® Registered trademark of the International Electrotechnical Commission

62C/XXX/RVCRESULT OF VOTING ON CDV

Project number:IEC 62667 Ed. 1.0

Reference number of the CDV62C/640/CDV

IEC/TC or SCSC 62C

Date of circulation     

Title of the TC or SC concernedEquipment for radiotherapy, nuclear medicine and radiation dosimetry

Title of the committee draft:Medical electrical equipment - Medical light ion beam equipment - Performance characteristics

The above-mentioned document was distributed to National Committees with a request that voting take place for approval for circulation as an FDIS or publication as an International Standard, Technical Specification or Technical ReportThe NC comments as attached are going to be discussed at the next SC 62C/WG 1 meeting in Beijing/China, June 20-24, 2016. The FDIS will be prepared accordingly.Voting results

see printout attached

Comments received – see annex 1)

THE CHAIR (in cooperation with the secretariat and the project leader) has taken one of the following courses of action.When the approval criteria have been met:a.1)a.2)

The committee draft for vote (CDV) will be registered as an FDIS by (date) December 2016The committee draft for vote (CDV) will be registered as an IS by (date) ..........

b The draft technical specification (DTS) will be registered as a Technical Specification by (date) ..........The draft technical report (DTR) will be registered as a Technical Report by (date) ..........

When the approval criteria have NOT been met:c A revised committee draft for vote (CDV) will be distributed by (date) ..........d A revised committee draft (CD) will be distributed by (date) ..........e The comments will be discussed at the next meeting of the on (date) ..........

NOTES a. 2) Only applies where no negative votes have been received on the committee draft for vote. The chair in cooperation with the secretariat shall also ensure that no technical changes i.e. changes to one or more of the normative requirements have been made between the committee draft for vote (CDV) and the text submitted for the publication of an  IS.

In the case of a proposal c or d made by the chair, if two or more P-members disagree within 2 months of the circulation of this compilation, then the draft shall be discussed at a meeting.

Name or signature of the Secretary

Norbert Bischof

Name or signature of the Chair

Geoffrey S. Ibbott

FORM RVC (IEC) 2009-01-09

®

1) to be collated on Form Comments and annexed.

Voting Result on 62C/640/CDVCirculation Date: 2016-02-26 Closing Date: 2016-05-27IEC 62667 Ed. 1.0 IEC 62667: Medical electrical equipment - Medical light ion beam equipment - Performance characteristics

Country Status Vote Comments ReceivedAustralia O Y - 2016-05-27Austria P Y Y 2016-05-25Belarus O Y - 2016-05-27Belgium P Y Y 2016-05-09Brazil P Y - 2016-05-25Canada P Y - 2016-05-18China P Y Y 2016-05-16Denmark P A - 2016-05-26Egypt P Y - 2016-03-29Finland P A - 2016-05-26France O A - 2016-05-26Germany P N Y 2016-05-19Greece O A - 2016-05-27Iran O A - 2016-05-25Ireland P A - 2016-04-01Italy P Y - 2016-05-27Japan P Y Y 2016-05-13Korea, Republic of P Y - 2016-05-24Malaysia P Y - 2016-04-13Netherlands P A - 2016-05-19Norway P Y - 2016-05-27Pakistan P Y - 2016-05-26Philippines, Rep. of the PPoland O Y - 2016-05-24Portugal - Y - 2016-05-27Qatar - A - 2016-05-24Romania O Y - 2016-05-25Russian Federation P Y - 2016-05-27Slovenia O A - 2016-05-25Spain O A - 2016-05-27Sweden P Y Y 2016-05-27Switzerland P Y - 2016-03-17United Kingdom P Y - 2016-05-12United States of America P Y Y 2016-05-25

Approval Criteria ResultP-Members voting: 18P-Members in favour: 17 = 94.4% >=66.7% APPROVEDTotal votes cast: 23 Total against: 1 = <=25% APPROVEDFinal Decision: APPROVED

Notes

Vote: Does the National Committee agree to the circulation of the draft as a FDIS: Y = In favour; N = Against; A = Abstention.Only votes received before the closing date are counted in determining the decision.Late Votes: (0).Abstentions are not taken into account when totalizing the votes.P-members not voting: Philippines, Rep. of the(1).

*Comments rejected because they were not submitted in the IEC Comment form.**Vote rejected due to lack of justification statement.

Page 2 of 26

Date Document Project Nr.2016-05-30 62C/640/CDV IEC 62667 Ed. 1.0

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 secretariat

AT ge AT votes “yes” for the CDV

SE15 Te 60601-2-64 has the definition “LIGHT ION RANGE”, e.g. “201.10.2.101.1.3 Selection, verification, and DISPLAY of LIGHT ION RANGE or ENERGY PER NUCLEON”.“LIGHT ION RANGE” occurs there in a number of places.In “640”, the term “LIGHT ION BEAM RANGE” is used with a “similar” definition, e.g. “6.2.1 Method of selection of ENERGY PER NUCLEON or LIGHT ION BEAM RANGE”.

The term “LIGHT ION RANGE” has been replaced, and “LIGHT ION BEAM RANGE” is used instead.60601-2-64 was published recently ...Why this change?

US3 all all E check use of INTERRUPTION not in small capitals

Check usage everywhere

SE7 207 3.11 Te The source given has been modified; the modification is that Notes 1 and 2 have been deleted. Note 2 relates to the French translation, Note 2 to “ISOCENTER”.

Keep the note about the “ISOCENTRE”!OK to delete the French translation note, but is that a modification? If no, delete modified.

SE1 239-240 3 First para Te Many definitions are taken from 60601-2-64, which is not mentioned here.

Add 60601-2-64 to the list.

JP1 255 3.2 NOTE 3 te The sentence is a repeat of the paragraph in Scope (line 210-214) and does not give any additional explanation of ACCOMPANYING DOCUMENTATION.

Delete NOTE 3.

Page 3 of 26

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 secretariat

SE2 259-264 3.3 Te From ICRU Report 85 (2011), the newest Report on Fundamental Quantities and Units for Ionizing Radiation:

Would it be wise to revise the definition and use the latest ICRU reference?If yes, revise.

SE3 262 3.3 Te Text reads “particle”. Change to “particles”

SE4 264 3.3 Te The source given has been modified; the modification is that NOTE 2 has been deleted.

Is that a modification?If no, delete modified.

