IEC Test

Test Report issued under the responsibility of:
SGS-CSTC
TEST REPORT
IEC 60601–1–3
Medical electrical equipment
Part 1-3: General Requirements for Radiation Protection in Diagnostic
X-Ray Equipment
Report Reference No. .................... : GZME140300018702

Date of issue .................................... : 2014-04-15
Total number of pages ...................... 31
Testing Laboratory ......................... : SGS-CSTC Standards Technical Services Co., Ltd. - E&E Lab
Guangzhou
Address ............................................ : 198 Kezhu Road, Scientech Park, Guangzhou Economic &
Technology Development District, Guangzhou, Guangdong, China
510663
Applicant’s name............................ : Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address ............................................ : Mindray Building, Keji 12th Road South, High-tech Industrial Park,
Nanshan, Shenzhen 518057, P.R.China
Test specification:
Standard ........................................... : IEC 60601-1-3:2008 (Second Edition) for use with IEC 60601-1: 2005
(Third Edition)
Test procedure ................................. : SGS-CSTC
Non-standard test method…………..: N/A
Test Report Form No. .................... : IEC60601_1_3D
Test Report Form(s) Originator ........ : Underwriters Laboratories Inc.
Master TRF ...................................... : Dated 2011-06
Copyright © 2011 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 and the reference to the CB
Scheme procedure 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 .....................: Radiography System
Trade Mark ....................................... :
Manufacturer .................................... : Same as applicant

Model/Type reference ...................... : DigiEye 280 , DigiEye 280T
Ratings ............................................. : 3～; 380/400/415/440 V; 50/60 Hz;
Continuous: 1 kVA; Momentary Max.: 90 kVA
Page 2 of 31 Report No. GZME140300018702
Testing procedure and testing location:
Testing Laboratory: SGS-CSTC Standards Technical Services Co., Ltd. – E&E

Lab Guangzhou
Testing location/ address ...................... : 198 Kezhu Road, Scientech Park, Guangzhou Economic &
Technology Development District, Guangzhou, Guangdong,
China 510663
Associated CB Laboratory:
Testing location/ address ...................... :
Tested by (name + signature) ..... : Fly Lu
Approved by (+ signature)........... : Jason Hoo
Testing procedure: TMP

Tested by (name + signature) .. :
Approved by (+ signature)............ :
Testing procedure: WMT
Tested by (name + signature) ..... :
Witnessed by (+ signature) .......... :
Approved by (+ signature)........... :
Testing procedure: SMT

Tested by (name + signature) ..... :
Approved by (+ signature)............ :
Supervised by (+ signature) ........ :
TRF No. IEC60601_1_3D

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

Tests according to the following standards were Buildings 9-13, Baiwangxin High-tech Industrial Park,
carried out: Baimang, Xili Town, Nanshan. Shenzhen 518108, P.
R. China
IEC 60601-1-3:2008
The submitted samples fulfilled relevant
requirements of above standard.
Summary of compliance with National Differences:

List of countries addressed:
None
Copy of marking plate:

See IEC 60601-1 Test Report

Test item particulars ................................................. :

Classification of installation and use ........................... : See IEC 60601-1 Test Report
NOMINAL X-RAY TUBE VOLTAGE (kV) ............................... : 150 kV
Application type ......................................................... : Indirect Radiography
Accessories and detachable parts included in the None
evaluation ..................................................................... :
Options included .......................................................... : None
Possible test case verdicts:
- test case does not apply to the test object ............... : N/A
- test object does meet the requirement ..................... : P (Pass)
- compliance with the requirement not evaluated ......: N/E (Not Evaluated)
- test object does not meet the requirement ............... : F (Fail)
Testing
Date of receipt of test item .......................................... : 2014-03-20
Date (s) of performance of tests ................................. : 2014-03-21 to 2014-04-15
General remarks:
"(see Attachment #)" refers to additional information appended to the report.
"(see appended table)" refers to a table appended to the report.
The tests 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 testing laboratory.
List of test equipment must be kept on file and available for review.
Additional test data and/or information provided in the attachments to this report.
This document is issued by the company under its General Conditions of Service accessible at
http://www.sgs.com/terms_and_conditions.htm. Attention is drawn to the limitation of liability,
indemnification and jurisdiction issues defined therein.
Any holder of this document is advised that information contained hereon reflects the Company’s findings
at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole
responsibility is to its Client and this document does not exonerate parties to a transaction from exercising
all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or
falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to
the fullest extent of the law.
Unless otherwise stated: (a) the results shown in this document refer only to the sample(s) tested and (b)
such sample(s) are retained for 3 months.
Throughout this report a comma / point is used as the decimal separator.
This Test Report contains the general safety requirements as related to radiation protection in
Diagnostic X-Ray equipment. It can only be used together with IEC 60601-1 Test Report with No.
GZME140300018701
The Risk Management Task Force originated the Risk Management tables in this TRF.

Manufacturer’s Declaration per sub-clause 6.2.5 of IECEE 02:

The application for obtaining a CB Test Certificate Yes
includes more than one factory location and a
Not applicable
declaration from the Manufacturer stating that the
sample(s) submitted for evaluation is (are)
representative of the products from each factory
has been provided................................................. :
When differences exist; they shall be identified in the General product information section.
Name and address of factory (ies) ........................ : SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD.
Buildings 9-13, Baiwangxin High-tech Industrial
Park, Baimang, Xili Town, Nanshan. Shenzhen
518108, P. R. China
General product information:
See IEC 60601-1 Test Report

IEC 60601-1-3
Clause Requirement – Test Result - Remark Verdict
4 GENERAL REQUIREMENTS FOR TESTS --

4.1 Statement of compliance is expressed in See Operator’s manual 1.4 P
accordance with this Collateral Standard .............:
4.2 Values of ATTENUATION EQUIVALENT, HALF-VALUE See the following test data P
LAYER, and QUALITY EQUIVALENT FILTRATION are
expressed as thicknesses of aluminium of 99,9 %
purity or higher ......................................................:
5 ME EQUIPMENT IDENTIFICATION, MARKING, AND DOCUMENTS --

5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts P
5.1.1 All removable sub-assemblies, components, and No such removable parts N/A
ACCESSORIES of X-RAY EQUIPMENT are marked to
ensure:
- they can be identified readily and correlated with No such removable parts N/A
ACCOMPANYING DOCUMENTS
- interchangeable devices are individually No such removable parts N/A

distinguishable to the OPERATOR in NORMAL USE and
for the purpose of replacement
All markings are permanently affixed and clearly No such removable parts N/A
legible according to Clause 7 of IEC 60601-1
5.1.2 General marking requirements applied according See 5.1.1 and 7.3 P
to 5.1.1, and indication of FILTER properties applied
according to 7.3
5.2 Accompanying documents P
5.2.1 ACCOMPANYING DOCUMENTS include the required See the detail clauses in table P
statements per sub-clauses in Table 2 ......................... : 2
5.2.2 ACCOMPANYING DOCUMENTS contain information and See 4.2.3 and 4.2.6 in install P
instructions on how to check and maintain the and maintenance manual
accuracy of dosimetric indications specified by
MANUFACTURER when dosimetric indications are
provided on the EQUIPMENT ....................................... :
5.2.3 ACCOMPANYING DOCUMENTS clearly identify the items See safety information in P
they refer to and include: operator’s manual
– replication of all information required in this See safety information in P
standard to be marked on the items operator’s manual
– the following information about the location and See safety information in P
content of required markings for subassemblies operator’s manual
forming part of the items:

