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Date Document Project Nr.

61/5947/CDV IEC 60335-2-115 ED1

MB/NC Line number(e.g. 17)

Clause/ Subclause(e.g. 3.1)

Paragraph/ Figure/ Table/

(e.g. Table 1)

Type of comment

Comments Proposed change Observations of the SecretariatObservations of PT 60335-2-115

1 FI01 ge The Finnish NC is in favour of this document but wishes to submit the following comment.

NotedPT agrees with the Observation of the Secretariat

2 DK01 ge The DK NC does not support the proposal.

Comments have not been discussed in sufficient depth at plenary meetings, and the PT have not had sufficient guidance from the TC. In this process we are not convinced that all our previous comments (for proposals 61/5788/CD and 61/5881/CD) have been considered.

As a result, we do not find that the current proposal provides the necessary clarity (for example in the scope) and in part does not provide for an adequate level of safety.

Delete the proposal Not accepted. The CDV is approved to proceed to FDIS.The RVC will be discussed at the next meeting of TC 61 and will be put on the agenda along with other RVCs relating to Parts 2-4, 2-30 and 2-53 as the first technical items for discussion.PT agrees with the Observation of the Secretariat

3 DE01 1288104202

1, 5,101

te The title of the standard has been changed to “skin beauty care appliance”. The same term shall be used in the main part of this standard.

change the “beauty care appliances” to “skin beauty care appliances”

Not accepted.Also See 5It would remove many appliances from the scope of the standard.

4 NL0112

88104212

Front pageIntroductionScopeScope5.101

ed The title of the standard has been changed to “skin beauty care appliance”. The same term shall be used in the rest of the document.

Change “beauty care appliances” to “skin beauty care appliances”

See 3 and 5PT agrees with the Observation of the Secretariat

5 JP01 83 te The term “skin” should be deleted in some portions for the following reasons.

Remove the term of “skin” as the following. Accepted

1

23

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(e.g. Table 1)

Type of comment


94

In order to distinguish from IEC 60335-2-23, "skin" was added at the front of "beauty care" in line 83 and line 94 in CDV, but this modification gives problems:

(1) Misinterpretation that beauty appliances that stimulates muscles are excluded from the scope.

(2) This doesn't harmonize with the following.

line 88:

This part of IEC 60335 deals with the safety of electric appliances for beauty care of persons and intended for household, commercial and similar purposes, their rated voltage being not more than 250 V.

line104:

–Beauty care appliances with ultrasonic outputs;

line106:

–Beauty care appliances for melting wax;

line83:

Part 2-115: Particular requirements for skin beauty care appliances

line94:

– Battery-operated appliances and other DC supplied appliances for skin beauty care;

6 DK02 88-140 1 te Despite improvements over previous proposals, the scope is still vague and does not ensure a clear determination of appliances covered by this standard.

Line 88-90 are very generic and would also cover all appliances (appart from those for animals) within the scope of -2-23. It should instead name the essential characteristics

Provide a clearer and identifying scope. Not accepted.

The scope as written follows the ISO/IEC Directives Part 2 concerning the use of Notes and it also follows the style used in many 60335 Parts 2 standards

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(e.g. Table 1)

Type of comment


which the appliances within the scope, have in common.

The scope does not follow the usual 60335 templates where examples of products in scope and outside scope are provided as a note. Instead, the scope is defined only by examples and not by the naming of characteristics.

With the above in mind, DK NC do not think that, IEC guide 104, clause 5.2.2 requiring a product standard scope to contain:“the description of the product or product family with its basic functions,” is fulfilled.

The scope must be sufficiently clear to ensure that the standard is only being applied to appliances for which it is intended and for which it provides correct and adequate requirements.

such as Part 2-14, 2-15, 2-23, 2-97. 2-103 etc. In future editions on these standards the scope will be aligned with the Directives as per Part 2-115.PT agrees with the Observation of the Secretariat

7 JP02 101 1 te In line 101, one of covered appliances overlaps with the following.

- Another covered appliance in line 95-96: Appliances with high frequency outputs including equipment for heat-producing effects on the skin

- Excluded appliance in line140: radio frequency appliances without contact to the skin

Delete line 101.

–Appliances using electro-magnetic fields (radio frequencies).

Accepted

8 FI02 126-140

1 ed We propose to add ultrasound appliances provided with focusing ultrasound transducers into a list of appliances which are not falling under the scope of this standard.Reason: On lines 709-710 (clause 22.115) it is said as follows: The treatment head of the ultrasound appliance shall contain only one

We propose to add into a list of appliances which are not falling under the scope of this standard the following:

- Ultrasound appliances provided with focusing ultrasound transducers.

AcceptedAlso in line 709-710, reposition the word “flat” after the word ‘one”.

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(e.g. Table 1)

Type of comment


single circle shaped, flat non-focusing ultrasound transducer.

9 DE02 163-164

3.1.9 te The relevant normal operation of appliances having steam-producing or spray-producing devices in IEC 60335-2-23 is defined as:“Appliances having steam-producing or spray-producing devices are operated with the container empty or filled, whichever is more unfavourable. However, if the appliance is marked to indicate that it is to be used with the container filled, the container is filled. Water is added, when necessary, to compensate for evaporation.”Similar normal operation condition shall also be applied in part 2-115.

Change line 163-164 to the following:“Appliances having vapour-producing or spray-producing devices are operated with the container empty or filled, whichever is more unfavourable. However, if the appliance is marked to indicate that it is to be used with the container filled, the container is filled. Liquid is added, when necessary, to compensate for evaporation.”

Not accepted. For these appliances operating empty is considered abnormal operation – see 19.2.Over filling is covered by 15.2 of Part 1.PT agrees with the Observation of the Secretariat

10 NL02 163-164

3.1.9 te Harmonise this requirement with the requirements in IEC 60335-2-23 for appliances having steam-producing or spray-producing devices.

Change line 163-164 as follows:

“Appliances also producing having vapour-producingor spray producing devices are operated in the normal position of use and filled with liquidthe container empty or filled, whichever is more unfavourable.However, if the appliance is marked to indicate that it is to be used with the container filled, the container is filled. Liquid is added, when necessary, to compensate for evaporation.”