SE5 274 3.5 Te The source given has been modified; the modification is that NOTE 1 has been deleted.

Why change the -2-64 definition?Is that change a modification? If no, delete modified.

SE6 293-294 3.9 Te Is it really necessary to change “ion” to “LIGHT ION”? Keeping “ion” makes the definition generic.

Change back to the original definition!

AT1 297 3.10 Figure 1 te The definition defines the ABSORBED DOSE at entrance at a water equivalent depth of 10 mm. Figure 1 indicates at “0mm”.

Add a 10mm line in Figure 1.

US1 297, 298

3.10 E water equivalent should have hyphen insert hyphen

AT2 299 3.10 te “… surface at a specified distance …”. Distance to what?

Specify distance to a reference point or line or axis or surface.

Page 4 of 26

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 secretariat

SE8 312-313 3.12 Te From ICRU Report 85 (2011), the newest Report on Fundamental Quantities and Units for Ionizing Radiation:

The text is actually “reformulated” from this definition.To be noted is, that there has been a modification made from -2-64!

Should the text be revised to follow ICRU85?If not, change to “Definition is derived from ICRU. 85.There is probably no need to mention the modification.

SE9 317-318 3.13 Te From ICRU Report 85 (2011), the newest Report on Fundamental Quantities and Units for Ionizing Radiation:

The text is actually “reformulated” from this definition.To be noted is, that there has been a modification made from -2-64!

Should the text be revised to follow ICRU85?If not, change to “Definition is derived from ICRU. 85.There is probably no need to mention the modification.

SE10 323 3.14 Te There is a Note added here!Compare to the note suggested in -2-1 Ed4!“NOTE The GANTRY is any mechanical device that supports the RADIATION HEAD regardless of movement limitations”

Add “modified” for the SOURCE.Discuss the wording of the Note!

Page 5 of 26

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 secretariat

JP2 after 325

after 3.14 te INITIATION OF IRRADIATION should be defined here, because its origin IEC 60601-2-17, as listed in INDEX OF DEFINED TERMS, is not either IEC 60580:2000, IEC 60601-1:2005 + A1:2012, IEC 60601-2-1:2009 + A1:2014, or IEC TR 60788:2004.

Define.

US4 326 3.15 E There is no definition of INTERRUPTION OF IRRADIATION or INTERRUPT IRRADIATION, even though these terms are used.

Insert definition

SE11 330 3.15 Te There are several newer sources available, e.g 60601-1-3 (2008)

Change the source to a newer one!

US2 330 new E should include definition of INTERUPTION insert definition of INTERUPTION/TO INTERRUPT

SE12 331-334 3.16 Ed Is it really necessary to change this definition, “used in presence of an isocentre”, to the longer wording?Do we really need to include ISOCENTRIC in the text at all?

No change needed.Delete 3.16.SE1Both ISOCENTRIC EQUIPMENT and ISOCENTRIC TREATMENT are included in the text.

SE13 340-358 3.20 Te This change should be NOTED for a future amendment of 60601-2-64!Note 1 in the original definition has been deleted. Why?

Save this change for a 60601-2-64 Amendment!Add Note 1 from the original definition, appropriately revised.

SE14 377-378 3.24 Te Note 1 in the original definition talks about aperture/bolus, bolus has been changed to accessory.

Just a question, this is an intended change?

SE16 398-399 3.28 Ed A Note has been added. Add “modified” to the SOURCE.

SE17 416 3.31 Te RMD is used in the text. Include the full text for RMD, range modulation device, as well. The program referred to is probably a “range modulation program”.

Add the full text for RMD.

Page 6 of 26

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 secretariat

SE18 418-421 3.32 Te The text talks about “TREATMENT segments treated automatically”, where “segments may consist of irradiation, motion of devices, or imaging”.Is “imaging” a TREATMENT segment? Sounds strange.Note, that “SEGMENT” will be a defined term in -2-1 Ed4.

Could another word be used here instead of segment ?To avoid possible confusion with -2-1?

JP3 420 3.42 ed Redundant expression: ”ratio of the ABSORBED DOSE on the LIGHT ION REFERENCE AXIS... to that at the depth of peak ABSORBED DOSE” and”both measurements made on the LIGHT ION REFERENCE AXIS.”

Delete ”both measurements made on the LIGHT ION REFERENCE AXIS.”

SE19 426-430 3.33 Ed This defined term is almost note modified. Note 2 about the French translation is deleted, some small caps changed, and target changed to TARGET VOLUME.DEPTH DOSE is a defined term.

Question: is this modified enough?DEPTH DOSE is a defined term, change to small caps! Occurs twice, 428 and 430.

SE20 438 3.35 Te This is a LIGHT ION term. The French Note has been” deleted, and “beam” changed to “RADIATION BEAM.DEPTH DOSE is a defined term.

Change “RADIATION BEAM” to “LIGHT ION BEAM”, as this term is purely LIGHT IONS.DEPTH DOSE is a defined term, change to small caps

SE21 445-451 3.36 Te This defined term, RMP, is almost identical to PRMP! Only “by varying the penetration and weighting factors of several component segments” from line 427 is missing on line 448!Are both defined terms needed?At least, delete “or program” here on line 447.DEPTH DOSE is a defined term.

Are both PRMP and RMP needed?If yes, delete “or program” on line 447. “DEPTH DOSE” is a defined term, 60788, change to small caps, line 449

SE22 454-456 3.37 Ed The modifications are “beam” changed to “RADIATION BEAM” and “and” changed to “, or”.

Are these changed “modifications” in IEC speak?If no, delete modified.

Page 7 of 26

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 secretariat

SE23 471-476 3.41 Te The modification, taking “exchangeable” out of the definition is appreciated!Chank also the proposed terminology in -2-1 Ed4!“PATIENT POSITIONER + TABLE TOP SUPPORT + TABLE TOP”

Can the structure from -2-1 Ed4 be used here?

US5 472 3.41 E change patient positioner to PATIENT SUPPORT change patient positioner to PATIENT SUPPORT

JP4 486 3.43 ed <RADIOTHERAPY> seems unnecessary. Delete.

SE24 491-498 3.44 Te Check the wording proposed in .2.1 Ed4.Could that be used partly, could Ed4 be revised?

Check wording in -2-1 Ed4.

SE25 508-511 3.46 Te The only changes are that “beam” has been changed to “RADIATION BEAM” twice.

