Guide to Application
for IECEE CB Certification

Cosmos Corporation

DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

1/14

Contents

I. Introduction ........................................................................................................... 3
1. About this Guide.................................................................................................. 3
II. Process of CB certification ................................................................................... 3
1. Scope of CB certification service ........................................................................... 3
2. Location and contact to provide CB certification service........................................... 3
3. Flow of CB certification service ............................................................................. 3
4. Handling of test sample........................................................................................ 4
5. Documents required for application ....................................................................... 4
6. Change of the contents in the application after receipt of the order of CB certification . 8
7. Confidentiality ..................................................................................................... 8
8. Consultancy........................................................................................................ 8
9. Change and withdrawal of CB certification ............................................................. 8
Ⅲ. Service fee and payment ..................................................................................... 9
1. Service fee concerning CB certification .................................................................. 9
2. How to make payment ......................................................................................... 9
Ⅳ. Rights and obligations of Applicant and CB certification holder .........................10
1. Rights of Applicant and CB certification holder .......................................................10
2. Obligations of Applicant and CB certification holder ................................................10
3. Obligations of CB certification holder ....................................................................10
4. Cancellation of CB certification ............................................................................11
5. Registration of CBTC to IECEE Online Database...................................................11
Ⅴ. CB certification holder requirements for maintenance of CB certification ...........11
1. Change of or addition to the scope of CB certification for the product .......................11
Ⅵ. Complaints and appeals .....................................................................................12
1. Flow of making an appeal ...................................................................................12
2. Flow of handling a complaint ...............................................................................12
Annex 1 Service fee for CB certification .......................................................................13

DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

2/14

I. Introduction
1. About this Guide
This Guide describes the service of issuing CB Test Certificate (hereinafter referred toas "CBTC") under IECEE CB Scheme, which is provided by Cosmos Corporation(hereinafter referred to as "Cosmos"), a National Certification Body (NCB). IECEE CB
Scheme is an international system for mutual acceptance of test data according to IEC
standards.
Applicants and CB certification holders must consent to the descriptions in this Guide
and to observe the requirements at any time. Therefore, even after CB certification is
granted, keep this Guide properly for easy reference when necessary.
If you have any question on this Guide or others, contact CS Department or
Engineering Department.
II. Process of CB certification
1. Scope of CB certification service
Our CB certification service is available for the following product categories:
・MED (medical devices): IEC 60601-1, IEC 60601-1-6
・MEAS (measurement and laboratory equipment): IEC 61010-1
2. Location and contact to provide CB certification service
CB Certification service is provided at the following offices.
Cosmos Corporation Matsusaka Headquarters
718-1 Katsurase, Matsusaka City, Mie Prefecture 515-1104 Japan
TEL: +81-598-30-5225

FAX: +81-598-30-5571

3. Flow of CB certification service
The steps from application to issue of CBTC and CBTR are as follows:<Step 1>
Download this Guide and Application Form for CB Certification from our website andcomplete the Application Form. Send the completed form to us together with documents
required for estimation as specified in 5. Documents required for application in thisGuide.

DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

3/14

<Step 2>
We will calculate CB certification fee according to above information and send an
estimate to you.
At that time, we will inform you of necessary information, sample, estimated period forevaluation, applicable standard(s), etc.
In some cases, we may not be able to accept your application.
<Step 3>
Send the signed Application Form for CB Certification (PDF file is acceptable), required
documents and test sample(s).
* Contact us if you want to cancel the application. Cancellation fee is charged, if wealready receive the signed Application Form for CB Certification.
<Step 4>
The application is formally accepted. We issue an invoice for the half amount of fee andstart testing and evaluation of the product applied for.
[In case of nonconformity]･ We will report nonconformity, if any, in an Assessment Report.
･ If you do not expect to make improvements but cancel the application, please informus. The fee for already completed works will be charged, and we will close theproject.
<Step 5>
Upon completion of all evaluations, review and decision of certification, we issue CBTC
and CBTR.
4. Handling of test sample
We conduct evaluation tests on the test sample(s) according to applicable standard(s).
Note that some of tests such as destructive tests may damage the supplied test sample
and test tools.
5. Documents required for application
Download the Application Form for CB Certification from our website. Complete theform and send it to us together with required materials and information listed in thefollowing table.
DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

4/14

* The documents marked with a circle (○) are required at the stage of estimation.
* We will inform you of documents required at the stage of evaluation when we send
you an estimate.
Document
Application of CB
Certification Work
[QAF1862]
List of factories
Authorization Letter