IEC 60601-1-3
a) Location of the markings and instructions for See safety information in P

accessible markings enabling them to be operator’s manual
inspected
b) For markings inaccessible in complete See safety information in P
assembly: operator’s manual
1) Replication of the information marked on the See safety information in P
sub-assemblies, or operator’s manual
2) A list of the subassemblies with references to See safety information in P
their ACCOMPANYING DOCUMENTS operator’s manual
For items supplied separately from main No such items supplied N/A
assemblies, technical descriptions with information separately from main
necessary to maintain compliance with this assemblies
standard within the relevant main assemblies
5.2.4 Instructions for use P
5.2.4.1 Instructions for use contain all information allowing See chapter 1 safety in P
user to minimize possibility of exposing PATIENTS to operator’s manual
RADIATION dose levels where deterministic effects
may occur in NORMAL USE to optimize RADIATION
dose to PATIENTS and to minimize IRRADIATION of
OPERATORS ............................................................ :
5.2.4.2 The following required information provided for each INTENDED USE of EQUIPMENT: P
− RADIATION QUANTITY (ies) useful for assessing the See 4.2.3 in operator’s manual P
RADIATION RISK to PATIENT used for describing the
RADIATION dose to PATIENT
− description of a specified test object See 4.2.3 in operator’s manual P

representative of an average PATIENT
− the specified procedure allowing measurement See 4.2.3 in operator’s manual P
of RADIATION QUANTITY (or quantities) for the
specified test object
− value of specified RADIATION QUANTITY (ies) when See 4.2.3 in operator’s manual P
the specified test object is used to simulate a
PATIENT when performing a procedure typical of
this INTENDED USE
− influence of the main adjustments or selections See 4.2.3 in operator’s manual P
available to the OPERATOR on the value of the
specified RADIATION QUANTITY
5.2.4.3 Method used to provide RADIATION dose indication See 4.2.3 in operator’s manual P
during NORMAL USE of the EQUIPMENT is described
directly or by reference to a published reference as
applicable ..............................................................:

IEC 60601-1-3
5.2.4.4 Instructions for use indicate when clinical protocols See 4.2.2 in operator’s manual P
are proposed by MANUFACTURER and preloaded on
EQUIPMENT constitute recommendations to be
applied directly to optimize operation, or when they
are only examples/starting points to be replaced by
specific protocols developed by user ....................:
5.2.4.5 Instructions for use indicate the facts in case there No such condition N/A
is a possibility of PATIENT exposure to RADIATION
dose levels where deterministic effects may occur
in NORMAL USE........................................................:
Particular MODES OF OPERATION, configurations, No such condition N/A
and circumstances in which deterministic effects
may occur are listed, and the following information
is provided:
a) Instructions indicating the need to manage high No such condition N/A
RADIATION doses, and when applicable, instructions
draw attention to the availability of selectable
settings that can have a significant effect on the
RADIATION QUALITY, delivered RADIATION dose, AIR
KERMA, or AIR KERMA RATE and image quality
b) Number of EXPOSURES or duration of LOADING No such condition N/A

necessary to reach deterministic effects on the
specified average PATIENT and obese PATIENTS are
stated
c) Available settings of LOADING FACTORS, No such condition N/A
technique factors, and operating parameters
affecting RADIATION QUALITY or the prevailing
RADIATION dose (rate) in NORMAL USE
5.2.4.6 Instructions for use draw attention to restrict See 1 in operator’s manual P
access to the EQUIPMENT in accordance with local
regulations for RADIATION PROTECTION
All information necessary to minimize IRRADIATION See 1 in operator’s manual P
of OPERATORS in NORMAL USE is provided
The following information is provided for each type See 1 in operator’s manual P
of procedure where OPERATORS have to stay during
NORMAL USE in SIGNIFICANT ZONES OF OCCUPANCY:
a) RADIATION dose resulting from operation of the See 4.2.3 in operator’s manual P
EQUIPMENT measured using a specified procedure
b) means to reduce RADIATION dose received by See 1 in operator’s manual P
the OPERATOR, such as RADIATION PROTECTION
provisions provided during installation of
EQUIPMENT, precautions in use, and adjustments of
EQUIPMENT settings

IEC 60601-1-3
c) a list of PROTECTIVE DEVICES and ACCESSORIES to No such protection N/A

be used for RADIATION PROTECTION
The listing, optionally, includes PROTECTIVE No such protection N/A
DEVICES such as PROTECTIVE CLOTHING,
recommended for use but not forming part of the
EQUIPMENT
6 RADIATION MANAGEMENT --
6.1 X-RAY EQUIPMENT enables management of the The X-radiation to the patient P
delivery of X-RADIATION to PATIENT in a safe and comply with the requirement
effective way
Measures taken according to 6.3 to 6.7 to achieve See 6.3 to 6.7 P
an acceptable dose-benefit balance
6.2 Initiation and termination of the IRRADIATION P
6.2.1 Each LOADING is initiated and maintained by means By the hand switch of operator P
of a control requiring continuous actuation by the console
OPERATOR and the OPERATOR can terminate the
LOADING at any time
Controls by which the LOADING of an X-RAY TUBE can By indicate lights on the table P
be initiated are protected against unintended of the operator console
actuation using means compatible with the INTENDED
USE of the X-RAY EQUIPMENT
6.2.2 IRRADIATION is terminated by a safety measure in A emergency button provided P

case of a failure of normal termination
Continuous actuation by OPERATOR was considered Continuous actuation of the P
sufficient as the safety measure when normal hand switch need to be
termination of IRRADIATION was not effected on the performed for loading an x-ray
basis of a RADIATION measurement tube
The system for normal termination of IRRADIATION The two system separated P
and the system used for the safety measure is
separated so that a failure in one system does not
affect termination by the other system
A visible indication was activated at the CONTROL By indication on the console P
PANEL whenever a LOADING was terminated by the and the interface of the
required safety means software
Another LOADING was not possible in the same MODE It is need to accept or refuse P
OF OPERATION untila control device provided for the image to start another
resetting was operated at the CONTROL PANEL loading
6.3 RADIATION dose and RADIATION QUALITY --
6.3.1 RADIATION dose to PATIENT can be restricted in line Restricted by loading voltage , P
with the INTENDED USE of X-RAY EQUIPMENT current and time