Is that change a modification?If no, delete modified.

SE26 521-526 3.48 Te “VIRTUAL SOURCE” is a defined term, “point from which the RADIATION appears to originate”, 60788 rm-37-01.With this definition, the VSAD definition becomes“distance from the VIRTUAL SOURCE to the ISOCENTRE (i.e.to the GANTRY axis of rotation) for ISOCENTRIC EQUIPMENT, or for NON-ISOCENTRIC EQUIPMENT, to the ERP.Alternative:“distance from the VIRTUAL SOURCE, the point from which the RADIATION appears to originate, to the ISOCENTRE (i.e. to the GANTRY axis of rotation) for ISOCENTRIC EQUIPMENT, or for NON-ISOCENTRIC EQUIPMENT, to the ERP

In Note 2, “or ERP” should be added after ISOCENTRE.Should VSAD be used for NON-ISOCENTRIC equipment!? Is there another more generic” wording? Perhaps just virtual source distance. VSD?!

Note to IEC: the defined term “VIRTUAL SOURCE” is not included in the on-line dictionary! Should be added!

Revise the text according to the principles suggested, both for the definition itself and for Note 2.Another term, perhaps VSD, where axis is not mentioned!

SE27 526 3.49 Te The words “for the type and energy of the active beam” in the last sentence are superfluous.

Delete the words “for the type and energy of the active beam”.

DE1 538 4.1. T Performance needs to be equipment specific and shall not be related to a location of installation

Delete the first part of the sentence before the colon

Page 8 of 26

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 secretariat

JP5 538 4.1 ed It would be difficult to identify all individual potential customers.

Replace ”each location” with ”locations.”

DE2 547 4.3. T This requirement about maintaining the performance after deformations cannot be tested and has no test procedure related to it. (Ion Beam equipment cannot be installed on a vibrating plate)

Either define an only equipment related test procedure to measure or delete this requirement

DE3 552 5.1. T Here the standard contradicts itself since it makes requirements for the ACCOMPANYING DOCUMENTS also in clause 4 but does not include formats for it in ANNEX A

Either make ANNEX A comprehensive or delete this requirement

DE4 554 5.2. T The latest changes to earlier comments make this clause even less acceptable. Manufacturers never give permission or allowance for IRRADIATION, this is a result of the clinical commissioning under the responsibility of the user. All performance characteristics are listed in the following clauses, thus this clause does not add anything.

Either delete this clause or replace it by an adaption of what is used in the IEC60976 performance standard l(clause 5.1) just adapted by clause numbers of this standard

The ACCOMPANYING DOCUMENTS shall state all functional performance characteristics contained in Clauses 4 and Clauses 6 to 14

US6 554 5.2 E “…describe the MANUFACTURER allowed combinations…” is not correct grammar.

change to MANUFACTURER'S

Page 9 of 26

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 secretariat

SE38 558 6 Ge There are tests mentioned for some subclauses, but not for all of them.Look at 6.8 ISOCENTRE,6.8.1 Information to the USER,For GANTRIES which are designed for ISOCENTRIC TREATMENT, the ACCOMPANYING DOCUMENTATION shall state the maximum displacement of the LIGHT ION REFERENCE AXIS from the ISOCENTRE for each RADIATION HEAD and LIGHT ION BEAM APPLICATOR.......The test method to assess the deviation of the LIGHT ION REFERENCE AXIS from the expected ISOCENTRE shall be provided in the ACCOMPANYING DOCUMENTATION....6.8.2 TestsInspect the ACCOMPANYING DOCUMENTATION to verify that the test method to assess the deviation of the LIGHT ION REFERENCE AXIS from the ISOCENTRE for GANTRIES which are designed for ISOCENTRIC TREATMENT is provided.Inspect the ACCOMPANYING DOCUMENTATION to verify that the deviation of the LIGHT ION REFERENCE AXIS 71from the ISOCENTRE is provided.

There are test presented in Annex A for clause 6

This structurex.1 Information to the USER

“shall be stated in the accompanying documents”x.2 Tests“inspect the accompanying documents to verify”could be used in clause 6 and following ...To be looked into perhaps?

Page 10 of 26

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 secretariat

BE1 573 6.2.2 n/a te The maximum and minimum ENERGY PER NUCLEON or LIGHT ION BEAM RANGE might depend on the LSD and RMD used in the RADIATION HEAD.The maximum beam range will indeed depend on the thickness of the LSD and RMD used.

The BEAM RANGE could be characterized at the entrance of the RADIATION HEAD, or after the energy selection device described in §6.2.1, or at exit of the RADIATION HEAD, but without any ACCESSORIES installed, and withtout LSD or RMD used.Replace by: “The ACCOMPANYING DOCUMENTATION shall state the maximum and minimum ENERGY PER NUCLEON or LIGHT ION BEAM RANGE without ACCESSORIES installed and without LSD or RMD in place, and the number of ENERGY PER NUCLEON levels or LIGHT ION BEAM RANGES available between this maximum and this minimum“.

JP6 577 6.2.2 te It should be clarified that all beam line devices inside the RADIATION HEAD (scatterer, range shifter…) are excluded. Note that in Safety Standard, the range shifter was dealt separately from ACCESSORIES.

Replace ”without ACCESSORIES installed” with ”without any beam modifying devices inside the RADIATION HEAD installed.”

JP7 582 6.2.4 ed MeV/nucleon MeV/n

US7 582 6.2.4 E inconsistent use of mm and cm in requirements and Annex A

change clauses and annex to report everything in mm except where cm is used in safety standard

JP8 596 6.4.1 a), NOTE ed Too large blank space after the colon. Make it normal.

SE28 602,605

6.4.2 a)And b)

Ed The text is nines 600-601 ends “shall provide”, which means that the following a) ... f) must be formulated accordingly.a) and b) must be reformulated, delete “shall be reported”

Delete “shall be reported” in a) and b).

JP9 606 6.4.2 b), NOTE ed Too large blank space after the colon. Make it normal.

JP10 607 6.4.2 c) ed energies per nucleon ENERGIES PER NUCLEON

JP11 609 6.4.2 d) ed In “°・s-1”, the multiplication symbol should not be superscript.

Make it a normal letter, or use the expression “/s.”

SE29 612-615 6.4.2. f) Second and third para

Te The text says “beam pointing angle”, sounds a bit strange. Why not use “beam direction” instead.Two places.

