Test Report issued under the responsibility of:

IEC 60601 - 1- 6
Medical electrical equipment
Part 1-6: General requirements for safety - Collateral Standard: Usability

Report Reference No.......................:      

Compiled by (+ signature)................: ....................................................
Approved by (+ signature)................: ....................................................
Date of issue....................................:

CB Testing Laboratory...................:
Address............................................:

Testing location/procedure...............: CBTL RMT SMT WMT TMP

Address............................................:
Applicant’s name............................:
Address............................................:

Test specification:
Standard...........................................: IEC 60601-1-6: 2006, Second Edition
Test procedure.................................: CB Scheme
Non-standard test method…………..: N/A
Test Report Form No......................: IEC60601_1_6C
Test Report Form Originator............: Underwriters Laboratories Inc.
Master TRF......................................: Dated 2007-02
Copyright © 2007 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE),
Geneva, Switzerland. All rights reserved.
This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as
copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from
the reader's interpretation of the reproduced material due to its placement and context.

If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo shall be removed
This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and
appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02.
Test item description.....................:
Trade Mark.......................................:
Manufacturer....................................:
Model/Type reference......................:
Ratings.............................................:
Testing procedure and testing location:

CB Testing Laboratory:
Testing location/ address.......................:

Associated CB Test Laboratory:

Testing location/ address.......................:

Tested by (name + signature)......:

Approved by (+ signature)...........:
Testing procedure: TMP
Tested by (name + signature)......:
Approved by (+ signature)............:
Testing location/ address.......................:

Testing procedure: WMT

Tested by (name + signature)......:
Witnessed by (+ signature)...........:
Approved by (+ signature)...........:
Testing location/ address.......................:

Testing procedure: SMT

Tested by (name + signature)......:
Approved by (+ signature)............:
Supervised by (+ signature).........:
Testing location/ address................:

Testing procedure: RMT

Tested by (name + signature)......:
Approved by (+ signature)............:
Supervised by (+ signature).........:
Testing location/ address.......................:
 Page 3 of 8 Report No.      

Summary of testing:

Tests performed (name of test and test clause): Testing location:

Summary of compliance with National Differences:

Copy of marking plate

TRF No.: IEC60601_1_6C

Test item particulars................................................:
Classification of installation and use...........................: See IEC 60601-1 Test Report
Clinical application ....................................................:
Mode of operation......................................................:
Surface temperature of APPLIED PART............................:
Possible test case verdicts:
- test case does not apply to the test object................: N/A
- test object does meet the requirement......................: Pass (P)
- test object does not meet the requirement................: Fail (F)
Testing:
Date of receipt of test items........................................:
Date(s) of performance of tests..................................:
Abbreviations used in the report:
- normal condition: N.C. - single fault condition: S.F.C.
- operational insulation: OP - basic insulation: BI
- double insulation: DI - supplementary insulation: SI
- basic insulation between - reinforced insulation: RI
parts of opposite polarity: BOP
General remarks:
The test results presented in this report relate only to the object tested.
This report shall not be reproduced, except in full, without the written approval of the Issuing testing
laboratory.
"(see Enclosure #)" refers to additional information appended to the report.
"(see appended table)" refers to a table appended to the report.

Throughout this report, a point (coma) is used as the decimal separator.

List of test equipment must be kept on file and available for review.
This Test Report contains the general safety requirements as related to the usability of Medical
Electrical Equipment. It can only be used together with IEC 60601-1 Test Report.
General product information:
 Page 5 of 8 Report No.      

IEC 60 601-1-6
Clause Requirement + Test Result - Remark Verdict

4 GENERAL REQUIREMENTS
4.1 ME EQUIPMENTprovides adequate USABILITY, and the
resulting from NORMAL USE and USE ERRORS are
RISKS
acceptable
4.2 Inspection of USABILITY ENGINEERING FILE assessing all
RISK ANALYSIS considerations

5 IDENTIFICATION, MARKING AND DOCUMENTS

5.1 ACCOMPANYING DOCUMENTS See Attachment #
A brief description of EQUIPMENT, its physical operating
principles, and significant physical and performance
characteristics relevant to its USABILITY included in the
instructions for use
The same information, when provided as a separate
document, included in the technical description
ACCOMPANYING DOCUMENTS for equipment are, optionally,
provided electronically, e.g., by electronic file format
or CD-ROM.................................................................:
USABILITY ENGINEERING PROCESS includes the information
that will need to be provided as a hard copy or as
markings on EQUIPMENT (e.g., to cover emergency
operation) when ACCOMPANYING DOCUMENTS are
provided electronically
ACCOMPANYING DOCUMENTS include a description of the
OPERATOR PROFILE

ACCOMPANYING DOCUMENTS are written at a level

consistent with the intended OPERATOR PROFILE
5.2 TRAINING and materials for TRAINING
–necessary TRAINING materials required for PRIMARY
OPERATING FUNCTIONS of EQUIPMENT provided by the
manufacturer
–TRAINING materials are available; or
– the manufacturer provides TRAINING
INTENDED USE is the basis for TRAINING and TRAINING
material
Instructions for use indicate the available TRAINING
options and when specific TRAINING for the EQUIPMENT is
required

TRF No.: IEC60601_1_6C

6 USE ERROR and USABILITY
6.1 Safety for the PATIENT, OPERATOR and other persons
A USABILITY ENGINEERING PROCESS conducted to provide See Attachment #
safety for the PATIENT, OPERATOR and other persons
related to USABILITY of the OPERATOR-EQUIPMENT INTERFACE
6.2 USABILITY ENGINEERING PROCESS