See 9PT agrees with the Observation of the Secretariat

11 DE03 180 3.5.102 ed “…vapour of liquid…” should be “…vapour or liquid….”

Change “of “ to “or” AcceptedPT agrees with the Observation of the Secretariat

12 DK03 210-211

5.10 te It does not appear appropriate or necessary that the relevant load shall be detailed by the manufacturer. Cl. 10.101 and 10.102 already indicate that a load resistor resulting in the maximum input power and current shall be applied. This should be sufficient to allow the test be carried out without additional specification

Delete line 210-211 Not accepted. The intent is to require the manufacturer to provide the details if the content of lines 380-382 or 396-398 are applicable.Referred to EG1PT agrees with the Observation of the Secretariat

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(e.g. Table 1)

Type of comment


13 NL03 216 5.102 te The word ‘powdered’ is missing as was determined in 61/5926a/CC (NL08) .

Add the word powdered as follows:The agar to be used for the test is prepared by mixing 6 g food grade powdered agar with 100 ml of water

Accepted to add “powdered” PT agrees with the Observation of the Secretariat

14 DE04 221 6.1 te According to IEC 60335-2-23/ cl.6.1: “…other steam-producing or spray producing appliances shall be class II or class III. “Same requirement shall also be applied for vapour or spray producing appliances under part 2-115

Change the sentence to the following: “Hand-held appliances, appliance incorporating vapour-producing or spray-producing and appliances that are washable according to the instructions shall be class II or class III.


15 NL04 221 6.1 te Harmonise this requirement with the requirements in IEC 60335-2-23 for appliances having steam-producing or spray-producing devices.

Modify as follows:“Hand-held appliances, appliance incorporating vapour-producing or spray-producing and appliances that are washable according to the instructions shall be class II or class III.

Accepted to add “appliances incorporating vapour-producing or spray producing” after “hand-held appliances” in line 221.Since Part 2-23 allows Class I for such appliances used by hair dressers.Add the following paragraph after line 222Appliances incorporating vapour producing or spray producing devices for use in beauty parlours and similar premises only may be Class I

Respectively, in line 676 table 104 ,in the second row we change “appliance for use in beauty parlours” to “appliance for use in beauty parlours and similar premises only”

16 DE05 224-225

6.2 te Clause 22.26 requires:”Hand-held parts of an appliance that can be cleaned under water according to the instructions shall be of class III construction having a working voltage not exceeding 24 V.”Line 228 states: “This classification does not

Change “hand-held parts of an appliance….” to“appliances that are washable according to the instructions”

Accepted.PT agrees with the Observation of the Secretariat

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(e.g. Table 1)

Type of comment


apply to parts of class III construction “Combine above two standard requirements, the clause 6.2 (line 224-225) requirement “hand-held parts of an appliance which can be cleaned under water according to the instructions shall be at least IPX7“ becomes invalid.

17 DK04 233 6.101 te How can compliance with this requirement be determined by tests?Which tests would that be?

Delete the part of line 233 that reads “and by the relevant tests”

Not accepted. The test specification is completely in line the Part 1 and other Parts 2 that have additional classification clausesPT agrees with the Observation of the Secretariat

18 NL05 243 7.1 te Harmonise warning with the meaning of symbol ISO 7010-P026 (2011-05) and to make sure it is in line with the explanation for the symbol as given in 7.12 (line 267).

Modify as follows:

WARNING: Do not use this appliance in a bathtub, shower, or water filled reservoir. near water.

AcceptedPT agrees with the Observation of the Secretariat

19 DK05 254 7.6 te In line with previous DK NC comments the sign for “not for household use” is not clear and cannot be expected to be generally understood by the general public and might lead to confusion.

It is also not a standardized sign covered by IEC 60417 or ISO 7000

As such the sign shall not be used in this standard.

The sign shall be proposed and accepted in IEC 60417 or in ISO 7000 before it can be used in this standard.

Not acceptedThis is a prohibition sign it is not a symbol. It used in other Parts 2 such as 2-27 and 2-113.PT agrees with the Observation of the Secretariat

20 NL06 289 7.12 ed Add space after the word ‘time’. Add space after the word ‘time’. AcceptedPT agrees with the Observation of the Secretariat

21 DE06 297 7.12 te For household environment, it is nearly possible for user judge “the depth of penetration on the face shall not exceed 0,5 mm (not applicable if a control limiting the penetration to a depth not exceeding 0,5 mm

Delete this sentence in 7.12, instead, add in 22.11 1 the following sentence:“The appliance used on the face shall be provided with a control limiting the

Accepted to delete the dashed item in 7.12 (line 297-298)Add in 6.101 the

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(e.g. Table 1)

Type of comment


is provided)”.To mention this requirement just in user manual would not give enough safety for the household user to properly operate.

penetration to a depth not exceeding 0,5mm.”

substances of the following:

Needling appliances shall be appliances for use in beauty parlours and similar premises only.

Referred to EG1

Change the test specification of 22.111 (line 688) to the following: Appliance is applied on the artificial skin without extra download pressure, other than the weight of the appliance itself.

22 NL07 297 7.12 ed Delete comma after ‘mm’. Delete comma after ‘mm’. Accepted

PT agrees with the Observation of the Secretariat

23 DE07 309 7.12 ed Type error “shaving” should be “having” “shaving” should be “having” Accepted and “appliance” should be “appliances”


24 NL08 309 7.12 ed Typo. “shaving” should be “having” Modify “shaving” to “having” Accepted


25 DE08 313 7.12 ed Sentence repeats line 302 Delete it Accepted

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(e.g. Table 1)

Type of comment



26 CN01 322-327

7.12 For appliances capable of producing vapour, additional warnings are needed. Add a dashed item after line 327:

-Warning: Contact with the overheated nozzle may cause burns.

- Do not use in subjects with capillary fragility or telangiectasia (dilated capillaries).

Not accepted Taking into account the temperature limits in 11.8 is the first dashed item necessary.

See lines 272 to 276PT agrees with the Observation of the Secretariat

27 JP03 327 7.12 te This requirement should not be applicable for vapour which contains only water, for the following reasons.

(1) Throughout the meeting for CD, the safety of vapour temperature is assured by the test of line456-457 in Clause 11.8.

In 61(Shanghai/PT60335-2-115)56, Observations of PT 60335-2-115 for Item 39 (JP 05) included the following, and it concluded that this requirement is based on a risk caused by substances other than water.

“Vapor may not just include water maybe include other substance.”

(2) According to the toxicity information in the Safety Data Sheet defined by GHS (Global

Add the underlined sentence as below.

–　Do not apply vapour to the eyes unless the eyes are covered by towelling or similar material, in case of vapour which includes substance other than water.

Not accepted

Comment 39 in 61/5926A/CC was not accepted.


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(e.g. Table 1)

Type of comment


Harmonized System of Classification and Labeling of Chemicals), Water is classified as non-irritating and irritating to eyes. This requirement is not needed for vapour which contains only water.

28 CN02 328-329

7.12 For radio frequency appliances, additional instructions are needed. After line 329, add the following:

Do not use in people with a pacemaker or an internal defibrillator.

To reduce the contact resistance between electrodes and skin and reduce emissions, use a liquid/gel/conducting cream.

Parts that come into contact with the skin must be cleaned between one treatment and the other using the reported normal cleaning methods in the user manual provided by the manufacturer.

