iec60601_1_1d报告模板
Test Report issued under the responsibility of:
TEST REPORT
IEC 60601–1–1
Medical electrical equipment
Part 1-1 - Collateral Standard: Safety Requirements for Medical Electrical Systems
Report Reference No. ................... :
Date of issue ................................... :
Total number of pages .....................
CB Testing Laboratory ................. :
Address .......................................... :
Applicant’s name .......................... :
Address .......................................... :
Test specification:
Standard ......................................... : IEC 60601-1-1: 2000 (Second Edition) for use with IEC 60601-1
(1988), Amts 1 (1991) and 2 (1995)
Test procedure ................................ : CB Scheme
Non-standard test method…………..: N/A
IEC60601_1_1D Test Report Form No. ................... :
Test Report Form(s) Originator ....... : Underwriters Laboratories Inc.
Master TRF ..................................... : Dated 2006-07
Copyright ? 2006 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 .................... :
Trade Mark ..................................... :
Manufacturer .................................. :
Model/Type reference ..................... :
Ratings ........................................... :
Page 2 of 12 Report No.
Testing procedure and testing location:
CB/CCA Testing Laboratory:
Testing location/ address ..................... :
Associated CB 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 ..................... :
TRF No. IEC601_1_1D
Page 3 of 12 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. IEC601_1_1D
Page 4 of 12 Report No.
Test item particulars ............................................ :
Classification of installation and use ...................... : See IEC 60601-1 Test Report
Possible test case verdicts:
- test case does not apply to the test object ............ : N/A
- test object does meet the requirement ................. : P (Pass)
- test object does not meet the requirement ........... : F (Fail)
Testing ................................................................. :
Date of receipt of test item ..................................... :
Date (s) of performance of tests ............................. :
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 comma (point) is used as the decimal separator.
This Test Report contains the general safety requirements as related to the programmable
electrical medical systems. It can only be used together with IEC 60601-1 Test Report. General product information:
TRF No. IEC601_1_1D
Page 5 of 12 Report No.
IEC 60601-1-1
Clause Requirement + Test Result - Remark Verdict
3 GENERAL REQUIREMENTS
— Situation No.(s) from Table BBB.201 with
indication which parts of the system are
considered as Equipment A, which are
Equipment B. (If none of the examples applies
description of the system) ................................ :
— Indicate solutions used to mitigate hazards
arising from interconnection of different
equipment (refer to Table BBB.201) ................ :
3.201 System after installation or subsequent
modification causes no safety hazard for the
patient, the operator or surroundings
System within the patient environment provides
the same level of safety as Medical Equipment
complying with IEC 60601-1
System outside the patient environment provides
the level of safety appropriate for non-medical
equipment complying with other IEC or ISO
standards
3.201.1 Medical Equipment complies with IEC 60601-1 (See appended Table 3.201)
and relevant particular standards
3.201.2 Non-medical equipment complies with relevant (See appended Table 3.201)
IEC or ISO standards
Equipment in which protection relies on basic
insulation only shall not be used in a system
3.201.3 A specified power supply according to 10.2.2.201
meets the requirements of IEC 60601-1 or
demonstrates an equivalent degree of safety
3.201.4 After installation or subsequent modification, the
system is in compliance with the requirements of
this collateral standard
6 IDENTIFICATION, MARKING AND DOCUMENTS 6.8.201 System accompanied by documents containing
all the data necessary for safe and intended use
Documents provided with the system include required documents:
a) accompanying documents for each item of
medical equipment
b) equivalent documents for each item of non-
medical electrical equipment
c) The following information is provided: TRF No. IEC601_1_1D
Page 6 of 12 Report No.