6.2.1 The results of the USABILITY ENGINEERING PROCESS See Attachment #

recorded in the USABILITY ENGINEERING FILE
The records and other documents that make up the
USABILITY ENGINEERING FILE form part of other
documents(e.g., a MANUFACTURER’S product file or RISK
MANAGEMENT FILE)

The USABILITY ENGINEERING PROCESS scaled based on the

significance of any modifications depending on the
results of the RISK ANALYSIS
6.2.2 Input for the USABILITY ENGINEERING PROCESS
6.2.2.1 ME EQUIPMENT application specification
Application of ME EQUIPMENT in the USABILITY ENGINEERING
FILE specified by the MANUFACTURER and includes

– medical purpose {e.g., conditions(s) or disease(s)

to be screened, monitored, treated, or diagnosed};
– PATIENT population (e.g., age, weight, region of
body, health, condition);
– part of the body or type of tissue applied to or
interacted with;
– intended OPERATOR PROFILE; and
– application (e.g.. environment, frequency of use,
location, mobility)
A summary of the ME EQUIPMENT application
specification included in the instructions for use
6.2.2.2 PRIMARY OPERATING FUNCTIONS

The MANUFACTURER has determined the PRIMARY See Attachment #

OPERATING FUNCTIONS and recorded them in the USABILITY
ENGINEERING FILE

6.2.2.3 Information for safety as a RISK CONTROL

For RISK CONTROL related to USABILITY, the MANUFACTURER See Attachment #
has decided what information is required for BASIC
SAFETY or ESSENTIAL PERFORMANCE (e.g., warnings or
limitation of use in the ACCOMPANYING DOCUMENTS,
marking, etc.)
Such information was subject to the USABILITY
ENGINEERING PROCESS

Disregarding this information considered ABNORMAL

USE

RISK CONTROL consisted of an integrated approach

using

TRF No.: IEC60601_1_6C

 Page 7 of 8 Report No.      

IEC 60 601-1-6
Clause Requirement + Test Result - Remark Verdict

a) inherent SAFETY by design;

b) protective measures in ME EQUIPMENT itself or in the
manufacturing PROCESS (e.g., ALARMSYSTEMS)
c) information for safety (e.g., warnings in the
instructions for use, display of a monitored variable)
The results of the RISK ANALYSIS or a reference to the See Attachment #
location of the results of the RISK ANALYSIS recorded in
the USABILITY ENGINEERING FILE
The RISK ANALYSIS for the ME EQUIPMENT or for the
corresponding generic device type was an input for
the USABILITY SPECIFICATION as required for the USABILITY
ENGINEERING PROCESS.

Any RESIDUAL RISK evaluation took into consideration

the results of the USABILITY VALIDATION
The evaluation of post-production information (post-
market surveillance) included USABILITY (see ISO
14971:2000, Clause 9)
6.2.3 USABILITY SPECIFICATION

MANUFACTURER developed a USABILITY See Attachment #

SPECIFICATIONrecorded in USABILITY ENGINEERING FILE as
part of the USABILITY ENGINEERING PROCESS
The USABILITY SPECIFICATION integrated into other
specifications and based on the following:
– application specification (see 6.2.2.1);
– HAZARDS related to the use of the ME EQUIPMENT
(results from RISK ANALYSIS described in 4.2); and
– predictable USE ERRORS associated with the ME
EQUIPMENT

The USABILITY SPECIFICATION describes at least:

– USE SCENARIOS for the ME EQUIPMENT;
– OPERATOR actions related to the PRIMARY OPERATING
FUNCTIONS;

– OPERATOR-EQUIPMENT INTERFACE requirements for the

PRIMARY OPERATING FUNCTIONS; and

– requirements for determining whether PRIMARY

OPERATING FUNCTIONS are easily recognizable by the
OPERATOR

6.2.4 USABILITY VERIFICATION

MANUFACTURER verified the OPERATOR-EQUIPMENT
interface design according to the USABILITY
SPECIFICATION as part of the ME EQUIPMENT DESIGN

The results of the verification are recorded in

USABILITY ENGINEERING FILE

TRF No.: IEC60601_1_6C

6.2.5 The MANUFACTURER has developed and maintains a See Attachment #
USABILITY VALIDATION plan specifying:

– any method used for VALIDATION of the USABILITY of

the PRIMARY OPERATING FUNCTIONS;
– the criteria for determining successful VALIDATION of
the USABILITY of the PRIMARY OPERATING FUNCTIONS (see
Table D.5); and
– the involvement of representative intended
OPERATORS (see D.4.3.2)

USABILITY VALIDATION performed in a laboratory setting..:

performed in a simulated use
USABILITY VALIDATION
environment............................................................:
performed in the actual use
USABILITY VALIDATION
environment............................................................:
The USABILITY VALIDATION plan addressed:
– worst case USE SCENARIOS derived from:
• the application specification (see 6.2.2.1),
• predictable USE ERRORS, and
• the results of the RISK ANALYSIS; and
– USE SCENARIOS representing frequent application
situations identified in the USABILITY SPECIFICATION
The USABILITY VALIDATION plan recorded in the USABILITY
ENGINEERING FILE

6.2.6 USABILITY VALIDATION

The MANUFACTURER validated OPERATOR-EQUIPMENT

INTERFACE design according to the USABILITY VALIDATION
plan
The results, including any required design See Attachment #
modification needed to satisfy the criteria as defined
in the USABILITY VALIDATION plan, recorded
The ACCOMPANYING DOCUMENTS are part of the ME
EQUIPMENT and are also subject to activities for
validating USABILITY
Individuals that were not directly involved in the
OPERATOR-EQUIPMENT INTERFACE design were involved in
the USABILITY VALIDATION

TRF No.: IEC60601_1_6C