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This technical report applies to medical electrical equipment. The object of this technical report is to provide guidance on general testing procedures according to IEC 60601-1:1988 (including the collateral provisions of IEC 60601-1-1:2000) and IEC 60601-1:2005 and IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

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PDF Pages	PDF Title
1	ANSI/AAMI/IEC TIR62354:2015, General testing procedures for medical electrical equipment
3	Title page
4	Copyright information
5	AAMI Technical Information Report ANSI Technical Information Report
6	Contents
7	Glossary of equivalent standards
8	Committee representation
9	Background of ANSI/AAMI adoption of IEC/TR 62354:2014
10	Foreword
12	Introduction
13	1 Scope and object 2 Normative references
14	3 Terms, definitions, abbreviations and acronyms 3.1 Terms and definitions 3.2 Abbreviations and acronyms 4 Types of tests 4.1 General
15	4.2 Visual inspection 5 State of the me equipment 6 Number of samples 7 Applicable test items to the clauses of IEC 60601-1
16	8 Sequence of tests 9 General testing condition
17	10 Power sources for tests 10.1 General 10.2 Connection to a separate power source
18	10.3 Connection to an external d.c. power source 10.4 Source of power for me equipment 10.5 Supply mains for testing me equipment 11 Measurement and test equipment 11.1 General requirements
19	11.2 Accuracy
20	11.3 Safety criteria for selection 11.4 Calibration 12 Treatments of unit symbols and measured values
21	Table 1 – Units outside the SI units system that may be used 13 Procedures for testing, including particular conditions 13.1 General 13.2 Tests to be performed by inspection
22	Table 2 – Tests to be performed by inspection
23	13.2.1 RISK MANAGEMENT PROCESS
25	13.2.2 Ratings on critical components
26	13.2.3 Determination of APPLIED PARTS and ACCESSIBLE PARTS
28	13.2.4 Durability and legibility of marking
30	13.2.5 Battery markings
31	13.2.6 PATIENT leads or PATIENT cables
32	13.2.7 Plugs, sockets
33	13.2.8 POTENTIAL EQUALIZATION TERMINAL
34	13.2.9 MAINS TERMINAL DEVICE Table 3 – NOMINAL cross-sectional area of conductors of a POWER SUPPLY CORD
36	13.2.10 Sharp edges
37	13.2.11 HAZARDS associated with support systems
39	13.2.12 Construction requirements for fire ENCLOSURE of ME EQUIPMENT
41	Figure 1 – Area of the bottom of an ENCLOSURE as specified in 11.3 b) 1) Figure 2 – Baffle
42	Table 4 – Acceptable perforation of the bottom of an ENCLOSURE
43	13.2.13 Marking, conductor colors, indicator lights and controls and ACCOMPANYING DOCUMENTS
44	13.2.14 USABILITY of ME EQUIPMENT
45	13.3 Measurements and tests performed on non-energized equipment Table 5 – Measurements and tests performed on non-energized equipment
46	13.3.1 Humidity preconditioning
47	13.3.2 Impedance of PE connection
49	13.3.3 Dielectric strength
51	13.3.4 Ball pressure
52	13.3.5 Resistance to environmental stress
53	13.3.6 Thermal cycling
55	13.3.7 CREEPAGE DISTANCES and AIR CLEARANCES
56	Figure 3 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 1 Figure 4 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 2
57	Figure 5 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 3 Figure 6 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 4 Figure 7 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 5 Figure 8 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 6
58	Figure 9 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 7 Figure 10 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 8
59	Figure 11 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 9 Figure 12 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 10
61	13.3.8 Strain relief (cord anchorage) Table 6 – Testing of cord anchorages
63	13.3.9 Cord guard flexing (Cord bending)
64	13.3.10 Access to hazardous moving parts
66	13.3.11 Gaps
68	Table 7 – Acceptable gaps a
69	13.3.12 Instability
73	13.3.13 Castors and wheels
75	13.3.14 Handle loading
77	13.3.15 Safety catch evaluation