Declaration Letter
Manufacturer
Declaration
Instruction Manual (inEnglish)Rating label

Installation manual or
installation
specification

Service manual
Drawing of marking ona package

Material of label andink, or printing method
Instructionsforoperation at maximum

Remarks

Required at
the stage of
estimation

Download it from our website.
○

It is required, if:① the Applicant delegates authority concerning theapplication to an agent; or② the Applicant differs from the Manufacturer.
It is required only when a trademark different from theApplicant's one is used.
It required only when there is more than one factory.
○
Rating label
Please include the following information as applicable:- Product name
Model
Electrical rating
Trademark- Manufacturer's name, etc.
- Instructions and graphical symbols for caution andwarning- A copy of rating label with its dimension◆ Indicate the location of labels on the product.
If the product has installation conditions, please provide
the document including the following information as
applicable:- operating environment (e.g. indoor, outdoor, floor type,
tabletop);- specified minimum clearance from peripherals (e.g.
wall);- provision of cooling equipment;- ventilation method;- capable to be used in a rack or not;- outer dimension (H x W x D), and so on.
Instructions for service personnel(in case of application according to IEC 60601-1)
Include permissible environmental conditions fortransport and storage (temperature, humidity,
atmospheric pressure).
This information is necessary to be included in CBTR
for marking, e.g. rating, cautions specified in the applied
standard.
Method which allows the operator to set and operate
the product.

DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

5/14

Document

Remarksload

Critical component list
Block diagram
Insulation block
diagramCircuit diagrams

Pattern diagrams andsilk-screens of printed
wiring boards
Appearance drawing of
the product

LicensesheetsofOperating conditions under which the power
consumption of the product becomes maximum.
The product must operate until the temperature ofmeasuring locations becomes constant.
Considering above, please prepare the instructions
including the following information as applicable:- maximum loading operation;- setting to achieve maximum continuous automatic
loading operation;- maximum operating ambient temperature;- Input voltage tolerance;- installation conditions;- installation condition in normal use of the product;- method for installation and setting of peripherals to beconnected the unit
Download its template from our website.
Send the diagrams showing the primary circuit,isolation between primary and secondary circuits andbetween primary circuit and ground, and high voltage
parts.
Send the diagrams showing the primary circuit,isolation between primary and secondary circuits andbetween primary circuit and ground, and high voltage
parts.
＊If the product is provided with any of the following
circuits, send their circuit diagrams:a - Protective circuit for lithium batteryb - Interlock circuitc - I/F (interface) circuitd - Inverter board for back light (for LCD, etc.)* Please note that the submitted diagrams have thesignatures and dates in the columns of "Approved","Reviewed", "Designed" and "Prepared" respectively.
Same as circuit diagrams.

Include the following information as applicable:- outer dimension (H x W x D);- location of labels;- bill of materials [including each part name,manufacturer's name, type designation, material,
minimum thickness, non-combustibility (for insulationmaterial only)];- total weight;- dimension of opening (H x W);- drawings for assembly/disassembly (which help us tounderstand how to assemble or disassemble eachcover)IEC or EN standard

DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

6/14

Required at
the stage of
estimation○○○

Document

Remarks

recognizedcomponents
Test report of switching
power supply and/or
AC adapter
Risk assessment sheet

UL standard (certification number is acceptable)
CSA standard
If these components are already approved, pleaseprovide the following information:- Copy of CBTC and CBTR
Applicable to application for certification to IEC 61010-1
only.
Applicable to application for certification to IEC 60601-1
only.
For evaluation of risk management process, pleaseprovide a risk management file according to ISO 14971.
Applicable to application for certification to IEC 60601-1
only.
Complete relevant pages of CBTR we send.
Applicable to application for certification to IEC 60601-1
only.
Complete relevant pages of CBTR we send.
Applicable to application for certification to IEC 60601-1
only.
For evaluation of usability, send a usability engineering
file.
Applicable to application for certification to IEC 60601-1
and the case where programmable electrical medical
system (Cl. 14) is used.
Complete relevant pages of CBTR we send.

Risk management file

Risk Management
Result Table
Usability engineering
file result table
Usability engineering
file

Result of evaluation of
IEC 60601-1, Cl. 14
Programmableelectrical medical
systemInterlock system
diagramIf an interlock circuit is spilt into several boards, send adrawing briefly describing which board disconnects
which supply circuit.
Send a drawing briefly describing which board
disconnects which supply circuit.