Not accepted

See lines 277 – 278

See line 288

See line 287PT agrees with the Observation of the Secretariat

29 NZ01 341 7.12 NOS te It is necessary to distinguish between appliances that produce a continuous pulse train (see AA.1.1) and appliances that produce burst of pulses or single pulses (see AA.1.2).

Add an instruction that appliances that produced a continuous pulse train the treatment head must be continuously moved during application.For appliances that produce a burst of pulses, the maximum number of pulses in a burst should be limited (value to be decided could be one or more) so as to distinguished this type of appliance from that producing a continuous pulse train. Operation of the application switch shall only produce a single burst of pulses. Re-application of a burst shall require a manual action (i.e operating the application switch again).

Clarify what is the continuous pulse train, and what is the burst of pulse:Add a note:Continuous pulse train: time may not be limited until you release the switch. Single burst of pulse or burst of pulse: produce pulse output: time is limited regardless you press the button In line 976, change “6 min” to “360s”.Based on the above refer to “Annex for comment 29” for a rewrite of Annex AA and as a consequence

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(e.g. Table 1)

Type of comment


changes to lines 259 to 260 in 7.10, lines 328 to 339 in 7.12 and 22.110

30 CN03 345-348

7.12 For ultrasound appliances, additional instructions are needed. Add the following instructions after line 348:

Check the constant presence of special gel, during operation

To ensure perfect contact between applicator and skin, apply some gel on the area to be treated.

Do not treat people with sensitive skin and/or gel intolerance conductive.

Do not use on subjects with active hearing implants and/or with hearing problems.

Not accepted.Covered by lines 271 to 290PT agrees with the Observation of the Secretariat

31 DE09 350 7.12 te For household environment, how can user judge “the plasma discharge shall not be applied for longer than 1 s;” it is nearly possible.To mention this requirement just in user manual would not give the safety.

Add requirement in clause 22.113 or 22.114,

“for plasma pen, the discharge time shall not be longer than 1 s. an over discharge protection shall be provided with the appliance.

Accepted in principleAnd add the following in 22.114, :for household appliances the arc shall not exceed 1 s

Referred to EG1.32 NL09 350 7.12 te It will be difficult or near impossible for the

average user to determine if a discharge is longer than 1 second. It seems this should be a design requirement not an instruction.

Delete line 350

Add requirement in clause 22.113 or 22.114, “for plasma pen, the discharge time shall not be longer than 1 s. an over discharge protection shall be provided with the appliance.

Not accepted.

See 31

33 CN04 351 7.12 For appliances having vacuum-pressure functions, additional instructions are needed.

After line 351 add the following: The instructions for appliances having vacuum-pressure functions, shall state the following:

Slide the suction cannula onto the surface to be treated, by carefully verifying the integrity of the cannula before of the

Accepted in principle.Rewrite with the substance of the followings:

Before use the suction head , visual inspection is

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(e.g. Table 1)

Type of comment


application on the subject. made to ensure the suction head is not damaged

22.107 is rewritten as follows:Delete the third dashed item;Modify the first dashed item as follows:Suction pressure shall not exceed 75kPa .

34 DE10 363364

8.1 te The output rating is defined in 22.104 for the electrical stimulators and in 22.110 for the radio frequency appliances.For better understanding it should be stated the explanation in clause 8.1.

add in line 364:after "considered to be live parts "add "as long as the clause 22.104 and 22.110 requirement is full filed. "

Not necessary – if 22.104 and 22.110 are not fulfilled the appliances does not comply with the standard.PT agrees with the Observation of the Secretariat

35 DK06 363-364

8 te In line with previous DK NC comments the proposed addition does not contain any requirements, limitations or otherwise condition to ensure that these parts are not to be considered as liveIt is understood that the addition in line 564 and 565 is providing some isolation from the mains but this is not sufficient to ensure safety of the relevant applied parts.

It is further noted that the additional requirements provided in cl. 22.104 (from line 597) only cover “electrical stimulators”. This leaves “radio frequency appliance without additional requirements ensuring protection against shock.

Without other appropriate requirements to protect against electric shock from all parts of all appliances covered, this addition is a critical breach of the safety principle in the standard.

Delete line 363-364 Not accepted because of the allowed output limits in 22.104 and 22.110. These limits are necessary for the appliance to perform its function.PT agrees with the Observation of the Secretariat

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(e.g. Table 1)

Type of comment


36 DE11 369 10.101 ed “electrical stimulatorshall” shall be “electrical stimulator shall”, a space is missing

Insert space AcceptedPT agrees with the Observation of the Secretariat

37 NL10 369 10.101 ed Typo “stimulatorsshall” should be “stimulators shall”

Modify “stimulatorsshall””into “stimulators shall”


38 US01 369 10.101 ed Need a space between the words “stimulators shall”


39 DE12 371 10.101 ed “1or” should be “ 1 or”. A space is missing Insert space AcceptedPT agrees with the Observation of the Secretariat

40 NL11 371 10.101 ed Typo “1or” should be “1 or” Modify “1or” into “1 or” See 39PT agrees with the Observation of the Secretariat

41 DE13 373 10.101 ed “rated voltagewitha” shall be “ rated voltage with a “ 2 spaces are missing

Insert space (2times) AcceptedPT agrees with the Observation of the Secretariat

42 NL12 373 10.101 ed Typo “rated voltagewitha” should be “rated voltage with a”

Modify “rated voltagewitha” into “rated voltage with a”


43 US02 373 10.101 ed Spaces needed between ”voltage with a “ See 41PT agrees with the Observation of the Secretariat

44 DE14 414 11.3 te “the measurement is performed after a contact period of 30 s” is not proper for appliance that can only be operated when in contact with the skin and normal skin contact stated in the instruction less than 30s.

Add the following sentence after line 414,“for appliance that can only be operated when in contact with the skin and normal skin contact stated in the instruction less than 30s, the measurement is started

Not accepted

The test probe measures the accessible surface’s temperature when the

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(e.g. Table 1)

Type of comment


The temperature rise of applied parts are according to the instructions as listed in table 101-103. The accessible surface temperature rise shall then apply for the same time period.

immediately when the skin contact is established.”

operating temperature is reached according to 11.7

45 DK07 436-442

11.8 te In line with previous DK NC comments the proposal to apply temperature limits based on the contact time is not acceptable.In this way the safety of the appliance directly depends on the user’s adherence to the specifications of the instructions.

This is not in line with the principle of safety integration (IEC guide 116) in which protection based on inherently safe design or the use of implemented safeguards shall take priority over information for use.

It cannot be expected that users are respecting the contact times stated in the instructions and so with the proposed limits there may be a risk of burns. The problem is worsened by the fact that the applied part may be applied by a different person who cannot of course respond to any perceived pain and remove the applied part.