Change “beam pointing angle” to “beam direction” or similar.Two places

SE30 616-630 6.4.3 Ge There are no tests included here, Should there be simple tests?

Page 11 of 26

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 secretariat

BE2 628 6.6 n/a te The maximum IRRADIATION FIELD SIZE available per applicator is lacking.

Add item: “the dimensions of the maximum LIGHT ION IRRADIATION FIELD SIZE supported by the LIGHT ION BEAM APPLICATOR, in centimetres, with coordinates stated along axes Xb and Yb”

SE34 645-685 6.7 te This is a clause on BLDs, there is nothing here about rotations of the BLDs

Include rotations of the BLDs in this clause.

CN1 646 6.7.1 E No need for a sub-clause number here, since only one requirement in 6.7.

Keep the requirement of 6.7.1, while delete its clause number and title.

DE5 648651667671672673674

6.7.1 a)6.7.1 b)6.7.1 d) 6)6.7.1 d) 8)6.7.1 d) 9)6.7.1 d) 10)6.7.1 d) 11)

ed The words 'at the mechanical device' are unusual.

replace by at the adjustable BLD

SE31 649 6.7.1 a) The text reads “... along axes X and Y (Xb and Yb, see IEC...)”. Change to “... along the axes Xb xn Yb, see IEC...”

Change the text as suggested in the Comment to the left.

SE32 650 6.7.1 a) Te The text “in relation to the LIGHT ION REFERENCE AXIS” is unnecessary. The coordinate system is defined with the Z axis as the beam axis,

Delete the text “in relation to the LIGHT ION REFERENCE AXIS”.

US8 651 6.7.1 E inconsistent use of mm and cm in requirements and Annex A

change clauses and annex to report everything in mm except where cm is used in safety standard

DE6 666 6.7.1 d) 5) te If the BLD is focused the thickness is not parallel to Zb. Also to be changed in the Annex A.

Replace 'parallel to the Zb axis' by ‘in the direction of the radiaton beam’

DE27 671, 672

6.7.1 d) 8) and 9)

te The accuracy should be given in millimetres. Change 'centimetres' to 'millimetres'.

BE3 678 6.7.1 d) 14) te The parameter d) 14) (dose behind BLD) is already present in the 60601-2-64 (required to be less than 0,75%).

Remove d) 14)

Page 12 of 26

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 secretariat

SE33 678-685 6.7.1 d) 14) Te This sounds like “leakage radiation through beam limiting devices” for linacs.There is just a requirement to state in the acc docs the average absorbed dose behind the BLD.For linacs, -2-1, there are requirements on the dose values. There are similar clauses in -2-64.

There area tests in -2-64. There are no tests here.Should there be tests?

SE35 685 6.7.1,6,7,2?

Te There are 6.7 and 6.7.1, but no 6.7.2!Next clause has 6.8 Information to the user, 6.8.2 Test.Should 6.7.2 be Test?

Should there be a 6.7.2 Tests, check.

SE36 686 6.8 Te This clause is called ISOCENTRE. Where are non-isocentric GANTRIES covered, the GANTRIES where the ERP is the “rreference point”?This is made clear both in 6.8.1 and 6.8.2.

Check that non-isocentric GANTRIES are covered somewhere.Add a sentence under 6.8 saying that this clause is applicable only for ISOCENTRIC GANTRIES, or similar..

CN2 687 6.8.1 E No need for a sub-clause number here, since only one requirement in 6.8.Also see CN3.

Keep the requirement of 6.8.1, while delete its clause number and title.

SE37 690-693 6.8.1 Ef The sentence starting “If the system ...” is difficult to read. There should be some commas inserted, or the text be revised.

Revise the sentence “If the system ...”. too long and nested.

US9 694 6.8.1 E inconsistent use of mm and cm in requirements and Annex A

change clauses and annex to report everything in mm except where cm is used in safety standard

JP12 695 & 697

6.8.1 ed It would be preferable to call GANTRY types in consistent with NOTE 1 in 3.14.

Replace “GANTRIES with continuous rotation” with “rotational GANTRIES” and “GANTRIES without continuous rotation” with “multiple-discrete angle GANTRIES.”

SE39 713-714 6.8.1 Te The NOTE is difficult to read. Should it be moved to the X-IGRT clause?

Please reformulate the note.

CN3 715 6.8.2 E Keep the same style as 6.1～6.7，where the test method of document inspection are not listed.

Delete whole clause of 6.8.2.

DE7 723 6.9.1 Ed Change 'LSDS' to 'LSDs'.

JP13 727 6.9.1 c) ed sub type subtype

Page 13 of 26

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 secretariat

DE8 744 6.9.3 E Notes makes a permission which should not be done

Either make this normative text or change wording to something like: Examples for shapes are square, rectangular or circular, so that it becomes an explanatory note

JP14 744 6.9.3 b), NOTE ed Too large blank space after the colon. Make it normal.

JP15 748 6.9.3 c), NOTE ed Too large blank space after the colon. Make it normal.

JP16 758 etc. 6.9.5.1 etc. ed Here and in many places (6.10.2.1, 6.10.13.1, 6.10.4.1, etc.) the title reads “Information for the USER,” while in other places (6.7.1, 6.8.1, 7.3.1, etc.) “Information to the USER.”

Unify the expression.

SE40 759-761 6.9.5.1 Te Thinking photons and electrons, VSAD is a distance from one point (VIRTUAL SOURCE) to another point (ISOCENTR/ERP), measured along Zg.The words on line 760 “relative to the ISOCENTRE or ERP” are superfluous.What values are to be given in the Xg and Yg directions?

Revise the text, perhaps as suggested.

SE41 776 6.9.5.2 a) Te The text reads “ISOCENTRE axis”. Delete “axis”.

SE43 779-784 6.9.5.2 b) Te The text is in principle a copy of a), which makes it “strange”.Delete the second sentence “Place a 2-D ....”. Insert “free-in-air” in the following sentence, “Expose the 2-D dosimeter free-in-air with the ...”.Include the EPR.

Change the text adoring to the comment.

SE42 781 6.9.5.2 b) Te Here, “ISOCENTRE or ERP” is used on line 781. Revise the text in 6.9.5.2 a) to include ERP.