IEC 60601-1-3
RADIATION QUALITY can be adjusted over a suitable The voltage , current and time P
range in line with the INTENDED USE of X-RAY can be adjusted
EQUIPMENT
Manual selection of loading factors and other The parameter selected P

parameters specified in this Sub-clause are in comply with the requirement
discrete steps and are selected from the series R'10
or R'20 according to Table B.1 from ISO 497
reprinted in Annex B
6.3.2 RISK MANAGEMENT FILE used to determine See RISK MANAGEMENT Table P
reproducibility of RADIATION output relative to fixed 6.3.2
LOADING FACTORS required for the INTENDED USE
The issue is addressed in
when this issue is not addressed by a particular
IEC60601-2-54
standard....................................................................:
Accuracy of RADIATION output stated in See appendix table A in P
accompanying documents operator’s manual
6.4 Indication of operational states --
6.4.1 An indication of X-RAY SOURCE ASSEMBLY and/or X- Not provision to select more N/A
RAY IMAGING ARRANGEMENT selected is activated on than one x-ray source
the CONTROL PANEL prior to LOADING of the X-RAY assembly
SOURCE ASSEMBLY when X-RAY EQUIPMENT has
provisions to select more than one X-RAY SOURCE
ASSEMBLY and/or X-RAY IMAGING ARRANGEMENT
Means provided at or near each X-RAY SOURCE Not provision to select more N/A
ASSEMBLY to indicate that this X-RAY SOURCE than one x-ray source
ASSEMBLY has been selected where X-RAY assembly
EQUIPMENT has provisions to initiate LOADING of more
than one X-RAY SOURCE ASSEMBLY from a single
location
6.4.2 LOADING STATE is unambiguously indicated in The indicator and the change P
NORMAL USE and SINGLE FAULT CONDITIONS to the of the software interface are
OPERATOR and others who are likely to be exposed obvious
to X-RADIATION
Termination is unambiguously indicated to the Termination of the loading P
OPERATOR by an audible signal when termination of state is a beep which can be
the LOADING STATE is determined by EQUIPMENT in heard by the operator
NORMAL USE
Series of LOADING STATES initiated by a single No such loading state N/A

actuation was considered as one LOADING

IEC 60601-1-3
6.4.3 Adequate information is available to OPERATOR See 4.2.3 in operator’s manual P

before, during, and after LOADING of an X-RAY TUBE,
regarding LOADING FACTORS or MODES OF OPERATION
enabling the OPERATOR to determine and preselect
optimal conditions for IRRADIATION, and
subsequently obtain data necessary for estimation
of RADIATION dose received by PATIENT ....................:
Accuracy of LOADING FACTORS required for INTENDED By application of a particular P
USE is determined in the RISK MANAGEMENT FILE or by standard IEC60601-2-54
application of a particular standard..........................:
Accuracy of LOADING FACTORS is stated in See appendix A in operator’s P
ACCOMPANYING DOCUMENTS manual
Accuracy of LOADING FACTORS was verified by review Verified comply with the P
of RISK MANAGEMENT FILE, ACCOMPANYING requirement
DOCUMENTS, and by the appropriate functional tests
6.4.4 Preselected mode of automatic operation is The operation mode is P

indicated on the CONTROL PANEL for X-RAY EQUIPMENT displayed on the software
operating with AUTOMATIC CONTROL SYSTEMS interface , such as AEC symbol
active
6.4.5 Means are provided to allow the user to estimate the A DAP(Dose Area Product) P
RADIATION dosedelivered to PATIENT provided
Relevant information in the ACCOMPANYING See 4.2.3 in operator’s manual P
DOCUMENTS, indication of dosimetric values, or a
combination of the two considered to meet this
requirement ..............................................................:
The resulting accuracy specified in ACCOMPANYING See 4.2.3 in operator’s manual P
DOCUMENTS
6.5 X-RAY EQUIPMENT provided with an AUTOMATIC An AEC mode provided P

CONTROL SYSTEM
An AUTOMATIC CONTROL SYSTEM provided in case the An AEC mode provided P

OPERATOR is unable to adjust the LOADING FACTORS
to match the PATIENT characteristics
Constancy of AUTOMATIC EXPOSURE CONTROLS By application a particular P
required for the INTENDED USE was determined in the standard IEC60601-2-54
RISK MANAGEMENT FILE or by application of a
particular standard ...................................................:
Accuracy of AUTOMATIC CONTROL SYSTEMS is stated See appendix A in operator’s P
in ACCOMPANYING DOCUMENTS manual
Accuracy of AUTOMATIC CONTROL SYSTEMS verified by Verified comply with the P
inspection of the RISK MANAGEMENT FILE and by requirement
appropriate functional tests ......................................:

IEC 60601-1-3
6.6 Means provided to reduce the influence of Grids are provided P

RADIATION scattered in the PATIENT to X-RAY IMAGE
RECEPTOR in case of significant influence on the
image quality
Removable means are clearly visible or indicated to Grids are provided P
OPERATOR, and proper use of the means are
See 4.2.4 in operator’s manual
described in instructions for use
6.7 Imaging performance P
6.7.1 To achieve a dose-benefit balance, the expected See 6.7.2 to 6.7.4 P
medical benefit justifies the IRRADIATION
Acceptable imaging performance achieved by taking 6.7.2 to 6.7.4 complied P
the measures in 6.7.2 to 6.7.4
6.7.2 The INTENDED USE of the EQUIPMENT is specified and See RISK MANAGEMENT Table P
described in the ACCOMPANYING DOCUMENTS and 6.7.2 and chapter 1 in
metrics describing imaging performance are defined operator’s manual
and specified for the INTENDED USE
6.7.3 The nominal focal spot values of X-RAY TUBE (S) See RISK MANAGEMENT Table P
FOCAL SPOTS in the EQUIPMENT are stated per IEC 6.7.3 and appendix C in
60336:1993 or later editions and are compatible operator’s manual
with each application within INTENDED USE
RISK MANAGEMENT FILE and ACCOMPANYING See RISK MANAGEMENT Table P
DOCUMENTS inspected for verification .....................: 6.7.3 and accompanying
documents
6.7.4 Contribution of RADIATION DETECTOR or X-RAY IMAGE See RISK MANAGEMENT Table P
RECEPTOR integrated in X-RAY EQUIPMENT to metrics 6.7.4 and appendix A in user
of imaging performance is specified and ensures manual
efficient use of RADIATION
Examples of X-RAY IMAGE RECEPTOR types or Image receptor is provided N/A
performance are described in ACCOMPANYING
DOCUMENTS when no X-RAY IMAGE RECEPTOR is
integrated in the system
7 RADIATION QUALITY --
7.1 RADIATION QUALITY of X-RAY BEAM provided by the X- Comply with the requirement P
RAY EQUIPMENT is appropriate to produce intended
images without unnecessary high DOSES to PATIENT
TOTAL FILTRATION in the beam is sufficient to prevent E7876X: 1,3mmAl/75kV P
unnecessary high DOSES to PATIENT
H1086X: 2,5mmAl/75kV
Collimator 1mmAL fixed and
0.5 or 1mmAL adjustable

IEC 60601-1-3
Minimum FILTRATION is expressed in terms of total Comply with the requirement P

