REQUEST FOR A CB TEST CERTIFICATE
CONFORMITY ASSESSMENT CERTIFICATES FOR ELECTROTECHNICAL EQUIPMENT AND
COMPONENTS
Reference documents:
-
IECEE 01 - IEC System of Conformity Assessment Schemes for Electrotechnical Equipment
and Components (IECEE) – Basis Rules
IECEE 02 – Scheme of the IECEE for Mutual Recognition of test certificates for
Electrotechnical Equipment and Components (CB Scheme) – Rules of Procedure
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CB Scheme Certification
May 2011
Conformity Assessment Certificates for Electromedical devices
Who should you contact?
Your contact:
Laboratoire national de métrologie et d’essais (LNE)
Arnaud ROBLIN
Tel : +33 1 30 69 13 13
Direction de la Certification et de la Formation (DCF)
1, rue Gaston Boissier -75724 PARIS CEDEX 15
Internet site: www.lne.fr
arnaud.roblin@lne.fr
PART1
-
What is the CB Scheme?
PART 2
How to apply for a CB
certificate?
APPLICANT
PART 3
How is a CB test
certificate obtained?
PART 5
What is the cost ?
PART 4
Which bodies are involved ?
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1.
WHAT IS THE CB SCHEME?
1.1
Interest
May 2011
The CB Scheme is based on the use of CB test Certificates that provide evidence that
representative specimens of the product have successfully passed tests showing their compliance
with the requirements of the relevant IEC standards.
An application for obtaining a CB Test Certificate is intended to reduce obstacles to international
trade which arise from having to meet different national certification or approval criteria.
This document, based on IECEE02 (Scheme of the IECEE for Mutual Recognition of Test
Certificates for Electrotechnical Equipment and Components (CB Scheme) – Rules of Procedure),
gives information on LNE’s scope for the issuance of CB test certificates, and on the conditions of
obtaining a CB test certificate from LNE.
The IECEE website contains much information on the CB Scheme and its members :
www.iecee.org
1.2
Scope
The complete and regularly updated list of standards for which the LNE is authorized to issue CB
certificates, is on the IECEE website at the following link :
http://members.iecee.org/IECEE/IECEEMembers.nsf/ShowScopeV2?openform&SelectedEntity_CleDoc=DOMM-78YJZK
2.
HOW TO APPLY FOR A CB TEST CERTIFICATE?
2.1
Requirements applicable to the Applicant
The applicant may be a manufacturer or a representative acting on behalf of a manufacturer. In
this latter case, evidence shall be submitted that the applicant is authorized to act on behalf of the
manufacturer and that the manufacturer undertakes the same obligations as the applicant.
The applicant will be the holder of the CB Test Certificate.
Any manufacturer wishing to obtain a CB Test Certificate for its product must first carefully read
this information note. More information about the CB scheme can be found on the IECEE website
(www.iecee.org).
The application is filled on the applicant's headed paper and using the application form (see
annexes 1 and 2). It must be sent to the LNE.
The application to the LNE shall contain as a minimum the following information:
 Name and address of the applicant
 Name and address of the manufacturer, if different from the applicant
 Names and addresses of the factories where the product is manufactured. If several
facilities are involved, the equivalence between the products has to be demonstrated by the
manufacturer
 Mark, trade marks or other markings by which the applicant, the manufacturer (if relevant),
and the factory can be unambiguously identified by the LNE
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 Type and designation and markings by which the product can be unambiguously identified
by the LNE
 Identification of the relevant standards used as a base for the test to be carried out by the
LNE’s accepted Testing Laboratory
 Specific test requests covering national specificities in the countries where the CB test
certificate will be used. If additional tests have been carried out, a report of their results may
be attached to the application, and are considered as part of the test report.
All documents must be written in French or English.
The purchase order corresponding to the quotation issued by the LNE is required before beginning
the assessment.
Documents to provide
 Application form (annex 1 to this document) and identification form (annex 2 to this
document, to be drawn up on the manufacturer's headed paper)
 Dimensioned drawing of all the products,
 The diagrams required for verifying electrical safety and electromagnetic compatibility.
 Operation of the products and instructions for use.
2.2
Requirements applicable to LNE
Upon receipt of an application for a CB Test Certificate, the LNE shall within one month
 Send the corresponding quotation to the applicant,
 Arrange for and schedule the testing of the equipment concerned,
The application, the results of the work and the information obtained in connection with the
application for a CB Test Certificate are kept confidential by the LNE.
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3.
PROCESS FOR OBTAINING A CB TEST CERTIFICATE
MANUFACTURER
LNE (DCF + DEV)
(as an accepted Issuing and
recognizing National
Certification Body)
LNE (DE)
(as an accepted Testing
Laboratory)
Documents required for the
application file
 Application for obtaining a CB
test Certificate
Quotation
 Purchase order
 documents to provide
Examination of the
application for certification
Tests*