Provide specific limiting values that ensures that there is not risk of burns even if the recommended contact times with the skin are exceeded.

Not accepted. No limiting values have been proposed and IEC guide 116 deals with “Guidelines for safety related risk assessment and risk reduction for low voltage Equipment”

The limits in 11.8 are base on the lower curve from IEC Guide 117 and as stated in the guide no burn is expected up to this limit.PT agrees with the Observation of the Secretariat

46 US03 444 Table 102 ed Add unit reference (t) in first row (to be consistent with table 103)


47 DE15 459 11.8 te “The temperature for surfaces of cooling appliances shall not be less than 0 °C.” If the “surfaces” meant “applied parts” the standard definition shall be used

Replace “surfaces” with “applied parts” AcceptedPT agrees with the Observation of the Secretariat

48 NL13 459 11.8 te Which surfaces of cooling appliances are intended? Surfaces applied to the skin?

Modify as follows:The temperature of applied partsfor surfaces of cooling appliances shall not be less than 0 °C

See 47 PT agrees with the Observation of the Secretariat

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(e.g. Table 1)

Type of comment


49 NL14 483 13.101 te As the leakage current is measured between the supply poles (e.g. mains supply) and the applied part, we see no reason to deviate from the leakage current limits in part 1 (e.g. 0,35 mA pk / 0,5 mA rms for class II constructions). Why should an appliance in part 2-115 have a lower leakage current from the mains supply than e.g. a shaver which has also a part applied to the human body (shaver head)?

In 61/5926a/CC to NL27 the observation was given that applied parts in 2-115 have electrical connections to the body while shavers have not. This is however not a valid rational as whether the applied part makes electrical connection to the body or not is not relevant for 13.101 as this clause deals with leakage current from mains supply to the applied part, which is a fully similar situation as a shaver with leakage current from mains to the shaver head. Further the observation mentions that the 0.1 mA limits was taken for the purpose of alignment with IEC 60601. Particular part IEC 60601-2-10 which was taken as an example for this part 2-115, does however not indicate any leakage current limits specifically for muscle and nerves stimulators meaning that the general leakage current limits from 60601-1 for Medical Electrical (ME) equipment apply for medical purpose muscle and nerves stimulators . In IEC 60335 series we are however not dealing with ME equipment and patients. Then why should we need to align with general IEC 60601leakage current limits for ME equipment, while we have our own leakage current limits in 60335-1 written for household appliances.

Modify as follows:The leakage current measured using the

circuit of Figure 105 shall not exceed 0,1mAthe limits specified in 13.2.

Not accepted.This kind of appliance is intended to apply the current to the human body. But the shaver is not intended to provide the current to the human body.The leakage current from the applied part aligns with IEC 60601-1 and compatible with the methodology of IEC 60990.The difference between a shaver and applied parts is clearly indicated in Figure105 which is based comment 107A in 61/5926A/CC.

50 NL15 490-491

16.2 te Though 16.2 states the text is an addition, the test specification will become clearer if the word also is added.

Modify as follows:For appliances with output circuits intended to make electrical connection to the human

Accepted in principle Referred to EG1.PT agrees with the

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(e.g. Table 1)

Type of comment


Further, in analogy to 13.2, the test is only applicable for appliances with output circuits intended to make electrical connection to the human body.Further some other editorial improvements.

body, the test voltage is also applied between live parts and the any output circuitsconnectedtogether.If there is more than one output circuit, the output circuits are connected together.

Observation of the Secretariat

51 NL16 492 16.2 te In line with NL14 the leakage current limits from 16.2 should be used instead of the general leakage current limit from 60601-1 for medical electrical equipment.

The leakage current measured using the circuit of Figure 105 shall not exceed 0,1 mAthe limits specified in 16.2.

Not acceptedSee 49

52 CN05 512 20.1 te Since in the recent versions of Part 2-8, 2-23, 2-32, 2-14, 2-52, the appliances which overturn are allowed as long as they comply with the necessary requirements.The appliances under Part 2-115 are similar with Part 2-23. So the same replacement of 20.1 shall apply.

Add 20.1 as follows:

20.1 Replacement:

Appliances, other than fixed appliances and hand-held appliances without a charging stand,intended to be used on a surface such as the floor or a table, shall have adequate stability.

Hand-held appliances with an integral rest shall have adequate stability when placed on theintegral rest.

Compliance is checked by the following test, appliances incorporating an appliance inlet beingfitted with an appropriate connector and flexible cord. Hand-held appliances are subjected tothe test while placed on their charging stand or integral rest.

The appliance, not connected to the supply mains, is placed in any normal position of use ona plane inclined at an angle of 10° to the horizontal, the supply cord resting on the inclinedplane in the most unfavourable position. However, if part of an appliance

Accepted.Aligns with Part 2-23.

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(e.g. Table 1)

Type of comment


comes into contact

with the horizontal supporting surface when the appliance is tilted through an angle of 10°, theappliance is placed on a horizontal support and tilted in the most unfavourable directionthrough an angle of 10°.

NOTE 101 The test on the horizontal support can be necessary for appliances provided with rollers, castors or

feet. In this case, castors or wheels can be blocked to prevent the appliance from rolling.

Appliances intended to be filled with liquid by the user in normal use are tested empty or filledwith the most unfavourable quantity of water up to the capacity indicated in the instructions.

The appliance shall not overturn unless the appliance or the part of the appliance which

overturns complies with all of the following:

– It only contains circuits operating at SELV according to 8.1.4;

– It only contains low power circuits according to 19.11.1;

– It is dropped from a height of 700 mm on a rigidly supported hard wood board 5 times, the

appliance being held in different positions likely to occur. After the drops, the appliance or

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(e.g. Table 1)

Type of comment


part of the appliance as relevant shall show no damage so that compliance with 15.1 and

20.2 is not impaired;

– It has a maximum weight of 450 g when ready for use;

– It does not have sharp edges when ready for use. An edge with a radius of 1 mm or moreis not considered a sharp edge.

The test is repeated on appliances with heating elements with the angle of inclination

increased to 15°. If the appliance overturns in one or more positions, it is subjected to the

tests of Clause 11 in each of these overturned positions.

During this test, temperature rises shall not exceed the values shown in Table 9.

53 DE16 513 20.101 te The same requirement shall also apply to appliance producing spray.

change the beginning of sentence to:“Vapour or spray emission…”

See 54

54 NL17 513 20.101 te Harmonise this requirement with the requirements in IEC 60335-2-23 for appliances having steam-producing or spray-producing devices.

Modify as follows:Vapouror spray emission from pressurised appliances shall be operated by a switch that automatically returns to the off-position when its actuating member is released.