QUALITY EQUIVALENT FILTRATION or of the first HALF-
VALUE LAYER for specified X-RAY TUBE VOLTAGE
The first HALF-VALUE LAYERS attained in the X-RAY See appended Table 7.1A P
BEAM incident on the PATIENT IN X-RAY EQUIPMENT, for
all configurations available in NORMAL USE, were not
less than the minimum permissible values given in
Table 3, except when the X-RAY EQUIPMENT was
exempted by a particular standard ..........................:
Alternatively, the TOTAL FILTRATION arising from See appended Table 7.1B N/A
materials in the X-RAY BEAM incident on the PATIENT
Not verified by the filtration
was not less than 2,5 mm AL QUALITY EQUIVALENT
FILTRATION, except when the X-RAY EQUIPMENT was
exempted by a particular standard ..........................:
7.2 The distribution of X-RAY TUBE VOLTAGES during The distribution of the x-ray P
LOADING did not produce excessive increase in low tube voltage during loading
energy RADIATION in the X-RAY BEAM, in particular, as comply with the requirement
applied to the following:
− rising phase of X-RAY TUBE VOLTAGE Rising phase inspected P
− falling phase of X-RAY TUBE VOLTAGE, and Falling phase inspected P
− shape and amplitude of X-RAY TUBE VOLTAGE Ripple inspected P
RIPPLE
X-RAY TUBE VOLTAGE waveform in conjunction with See RISK MANAGEMENT Table P
TOTAL FILTRATION in X-RAY EQUIPMENT resulting in an 7.2
acceptable RADIATION dose for the INTENDED USE is
determined in the RISK MANAGEMENT FILE or by
application of a particular standard..........................:
7.3 Indication of FILTER properties P
− Means provided to indicate the PERMANENT Marked on the X-ray tube and P
FILTRATION IN THE X-RAY BEAM................................ : detailed in the user manual
− Means provided to indicate thickness and mmAl P
chemical composition of each ADDED FILTER ......... :
- X-RAY TUBE ASSEMBLIES marked with their E7876X: 1,3mmAl/75kV P
PERMANENT FILTRATION or thickness of materials
H1086X: 2,5mmAl/75kV
concerned together with their chemical symbols .. :
- Added filters including EDGE FILTERS are marked 0.5mmAL， 1mmAL P

with the thickness and chemical symbol of each
material.................................................................. :
The marking is, optionally, provided in the form of a Marking provided on the X-ray P
reference to a statement of these particulars in the tube and the statement
ACCOMPANYING DOCUMENTS described in user manual
appendix A

IEC 60601-1-3
- ACCOMPANYING DOCUMENTS state the QUALITY 0.5mmAL， 1mmAL P

EQUIVALENT FILTRATION in thickness of Al or other
suitable reference material and the radiation quality
used for its determination for all ADDED FILTERS
Value of QUALITY EQUIVALENT FILTRATION provided Value given comply with the P
for EDGE FILTERS relates to the low-energy side of requirement
the discontinuity
- Fixed layers of material in the X-RAY BEAM Marked on the X-ray tube P
incident on the PATIENT, other than ADDED FILTERS
and irremovable materials in X-RAY TUBE
ASSEMBLIES, are marked to show the QUALITY
EQUIVALENT FILTRATION in thickness of aluminium
together with RADIATION QUALITY used for its
determination
The marking is, optionally, provided in the form of a Appendix A in user manual P
reference to a statement of these particulars in the
ACCOMPANYING DOCUMENTS
The layers do not exceed a QUALITY EQUIVALENT Such layers did not considered P
FILTRATION of 0,2 mm Al and are not intended to be
taken into account as part of the TOTAL FILTRATION
required for compliance with 4th paragraph of 7.1,
therefore, they are not marked
− The selected ADDED FILTER is indicated on the Not by remote control or N/A
CONTROL PANEL when X-RAY EQUIPMENT has automatic systems
provisions to select ADDED FILTERS by remote control
or automatic systems
X-RAY TUBE ASSEMBLIES, filtering materials, and User manual and marking P
ADDED FILTERS inspected; and ACCOMPANYING inspected
DOCUMENTS reviewed for verification
7.4 FILTRATION by irremovable materials in the X-RAY Determined not by test N/A
SOURCE ASSEMBLY determined by adding the values
of QUALITY EQUIVALENT FILTRATION from each
irremovable layer of material intercepting the X-RAY
BEAM ...................................................................... :
QUALITY EQUIVALENT FILTRATION determined See appendix C in operator’s P

according to IEC 60522 when the above information manual
could not be obtained ..............................................:
7.5 The QUALITY EQUIVALENT FILTRATION of ADDED The added filters provided in N/A
FILTERS and other materials forming part of the mmAl
TOTAL FILTRATION under NARROW BEAM CONDITIONS
determined as the thickness of aluminium resulting
in the same first HALF-VALUE LAYER as the material
under test ..............................................................:

IEC 60601-1-3
A RADIATION QUALITY appropriate to the low-energy The added filters provided in N/A
side of the discontinuity used when the QUALITY mmAl
EQUIVALENT FILTRATION of an EDGE FILTER was to be
determined
7.6 The first HALF-VALUE LAYER under NARROW BEAM See appended Table 7.1 P
CONDITIONS with the X-RAY EQUIPMENT operating at
selected values of X-RAY TUBE VOLTAGE ................:
8 LIMITATION OF THE EXTENT OF THE X-RAY BEAM AND RELATIONSHIP --

BETWEEN X-RAY FIELD AND IMAGE RECEPTION AREA
8.1 X-RAY EQUIPMENT limits the RADIATION FIELD not Such device provided P
contributing to the formation of the image
Implementation considered in RISK MANAGEMENT By using particular standards P
FILE or by using particular standards ..................... : IEC60601-2-54
8.2 X-RAY TUBES are utilized as part of an X-RAY Utilized as part of an x-ray P
SOURCE ASSEMBLY including the functions of an X- source assembly
RAY TUBE HOUSING and a BEAM LIMITING SYSTEM
8.3 X-RAY TUBE ASSEMBLY does not have a RADIATION Not larger than needed to P
APERTURE larger than needed to provide the provide the largest X-ray beam
largest X-RAY BEAM required for its specified required for its specified
applications applications
RADIATION APERTURE is restricted to the appropriate Such device provided to limit P
size by means of a fixed-size DIAPHRAGM fitted as the radiation aperture
close as practicable to the FOCAL SPOT
8.4 Contribution of EXTRA-FOCAL RADIATION to X-RAY The radiation beam limited P
IMAGE RECEPTOR and to PATIENT dose is limited to an
acceptable level in accordance with the particular
standards
Technical description and design data were See user manual appendix A P
reviewed for verification ............................................ :
8.5 Relationship between X-RAY FIELD and IMAGE RECEPTION AREA P
8.5.1 X-RAY BEAM can be safely directed and aligned in See also Clause 8.5.3 P
relation to PATIENT and to X-RAY IMAGE RECEPTOR as
appropriate to the specified applications to ensure X-
RAY EQUIPMENT can be used without excessive RISK
of administering RADIATION to PATIENT, from which
useful diagnostic information cannot be derived ...... :
8.5.2 – particular values or ranges of FOCAL SPOT TO IMAGE See appendix A in user manual P
RECEPTOR DISTANCE for NORMAL USE are included in
ACCOMPANYING DOCUMENTS ....................................... :