Samples
Test report
Decision and notification
Issuing of the CB Test
Certificate
Information to IECEE

CB test Certificates + Test
report
720 CB 0701-3a Rev 1 – 24/05/2011
* The tests can be carried out in
application of the TMP procedure
(operation of Testing at Manufacturers’
Premises)
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3.1.
May 2011
Examination of the certification application
The applied version of CB Scheme requirements is the one in force at the date of the quotation.
The technical file and the purchase order are sent to the LNE.
The file is examined before carrying out tests.
If some elements do not correspond to the requirements of the certification regulations, the LNE
informs the applicant and requests the missing information. Tests are initiated once a new file is
presented and completed.
When the file is complete, the number of samples necessary to carry out the tests is confirmed and
the necessary information given to the applicant.
3.2.
Tests
Tests of conformity to the applicable standards are performed by the LNE’s testing laboratories
(Direction des Essais) on the products provided by the manufacturer.
Samples must be shipped directly to the testing laboratory carriage-free and customs-cleared if
necessary, within 15 days at most from the time of sampling.
The test report written by the LNE Testing Laboratory (Direction des Essais) is assessed by LNE
Certification department (Direction Certification et Formation).
In case of testing performed at the manufacturer’s premises, the TMP specific procedure applies
(operation of testing at manufacturer’s premises).
3.3.
Issuing of a CB certificate by LNE
Upon receipt of the Test Report, the LNE (DCF) examines the document, verifies that the format of
the report is in compliance with the format included in the list of available and recognized IECEE
test report formats and, if test results are favourable issues the CB Test certificate within 15
working days from the receipt of the test report.
3.4
Modification of an issued CB Test certificate
A new CB test certificate is issued (new reference n°) when there is a new edition or amendment of
the standard(s) applied.
The CB test certificate shall be re-issued with the same reference n° and a new revision suffix
when there are misprints, changes in names and addresses.
Modifications on a certified product are limited to 3, after which a new CB test certificate shall be
issued.
Any change related to the items provided in the application form or to the device shall be declared
to the LNE which will perform appropriate assessment (including tests if necessary) in order to
issue either a modified certificate or a new one.
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3.5
May 2011
Cancellation of a CB Test certificate
A CB test certificate may be cancelled if:
-
the certificate is misused,
the certificate has been issued by mistake,
the equipment no longer corresponds to the specimens tested and described in the
attached test reports,
the holder of the certificate requests cancellation.
4.
Which bodies are involved ?
4.1
Issuing and recognizing National Certification Body
LABORATOIRE NATIONAL DE METROLOGIE ET D'ESSAIS (LNE)
Certification and Training Direction (DCF)
1, rue Gaston Boissier
75724 PARIS CEDEX 15
Tel. +33 1 40 43 37 00
4.2
CB Testing Laboratory
The LNE entrusts the tests to the laboratory named below:
LABORATOIRE NATIONAL DE METROLOGIE ET D'ESSAIS (LNE)
Direction des Essais (DE)
29, avenue Roger Hennequin
78197 TRAPPES Cedex
Tel. -+33 1 30 69 10 00
5.
APPLICABLE FEES
Fees for the services required for obtaining a CB Test certificate revised annually.
Based on the information contained in annexes 1 and 2 of this document, a quotation is
established, within 10 working days,
The quotation differs:
 The fee for the review of the test reports and issuance CB test certificates
 The fee corresponding to the conformity tests and related report issue (adjusted for each
application)
An applicant in a country with no Member Body of the IECEE, and an applicant acting on behalf of
a manufacturer in such a country shall pay a contribution to the costs of the IECEE in the form of
surcharge for each CB Test Certificate issued, the amount to be decided by the IECEE. The
surcharge is to be collected by the LNE, which then remits it to the IECEE account. These costs
are given in CH francs.
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The LNE fees are given in Euros, excl. VAT.
ANNEX 1
APPLICATION FOR ADMISSION
(to be drawn up on the manufacturer's headed paper)
Managing Director of
LABORATOIRE NATIONAL DE
METROLOGIE ET D'ESSAIS
Direction du Développement
1, rue Gaston Boissier
75724 PARIS CEDEX 15
PURPOSE: Application for a CB Test Certificate for electromedical devices and components
Dear Sir
I the undersigned (name and position) ...........................................................................................
representing the company (identification of the company - registered office).................................
request the LNE to carry out the verifications required for obtaining a CB Test Certificate for the electromedical
device (type of device, reference)…………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………………………….
according to the following standard(s) (tick the boxes):
 IEC 60601-1 ed 2 : Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance,
 IEC 60601-1 ed 3 : Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance
 IEC 60601-1-2 ed2 : Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests,