Structural specificationof component parts

Resin material used for
reduction of separation
distances (conformal
coating)(e.g. potting)Information of protective
earthing

Test report of laser and
LED

CBTC and CBTR oflithium-ion battery
Sample- Manufacturer's name/type designation- Flammability rating- Material- Upper temperature limit- Each material (including plating) of terminal, fixing
screw, fastener and housing- Diameter and upper temperature limit of protective
earthing conductor- Connecting method of protective earthing conductor
Applicable to the product using a laser or LED as a lightsource.
- Test report according to IEC/EN 60825-1, or- Test report according to IEC/EN 62471
Applicable to the product using a lithium-ion battery.
CBTC and CBTR according to IEC 62133
At least three units (we will inform you when we issue
the formal estimate)

DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

7/14

Required at
the stage of
estimation

Document

Peripherals to operate
the productSingle components

Remarks

Required at
the stage of
estimation

Additional sample may be required depending on
product.
Same as the amount of sample
We will inform you when we issue the formal estimate.

(for construction checkand repair)

6. Change of the contents in the application after receipt of the order of CB certification
If you want to change any of the contents of the application after we receive it (e.g.
change of construction, addition of component), you need to request the change to us.
Send us corrected Application Form for CB Certification with changes made. Somekinds of change may require additional fee. In such case, we issue an extra estimate or
modify the original estimate. Contact us in advance.
7. Confidentiality
We will keep your secrets known in the process of CB certification service strictly
confidential. We will not disclose them to third parties, unless such disclosure isrequested according to applicable legislations.
8. Consultancy
We do not offer or provide consultancy, because it is prohibited under ISO/IEC 17065.
9. Change and withdrawal of CB certification(1) Issue of supplement to CBTC, etc.
Apply for change of descriptions in CBTC, etc., if any change is made to CBTC.
① Change of address of the Applicant or production manager described in CBTC,
etc. (including change of the writing and relocation)② Change of address of the factory described on CBTC, etc. (including change of
the writing and relocation)③ Relocation of the factory described on CBTC, etc.
④ Addition of other factory to CBTC, etc.
⑤ Change of rating on CBTC and CBTR, etc., rating label, critical component,
circuit, pattern and appearance* Such change due to technical changes to the certified product are limited tomaximum three times according to the requirements of IECEE OPERATIONALDCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

8/14

DOCUMENT IECEE OD-2020.
⑥ Change of construction (e.g. addition of alternate or new component)* Such change due to technical changes to the certified product are limited tomaximum three times according to the requirements of IECEE OPERATIONAL
DOCUMENT IECEE OD-2020.
⑦ Change of trademark, addition of other trademark⑧ Updating the applied standard(not involving significant revision of CB Test Report Form)⑨ Addition of new model similar to the certified product (meeting the definition in
IECEE OPERATIONAL DOCUMENT IECEE OD-2027)(2) Issue of new CBTC, etc.
Apply for change of descriptions in CBTC, etc., if any change is made to CBTC.
① Change of name of Applicant and/or production manager described on CBTC,etc.
② The fourth technical change due to change of rating described on CBTC and
CBTR, etc., rating label, critical component, circuit, pattern or appearance③ The fourth technical change due to construction change④ Updating the applied standard (involving revision of CB Test Report Form)⑤ Addition of new model similar to the certified product (not meeting the definition
in IECEE OPERATIONAL DOCUMENT IECEE OD-2027)(3) Cancellation of CB certificate
If the mass-produced products do not comply with the assessed test sample and
CBTR, we may cancel the granted CB certification. Once cancelled, IECEE will
immediately inform the production manager and all other NCBs of the cancellation of
CBTC and CBTR concerned and its reason.
Ⅲ. Service fee and payment
1. Service fee concerning CB certification
We charge the service fee as prescribed (please refer to Annex 1).
2. How to make payment
The half amount of CB certification fee on formal estimate is billed when an applicationis accepted by us and the remainder is billed after the project is completed. If additional
assessment is required due to improvement against nonconformity found by the
DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