IEC 60601-1-1
Clause Requirement + Test Result - Remark Verdict
- instruction for cleaning, sterilization, or
disinfection of each item of the system
- additional safety measures which should be
applied during installation of the system
- which parts of the system are suitable for use
within the patient environment
- additional measures which should be applied
during preventive maintenance
- a warning that Multiple Portable Socket-Outlets
(MPSO) shall not be placed on the floor
- a warning that an additional MPSO or extension
cord shall not be connected to the system
- a warning not to connect items which are not
specified as part of the system
- the maximum permitted load for any MPSO(s)
- instruction that MPSO provided with the system
shall only be used for powering equipment which
forms part of the system
- explanation of the risks of connecting a non-
medical equipment, which has been supplied as
a part of the system, directly to the wall outlet
when the system is supplied via MPSO with a
separating transformer
- explanation of the risks of connecting electrical
equipment which, has not been supplied as a
part of the system, to the MPSO
- any restrictions in the environmental conditions
to ensure safety
- instructions to the operator not to touch parts
referred to in clause 16.201 and the patient
simultaneously
d) advice to the installer, recommending that the
system be installed in a way that enables the
user to achieve optimal use
- advice to the user, to carry out all cleaning,
adjustment, sterilization and disinfection
procedure specified herein
10 ENVIRONMENTAL CONDITIONS 10.2.2.201 A power supply from another equipment for use in
a system equipment is specified by the
manufacturer.
TRF No. IEC601_1_1D
Page 7 of 12 Report No.
IEC 60601-1-1
Clause Requirement + Test Result - Remark Verdict
16 ENCLOSURES AND PROTECTIVE COVERS 16.201 Within the patient environment parts of non-medical electrical equipment which,
after removal of covers (without use of a tool) may be contacted by the operator:
- operate at a voltage not exceeding 25 V ac,
or 60 V dc
- peak value supplied from a source, which is
separated from the supply mains by one of the
methods from 17g of IEC 60601-1
17 SEPARATION 17.201 Separation device is provided - if leakage current limits could be exceeded by
connecting different parts of the system
Separating device has the dielectric strength, (See appended Table 17.201)
creepage distances and air clearances for the
highest voltage occurring across the device during
a fault condition.
19 LEAKAGE CURRENTS 19.201.1 Enclosure leakage current in NC measured from (See Table 19.201.1)
or between parts of the system within the patient
environment does not exceed 0.1 mA
Enclosure leakage current in the event of (See Table 19.201.1)
interruption of any non-permanently installed
protective earth conductor (SFC) does not exceed
0.5 mA
If system or part of the system is supplied from a (See Table 19.201.1)
MPSO, leakage current in the protective earth
conductor of the MPSO does not exceed 0.5 mA
19.201.2 Patient leakage current in NC does not exceed (See Table 19.201.1)
0.1 mA for Type B and BF and 0.01 mA for
Type CF
19.201.3 If SIP/SOPs of medical equipment are specified in accompanying documents for
exclusive connection to a Class I device, than the specific device is connected:
- to the common protective earth of the system
- to a separation device
22 MOVING PARTS TRF No. IEC601_1_1D
Page 8 of 12 Report No.
IEC 60601-1-1
Clause Requirement + Test Result - Remark Verdict
22.7 If movement of equipment/parts in a system may (See Table ”Additional Tests”)
cause safety hazard, the system is provided with a
protective means in accordance with 22.7 of
IEC 60601-1.
44 OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY, INGRESS OF LIQUIDS,
CLEANING, STERILIZATION, DISINFECTION, AND COMPATIBILITY 44.7.201 System is installed in such a way that the user is
able to carry out the necessary cleaning,
sterilization or disinfection.
49 INTERRUPTION OF THE POWER SUPPLY 49.201 Interruption and restoration of the power supply to (See appended Table
any single equipment in the system does not result “Additional Tests”)
in a safety hazard.
56 COMPONENTS AND GENERAL ASSEMBLY 56.3.201 Design and construction of accessible
connections, removable without the use of a tool,
SAFETY HAZARD prevent a
- Connectors comply with Clause 17g of the
General Standard
- Patient leads cannot be connected to other
outlets on the same system, which are likely to be
located in the patient environment
57 MAINS PARTS, COMPONENTS AND LAYOUT 57.2.201 Multiple Portable Socket-Outlet
Connection of equipment used in medical practice
to MPSO is only possible by using a tool, or MPSO
is supplied via separating transformer.