 IEC 60601-1-2 ed3 : Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard:
Electromagnetic compatibility – Requirements and tests
 IEC 60601-1-1 ed 2 : Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard:
Safety requirements for medical electrical systems,
 IEC 60601-1-3 ed 1 : Medical electrical equipment – Part 1-3: General requirements for safety – Collateral standard:
General requirements for radiation protection in diagnostic X-ray equipment,
 IEC 60601-1-3 ed 2 : Medical electrical equipment – Part 1-3: General requirements for safety – Collateral standard:
General requirements for radiation protection in diagnostic X-ray equipment
 IEC 60601-1-4 ed 1 : Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard:
Programmable electrical medical systems
 IEC 60601-1-6 ed 2 : Medical electrical equipment – Part 1-6: General requirements for safety – Collateral standard:
Usability,
 IEC 60601-1-6 ed 3 : Medical electrical equipment – Part 1-6: General requirements for safety – Collateral standard:
Usability
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 IEC 60601-1-8 ed 1 : Medical electrical equipment – Part 1-8: General requirements for safety – Collateral
standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical
electrical systems
 IEC 60601-1-8 ed 2 : Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard:
General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical
systems
 IEC 60601-2-7 ed2 : Medical electrical equipment – Part 2-7: Particular requirements for the safety of high-voltage
generators of diagnostic X-ray generators,
 IEC 60601-2-12 ed2 : Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung
ventilators – Critical care ventilators
 IEC 60601-2-18 ed 2 : Medical electrical equipment – Part 2-18: Particular requirements for the safety of endoscopic
equipment. Includes NF EN 60601-2-18 (01/01/1997) and NF EN 60601-2-18/A1 (01/02/2006)
 IEC 60601-2-18 ed 3 : Medical electrical equipment – Part 2-18: Particular requirements for the safety of endoscopic
equipment. Includes NF EN 60601-2-18 (01/01/1997) and NF EN 60601-2-18/A1 (01/02/2006)
 IEC 60601-2-32 ed 1 : Medical electrical equipment – Part 2-32: Particular requirements for the safety of associated
equipment of X-ray equipment,
 IEC 60601-2-37 ed 1 : Medical electrical equipment – Part 2-37 : Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment
 IEC 60601-2-37 ed 2 : Medical electrical equipment – Part 2-37 : Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment
 IEC 60601-2-38 ed 1 : Medical electrical equipment – Part 2-38 : Particular requirements for the safety of electrically
operated hospital beds. Includes NF EN 60601-2-38 (01/12/1999) and NF EN 60601-2-38/A1 (01/02/2006),
 IEC 60601-2-43 ed 1 : Medical electrical equipment – Part 2-43: Particular requirements for the safety of X-ray
equipment for interventional procedures,
IEC 60601-2-43 ed 2 : Medical electrical equipment – Part 2-43: Particular requirements for the safety of X-ray
equipment for interventional procedures
IEC 60601-2-52 ed 1 : Medical electrical equipment - Part 2-52: Particular requirements for basic safety and
essential performance of medical beds
and according to the provisions of the rules of CB scheme certification.
I undertake to comply with the provisions of the information note and the document IECEE 02 – IEC System of
Conformity Assessment Schemes for Electrotechnical Equipment and Components. Rules of procedures.
Date
Stamp and signature
of the agent's applicant
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ANNEX 2
IDENTIFICATION FORM
(to be drawn up on the manufacturer's headed paper)
(to be established and completed by the applying manufacturer and to be enclosed with their
application file)
- Applicant’s details (head office)
. Name
. Contact person
. Address
. Telephone
. Fax
. E-mail
- Manufacturer’s details (if different)
. Name
. Contact person
. Address
. Telephone
. Fax
. E-mail
- Premises* where the device is manufactured
. Name
. Contact person
. Address
. Telephone
. Fax
. E-mail
*: if the device is manufactured in several premises, the equivalence between devices from the
different plants shall be demonstrated and documented in the CB Test certificate application file.
-
Name, Trade name and references and/or number (etc…) that precisely identify the device
without ambiguity :
-
Name, Trade name (etc…) that precisely identify the manufacturer without ambiguity :
-
Medical device category :
Information to be provided for the preparation of the quotation:
- questionnaire below, duly completed.
- A general block diagram of your device (essential).
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1 - GENERAL
Type of medical device: _______________________________________________________
___________________________________________________________________________
_
Commercial designation:
__________________________________________________________________________
Dimensions: ________________________________________________________________
Mass: __________________________
Connection:
Connection:
- to fluids: water compressed air other:
_______________________________
- to electrical: 230V/50Hz 115V/60Hz  other: __________________
Number of P/Ns to be tested: ________
Desired testing start date: _____/___/20__
OR
Desired date of delivery of reports: _____/___/20__
2 - TECHNIQUE
2.1 SAFETY TESTS, IEC/EN 60601-1
1-
Does your device have a appliance inlet ?
Yes 
No 
2-
Does your device include motors?
Yes 
No 
If yes, how many: ________
P/N, Type
Conformity
Yes
No