IEC 60601-1-3
– currently selected value of FOCAL SPOT TO IMAGE Measured by the ruler attached P
RECEPTOR DISTANCE is indicated on the EQUIPMENT to the X-ray tube assembly
when the value is adjustable and the specified
applications require the value to be known to
operator prior to LOADING
– FOCAL SPOT TO IMAGE RECEPTOR DISTANCE does not Not more than 5% P
differ from any corresponding value indicated on the
EQUIPMENT or any corresponding value stated in the
ACCOMPANYING DOCUMENTS by more than 5 % ......... :
Functional tests conducted, ACCOMPANYING See appended Table 8.5.2 P

DOCUMENTS examined, and, when applicable, the
FOCAL SPOT TO IMAGE RECEPTOR DISTANCE measured
in selected configurations and settings of the
EQUIPMENT.................................................................. :
8.5.3 Correspondence between X-RAY FIELD and EFFECTIVE IMAGE RECEPTION AREA P
Means provided to adjust the X-RAY FIELD position According to IEC60601-2-54 P
and size correspond to the EFFECTIVE IMAGE
RECEPTION AREA within an acceptable accuracy
according to the particular standards or the RISK
MANAGEMENT FILE ....................................................... :
8.5.4 The extent of irradiated area can be restricted to the Can be restricted by the X-ray P
clinically required value for the INTENDED USE tube assembly
All areas on the PATIENT body that are permitted to Comply with the requirement P
be scanned are visible on the image
9 FOCAL SPOT TO SKIN DISTANCE --

9.1 FOCAL SPOT TO SKIN DISTANCES in NORMAL USE is Large to 200cm P
sufficiently large to limit the RADIATION dose to
PATIENT as low as reasonably achievable
Implementation of a minimum FOCAL SPOT TO SKIN By using particular standard P

DISTANCE is
taken into consideration in the RISK IEC60601-2-54
MANAGEMENT FILE or by using particular standards :
9.2 Effects of changes in the FOCAL SPOT TO SKIN See 2.2.3.2 in user manual P
DISTANCE on the RADIATION dose to the PATIENT are
described in instructions for use ........................... :
10 ATTENUATION OF THE X-RAY BEAM BETWEEN THE PATIENT AND THE X- --

RAY IMAGE RECEPTOR

IEC 60601-1-3
10.1 ATTENUATION of X-RAY BEAM by material interposed Kept as low as reasonably P

between PATIENT and X-RAY IMAGE RECEPTOR is achievable
kept as low as reasonably achievable to avoid
unnecessary high doses to PATIENT, and through
STRAY RADIATION to OPERATOR
Values of ATTENUATION EQUIVALENT and RADIATION By application of a particular P

CONDITIONS for testing required for the INTENDED standard IEC60601-2-54
USE are determined in the RISK MANAGEMENT FILE or
by application of a particular standard ................... :
10.2 The maximum value of ATTENUATION EQUIVALENT of See appendix A in user manual P
each item interposed between PATIENT and X-RAY
IMAGE RECEPTOR and forming part of the X-RAY
EQUIPMENT stated in ACCOMPANYING DOCUMENTS .... :
Instructions for use indicate the possible adverse See appendix A in user manual P
effects of materials located in the X-RAY BEAM for
diagnostic X-RAY EQUIPMENT specified for use in
combination with accessories or other items not
forming part of the same or other diagnostic X-RAY
EQUIPMENT
11 PROTECTION AGAINST RESIDUAL RADIATION --

RADIATION dose resulting from RESIDUAL RADIATION Addressed by IEC60601-2-54 N/A
is evaluated in RISK MANAGEMENT FILE for
equipment where this item is not addressed by a
standard as follows ............................................... :
− for PATIENT, relative to RADIATION dose resulting Addressed by IEC60601-2-54 N/A
from examination
− for other persons, relative to the dose resulting Addressed by IEC60601-2-54 N/A
from X-RADIATION scattered off the PATIENT
PRIMARY PROTECTIVE SHIELDING incorporated in the Addressed by IEC60601-2-54 N/A
X-RAY EQUIPMENT to prevent effects of RESIDUAL
RADIATION dose received by OPERATORS, other
individuals present in the examination room during
LOADING, and parts of the PATIENT body other than
those being scanned in NORMAL USE
PRIMARY PROTECTIVE SHIELDING is provided with Addressed by IEC60601-2-54 N/A
appropriate extent and capability to attenuate the
RESIDUAL RADIATION when required
12 PROTECTION AGAINST LEAKAGE RADIATION --

12.1 Appropriate measures are taken to protect the Beam limited device P
PATIENT, OPERATOR, and staff against LEAKAGE
Shielded room
RADIATION ................................................................ :

IEC 60601-1-3
RADIATION dose acceptable within INTENDED USE See RISK MANAGEMENT Table P
and resulting from LEAKAGE RADIATION is 12.1
determined in RISK MANAGEMENT FILE or by
application of a particular standard for PATIENT
relative to RADIATION dose from examination and
other persons, relative to the dose from X-RADIATION
scattered off the PATIENT ...........................................:
LEAKAGE RADIATION does not contribute significantly Does not contribute P
to RADIATION dose received by OPERATOR, other significantly
persons present in examination room during
LOADING, and parts of the PATIENT body other than
those being scanned
12.2 X-RAY SOURCE ASSEMBLIES and X-RAY IMAGE Need not be hand held during P
RECEPTOR need not be hand held during LOADING in loading in normal use
NORMAL USE
Exceptions are justified in the RISK MANAGEMENT No exceptions N/A

FILE or
by application of a particular standard ........ :
12.3 Values of LOADING FACTORS corresponding to the See appendix A in user manual P
maximum specified energy input to ANODE in one
hour when applied at the NOMINAL X-RAY TUBE
VOLTAGE are stated in ACCOMPANYING DOCUMENTS
for X-RAY TUBE ASSEMBLIES and X-RAY SOURCE
ASSEMBLIES .............................................................
Maximum specified energy input in one hour was Not corresponding to total N/A
the value permitted by LOADING in RADIOGRAPHY at current time product
the applicable X-RAY TUBE VOLTAGE according to
RADIOGRAPHIC RATINGS corresponding to a total
CURRENT TIME PRODUCT, or
- the value corresponding to the specified Corresponding to input power P

CONTINUOUS ANODE INPUT POWER
12.4 In the LOADING STATE operating at NOMINAL X-RAY Not exceed 1mGy/h P
TUBE VOLTAGE, the AIR KERMA at 1 m from the FOCAL
SPOT did not exceed 1.0 mGy in 1 hour .................. :
Tests conducted in accordance with Sub-clauses See appended Table 12.4 P

12.4 a) through 12.4 h)
12.5 When not in the LOADING STATE, the AIR KERMA due See appended Table 12.5 P
to LEAKAGE RADIATION from X-RAY TUBE and SOURCE
2
ASSEMBLIES averaged over any area of 10 cm did
not exceed 20 Gy/hour ........................................:
Tests conducted in accordance with Sub-clauses Tested comply with the P
12.5 a) through 12.5 d) requirement
13 PROTECTION AGAINST STRAY RADIATION --