78	13.3.16 Support loading
79	Figure 13 – Human body test mass
81	13.3.17 Overflow
82	13.3.18 Spillage
83	13.3.19 Leakage
84	13.3.20 Ingress of water or particulate matter
89	13.3.21 Cleaning, sterilization and disinfection
90	13.3.22 Push (rigidity)
91	13.3.23 Impact
93	13.3.24 Drop impact Table 8 – Drop height
95	13.3.25 Rough handling
97	13.3.26 Mould stress relief
98	13.3.27 Actuating parts of controls (Knob pull and limitation of movement)
99	Table 9 – Test torques for rotating controls
100	13.3.28 Construction of transformers
102	13.4 Measurements and tests for equipment that is operating Table 10 – Measurements and tests for equipment that is operating
103	13.4.1 ESSENTIAL PERFORMANCE – Functional
105	13.4.2 Power consumption (input) single phase and polyphase
106	13.4.3 Voltage mismatch
107	13.4.4 Limitation of voltage, current or energy
108	13.4.5 DEFIBRILLATION-PROOF APPLIED PART protection
109	Figure 14 – Application of test voltage to bridged PATIENT CONNECTIONS (common mode) for DEFIBRILLATION-PROOF APPLIED PARTS
110	Figure 15 – Application of test voltage to individual PATIENT CONNECTIONS (differential mode) for DEFIBRILLATION-PROOF APPLIED PARTS
114	13.4.6 Energy reduction Figure 16 – Application of test voltage to testthe delivered defibrillation energy (energy reduction test)
116	13.4.7 EARTH LEAKAGE CURRENT Figure 17 – Example of a measuring device and its frequency characteristics
118	Figure 18 – Measuring circuit for the EARTH LEAKAGE CURRENTof CLASS I equipment, with or without APPLIED PARTS
120	13.4.8 TOUCH CURRENT
121	Figure 19 – Measuring circuit for the TOUCH CURRENT
122	13.4.9 PATIENT LEAKAGE CURRENT
123	Figure 20 – Measuring circuit for the PATIENT LEAKAGE CURRENTfrom the PATIENT CONNECTION to earth
124	Figure 21 – Measuring circuit for the total PATIENT LEAKAGE CURRENT with all PATIENT CONNECTIONS of allAPPLIED PARTS of the same type (TYPE B APPLIED PARTS, TYPE BF APPLIED PARTS or TYPE CF APPLIED PARTS)connected together
125	13.4.10 PATIENT LEAKAGE CURRENT with mains on F-TYPE APPLIED PART
126	Figure 22 – Measuring circuit for the PATIENT LEAKAGE CURRENT viathe PATIENT CONNECTION(S) of an F-TYPE APPLIED PART to earth causedby an external voltage on the PATIENT CONNECTION(S)
127	Figure 23 – Measuring circuit for the PATIENT LEAKAGE CURRENTfrom PATIENT CONNECTION(S) to earth caused by an external voltageon a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED
128	13.4.11 PATIENT LEAKAGE CURRENT with mains on SIP/SOP
129	Figure 24 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT CONNECTION(S) toearth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART
130	13.4.12 PATIENT AUXILIARY CURRENT
131	Figure 25 – Measuring circuit for the PATIENT AUXILIARY CURRENT
132	13.4.13 WORKING VOLTAGE measurement
134	13.4.14 Sound pressure level measurements
135	13.4.15 Hydrostatic pressure Figure 26 – Ratio between hydraulic test pressureand maximum permissible working pressure
137	13.4.16 X-radiation (ionizing radiation) measurement
138	13.4.17 Normal heating
141	13.4.18 Operation to a specified temperature
142	13.4.19 Identification of source of ignition Figure 27 – Spark ignition test apparatus
144	Figure 28 – Maximum allowable current I as a function of the maximum allowable voltage Umeasured in a purely resistive circuit in an OXYGEN RICH ENVIRONMENT Figure 29 – Maximum allowable voltage U as a function of the capacitance C measured in acapacitive circuit used in an OXYGEN RICH ENVIRONMENT
145	Figure 30 – Maximum allowable current I as a function of the inductance L measured in aninductive circuit in an OXYGEN RICH ENVIRONMENT
146	13.4.20 Interruption of power supply
147	13.4.21 Limited power circuit
148	13.4.22 Failures of THERMOSTATS
149	13.4.23 Impairment of cooling
150	13.4.24 Locking of moving parts
152	Table 11 – Allowable maximum temperatures for skin contactwith ME EQUIPMENT APPLIED PARTS Table 12 – Allowable maximum temperatures for ME EQUIPMENT partsthat are likely to be touched