9/14

evaluation or other reason, an extra fee is charged after completion of assessment.
Ⅳ. Rights and obligations of Applicant and CB certification holder
1. Rights of Applicant and CB certification holder
Applicants and CB certification holders have the rights to acquire CB certification
objectively, fairly and impartially and to exercise the following rights over Cosmos.
(1) Challenge to certifier (with due reason)(2) Reflection of various circumstances of Applicant or CB certification holder in plan of
implementation of assessment (CB certification is granted in the order ofagreement formation, unless we must stop the service to the Applicant or CB
certification holder for any reason attributable to the Applicant or CB certification
holder)(3) Safeguarding confidentiality of the Applicant's or CB certification holder'sinformation known in the process of assessment activities for CB certification(4) Making an appeal to decision on CB certification(5) Making a complaint(6) Filing a dispute(7) Use of and reference to CBTC and CBTR (for CB certification holder only)
2. Obligations of Applicant and CB certification holder
Obligations of Applicant and CB certification holder are as follows:(1) Taking corrective actions on findings arising from the assessment for CB
certification and report of these actions to Cosmos(2) Providing all documents concerning the application for CB certification anddisclosure of records(3) Payment of service fee concerning the assessment for CB certification
3. Obligations of CB certification holder
Obligations of CB certification holder are as follows:(1) ensuring the certified product always comply with the requirements;(2) making records of complaints from customers, including:- situation of occurrence;- investigation of causes;- corrective or preventive actions; and- disclosing them to us upon our request;(3) avoiding misuse and misleading use of CB certification;
DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

10/14

(4) correct but not misleading reference to CB certification; and(5) control of CBTC to avoid unauthorized use.
4. Cancellation of CB certification
If nonconformity to CB certification is proven or we receive a request of cancellationfrom Applicants, we send a cancellation notice for CB certification.
In addition, we will ask to discontinue the use of all advertisements and promotional
materials referencing the CB certification concerned.
5. Registration of CBTC to IECEE Online Database
When we issue CBTC, we will send a confirmation request letter for registration to
IECEE Online Database to know your intention of the registration. You may choose
non-disclosure. We will register your CBTC according to your request.
Ⅴ. CB certification holder requirements for maintenance of CB certification
CB certification holders must continuously comply with all the following requirements
and have a procedure to always keep the information provided for us updated.
1. Change of or addition to the scope of CB certification for the product(1) CB certification holders must inform our CS Department of any of the followingchange and addition before doing it. In such case, please be sure to attach adocument clearly describing the point of change and reason.
(a) Change of the information of CB certification holder and/or factory in the application(e.g. addition, relocation, change of parcel number or withdrawal)(b) Change concerning the conformity to standard for CB-certified product (change of
product specification, rating, component, etc.)(c) Change of the contents of registration of CB-certified model(d) Cancellation of registration of CB-certified model(2) Use of CBTC
CB certification holder must avoid unauthorized use of copy of CBTC.

DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

11/14

Ⅵ. Complaints and appeals
Applicants are encouraged to contact our CS Department for complaints on evaluation
and CB certification in general and appeals against our decision on CB certification.
For appeals, we will send a Form for Making Appeals to understand the details of appeal.
Complete and send it back to us.
After we receive it, we will respond to it later.
1. Flow of making an appeal
ApplicantCosmosForm of Appeal
Proceeding(QAF1413)

Receipt of Form for
Making Appeals
Validation
Preparation of Response
to Appeals(QAF1414)

Receipt

2. Flow of handling a complaint

ApplicantCosmosComplaint

Receipt of complaint
Action to resolve acomplaint

Receipt

Report

DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

12/14

Annex 1 Service fee for CB certification

The service fee for CB certification is calculated according to the following tables.
■新規
Brand-new
Title
Contents

費用 (消費税別)
Fees (Consumption tax is notincluded)

技術費用
Engineering fee

弊社料金算出規定によります。
Our rule on estimate shall apply

試験費用
Testing fee

弊社料金算出規定によります。
Our rule on estimate shall apply

製品書類審査料
Document assessmentfee

技術費用+試験費用の 20％となります。 (最低 100,000 円)
20% of Engineering fee + Testing fee(Min. 100,000 JPY)

CB 証明書発行手数料
CB certificate issuancefee

60,000 円
60,000 JPY■技術的変更Technical modification
Title
Contents

弊社料金算出規定によります。
Our rule on estimate shall apply

試験費用
Testing fee

弊社料金算出規定によります。
Our rule on estimate shall apply

製品書類審査料
Document assessmentfee

技術費用+試験費用の 20％となります。 (最低 80,000 円)
20% of Engineering fee + Testing fee(Min. 80,000 JPY)