IEC 60601-1-3
13.1 Appropriate measures to protect the OPERATOR and See 13.2 to 13.5 P
staff against STRAY RADIATION have been taken .....:
13.2 Means provided to allow implementation of the Means provided P
following control functions from a PROTECTED AREA
after installation for X-RAY EQUIPMENT intended
exclusively for examination not requiring the
OPERATOR or staff to be near to PATIENT during
NORMAL USE
− selection and control of MODES OF OPERATION Modes of operation can be P

selected
− selection of LOADING FACTORS Loading factors can be P
selected
− actuation of the IRRADIATION SWITCH Actuation hand switch provided P
− other necessary controls for the OPERATOR Indicator provide P
during LOADING
Relevant instructions are included in See 4.2.3 in user manual P
ACCOMPANYING DOCUMENTS ................................... :
A statement indicating the need for provision of No such means needed N/A
means for audio and visual communication
between OPERATOR and PATIENT is included in
ACCOMPANYING DOCUMENTS .................................... :
Exceptions to this sub-clause are justified in the No such exception N/A

RISK MANAGEMENT FILE, or by application of a
particular standard, and comply with Cl. 13.3 .......:
13.3 Protection against STRAY RADIATION in X-RAY 13.2 applied N/A
EQUIPMENT intended exclusively for examination
not requiring the OPERATOR, staff, or other persons
to be near PATIENT in NORMAL USE is achieved by
enabling the OPERATOR to control IRRADIATION from
a sufficiently long distance
Distance required and RADIATION dose resulting See Risk management Table N/A
from the STRAY RADIATION is determined in the RISK 13.3
MANAGEMENT FILE or by application of a particular 13.2 applied
standard .................................................................:
Information provided in ACCOMPANYING DOCUMENTS 13.2 applied N/A
on the impact of distance on RADIATION dose when
protection is effected by distance
Possible need for PROTECTIVE DEVICES and 13.2 applied N/A
PROTECTIVE CLOTHING, as appropriate for the
workload involved, is stated in ACCOMPANYING
DOCUMENTS
EQUIPMENT, the RISK MANAGEMENT FILE, and the See Risk management Table N/A
ACCOMPANYING DOCUMENTS inspected and 13.3
reviewed for verification .........................................: 13.2 applied

IEC 60601-1-3
13.4 At least one SIGNIFICANT ZONE OF OCCUPANCY for Not requires the operator or N/A
use of the OPERATOR and staff, designated in the staff to be close to the patient
instructions for use, provided for X-RAY EQUIPMENT during normal use
intended for RADIOLOGICAL examination requiring
the OPERATOR or staff to be near the PATIENT, or X-
RAY EQUIPMENT not complying with 13.2 or 13.3
A floor area  to 60 cm x 60 cm and a height  200 Not requires the operator or N/A
cm provided for SIGNIFICANT ZONES OF OCCUPANCY staff to be close to the patient
designated per this sub-clause during normal use
Designation of each SIGNIFICANT ZONE OF Not requires the operator or N/A

OCCUPANCY in accordance with this sub-clause staff to be close to the patient
includes the following information in the during normal use
instructions for use:
− types of RADIOLOGICAL examinations for which Not requires the operator or N/A
the SIGNIFICANT ZONE OF OCCUPANCY is designated staff to be close to the patient
to be used during normal use
− location of the SIGNIFICANT ZONE OF OCCUPANCY, Not requires the operator or N/A
shown on a representative outline drawing, staff to be close to the patient
indicating the positions of its boundaries relative to during normal use
clearly recognizable features of X-RAY EQUIPMENT
− at least one profile of STRAY RADIATION in the Not requires the operator or N/A
SIGNIFICANT ZONE OF OCCUPANCY with respect to the staff to be close to the patient
height above the floor, under stated representative during normal use
operating conditions
At least one profile contains the point with the Not requires the operator or N/A
highest dose level (e.g., See Figure 1) staff to be close to the patient
during normal use
− information about the effectiveness of Not requires the operator or N/A
PROTECTIVE DEVICES together with appropriate staff to be close to the patient
information about their application and use during normal use
provided when removable PROTECTIVE DEVICES are
specified for use with X-RAY EQUIPMENT
− details of the test arrangement used Not requires the operator or N/A
staff to be close to the patient
during normal use
− instructions for obtaining the LOADING FACTORS Not requires the operator or N/A
used for testing when these are controlled only by staff to be close to the patient
an AUTOMATIC CONTROL SYSTEM during normal use
13.5 Handgrips and control devices handled during Hand switch provided N/A
LOADING are not positioned in the X-RAY BEAM
13.6 - Levels of STRAY RADIATION did not exceed the See appended Tables 13.6A & N/A
permissible values ...................................................: 13.6B
Not protected by distance or
occupied area

IEC 60601-1-3
Tests conducted in accordance with 13.6a) through Not protected by distance or N/A
13.6i) occupied area
6.3.2 RM RESULTS TABLE: Reproducibility of the RADIATION output N/A

Clause of Document Ref. in RMF Result – Remarks Verdict
ISO 14971 (Document No. & paragraph)
4.2 / The issue is addressed in IEC60601-2-54 /
4.3 / / /
Supplementary information:
RISK MANAGEMENT is not required if particular standard is used.
6.4.3 RM RESULTS TABLE: Indication of LOADING FACTORS and MODES OF OPERATION N/A
4.2 / By application of a particular standard IEC60601- /
2-54
4.3 / / /
6.5 RM RESULTS TABLE: AUTOMATIC CONTROL SYSTEM N/A

ISO (Document No. & paragraph)
14971
4.2 / By application a particular standard IEC60601-2-
/
54
4.3 / / /
6.7.2 RM RESULTS TABLE: System performance P

14971
4.2 The report of risk management The system performance was recorded in P
No. KF-DR15-2-008-01 chapter 3
Chapter 3
6.7.3 RM RESULTS TABLE: Nominal focal spot value P

14971
4.2 The report of risk management The nominal focal spot value was recorded in P
No. KF-DR15-2-008-01 chapter 3
Chapter 3

IEC 60601-1-3
6.7.4 RM RESULTS TABLE: RADIATION DETECTOR or X-RAY IMAGE RECEPTOR P

14971
4.3 The report of risk management The risk about the performance of the receptor
No. KF-DR15-2-008-01 table 3 was identified P
item 1.2.15
4.4 The report of risk management Evaluated in the risk management report
No. KF-DR15-2-008-01 table 3 P
item 1.2.15
7.1A Table: Measured first HALF-VALUE LAYER for all configurations in NORMAL USE P
Specified Application X-RAY TUBE VOLTAGE Minimum permissible Measured first HALF-
(KV) first HALF-VALUE LAYER VALUE LAYER
(mm Al) (mm Al)
X-Ray tube assembly: E7876X
Radiography 40 1,4 1,49
50 1,8 2,4
60 2,2 2,4
70 2,5 2,8
80 2,9 3,2
90 3,2 3,5
100 3,6 3,8
110 3,9 4,1
120 4,3 4,5
130 4,7 4,7
140 5,0 5,0
150 5,4 5,4
X-Ray tube assembly: H1086X
Radiography 40 1,4 1,49
50 1,8 2,4
60 2,2 2,4
70 2,5 2,8
80 2,9 3,2
90 3,2 3,5
100 3,6 3,8