Separating transformer and MPSO complies with
Annex EEE.
57.10.201 Separation Device
Separation device complies with required (See appended Table 17.201)
creepage and air clearance from Table 201.
58 PROTECTIVE EARTHING - TERMINALS AND CONNECTIONS TRF No. IEC601_1_1D
Page 9 of 12 Report No.
IEC 60601-1-1
Clause Requirement + Test Result - Remark Verdict
58.201 Protective earth connection is made in such a way
that removal of any single item of the system does
not interrupt protective earth connection to any
part of the system, without at the same time
disconnecting the supply
Protective earth conductors are routed together
with the power supply cord.
Additional Protective Earth Conductor:
Permanently connected to non-mobile item of
System
Detachable only with the use of a tool
59 CONSTRUCTION AND LAYOUT 59.201 Conductors connecting different items of
equipment within the system are protected from
mechanical damage
ANNEX EEE - REQUIREMENTS FOR MPSO EEE.1 MPSO With Separating Transformers
Separating transformer complies with IEC 60989 (See Enclosure No. )
with exception of rated output power and IP
protection
Transformer assembly is Class I
If necessary transformer assembly has a specified
protection against ingress of water as detailed in
IEC 60529.
In addition to marking requirements of IEC 60989,
the transformer assembly marked according to 6.1
and 6.2 of IEC 60601-1.
MPSO is marked with maximum allowed output
MPSO is permanently connected to the
transformer.
Socket-outlet does accept mains plug made
according to IEC/TR3 60083
MPSO is marked with Symbol 14 of Table D1,
IEC 60601-1
TRF No. IEC601_1_1D
Page 10 of 12 Report No.
IEC 60601-1-1
Clause Requirement + Test Result - Remark Verdict
EEE.2 MPSO
MPSO complies with IEC 60884-1 and as follows:
- Creepage and air clearances comply with Cl.
57.10 of IEC 60601-1
- MPSO is Class I and protective earth conductor
is connected to earthing contacts of the output
sockets.
- Protective earthing terminals and connections
comply with Cl. 58 of IEC 60601-1.
- Enclosures comply with Cl. 16 of IEC 60601-1.
- Mains terminal devices comply with Cl. 57.5 of
IEC 60601-1.
- Ratings of components do not conflict with
condition of use.
- Connections comply with Cl. 56.3 of
IEC 60601-1.
- Power supply cord complies with Cl. 57.3 and
57.4 of IEC 60601-1.
- Protective earthing complies with Cl. 18 of
IEC 60601-1.
- MPSO is marked with Symbol 14 of Table D1,
IEC 60601-1.
TRF No. IEC601_1_1D
Page 11 of 12 Report No.
IEC 60601-1-1
Clause Requirement + Test Result - Remark Verdict
3.201 TABLE: System Configuration
Intended use
In patient Outside patient environment
environment
(yes/no)
Component of In medically-Non-medically Certification Certifier the system used room used room (IEC, ISO standard)
(yes/no) (yes/no)
Supplementary information:
17.201 TABLE: Dielectric Test for Separating Devices
Required Measured Device Reference Test Remarks Air Creepage Air Creepage Voltage Voltage Clearance Clearance
Supplementary information:
TRF No. IEC601_1_1D
Page 12 of 12 Report No.
IEC 60601-1-1
Clause Requirement + Test Result - Remark Verdict
19.201.1 TABLE: System Leakage Current
Leakage current measured from Measured Measured Remarks or between the following parts: Value (NC) Value (SFC)
Supplementary information:
AT TABLE: Additional Tests
Clause Test type and condition Remarks and observed results
Supplementary information:
TRF No. IEC601_1_1D
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