Not accepted.There is no such requirement in Part 2-23.See also 22.102 lines 580-581 which clarifies the reason for 20.101.PT agrees with the Observation of the

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(e.g. Table 1)

Type of comment


Secretariat55 NL18 513 20.101 ed There is green text “operated by a switch”. Modify the colour of the text “operated by a

switch”Accepted

56 NL19 528-529

21.102 te As 24.2 of this part 2 allows any appliance (not only hand-held but also portable or stationary appliances) to be provided with a detachable power supply part, the requirement of 21.102 shall apply to all appliances and not only to hand-held appliances. For portable or stationary appliances there is even an increased risk of stepping-on (crushing) the power supply than for hand-held appliances since portable or stationary appliances may not be stored / are not stored after each use.As a consequence the part of the sentence stating ‘and a hand-held part of class III construction’ needs deletion.

Modify the first sentence of 21.102 as follows:For appliances with a detachable power supply part and a hand-held part of classIIIconstruction,the enclosure of the detachable power supply part shall have adequate mechanical strength against crushing.

Accepted.PT agrees with the Observation of the SecretariatSame deletion applies to 21.103, because of the text in 21.101.

57 DE17 540-541

21.102 te “The detachable power supply part shall not be damaged to such an extent that compliance with this standard is impaired.”

This sentence can be interpreted that the compliance with this standard from clause 1 to clause 32 shall not be impaired.

Modify the sentence as following: “The detachable power supply part shall not be damaged to such an extent that compliance with clause 8 and 29 is impaired, and it shall not emit flames or have molten material.”


58 NL20 540-542

21.102 te The current text is ambiguous. Modify as follows:“The detachable power supply part shall not be damaged to such an extent that compliance withthis standard is impaired. In particular,clause 8 and 29 is impaired, and it shall not emit flames or have molten material and the requirements of clauses 8 and 29 shall be fulfilled.”


59 CN06 564 ed Here, “they” refer to “the applied parts” not “appliances”

“they” changed to “the applied parts” Accepted

-19- 61(2020Web/PT60335-2-115)37




(e.g. Table 1)

Type of comment



60 DE18 564-565

22.26 te For electrical stimulators and radio frequency appliances, they shall be isolated from the supply mains through an isolating transformer.Isolating transformer is not defined!

Change “Isolating transformer” into “Safety Isolating transformer”.

Not accepted The major difference between an isolating transformer (IEC 61558-2-4) and a safety isolating transformer (IEC 61558-2-6) is the output voltage. IEC 61558-2-4 allows for a higher output voltage which is necessary for 22.104 and 22.110.PT agrees with the Observation of the Secretariat However, Add IEC 61558-2-4 in normative references of Clause 2.

Also add in 24.1.2 “The relevant standard for isolating transformers is IEC 61558-2-4. If they have to be tested, they are tested in accordance with Annex XX”.Add a definition of isolating transformer by using the term definition text of 3.4.3 but add “a voltage higher than” before “safety extra-low voltage”.

Add a new Annex XX using the text of Annex BB from IEC 60335-2-29 Ed 5.1

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(e.g. Table 1)

Type of comment


61 NL21 564-565

22.26 te Not the entire appliances need to be isolated, only those applied parts.

Modify as follows:Applied parts ofFor electrical stimulators and radio frequency appliances, they shall be isolated from the supply mains through an isolating transformer.

AcceptedPT agrees with the Observation of the SecretariatAlso See 59

62 DK08 597-627

22.104 te In line with previous DK NC comments the limits provided for the output current cannot be considered as safe.

In general, the limits provided in cl. 8.1.4 are those that are considered as safe (not considered to be a live voltage) The proposed limits are vastly exceeding cl. 8.1.4 limits and without a clear rationale showing that the proposed limits are still ensuring same level of safety, they cannot be considered as safe.Such rationale has not been provided.

In fact, the limits of up to 50mA are very high and depending on the path through the body may be near to the values that are known to cause significant physiological effects (electric shock). 35-40mA is known to be able to cause ventricular fibrillation at 50Hz whereas at higher frequencies the limits may be higher.

In addition, considering the influence of the frequency upon the current-tolerance in the body and hence the safety, substantial requirements for the stability of the output frequency and the reliability of the associated circuits and components must be given.

Provide adequate limit and requirements that will ensure a safe and risk-free use of the appliances following the safety principles of the IEC 60335-standards taking into consideration the limits provided in cl. 8.1.4.

Not accepted.See 35PT agrees with the Observation of the Secretariat

63 NL22 22.104 te From the text in 22.104 it is still not clear if the output must comply with the limits of all electrical quantities (current, voltage, …) or just one (e.g. if the current is below 2.5 mA the voltage may exceed 20 V, or not?).From 60601-2-10 it seems an output must

Add the word ‘all’ in line 598-599 as follows:For application to human body parts from the neck and above the output shall comply with all the following limits:Similar, add the word ‘all’ in line 607-608:

Accepted in principle.Make lines 600 to 602 into dashed items as per lines 609 to 613.Then because there is no use of the word “or” it

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(e.g. Table 1)

Type of comment


comply with all limits. For application to human body parts below the neck the output shall comply with all the following limits:

means all of the dashed item limits apply.

64 JP04 609-610

22.104 te Because the limit value of output current of electrical stimulators is specified as 50% of the current in IEC 60601-2-10, the limit of output voltage in the open circuit conditions also should be specified as 50% of the voltage in IEC 60601-2-10 (this means 250 V) to harmonize with the limit value of output current.

Change 200 V to 250 V as below.

The output voltage shall not exceed a peak value of 200 250 V, when measured under open-circuit conditions.

Accepted, also change “120 mJ” in line 612 to “150mJ’ in order to align with the 50% reduction from IEC 60101-2-10.

65 NL23 611-612

22.104 ed The test specification (lines 616-617) already indicates that the measurement is to be done with a resistance of 500 Ω. See also NL25.Further the word ‘for’ in line 612 can be deleted.

Modify as follows:For pulse durations of less than 0,1s the pulse energy with a load resistance of 500 Ω shall not exceed 120 mJ per pulse and for the output current shall not exceed the following:

AcceptedPT agrees with the Observation of the SecretariatSee also 64

66 CN07 612 ed Grammar error Delete “for” AcceptedPT agrees with the Observation of the Secretariat

67 JP05 612 22.104 ed A number of table is missing. Add a number of table. Accepted in principle referred to EG1.PT agrees with the Observation of the Secretariat

68 NL24 614-615

22.104 te/ed The text is a requirement and not a test specification. It shall therefore not be in italic font.And add a space after the word ‘exceed’ (615).