CB 証明書発行手数料
CB certificate issuancefee

60,000 円
60,000 JPY

Title
Contents

弊社料金算出規定によります。
Our rule on estimate shall apply

試験費用
Testing fee

0円
0 JPY
技術費用+試験費用の 20％となります。 (最低 80,000 円)
20% of Engineering fee + Testing fee(Min. 80,000 JPY)

CB 証明書発行手数料
CB certificate issuancefeeRemarks
Note
製品・評価内容などに基づき時間工数で算出致します。
Calculate by time man-hours based on product andevaluation contents
製品・評価内容などに基づき時間工数で算出致します。
Calculate by time man-hours based on product andevaluation contents
技術費用+試験費用の 20%が 80,000 円を下回る場合は80,000 円を適用致します。
Apply 80,000 JPY when the 20% of Engineering fee +Testing fee becomes less than 80,000 JPY
証明書発行、維持管理、IECEE への支払費用含みます。
Including issuance of certificate, maintenance, payment
for IECEE

試験無しの場合
Without testing
費用 (消費税別)
Fees (Consumption tax is notincluded)

技術費用
Engineering fee

製品書類審査料
Document assessment
fee

製品・評価内容などに基づき時間工数で算出致します。
Calculate by time man-hours based on product andevaluation contents
製品・評価内容などに基づき時間工数で算出致します。
Calculate by time man-hours based on product andevaluation contents
技術費用+試験費用の 20%が 100,000 円を下回る場合は
100,000 円を適用致します。
Apply 100,000 JPY when the 20% of Engineering fee +Testing fee becomes less than 100,000 JPY
証明書発行、維持管理、IECEE への支払費用含みます。
Including issuance of certificate, maintenance, payment
for IECEE

試験有りの場合
With testing
費用 (消費税別)
Fees (Consumption tax is notincluded)

技術費用
Engineering fee■技術的変更Technical modification

Remarks
Note

60,000 円
60,000 JPY

Remarks
Note
製品・評価内容などに基づき時間工数で算出致します。
Calculate by time man-hours based on product andevaluation contents
試験は要求されません。
No testing required
技術費用+試験費用の 20%が 80,000 円を下回る場合は80,000 円を適用致します。
Apply 80,000 JPY when the 20% of Engineering fee +Testing fee becomes less than 80,000 JPY
証明書発行、維持管理、IECEE への支払費用含みます。
Including issuance of certificate, maintenance, payment
for IECEEDCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

13/14

■管理上の変更 （工場追加等）
Administrative modification (addition of factory etc.)
費用 (消費税別)
Title
Fees (Consumption tax is notContents
included)
技術費用
Engineering fee

弊社料金算出規定によります。
Our rule on estimate shall apply

試験費用
Testing fee

0円
0 JPY
技術費用+試験費用の 20％となります。 (最低 10,000 円)
20% of Engineering fee + Testing fee(Min. 10,000 JPY)

製品書類審査料
Document assessmentfee
CB 証明書発行手数料
CB certificate issuancefee

60,000 円
60,000 JPY

Remarks
Note
製品・評価内容などに基づき時間工数で算出致します。
Calculate by time man-hours based on product andevaluation contents
試験は要求されません。
No testing required
技術費用+試験費用の 20%が 10,000 円を下回る場合は10,000 円を適用致します。
Apply 10,000 JPY when the 20% of Engineering fee +Testing fee becomes less than 10,000 JPY
証明書発行、維持管理、IECEE への支払費用含みます。
Including issuance of certificate, maintenance, payment
for IECEE■その他
Others・Non-CB メンバーの国に所在する Applicant, Manufacturer, Factory の場合、20,000 円が別途必要となります。
For Applicant, Manufacturer and Factory of non-CB members, 20,000 JPY is required separately.
・1 モデルにつき 1 ライセンスが発行されます。
One license is issued for one model.
・トレードマークまたはブランドネームが複数ある場合、各トレードマークもしくはブランドネームにつき 1 ライセンス発行されます。
For more than one trademark or brand name, one license is issued for each trademark or brand name.
・２枚以上の証明書発行時は、追加証明書１枚あたり 12,000 円が別途必要となります。
When two or more certificates are issued, 12,000 JPY per additional certificate is required.

DCN：QAF1870-1 Issued: 21/05/20 Revised：--/--/-- Translated: 21/05/21

14/14