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Standard applied




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3-
Yes 
Does your device include heating elements?
If yes, how many: ________
Conformity
Yes
No
P/N, Type


4-
Standard applied


Does your device include a ventilation system?
Yes 
Conformity
Yes
No
P/N, Type
No 
No 
Standard applied
(blower, cooling unit, etc.)


5-


Does your device include pressure vessel ?
If yes, how many: ________
Yes  No 
Conformity
Yes
No
P/N, Type


Standard applied


6-
Are there suspended masses?
Yes 
No 
7-
Does your device have carrying handles?
Yes 
No 
8-
Does your device include switched-mode power supplies?
Yes 
No 
P/N, Type
Conformity
Yes
No Standard
applied


9-
per power supply


Yes 
Does your device include power supply transformers?
If yes, how many: ________
P/N, Type
Conformity
Yes
No Standard
applied


10 -
Number of outputs
Number of secondaries
per transformer


Is your device protected against the ingress of liquids (IPX1, IPX4, etc.)?
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No 
Yes  No 
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Does your device include a PES (Programmable Electronic System)?
Yes 
No 
Did you follow standard IEC 62304 for its development?
Yes 
No 
12 -
Is your device protected against anaesthetics gas (AP, APG)?
Yes 
No 
13 -
Number of Applied Parts (.A.P) to the patient:
Yes 
No 
11 -
A.P:___________________
Degree of protection: B , BF  or CF 
A.P: ___________________
Degree of protection: B , BF
A.P: ___________________
Degree of protection: B , BF  or CF 
14 -
Maximum altitude claimed:________
15 -
Does your device include moulded components?
If yes, how many: ________
 or CF 
Type
______________________________________________________________________________
16 -
Presence of acoustic energy?
Yes 
No 
17 -
Does your device deliver vibrations to the hand?
Yes 
No 
18 -
Does your device include a laser or a LED?
Yes 
No 
19 -
Is your device intended for use in an O²-rich environment?
Yes  No 
20 What is the method of sterilization, cleaning, disinfection?
__________________________________
21 -
Do you have a " usability engineering file" file in accordance with standard IEC 60601-1-6?
Yes  No 
22 -
Does your device include alarms?
Yes 
No 
23 -
Does your device include power strips?
Yes 
No 
24 -
Does your device include an isolation transformer?
Yes 
No 
25 -
Does your device include winding wires not separated by insulation?
Yes 
No 
26 -
Does your device include closed-loop physiological regulators (60601-1-10)Yes 
27 -
Is your device intended for home use (60601-1-11)?
28-
desired national deviations :
USA
Korea*
Denmark*
Canada
Singapore*
Others
Switzerland
Australia*
Yes 
No 
No 
Israël*
Japan*
(*) available only for the 2nd edition of the standard IEC 60601-1
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2.2 ELECTROMAGNETIC COMPATIBILITY TESTS
STANDARD IEC/EN 60601-1-2:2001 OR EN 60601-1-2:2007
1- Number of interconnecting cables (other than power supply):
. < 1 m: ________
. 1 m and  3 m: ________
. 3 m and  30 m: ________
.  30 m: ________
Attention: A given cable belongs to only one category.
Number of power cords:________
2- Modules:
Number of distinct modules:________
(Example: remoted probe, remoted display unit, remote control, alarm, etc.)
3- Modes of operation:
Number of different modes:________
(Example: different motor speeds, forward, reverse, use of different functions, etc.)
4- Criteria of proper operation:
(degraded operation acceptable)
-
Please provide a general block diagram of your device
(circuit diagram) photographs or manuals (essential).
Date
Stamp and signature
of the agent's applicant
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