DE9 806 6.10.2.2 T What about single room solutions? Add if more than one treatment room is provided

DE10 832 6.10.4.1 T Specified conditions, specified by whom Add conditions specified by the MANUFACTURER

JP17 832 6.10.4.1 ed specified SPECIFIED

SE44 848 6.10.6 Te All other clauses uses time, not times! Change times to time.

SE45 850 6.10.6.1 Ed See above. Change times to time.

JP18 862 6.10.7.2 ed tcp TCP

US10 862 6.10.7.2 E Interrupt should be in small capitals change "Interrupt" to "INTERRUPT"

Page 14 of 26

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 secretariat

JP19 864 6.10.7.2 NOTE te The restart process may include some internal checks of the equipment, and how to deal with these should be clarified.

Add NOTE “Software sequences after a restart command is issued, such as reconfirmation of irradiation devices, are considered part of the time to restart IRRADIATION.”

SE46 905-908 7.3.1 Revise the text as follows:The ACCOMPANYING DOCUMENTATION shall state the reproducibility of MU delivery expressed as the maximum COEFFICIENT OF VARIATION and the maximum deviation from the average value of the ratio of the measured RADIATION DETECTOR response and the delivered DOSE MONITOR UNITS for LIGHT ION RADIATION, when if the same value of DOSE MONITOR UNITS is set under otherwise identical conditions for IRRADIATION.

Change the text as suggested in the comment.

SE47 914 7.3.2 Te It is not the “coefficient of variation” that shall be tested, it is the reproducibility of MU delivery!

Change the text to “Measurements shall be made for:"

JP20 916 7.3.2 b) te An applicable condition is missing. Add “if the system has a plurality of beam delivery modes”

SE48 920 7.3.2 Formula Ed The term “n-1” doesn’t seem to be written correctly.

Edit the formula, check “n-1”.

SE49 922-924 7.3.2 Ed This ratio R is used in many places, sometimes without a definition.

Could this ratio be defined sort of“centrally”?

SE50 925 7.3.1 Ed Do not use “determination” here. Change determinations to measurements.

DE11 928 7.3.2 te What is a 'hypothetical small water volume'? Can a hypothetical thing be positioned in the real world?

Clarify.

JP21 931 7.3.2 Table 1 ed Rule lines are not adequate in the “Angular position” column.

Correct.

Page 15 of 26

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 secretariat

SE51 935-942 7.4.1 Te It is confusing to introduce new concepts here!Actually, the old R = D / U, i.e. S = R, as it is written!Note, that R is used on line 966!The measured response is one thing, the calculated response (S*U) is something else.Change toDcalc is the calculated DETECTOR responseDmeas is the measured DETECTOR responseDcalc = S * UR = Dmeas / U

SE52 944-945 7.4.2 Insert “calculated response” etc Change the text:The ACCOMPANYING DOCUMENTATION shall state the maximum deviation of the measured RADIATION DETECTOR response (Dmeas) from the calculated response Dcalc, the product of the DOSE MONITOR UNITS U and the proportionality factor S.

JP22 950 7.4.2 te The expression “available ranges” is vague. It should match with the test.

Change to “ranges between maximum and minimum specified values”

SE53 954 7.4.3 Ed Insert “of MU delivery”. Change the text to “the proportionality of MU delivery shall be tested for”.

SE54 966 7.4.3 Te Here, R suddenly appears! If R is introduced earlier, as suggested, it makes sense, as S is measured as Dmeas/U.

Has to be explained, if not as suggested, in some other way.

CN4 969 7.4.3 Table 2 T The lase column “One ENERGY PER NUCLEON or LIGHT ION BEAM RANGE” is different from Line 948, where three “the maximum, minimum, and (max + min)/2 available ENERGY PER NUCLEON” are required.

“One ENERGY PER NUCLEON or LIGHT ION BEAM RANGE” change to “maximum, minimum, and (max + min)/2 available ENERGY PER NUCLEON levels or LIGHT ION BEAM RANGES”

JP23 969 7.4.3 Table 2 te Meaning of “SPOT map” in the “radiation field” column is unclear.

Clarify.

JP24 969 7.4.3 Table 2 ed Rule lines are not adequate in the “Angular position” column.

Correct.

Page 16 of 26

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 secretariat

SE55 973-978 7.5.1 Te Here is R again! To be explained! See 7.7!

BE4 980 7.5.2 n/a te The test only requires “various off-axis locations”. It could be more precise, e.g. requesting at least 16 off-axis positions as in the spot pattern described in §9.2.1.2.

Replace by: “The ratio shall be measured at 16 or more off-axis locations equally distributed on the entire active beam FLUX monitor area.”

JP25 987 7.5.2 Table 3 ed Rule lines are not adequate in the “Angular position” column.

Correct.

SE56 992-996 7.6.1 Te Here is R again! To be explained! See 7.7!

JP26 1005 7.6.2 Table 4 ed Rule lines are not adequate in the “radiation field” column.

Correct.

JP27 1016 7.7.1.1 b) te It is difficult to understand why 3 Gy should be used for this test rather than 2 Gy in other tests.

Add a NOTE for reasoning, or change to 2 Gy.

JP28 1029 7.7.1.2 Table 5 te A representative of the gantry angle should be the same as in other tables.

Replace “90 °” with “0 °”

JP29 1029 7.7.1.2 Table 5ed

The expression in the “dose monitor unit rate” column should be the same as in other tables

Replace “One” with “One fixed”.

JP30 1036 7.7.2.1 ed This sentence is not easy to comprehend. Replace“a percentage of the mean value R of all measured values of R”with“a percentage of the mean value of all measured values of R”

JP31 1038 7.7.2.2 te Conditions should be the same as other tests. Replace “test conditions given in table 6”with “test conditions given in 7.2 and table 6”

JP32 1044 7.7.2.2 Table 6 te A representative of the gantry angle should be the same as in other tables.

Replace “90 °” with “0 °”

JP33 1044 7.7.2.2 Table 6 ed The expression in the “dose monitor unit rate” column should be the same as in other tables

Replace “One” with “One fixed”.

SE57 1046,1049

8 Ed DEPTH DOSE is a defined term!There are some other places as well ...

Change to small caps!Check DEPTH DOSE for small caps elsewhere.

Page 17 of 26

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 secretariat

BE5 1047 8.1 n/a te The Distal Dose Fall-off is requesed for range modulated portals in §8.3.1 b), but not for non-range modulated portals in §8.1.This is an important parameter that can easily be extracted from the datasets required in §8.1.1.