IEC 60601-1-3
110 3,9 4,1

120 4,3 4,5
130 4,7 4,7
140 5,0 5,0
150 5,4 5,4
/
7.1B Table: Measured TOTAL FILTRATION N/A
Specified Application X-RAY TUBE VOLTAGE Minimum permissible Measured TOTAL

(KV) TOTAL FILTRATION FILTRATION
(mm Al) (mm Al)
/ / 2,5 /
/ / 2,5 /
Supplementary information: Not verified by the filtration
7.2 RM RESULTS TABLE: Waveform of the X-RAY TUBE VOLTAGE N/A

14971
4.2 / By application of a particular standard IEC /
60601-2-54
4.3 / / /
4.4 / / /
5 / / /
6.2 / / /
6.3 / / /
6.4 / / /
7.5 Table: Measurement of the thickness of aluminium resulting in the same first N/A
HALF-VALUE LAYER in
accordance with Table 3
Specified Application X-RAY TUBE VOLTAGE Minimum permissible Measured FILTRATION

(KV) FILTRATION (mm Al)

IEC 60601-1-3
(mm Al)
/ / / /
/ / / /
Supplementary information: The added filters is aluminium
7.6 Table: Measurement of first HALF-VALUE LAYER under NARROW BEAM CONDITIONS P
with X-RAY EQUIPMENT operating at X-RAY TUBE VOLTAGES in Table 3 at
corresponding LOADING FACTORS in NORMAL USE
Specified Application X-RAY TUBE VOLTAGE Minimum permissible Measured first HALF-
(KV) first HALF-VALUE LAYER VALUE LAYER
(mm Al) (mm Al)
/ / / /
/ / / /
Supplementary information: see table 7.1
8.1 RM RESULTS TABLE: Limitation of the extent of the X-RAY BEAM (General) N/A
14971
4.2 / By using particular standards IEC60601-2-54 /
4.3 / / /
4.4 / / /
5 / / /
6.2 / / /
6.3 / / /
6.4 / / /
8.5.2 Table: Measurement of FOCAL SPOT TO IMAGE RECEPTOR DISTANCE in selected P

configurations and settings of EQUIPMENT
Selected FOCAL SPOT TO IMAGE FOCAL SPOT TO IMAGE Per cent

configuration RECEPTOR DISTANCE RECEPTOR DISTANCE deviation
Remarks
indicated on EQUIPMENT, measured (mm) (%)
(mm)
DigiEye 280 700 714,2 2,03 /

IEC 60601-1-3
DigiEye 280 2000 2046,5 2,33 /

8.5.3 RM RESULTS TABLE: Correspondence between X-RAY FIELD and EFFECTIVE

N/A
IMAGE RECEPTION AREA
14971
Supplementary information: RISK MANAGEMENT is not required if particular standard is used.
For clause 4.4 and 5.0 of ISO 14971, see also 8.5.1.
9.1 RM RESULTS TABLE: FOCAL SPOT TO SKIN DISTANCE N/A

14971
5 / / /
10.1 RM RESULTS TABLE: ATTENUATION of the X-RAY BEAM between the

N/A
PATIENT and the X-RAY IMAGE RECEPTOR
14971
4.3 / / /
11 RM RESULTS TABLE: Protection against RESIDUAL RADIATION N/A

14971
4.4 / / /

IEC 60601-1-3
12.1 RM RESULTS TABLE: Protection against LEAKAGE RADIATION P

14971
4.2 The report of risk management Equipment with X-ray tube assembly P
No. KF-DR15-2-008-01,
Chapter 3
4.3 The report of risk management The risk of the leakage radiation was identified P
No. KF-DR15-2-008-01,
Chapter 3 and 4
4.4 The report of risk management Evaluated in the risk management report P
No. KF-DR15-2-008-01,
Chapter 5
5 The report of risk management Risk evaluated : to be reduced P
No. KF-DR15-2-008-01,
Chapter 5
6.2 The report of risk management Measurement : add shielded cover P
No. KF-DR15-2-008-01,
Chapter 5
6.3 The report of risk management The collimator and X-ray tube assembly with PB P
No. KF-DR15-2-008-01, shielded cover
Chapter 5
6.4 The report of risk management Evaluated in the risk management report P
No. KF-DR15-2-008-01,
Chapter 5
12.2 RM RESULTS TABLE: Mounting of X-RAY SOURCE ASSEMBLIES and X-RAY

N/A
IMAGING ARRANGEMENTS
14971
4.2 / No exceptions /
4.3 / / /
RISK MANAGEMENT is not required if there is no exception or particular standard is used.
12.4 Table: Measured LEAKAGE RADIATION in the LOADING STATE P

Conditions of LOADING Allowed limit Averaged
Point of Mode of CURRENT, (mA) or X-RAY TUBE of LEAKAGE LEAKAGE
measurement operation CURRENT TIME PRODUCT, VOLTAGE, RADIATION RADIATION
(mAs) (kV) (mGy/h) (1) (mGy/h)

IEC 60601-1-3
E7876X A1 Exposing 320mA 160ms 150kV 1 0,0077

E7876X B1 Exposing 320mA 160ms 150kV 1 0,0073
E7876X C1 Exposing 320mA 160ms 150kV 1 0,0077
H1086X A1 Exposing 320mA 160ms 150kV 1 0,091

IEC 60601-1-3
H1086X B1 Exposing 320mA 160ms 150kV 1 0,087

H1086X C1 Exposing 320mA 160ms 150kV 1 0,127
(1) Particular standards may specify different limits of LEAKAGE RADIATION for specific X-RAY
EQUIPMENT
(2) Measured at 24 points on 3 plane (A1-A8, B1-B8, C1-C8)

IEC 60601-1-3
12.5 Table: Measured LEAKAGE RADIATION when not in the LOADING STATE P
Conditions of NORMAL USE Allowed limit Averaged
Points of Mode of CURRENT, (mA) or X-RAY TUBE of LEAKAGE LEAKAGE
measurements operation CURRENT TIME PRODUCT, VOLTAGE, RADIATION RADIATION
(mAs) (kV) (mGy/h) (mGy/h)
E7876X A1 Standby / / 0,02 0,00004