Change to non italic. AcceptedPT agrees with the Observation of the Secretariat

69 NL25 616-617

22.104 te The supply voltage must be specified at which the test/measurement is to be done.It must be specified that the test/measurement is to be done with any output amplitude control set to its maximum position.Further the output voltage is not to be measured with a 500 Ohm load as the voltage

Replace 616-617 by the following:Compliance is checked by inspection and measurement. The appliance is supplied at rated voltage with any output amplitude control set to its maximum position. The output current and pulse energy are measured using a non-inductive resistive

Accepted for rated voltage. The control position is covered by 5.6 of Part 1.PT agrees with the Observation of the SecretariatAlso add the last sentence

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(e.g. Table 1)

Type of comment


limits are open circuit voltages (see line 602 and 609/610). This is not clear from the text in 616-617.

load of 500 Ω. of the proposal by NL “output voltage is measured under the no-load condition”. Referred to EG1.

70 DK09 22.106 te In line with previous DK NC comments the use of different limiting values for the output depending on which part of the body they are intended to be used on is not acceptable.

In this way the safety of the appliance directly depends on the user’s adherence to the specifications of the instructions.

This is not in line with the principle of safety integration (IEC guide 116) in which protection based on inherently safe design or the use of implemented safeguards shall take priority over information for use.

It cannot be expected that users are applying the appliances correctly according to the instructions and so the safety of the appliance in terms of the risk of electric shock shall not depend on strictly following the instruction for use.

We have to keep in mind that the use of these appliances cannot be assumed to be entrusted only to specially qualified persons.

Provide limiting values that ensure the appliance is safe to use and does not pose a risk of electric shock without relying on user instructions.


71 JP06 632-635

22.106 te In 61/5926A/CC for 3rd CD, NL 35 was accepted and the resistance load was changed from 1000 Ω to 500 Ω for the reason that "IEC 60601-2-10 uses a 500 ohm load". However, this had a misunderstanding.

IEC 60601-2-10 specifies different values of load resistance in each clause. The requirement in clause 22.106 in the CDV is based on clause 201.12.4.103 in IEC 60601-2-10, which specifies 1000 Ω as a resistance

Change 500 Ω to 1000Ω as below.

An indication of the presence of an output under normal condition and under single fault condition shall be incorporated in electrical stimulators that can deliver into a load resistance of 5001 000 Ω an output in excess of 10 mA or 10 V or pulses having an energy exceeding 10 mJ per pulse. If the indication is by means of a signal lamp, its

Accepted for the reason given in the comment. Clause 201.12.4.103 in IEC 60601-2-10, specifies 1000 Ω as the resistance loadPT agrees with the Observation of the Secretariat

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(e.g. Table 1)

Type of comment


load. colour shall be yellow.

72 NL26 632-633

22.106 te The requirement in 22.106 states that the indication of output shall exist both under normal and abnormal conditions. The test specification mentions further that faults in electronic circuits must be applied if these are relied upon for compliance. This test specification together with the requirement could be interpreted as that faults shall to be applied in those electronic circuits that ensure compliance during normal or abnormal operation. This cannot be the meaning of 22.106.Note that in no any subclause of 22 of any part 2, where it is required to evaluate those electronic circuits that ensure compliance with the requirement, the term ‘under normal condition and under single fault condition’ is used in the requirement. See e.g. 22.104 of this part 2. It follows from the test specification that the requirement shall be maintained even under fault conditions in electronic circuits.

Modify the first sentence of 22.106 as follows:An indication of the presence of an output under normal condition and under single fault condition shall be incorporated in electrical stimulators that can deliver into a load 633 resistance of 500 Ω an output in excess of 10 mA or 10 V or pulses having an energy exceeding 10 mJ per pulse.

Accepted. But for the load value see 71PT agrees with the Observation of the Secretariat

73 NZ02 637-638

22.106 ed Wrong style for electronic circuit – it should be bold

Bold “electronic circuit” in two places AcceptedPT agrees with the Observation of the Secretariat

74 AU01 639 22.107 ed All three dashed items in clause 22.107 relate to not causing damage such as purpura to skin

add “suction pressure shall not cause damage such as purpura to skin ” to line 639 and delete the last dashed item

Accepted for line 639.PT agrees with the Observation of the SecretariatFor the last dashed item, See 33.

75 CN08 642 ed “use” is missing after “during normal” Add “use” after “during normal” AcceptedPT agrees with the Observation of the Secretariat

76 NZ03 644-645

22.107 te We doubt that this requirement can be met without conducting a test on real skin. The 75

Delete line 644-645 See 74

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(e.g. Table 1)

Type of comment


kPa limit is sufficient. PT agrees with the Observation of the Secretariat

77 CN09 645 22.107 te The diameter of cannula shall be limited to prevent excessive pressure. Add a dashed item after line 645:

a glass cannula, metal, plastic or other suitable material, not having a diameter of more than an inch.

Not accepted.In IEC standards we use metric dimensions and irrespective of the dimension the safety limit is given by the first dashed item.PT agrees with the Observation of the Secretariat

78 US04 651-653

22.107 te The evaluation of the software of a programmable control is included but the hardware component faults and electromagnetic phenomena are not currently included.

Add the following before line 651:

If compliance relies on the operation of an electronic circuit, the test is repeated under the following conditions applied separately:

– the fault conditions in a) to g) of 19.11.2 applied one at a time to the electronic circuit;

– the electromagnetic phenomena tests of 19.11.4.2 and 19.11.4.5 applied to the appliance.

Accepted.

79 JP07 663 22.110 te Regarding the requirement of RF appliances described in Clause 22.110 and ANNEX AA, in the last Web meeting for CD3, it was concluded that the conversion method was revised for CDV, and the content of the conversion method was changed from CD3 to CDV.

JPNC still wonders about the judgment (criteria) using SAR and the validity of the

Provide the measurement results using actual appliances carried out by each NC.

Provide the opinion about the confirmation for the validity of the CDV contents by each NC.

Noted.No proposal is made to change 22.110.PT agrees with the Observation of the Secretariat

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(e.g. Table 1)

Type of comment


conversion method (not the limit value),

80 US05 685-692

22.111 te The requirement as written in 685-686 does not indicate the maximum depth of skin penetration of the needles. Requirement should be in the normative portion of the sentence and not in the test. In addition, the last paragraph is a requirement, not a part of the test, so it should be moved to the requirement.

Modify 22.111 as follows:

22.111 The maximum depth of skin penetration of the needles in a micro-needling appliance shall be limited not exceed 1,00 mm.

If the depth of penetration can exceed 0.5 mm, then the appliance shall be provided with a control that allows the depth of penetration to be set. The control shall indicate the set depth of penetration.

Compliance is checked by inspection and measurement when the appliance is supplied at rated voltage and applied as in normal use to the artificial skin.

Not accepted. See 21.The style used follows what is generally used in other Parts 2. See also for example 22.113 in the CDV.PT agrees with the Observation of the Secretariat

81 US06 696-700, 707-711

22. 113, 22.115

te If compliance with these clauses relies on an electronic control, compliance as a result of a failure of the control should be considered.