Add §8.1.5 Distal dose fall off, using same definition as in §8.3.1 b).

BE6 1053 8.1.1 a) te Methods that use scatterers or UNIFORM SCANNING are normally range modulated. It is not clear what is the purpose of such plots.

Delete a)

BE16 1053 8.1.1 a) te Same comment as line 1109 below. LIGHT ION BEAM APPLICATOR will not impact the DEPTH DOSE distribution.

If not deleted per previous comment, replace by: “for the largest IRRADIATION FIELD SIZE available for each relevant combination of LSD, for IRRADIATION methods that use scatterers or UNIFORM SCANNING”

JP34 1061-1062

8.1.2 te This subclause is for non-range modulated portals. Allowance of a RMD, such as a ripple filter, is not appropriate.

Delete this paragraph

JP35 1065-1066

8.1.2 ed Why the detector size information so important, when even the type of detector is not standardized?

Delete this paragraph

JP36 1070 8.1.3 ed A full stop is missing at the end of the sentence. Add.

JP37 1073 8.1.4 ed A full stop is missing at the end of the sentence. Add.

JP38 1082, 1083

8.2.1 NOTE 1NOTE 2

ed Examples of “type” and “subtype” are reversed compared to Note 1 of 3.35.

Make them consistent.

BE7 11091112

8.3.1 n/a te While it is true that the DEPTH DOSE distribution depends on the the FIELD SIZE (e.g., for the largest field size, thick scatterers are necessary, and reduce the largest available beam range), the LIGHT ION BEAM APPLICATOR does not directly impact the DEPTH DOSE distribution.

Replace by: “DEPTH DOSE distributions shall be provided for each beam delivery technique provided by the MANUFACTURER for each relevant combinations of RMD and LSD, as specified by the MANUFACTURER.The data shall be acquired for each LIGHT ION species, beam delivery technique and relevant combination of RMD and LSD, using the maximum IRRADIATION FIELD SIZE availabe for this combination.”

Page 18 of 26

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 secretariat

BE8 1125 8.3.1 b) te The parameter described in b) is representative of the Distal Dose Fall-off (DDF), which is defined in ICRU-78 as the distance in water between the 80% and 20% dose points.Furthermore, the Lateral Penumbra parameter in §9.1.3 is defined using 80% and 20% dose points, which is not coherent with this definition using 90% and 10% dose points.

Replace by: “difference between depths in water of the point distal from the peak where the ABSORBED DOSE is 80 % of the ABSORBED DOSE of the peak and the point distal from the peak where the ABSORBED DOSE is 20 % of the ABSORBED DOSE of the peak, measured on the LIGHT ION REFERENCE AXIS in the RADIATION FIELD specified in 8.3.1.”

JP39 1125 8.3.1 b) te Because we are dealing with physical doses, for light ion species heavier than protons, the difference between depths of distal 90 % and 10 % physical dose points does not appear very meaningful.

Add a sentence declaring this quantity is not required for light ion species heavier than protons.

JP40 1125 - 1127

8.3.1 b) te Because this is for range modulated portals, the expression “peak” is not suitable.

Replace “peak” with “nominal centre of modulation” (4 places).

JP41 1128 8.3.1 b) te This is subclause 8.3.1, and referring to 8.3.1 is recursive.

Replace “8.3.1” with a correct reference.

JP42 1128 8.3.1 b) ed Punctuation is different from a) and c). Replace a full stop with a semicolon at the end of the sentence.

AT3 1149 8.4.1.1 ed Add space between “+” and “minimum” Add space between “+” and “minimum”

JP43 1149 8.4.1.1 ed A space is missing in “+minimum” Replace “maximum +minimum”with “maximum + minimum”

JP44 1159etc.

8.4.1.3etc.

te It is sufficient for this Performance Disclosure Standard to state, as in 8.4.1.1, “The ACCOMPANYING DOCUMENTATION shall state…” This Safety-Standard-like “Inspection” subclause is unnecessary..

Delete 8.4.1.3 etc.

AT4 1166 8.4.2.1 ed Add space between “+” and “minimum” Add space between “+” and “minimum”

JP45 1166 8.4.2.1 ed A space is missing in “+minimum” Replace “maximum +minimum”with “maximum + minimum”

BE9 1168 8.4.2.1 n/a te Same comment as line 1109 above. The LIGHT ION BEAM APPLICATOR will not impact the beam range.

Replace by: “The data shall be acquired for each LIGHT ION species, beam delivery technique and relevant combinations of RMD and LSD, as specified by the MANUFACTURER, using the maxium IRRADIATION FIELD SIZE available”.

Page 19 of 26

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 secretariat

CN5 1176 8.4.2.2 Table 8 E Note b in the second column” RADIATION FIELD” is unsuitable.

Delete note b in the second column” RADIATION FIELD”.

BE10 1200 9.1.1.1 n/a te The flatness specification is expected to only hold in the flattened area, not in the whole RADIATION FIELD. The averaging should therefore be done in the flattened area.

Replace by “averaged over not more than 1 cm² anywhere in the flattened area”

BE11 1202 9.1.1.1 n/a Te The clause asks to average the ABSORBED DOSE at the LIGHT ION REFERENCE AXIS “anywhere in the flattened area”. The average is usually done around the LIGHT ION REFERENCE AXIS.

Replace by: “averaged over not more than 1 cm² around the LIGHT ION REFERENCE AXIS”.

AT5 1211 9.1.1.1 ed Change “plus” by “+” for consistency Change “plus” by “+”

BE12 1211 9.1.1.1 n/a te While it is true that the flatness depends on the FIELD SIZE, the LIGHT ION BEAM APPLICATOR will not directly impact the flatness.

Replace by: The maximum and minimum values shall be given for the maximum, minimum, and (maximum plus minimum)/2 ENERGY PER NUCLEON levels available, for the maximum IRRADIATION FIELD SIZE possible for each relevant combination of RMD and LSD, as specified by the MANUFACTURER, for each LIGHT ION species, and for angular positions of the GANTRY of 0°, 90°, and 270°.”