153	Table 13 – Allowable maximum temperatures of parts Table 14 – Temperature limits of motor windings
154	Table 15 – Maximum motor winding steady-state temperature Table 16 – Maximum allowable temperatures of transformer windings under overload andshort-circuit conditions at 25 °C (± 5 °C) ambient temperature
155	13.4.25 Interruption or short circuit of motor capacitors
157	13.4.26 Motor running overload
159	13.4.27 Heating element overload
162	13.4.28 Rechargeable battery overcharge/discharge
164	13.4.29 Mains transformers
166	Table 17 – Test current for transformers
169	Annex A: Sequence of testing A.1 Sequence of testing (IEC 60601-1:1988)
170	A.2 Sequence of testing (IEC 60601-1:2005)
171	Annex B: Information typically required for product safety testing (Guide) B.1 Purpose B.2 Description B.3 Intended use environment B.4 Construction B.5 List of safety-related components and relevant approvals B.6 Test system B.7 Power B.8 Grounding B.9 Modes of operation; configurations
172	B.10 Failure modes B.11 Risk analysis according with ISO 14971 B.12 Software B.13 Auxiliary equipment B.14 Transformers and chokes
173	Annex C: Testing and measuring equipment Table C.1 – IEC 60601-1:1988+AMD1:1991 and AMD2:1995
175	Annex D: Suitable measuring supply circuits Figure D.1 – Measuring supply circuit with one side of the SUPPLY MAINS at approximatelyearth potential Figure D.2 – Measuring supply circuit with SUPPLY MAINSapproximately symmetrical to earth potential
178	Annex E: Preventive maintenance E.1 General E.2 Cleaning and disinfection E.3 Preventive maintenance checklist E.4 Operator checks
179	Annex F: Test probes
180	Figure F.1 – Standard test finger
181	Figure F.2 – Test hook Figure F.3 – Test pin
182	Figure F.4 – Ball-pressure test apparatus
183	Annex G: Index of tests (IEC 60601-1:2005 clauses order)
186	Annex H: Index of tests for an internally powered equipment – battery only – (IEC 60601-1:2005 clauses order)
188	Annex I: Index of tests (IEC 60601-1:2005 alphabetic order)
191	Annex J: Index of tests for an internally powered equipment – battery only – (IEC 60601-1:2005 alphabetic order)
193	Annex K: Production line tests K.1 Production-line dielectric voltage-withstand test
194	K.2 Production-line grounding-continuity test K.3 Production-line earth leakage current test K.4 Recommended features for specific test equipment K.4.1 Hipot test equipment
195	K.4.2 120 kΩ leakage impedance K.4.3 Leakage current test equipment
196	Annex L: Evaluation of the laboratory power source characteristics L.1 Purpose L.2 Application L.3 Definitions L.3.1 Definitions unique to this annex
197	L.3.2 Acronyms unique to this annex L.3.3 Equations unique to this annex
198	L.4 Testing Table L.1 – Method for testing a single phase laboratory power source
200	Form 1
201	Annex M: Traceability of calibrations and calibration intervals M.1 Purpose M.2 Traceability of calibrations M.3 Calibration intervals for test equipment requiring calibration
203	Annex N: Guidance for preparation, attachment, extension, use of thermocouples and acceptance of thermocouple wire N.1 General N.2 Preparation Figure N.1 – Thermocouple preparation N.3 Placement
204	N.4 Attachment Figure N.2 – Securing of thermocouples
205	Figure N.3 – Example of confinement of a thermocouple
206	N.5 Extension Figure N.4 – Example where thermocouple connectors need not be used N.6 Use N.7 Acceptance of thermocouples wire
207	Annex O: Guideline for safe laboratory work O.1 basic safety guidelines for working with test instruments
209	O.2 Basic guidelines for performing safety tests
210	O.3 Basic guidelines regarding test personnel and test areas
212	O.4 Contents of a documented safe environment for working in a testing laboratory
213	Bibliography
214	Index of defined terms

Published By	Publication Date	Number of Pages
AAMI	2015	217


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Standard Title	AAMI/IEC TIR62354:2015 – General testing procedures for medical electrical equipment
Published Code	AAMI
Publication Date	2015
Pages Count	217