Add the following at the end of 22.113 and 22.115:If compliance relies on the operation of an electronic circuit, the test is repeated under the following conditions applied separately:

– the fault conditions in a) to g) of 19.11.2 applied one at a time to the electronic circuit;

– the electromagnetic phenomena tests of 19.11.4.2 and 19.11.4.5 applied to the appliance.

If the electronic circuit is programmable, the software shall contain measures to control the fault/error conditions specified in Table R.1 and is evaluated in accordance

Accepted.And also change to Annex R modifications.

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(e.g. Table 1)

Type of comment


with the relevant requirements of Annex R.

82 DK10 719 24.2 te In line with previous DK NC comments the use of power supplies in flexible cords is generally prohibited in 60335. There does not appear to be any consideration or special use conditions with appliances covered by this standard that would necessitate constructions using power supplies in flexible cords.Without any such special consideration there is no option to deviate from the general prohibition of this type of construction

Delete line 719

As a consequence, also line 528-556 shall be deleted

Not accepted.

Based on this CDV a number of Parts 2 have accepted proposals for amendment. Also the Ed 6 of Part 1 at stage RFDIS will accept it as does ISH 1 for Ed 5.2 of Part 1.PT agrees with the Observation of the Secretariat

83 DE19 725-726

25.7 te Why light PVC cord is allowed regardless of the mass of the appliances?What are the rationales?

Delete line 725 and 726. Not accepted. It was included to align with Part 2-23.

84 NL27 725-726

25.7 te The NLNC sees no reason for reducing the safety requirements.

Delete proposal. See 83PT agrees with the Observation of the Secretariat

85 NL28 727-728

25.7 te The NLNC sees no reason for reducing the safety requirement.

Delete proposal. See 83PT agrees with the Observation of the Secretariat

86 CN10 908 ed (min cm3) is meaningless here. delete Not accepted. The intent is to make sure that the local SAR is not exceeded in a tissue volume of minimum 10 cm3

see lines 886-887PT agrees with the Observation of the Secretariat

87 FI03 913-915 and 916-923

AA.1.2 Annex AA ed The same measuring is described in the first paragraph (on lines 913-915) and in the second paragraph (on lines 916-923).

We propose to delete the first paragraph on lines 913-915.

AcceptedSee 29PT agrees with the Observation of the Secretariat

-27- 61(2020Web/PT60335-2-115)37

4

-28- 61(2020Web/PT60335-2-115)37

Annex to comment 29

Annex AA(normative)

Estimation of the local specific absorption rate (local SAR)

AA.1 Examples of output waveforms from radio frequency appliances are shown in Figure AA.1. The value of Tw and the value of Tbw shall be less than 360 s.

For appliance providing a continuous power output or a continuous pulse train, the output is started by a manual action and stopped by a manual action or a timer.

For appliance providing an output consisting of a single pulse or a pulse burst the output requires a manual action to apply each single pulse or pulse burst.

The output power from the appliance shall be measured and converted to local SAR as specified in AA.2.

AA.2 Bipolar and multipolar treatment heads

NOTE A bipolar treatment head has two electrodes with opposite polarities. A multipolar treatment head has more than two electrodes with opposite polarities.

The dimensions of the active part of the treatment head is measured and the tissue volume (Vt) in which most of the power is absorbed (see informative Annex BB for guidance) is calculated. If Vt is less than 10 cm3, it is assumed that the power is absorbed in a tissue mass of 10 g. In this case the value of Vt used for estimation of the local SAR shall be 10 cm3 .

Appliance is supplied at rated voltage with non-inductive load resistors varied from 100 Ω to 1000 Ω connected across the output applicator. If the manufacturer states that a specific resistance shall be used for the test, that shall also be applied even if outside the 100 Ω to 1000 Ω range.

To carry out the test, a specially prepared sample may be needed with the load resistor attached across the output applicator.

AA.2.1 Appliances providing a continuous power output or a continuous pulse train

To obtain the output power, the voltage across the non-inductive load resistor is measured over any 360 s period.

The average output power is calculated for each value of load resistor as follows:

PAVG =U rms

2

R

Where

PAVG = average RF power in wattsUrms = measured root mean square voltage across the resistive load in voltsR = resistance value of the load in ohms

The local SAR for static exposure is then estimated as follows:

SARcont = PAVG

0,001∗V t

Where

5

6789

1112

1314

1516

1718

19

2021

22232425

26272829

3031

32

3334

35

36

37

383940

41

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43

-29- 61(2020Web/PT60335-2-115)37

SARcont = local SAR for static exposure in W/kgPAVG = average RF power over 360 s in wattsVt = calculated tissue volume in which most of the power is absorbed in cm 3 0,001 = a constant taken as the assumed averaged density of the tissue in kg/cm 3

NOTE Treatment heads of appliances providing a continuous output power or a continuous pulse train are typically intended to be constantly moved during the treatment procedure. See AA.4 for estimation of the local SAR when specific treatment instructions are provided.

AA.2.2 Appliances providing a single pulse or a pulse burst

To obtain the output power, the voltage across the non-inductive load resistor is measured

for appliances providing a single pulse, over any pulse duration T w;

for appliances providing pulse bursts, over any pulse burst duration T bw.

For each measurement, the value of Tw or Tbw is recorded as applicable and shall be less than 360 s.

The average output power for each value of load resistor is calculated as follows:

AA.2.2.1 For appliances providing a single pulse:

PAVG,Tw =U rms

2

R

Where

PAVG,Tw = average RF power over the pulse duration in wattsUrms = measured root mean square voltage across the resistive load in voltsR = resistance value of the load in ohms

The output energy is the product of PAVG,Tw and Tw.

The local SAR for static exposure of a single application is estimated as follows:

SARpulse =P AVG,Tw∗T w0,36∗V t

Where

SARpulse = local SAR for static exposure of single application in W/kgPAVG,Tw = average RF power over the pulse duration in wattsVt = calculated tissue volume in which most of the power is absorbed in cm 3 Tw = measured duration of the pulse duration in seconds (max. 360 s)0,36 = a constant taken as the product of the assumed averaged density of the tissue in kg/cm3 and the 360 s period over which the output power of appliances providing continuous power or a continuous pulse train is measured

AA.2.2.2 For appliances providing pulse bursts:

PAVG,Tbw =U rms

2

R

Where

PAVG,Tbw = average RF power over the pulse duration in wattsUrms = measured root mean square voltage across the resistive load in voltsR = resistance value of the load in ohms

The output energy is the product of PAVG,Tbw and Tbw.