JP46 1211 9.1.1.1 ed Use of “plus” does not match other parts. Replace “maximum plus minimum”with “maximum + minimum”

AT6 1214 9.1.1.1 te Also for 180° the mechanics in principle could lead changes of flatness

Add “180°”

AT7 1241 9.1.1.1 te Rotational gantries covering less than 360° of angular positions are not adequately covered

Add "for rotational type gantries with less 360° rotation for angular positions of the GANTRY for min, max, angular position and available angular positions at 0°, 90°, 180° and 270°"

BE13 1245 9.2.1.1 n/a te In some systems, the spot size is adjustable (e.g., by means of a scatterer of different thickness). The information required in this § shall be given for each available spot size.Furthermore, the test requires the pattern at three different energies, whereas the clause does not mention those energies.

Replace by: “For systems that use MODULATED SCANNING, the ACCOMPANYING DOCUMENTATION shall provide the following information for the scanning SPOT for each GANTRY, for each nominal SPOT size, at the maximum, minimum and (maximum plus minimum)/2 ENERGY PER NUCLEON levels, and for each LIGHT ION species:”

Page 20 of 26

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 secretariat

JP47 12471250

9.2.1.1 b)c)

te The coordinate system rotating with a BLD is not appropriate for describing spot positions.

Change to the gantry system coordinates of IEC 61217.

DE12 1254 9.2.1.1 f) te Can all results be given in millimetres and degrees? In Annex A only millimetres are required.

Delete degrees.

JP48 1257 9.2.1.2 te A simpler spot pattern will be preferable. Change to 25 (= 5 x 5) spots.

AT8 1260 9.2.1.2 te Rotational gantries covering less than 360° of angular positions are not adequately covered

Add "for rotational type gantries with less 360° rotation for angular positions of the GANTRY for min, max, angular position and available angular positions at 0°, 90°, 180° and 270°"

JP49 1261 9.2.1.2 ed Use of “plus” does not match other parts. Replace “maximum plus minimum”with “maximum + minimum”

BE14 1263 10 n/a Te It is not clear what the energy and FLUENCE modulation (EFM) capability is.

Add definition or note to explain EFM.

JP50 1285 11.1 te This clause is for time to irradiate specified volumes. The lateral profiles are already reported elsewhere. Why not use the same condition?

Delete this paragraph.

DE13 1301 11.2. T This is not a test but an additional requirement on what to test.

Include this in 11.1. and add a test

JP51 1342 12.3.2.1 Table 9 ed The rule line is not adequate in the first to second rows.

Correct.

JP52 1342 12.3.2.1 Table 9 ed Wrong axis assignment for “Angular position of gantry”

Replace “Axis 1” with “Axis 4”

AT9 1352 12.3.2.2 te Rotational gantries covering less than 360° of angular positions are not adequately covered

Add "for rotational type gantries with less 360° rotation for angular positions of the GANTRY for min, max, angular position and available angular positions at 0°, 90°, 180° and 270°"

AT10 1369 12.3.3.2 te Rotational gantries covering less than 360° of angular positions are not adequately covered

Add "for rotational type gantries with less 360° rotation for angular positions of the GANTRY for min, max, angular position and available angular positions at 0°, 90°, 180° and 270°"

Page 21 of 26

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 secretariat

BE15 1379 12.4.2 n/a te It is not clear what are the “proximal and distal extremes of the working range of the LIGHT FIELD”

“One exposure of a RADIATION DETECTOR is made for each set of test conditions. The maximum deviation between the LIGHT FIELD and the LIGHT ION RADIATION FIELD is determined by exposing the RADIATION DETECTOR oriented perpendicularly to the LIGHT ION REFERENCE AXIS at the ERP and the proximal and distal extremes of the working range of the LIGHT FIELD along the LIGHT ION REFERENCE AXIS.”

AT11 1389 12.4.2 te Rotational gantries covering less than 360° of angular positions are not adequately covered

Add "for rotational type gantries with less 360° rotation for angular positions of the GANTRY for min, max, angular position and available angular positions at 0°, 90°, 180° and 270°"

SE58 1391 etc

13 Te Check the suggestions in -2-1 Ed4 on PATIENT SUPPORT

See the comment.

DE14 1404 13.2.2 a) Note te A water phantom cannot be part of a table top as per definition 3.41..

A patient is never placed on a water phantom which is required in order to be called a table top as per 3.41. Delete water phantom..

.

JP53 1404 13.2.2 a) NOTE ed A too large space after “NOTE:” Correct.

US11 1404 13.2.2 E water phantom comment in note is confusing add a separate note for items other than patients such as for water tank

JP54 14111416

13.2.2 c)e)

te It is not obvious what table top types of double C-arm, fork and C-arm are.

Define these.

AT12 1425 13.2.4.1 te Under what conditions? Same as for difference of heights? If yes change “;” to “and”

change “;” to “and”

AT13 1427 13.2.4.1 ed It seems, that bullet point 3 and 4 of the list are conditions for bullet point 2

change “;” to “:”

AT14 1428 13.2.4.1 ed It seems, that bullet point 3 and 4 of the list are conditions for bullet point 2

Change/indent list level

JP55 1428 - 1432

13.2.4.1 ed It is confusing to place the third, fourth and fifth bullets at the same level as the first two.

Change the indentation and the symbol for the third, fourth and fifth bullets.

Page 22 of 26

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 secretariat

DE15 1428-1429

13.2.4. E These bullet points are not to be stated in the ACCOMPANYING DOCUMENTATION but are more like test conditions

Move into the test clause or as a minmum replace the “ ; ” in line 1427 by a “ : “ and place the new bullets further to the right as a second indent

AT15 1430 13.2.4.1 ed It seems, that bullet point 3 and 4 of the list are conditions for bullet point 2

Change/indent list level

AT16 1432 13.2.4.1 te It is not clear, what the las bullet point of the list means, or to what phrase it belongs

Delete or clarify

CN6 1434 13.2.4.1 T The note here has nothing to do with the requirement in this clause.

Delete this note.

