surface of non-metallic ENCLOSURES d) arts made of insulating material supporting parts connected to MAINS supply measured e) Terminals carrying a current more than 0,5 A measured 10.4 Conduct of temperature tests Tests conducted under reference test conditions and manufacturer s instructions (see Form A.26A) Temperature measurement of heating equipment Tests conducted in test corner (see Form A.26A) Equipment intended for installation in a cabinet or wall

32 age 32 Of 4 Equipment built in as specified in installation instructions (see Form A.26A) 10.5 Resistance to heat Integrity of CLEARANCE and CREEAGE DISTANCES (see Form A.16) Non-metallic ENCLOSURES (see Form A.27) Within 10 min after treatment: Equipment subjected to suitable stresses of 8.2 and 8.3 complying with criteria of Insulating material - a) arts supporting parts connected to MAINS supply All parts are confirmed b) TERMINALS carrying a current more than 0,5 A All parts are confirmed Examination of material data; or in case of doubt: 1) Ball pressure test; or (see Form A.28) 2) Vicat softening test of ISO 306 (see Form A.29) 11 ROTECTION AGAINST HAZARDS FROM FLUIDS rotection to OERATORS and surrounding area provided by EQUIMENT All fluids specified by manufacturer considered The equipment must be used in biological laboratory Cleaning (see Form A.30) 11.3 Spillage (see Form A.30) 11.4 Overflow (see Form A.30) 11.5 Battery electrolyte Battery electrolyte leakage presents no HAZARD 11.6 Specially protected equipment (see Form A.30) 11.7 Fluid pressure and leakage Maximum pressure... : Maximum pressure of any part does not exceed RATED (see Form A.31) Leakage and rupture at high pressure Fluid-containing parts subjected to hydraulic test if...: (see Form A.31) a) product of pressure and volume > 200 kal; and b) pressure > 50 ka arts of refrigerating systems meets pressure-related requirements of IEC or IEC Leakage from low-pressure parts (see Form A.32)

33 age 33 Of Overpressure safety device Does not operate in NORMAL USE a) Connected as close as possible to parts intended to be protected b) Easy access for inspection, maintenance and repair c) Adjustment only with TOOL d) No discharge towards person e) No HAZARD from deposit of discharged material f) Adequate discharge capacity No shut-off valve between overpressure safety device and protected parts 12 ROTECTION AGAINST RADIATION, INCLUDING LASER SOURCES, AND AGAINST SONIC AND ULTRASONIC RESSURE 12.1 Equipment provides protection 12.2 Equipment producing ionizing radiation Ionizing radiation (see Form A.33) Equipment meets the following requirements: a) if intended to emit radiation meets requirements of ; or tested, classified and marked in accordance to IEC b) if only emits stray radiation meets requirements of Equipment intended to emit radiation Effective dose rate of radiation measured... : If dose rate exceeds 5 µsv/h marked with the following: a) symbol 17 (ISO 361) b) abbreviations of the radionuclides...: c) with maximum dose at 1 m; or...: with dose rate value between 1 µsv/h and 5 µsv/h in m... : Equipment not intended to emit radiation (see Form A.34) Limit for unintended stray radiation of 1 µsv/h at any easily reached point kept... : Accelerated electrons Compartments opened only by the use of a TOOL 12.3 Ultraviolet (UV) radiation No unintentional HAZARDOUS escape of UV radiation:

34 age 34 Of 4 checked by inspection; and evaluation of RISK assessment documentation 12.4 Microwave radiation ower density does not exceed 10 W/m 2... : 12.5 Sonic and ultrasonic pressure Sound level (see Form A.35) No HAZARDOUS sound emission Maximum sound pressure level measured and calculated for maximum sound power level as specified in ISO 3746 or ISO Instruction describes measures for protection Ultrasonic pressure (see Form A.36) Equipment not intended to emit ultrasound does not exceed limit of 110 db between 20 khz and 100 khz Equipment intended to emit ultrasound: Outside useful beam does not exceed limit of 110 db between 20 khz and 100 khz If inside useful beam above values exceeded: Marked with Symbol 14 of table 1 and following information in the documentation: a) dimensions of useful beam b) area where ultrasonic pressure exceed 110 db c) maximum sound pressure inside beam area 12.6 Laser sources Equipment meets requirements of IEC ROTECTION AGAINST LIBERATED GASES AND SUBSTANCES, EXLOSION AND IMLOSION 13.1 oisonous and injurious gases and substances No poisonous or injurious gases or substances liberated in NORMAL CONDITION Attached data/test reports demonstrate conformity 13.2 Explosion and implosion Components Components liable to explode: ressure release device provided; or Apparatus incorporates operator protection (see also 7.7) ressure release device: Discharge without danger