E7876X A2 Standby / / 0,02 0,00004
E7876X A3 Standby / / 0,02 0,00008
E7876X A4 Standby / / 0,02 0,00002
E7876X A5 Standby / / 0,02 0,00007
E7876X A6 Standby / / 0,02 0,00003
E7876X A7 Standby / / 0,02 0,00005
E7876X A8 Standby / / 0,02 0,00002
E7876X B1 Standby / / 0,02 0,00007
E7876X B2 Standby / / 0,02 0,00002
E7876X B3 Standby / / 0,02 0,00008
E7876X B4 Standby / / 0,02 0,00005
E7876X B5 Standby / / 0,02 0,00005
E7876X B6 Standby / / 0,02 0,00003
E7876X B7 Standby / / 0,02 0,00005
E7876X B8 Standby / / 0,02 0,00001
E7876X C1 Standby / / 0,02 0,00005
E7876X C2 Standby / / 0,02 0,00003
E7876X C3 Standby / / 0,02 0,00007
E7876X C4 Standby / / 0,02 0,00005
E7876X C5 Standby / / 0,02 0,00007
E7876X C6 Standby / / 0,02 0,00002
E7876X C7 Standby / / 0,02 0,00004
E7876X C8 Standby / / 0,02 0,00003
H1086X A1 Standby / / 0,02 0,00005
H1086X A2 Standby / / 0,02 0,00008
H1086X A3 Standby / / 0,02 0,00004

IEC 60601-1-3
H1086X A4 Standby / / 0,02 0,00003

H1086X A5 Standby / / 0,02 0,00004
H1086X A6 Standby / / 0,02 0,00007
H1086X A7 Standby / / 0,02 0,00003
H1086X A8 Standby / / 0,02 0,00006
H1086X B1 Standby / / 0,02 0,00001
H1086X B2 Standby / / 0,02 0,00003
H1086X B3 Standby / / 0,02 0,00004
H1086X B4 Standby / / 0,02 0,00004
H1086X B5 Standby / / 0,02 0,00002
H1086X B6 Standby / / 0,02 0,00002
H1086X B7 Standby / / 0,02 0,00003
H1086X B8 Standby / / 0,02 0,00003
H1086X C1 Standby / / 0,02 0,00002
H1086X C2 Standby / / 0,02 0,00006
H1086X C3 Standby / / 0,02 0,00004
H1086X C4 Standby / / 0,02 0,00007
H1086X C5 Standby / / 0,02 0,00001
H1086X C6 Standby / / 0,02 0,00003
H1086X C7 Standby / / 0,02 0,00005
H1086X C8 Standby / / 0,02 0,00005
Measured at 24 points on 3 plane (A1-A8, B1-B8, C1-C8)
13.2 RM RESULTS TABLE: Control of X-RAY EQUIPMENT from a PROTECTED AREA N/A
Clause of Document Ref. in RMF Result - Remarks Verdict
14971
4.2 / No exceptions /
4.3 / / /
Supplementary information: See also 13.3
13.3 RM RESULTS TABLE: Protection by distance N/A

IEC 60601-1-3
Clause of Document Ref. in RMF Result - Remarks Verdict

4.2 / Not such protect means /
4.3 / / /
Supplementary information: See also 13.2
13.6A Table: STRAY RADIATION of X-RAY EQUIPMENT N/A

Region of height (above floor) Highest permissible AIR Measured STRAY
Orientation of in SIGNIFICANT ZONE OF KERMA in one hour, RADIATION in
one hour,
PATIENT SUPPORT OCCUPANCY, cm mGy mGy
Horizontal or / / /
Vertical
Horizontal / / /
Vertical / / /
Not protected by distance or occupied area
13.6B Table: Limits of AIR KERMA in one hour N/A

Highest permissible AIR Measured AIR KERMA in
Frequency of handling KERMA inone hour, mGy one hour, mGy Remarks
Infrequently or Momentary / / /
Frequently / / /
Not protected by distance or occupied area
-- End of the report --

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Test Report issued under the responsibility of:

Report Reference No. .................... : GZME140300018702

Manufacturer .................................... : Same as applicant

Testing procedure and testing location:

Testing Laboratory: SGS-CSTC Standards Technical Services Co., Ltd. – E&E

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

Approved by (+ signature)........... : Jason Hoo

Testing procedure: TMP

Testing procedure: SMT

TRF No. IEC60601_1_3D

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

Summary of compliance with National Differences:

Copy of marking plate:

TRF No. IEC60601_1_3D

Test item particulars ................................................. :

TRF No. IEC60601_1_3D

Manufacturer’s Declaration per sub-clause 6.2.5 of IECEE 02:

See IEC 60601-1 Test Report

TRF No. IEC60601_1_3D

4 GENERAL REQUIREMENTS FOR TESTS --

5 ME EQUIPMENT IDENTIFICATION, MARKING, AND DOCUMENTS --

- interchangeable devices are individually No such removable parts N/A

TRF No. IEC60601_1_3D

a) Location of the markings and instructions for See safety information in P

− description of a specified test object See 4.2.3 in operator’s manual P

TRF No. IEC60601_1_3D

b) Number of EXPOSURES or duration of LOADING No such condition N/A

TRF No. IEC60601_1_3D

c) a list of PROTECTIVE DEVICES and ACCESSORIES to No such protection N/A

6.2.2 IRRADIATION is terminated by a safety measure in A emergency button provided P

TRF No. IEC60601_1_3D

Manual selection of loading factors and other The parameter selected P

Series of LOADING STATES initiated by a single No such loading state N/A

TRF No. IEC60601_1_3D

6.4.3 Adequate information is available to OPERATOR See 4.2.3 in operator’s manual P

6.4.4 Preselected mode of automatic operation is The operation mode is P

6.5 X-RAY EQUIPMENT provided with an AUTOMATIC An AEC mode provided P

An AUTOMATIC CONTROL SYSTEM provided in case the An AEC mode provided P

TRF No. IEC60601_1_3D

6.6 Means provided to reduce the influence of Grids are provided P

TRF No. IEC60601_1_3D

Minimum FILTRATION is expressed in terms of total Comply with the requirement P

- Added filters including EDGE FILTERS are marked 0.5mmAL， 1mmAL P

TRF No. IEC60601_1_3D

- ACCOMPANYING DOCUMENTS state the QUALITY 0.5mmAL， 1mmAL P

QUALITY EQUIVALENT FILTRATION determined See appendix C in operator’s P

TRF No. IEC60601_1_3D

8 LIMITATION OF THE EXTENT OF THE X-RAY BEAM AND RELATIONSHIP --

TRF No. IEC60601_1_3D

Functional tests conducted, ACCOMPANYING See appended Table 8.5.2 P

9 FOCAL SPOT TO SKIN DISTANCE --

Implementation of a minimum FOCAL SPOT TO SKIN By using particular standard P

10 ATTENUATION OF THE X-RAY BEAM BETWEEN THE PATIENT AND THE X- --

TRF No. IEC60601_1_3D

10.1 ATTENUATION of X-RAY BEAM by material interposed Kept as low as reasonably P

Values of ATTENUATION EQUIVALENT and RADIATION By application of a particular P

11 PROTECTION AGAINST RESIDUAL RADIATION --

12 PROTECTION AGAINST LEAKAGE RADIATION --

TRF No. IEC60601_1_3D

Exceptions are justified in the RISK MANAGEMENT No exceptions N/A

- the value corresponding to the specified Corresponding to input power P

Tests conducted in accordance with Sub-clauses See appended Table 12.4 P

13 PROTECTION AGAINST STRAY RADIATION --