AT17 1435 13.2.4.2 te Test description for pitch is missing. Add test for measuring of pitch

DE16 1454 13.2.5.1 T A 10 in a circle is not 61217 compliant. Replace all directions in 13.2.5 with IEC 61217 compliant terms

US12 1456 13.2.5.1 E inconsistent use of mm and cm in requirements and Annex A

change clauses and annex to report everything in mm except where cm is used in safety standard

AT18 1459 13.2.5.1 te To be consistent with clauses before add phrase for shorter TABLE TOPS

add "or, if the length of the TABLE TOP is less than 2 m, over the length of the TABLE TOP"

SE59 1474 etc

13 Te Lots to be done!!! No suggestions really.

AT19 1493 13.4.2.1 ed “table” should be “TABLE TOP” change to "TABLE TOP"

AT20 1494 13.4.2.1 te To be consistent with clauses before add phrase for shorter TABLE TOPS

Add “or, if the length of the TABLE TOP is less than 1 m, over the length of the TABLE TOP”

AT21 1495 13.4.2.1 te To be consistent with clauses before add phrase for shorter TABLE TOPS

add "or, if the length of the TABLE TOP is less than 2 m, over the length of the TABLE TOP"

JP56 1539-1694

14 te As described in line 1543-1545, requirements of “14 KILOVOLTAGE X-IGRT EQUIPMENT” apply to KILOVOLTAGE X-IGRT EQUIPMENT with a mechanical or electrical connection to the LIGHT ION BEAM ME EQUIPMENT. Therefore, the requirements are system requirements, and are out of scope of IEC 62667 since the scope of IEC 62667 is only LIGHT ION BEAM ME EQUIPMENT.

“14 KILOVOLTAGE X-IGRT EQUIPMENT” should be deleted.

DE17 1564 14.2.2. E Throughout the document these were named test and not inspections

Change to test also throughout chapter 14

Page 23 of 26

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 secretariat

DE18 1597 14.7.1. T IEC 62220-1-1:2015 becomes normative this way Either add IEC 62220-1-1 to the normative reference or (preferred) add DQE to the list of defined terms in chapter 3 and to the INDEX at the end

JP57 1606 14.8.1 te No test method is specified. Specify.

DE19 1614 14.9.1 T This is a leftover from Portal Imaging devices which may also be used for exit dosimetry. It references the dynamic range used for treatment. However this clause is not about proton radiography as per the scope in 14.1. Exit dosimetry with a particle beam is for sure not ready for standardization, even proton radiography is more a matter of research and in most cases not using treatment energies with the Bragg Peak in the target depth.

Delete this clause or rewrite it completely so that no reference to the treatment beam and dosimetry is made

JP58 1615 14.9.1 te No test method is specified. Specify.

JP59 1622 14.10.1 te No test method is specified. Specify.

DE20 1662 14.13.1 T This is not required for other performance standards for EID like 60976 why here

Delete clause to be consistent throughout standards developed within IEC SC62C

JP60 1675 14.13.2 te Measured RADIATION DETECTOR responses per delivered ;AIR KERMA should be used instead of these ratios.

Replace R’s with appropriate RADIATION DETECTOR response.

SE60 1675 14.13.2 formula Ed The same problem with “n-1” as before. Check the formula, “n-1”.

JP61 1677-1686

14.13.2 te The description is for light ion dose monitors (the same as in 7.3.2).

Rewrite test for an x-ray system.

SE61 1680 14.13.2 Te Change determinations to measurements Change according to the comment.

JP62 1687 14.13.2 Table 11 te The table seems unnecessary, since no specific information is contained.

Delete Table 11.

AT22 1697 ed A heading indicating, that figures follow should be added

Add he heading for figures

AT23 1726 Figure 3 ed Caption should be at same page as figure Move caption to page where the figure has been placed.

JP63 1735 Figure 6a ed In the figure title it is “Flattened area (shown shaded)” while in the note in the figure it is “Flattened area (hatched).”

Unify the expression.

Page 24 of 26

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 secretariat

JP64 1738 Figure 6b ed In the figure title it is “Flattened area (shown shaded)” while in the note in the figure it is “Flattened area.”

Unify the expression.

US13 1740Annex

all E should spell out all abbreviations spell out all abbreviations

US14 1740Annex

all E include units in all columns insert units in all columns

JP65 1751 ed It is preferable for ease of read that a single table does not span multiple pages (also in lines 1761, 1912, 1915, 1938, 1945, 1953, 1954, 1990, 1999, and 2009).

Make a single table contained in a single page, if possible.

DE21 1788 Annex A, 6.2.4

ed Wrong unit. Replace 'cm' by 'mm'.

JP66 1792 ed Item “Method” is divided into two pages. Make a single item contained in a single page, if possible.

DE22 1835 Annex A, 6.7

ed Change '@' to 'at'.

US15 1835 table E first letter of abbreviation is in capital-small capitals instead of all small capitals

change to all small capitals

JP67 1879 ed The title and its items are in separate pages. (also in lines 1897, 2045 and 2064).

Make a title and its item contained in a same page, if possible.

US16 1891 annex 6.10.6

E use defined terms change to TERMINATE

US17 1892 annex 6.10.6

E use defined terms change to INTERRUPT

US18 1938 table E include both potential units in column header

US19 1938 table E separate table better use double line under headingsmerge cells of same light ion species and light ion beam applicator

JP68 1960 ed At the end of the page, a new page stars in the middle of a row.

Page division should be carried out with care.

Page 25 of 26

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 secretariat

US20 1964 table E separate table better use double line under headingsmerge cells of same light ion species and light ion beam applicator

JP69 1968 ed The table is too large. Remove “LIGHT ION species” and “LIGHT ION BEAM APPLICATOR” columns from the table and prepare a single table for each combination of LIGHT ION species and LIGHT ION BEAM APPLICATOR.

JP70 1976 ed Irregular position of “(mm)” in “Max X FWHM“ column heading.

Change to “Max X FWHM dev (mm)”

JP71 1976 ed The table is too large. Remove “LIGHT ION species” column from the table and prepare a single table for each LIGHT ION species.

US21 2007 table heading

E change 13.2.1 to 13.2.2

DE23 2009 Annex A, 13.2.2

ed Change '13.2.2' to '13.2.3'.

US22 2009 table heading

E change 13.2.2 to 13.2.3

DE24 2012 Annex A, 13.2.3

ed Change '13.2.3' to '13.2.4'.Change 'cm' to 'mm'.

US23 2012 table heading

E change 13.2.3 to 13.2.4

DE25 2015 Annex A, 13.2.4

ed Change '13.2.4' to '13.2.5'.Change 'cm' to 'mm'.

US24 2015 table heading

E change 13.2.4 to 13.2.5

DE26 2068 Annex A, 14.10

ed Change 'ntd' to 'NTD'.

Page 26 of 26