44454647

484950

51

52

53

54

5556

57

58

59

60

616263

64

65

66

67

68697071727374

75

76

77

787980

81

-30- 61(2020Web/PT60335-2-115)37

The local SAR for static exposure of a single application is estimated as follows:

SARpulse =P AVG,Tbw∗T bw0,36∗V t

Where

SARpulse = local SAR in W/kgPAVG,Tbw = average RF power over the pulse burst duration in wattsVt = calculated tissue volume in which most of the power is absorbed in cm 3 Tbw = measured duration of the pulse burst duration in seconds (max. 360 s)0,36 = a constant taken as the product of the assumed averaged density of the tissue in kg/cm3 and the 360 s period over which the output power of appliances providing continuous power output or a continuous pulse train is measured.

NOTE See AA.4 for estimation of the local SAR when specific treatment instructions are provided.

AA.3 Monopolar treatment heads

NOTE Monopolar treatment head is equipped with a single electrode. If an electrode with opposite polarity is used, it is a separate unit (e.g. a metal plate). The requirements for monopolar treatment heads are not currently covered by this standard.

AA.4 Estimation of the local SAR when treatment instructions are provided

AA.4.1 For appliances providing continuous power output or a continuous pulse train, the local SAR can be reduced by moving the treatment head over a large treatment area or by reducing the exposure by limiting the treatment duration. If the appliance is intended for this type of operation, treatment instructions specifying treatment area sizes and maximum exposure times shall be provided with the appliance.

The maximum exposure times shall be specified in either seconds or the maximum exposure time related to a treatment area shall be specified (e.g. the maximum treatment time for an area of 100 cm2 is 60 s). If the appliance has means for altering the output power setting, the maximum exposure time shall be specified for each setting separately. In calculating the local SAR, an exposure time of 360 s shall be used even if longer treatment durations are specified in the instructions.

The instructions shall also state that the treatment head is to be kept in constant motion during the treatment and that once the maximum exposure time has been reached, the area shall not be subjected to any further exposure until a period of at least 360 s from the start of the initial treatment has elapsed.

The manufacturer shall also specify the speed of movement of the treatment head, the area over which the treatment is carried out and the maximum treatment time for each treatment.

The average local SAR within the treatment area can then be calculated as follows:

SARAVG =

SARcont∗AapplAarea

∗T ex

360

Where

SARAVG = average local SAR in the treatment area in W/kgSARcont = local SAR for continuous static exposure in W/kgAappl = active area of the treatment head in cm 2 (see informative Annex BB)Aarea = treatment area in cm2

Tex = maximum exposure time for the treatment area in seconds (<. 360 s)360 = a constant taken as the 360 s period over which the output power of appliances providing continuous power output or a continuous pulse train is measured

82

83

84

85868788899091

92

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97

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100101102

103104105106107108

109110111112

113114

115

116

117

118119120121122123124

-31- 61(2020Web/PT60335-2-115)37

The resulting average local SAR (SARAVG) shall not exceed the relevant local SAR limits of Table 104.

AA.4.2 For appliances providing single pulse or a pulse burst with the treatment head intended to remain static during the treatment procedure , the maximum allowed number of applications on the same treatment area within 360 s can be calculated by dividing the relevant local SAR limits of Table 104 with SARpulse and rounding down to the nearest integer.

For appliances providing a single pulse or a pulse burst with treatment heads intended to be constantly moved within the treatment area, the local SAR is calculated as follows:

SARAVG = SAR pulse∗Aappl

Aarea∗nappl

Where

SARAVG = average local SAR in the treatment area in W/kgSARpulse = local SAR for static exposure of single application in W/kgAappl = active area of the treatment head in cm 2 (see informative Annex BB)Aarea = treatment area in cm2 napp = number of applications within 360 s

The maximum number of applications to each treatment area shall be stated in the instructions and the resulting average local SAR (SARAVG) shall not exceed the relevant local SAR limits of Table 104. If the appliance has means for altering the output power setting, the maximum number of applications shall be specified for each setting separately.

The instructions shall also state that

once the maximum number of applications have been administered to a treatment area, the area shall not be subjected to any further exposure until a period of 360 s from the initial application has elapsed.

the treatment head is to be kept in constant motion throughout the procedure.

125126

127128129130131

132133

134

135

136137138139140

141142143144

145

146147148

149

150

-32- 61(2020Web/PT60335-2-115)37

Continuous power output or continuous pulse train

Continuous power output (CPO) illustration

Where Tw = individual pulse durationTi = time interval between pulsesDuty cycle = 100*Tw/(Tw + Ti)%

Continuous pulse train (CPT) illustration

If Ti = 0, then the CPT type is a CPO type

Single Pulse or Pulse bursts

Where Tw = single pulse duration

Single pulse (SP) illustration

Where Tw = individual pulse durationTi = time interval between pulsesTbw = pulse burst duration (< 360 s)

Pulse bursts (PB) illustration

Figure AA.1 – Examples of radio frequency appliance output types

TiTw

Tbw

TiTw

TwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTwTw

151

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155

156157158159

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169170171172

173

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-33- 61(2020Web/PT60335-2-115)37

7.10 In lines 259 to 260 add “or” after output power” in line 259 and delete “maximum output power density” and “or maximum output energy density”

7.12 Replace lines 328 to 339 by the following:

The instructions for radio frequency appliances producing a continuous power output or a continuous pulse train shall specify the maximum output power (W).

The instructions for radio frequency appliances producing single pulses or pulse bursts shall specify the maximum output energy (J).

22.110 For radio frequency appliances the maximum output power shall be limited and they shall incorporate a control to regulate the output power.

The output power is converted to local specific absorption rate (local SAR) as detailed in normative Annex AA. The local SAR shall not exceed the values given in Table 104 averaged over a 360 s time period.

The local SAR at lower output settings shall be verified using the same resistance that yielded the maximum local SAR.

The measured power output or output energy shall not exceed the stated value in the instructions by more than 20%. This applies to all power settings.

Compliance is checked by inspection and the measurement specified in AA. of normative Annex AA, as well as the following test.

The instructions for carrying out treatments provided with the device shall be taken into account as presented in AA.4 of normative Annex AA.

Table 104 –Local SAR limits

Appliance type Maximum local SAR for head and torso (W/kg)

Maximum local SAR for limbs (W/kg)

Appliance for household use 2 4

Appliance for use in beauty parlours and similar premises

10 20

If compliance with the output limits relies on the operation of an electronic circuit, the test is repeated under the following conditions applied separately:

the fault conditions in a) to g) of 19.11.2 are applied one at a time to the electronic circuit;the electromagnetic phenomena tests of 19.11.4.1 and 19.11.4.2 are applied to the appliance.

If the electronic circuit is programmable, the software shall contain measures to control the fault/error conditions specified in Table R.1 and is evaluated in accordance with the relevant requirements of normative Annex R.

175176

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