This Technical Report contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the second edition of IEC 60601-1. This Technical Report is primarily intended to be used by manufacturers of MEDICAL ELECTRICAL EQUIPMENT; test houses and others responsible for assessment of compliance with IEC 60601-1; and those developing subsequent editions of IEC 60601-1. The object of this Technical Report is to make the recommendations/interpretations developed by the experts in IEC/SC 62A/WG 14 available to those interested in the application of the second edition of IEC 60601-1.

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1	ANSI/AAMI/IEC TIR62296:2009, Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
3	Title page
4	Copyright information
5	AAMI Technical Information Report ANSI Technical Report
6	CONTENTS
8	Glossary of equivalent standards
10	Committee representation
11	Background of ANSI/AAMI adoption of IEC/TR 62296:2009
12	FOREWORD
14	INTRODUCTION
15	1 Scope and object 1.1 Scope 1.2 Object
16	2 Recommendations 2.1 Summary of all recommendations prepared by SC 62A/WG 14
18	2.2 Recommendation sheets 2.2.1 Separation: Reliability of component impedance
20	2.2.2 Separation: Non-complying creepage distance and air clearances
21	2.2.3 Mains supply transformers: Overload test
22	2.2.4 Mains supply transformers: Short circuit and overload tests
23	2.2.5 Creepage distance and air clearances: Values
24	2.2.6 Dielectric strength
25	2.2.7 Failure of components: Evidence of reliability
26	2.2.8 ENCLOSURES and protective covers
27	2.2.9 INTERNALLY POWERED EQUIPMENT: 110 % of the maximum supply voltage
28	2.2.10 Creepage distances and air clearances: Values under 1 mm
29	2.2.11 Separation: Secondary circuit impedance limit LEAKAGE CURRENT
30	2.2.12 ENCLOSURES and PROTECTIVE COVERS: Lampholder/switching device
31	2.2.13 Fixing, prevention of maladjustment: Torque test
32	2.2.14 Batteries not intended to be changed by OPERATOR: Lithium batteries
33	2.2.15 Excessive temperatures: Ambient temperatures
34	2.2.16 Continuous LEAKAGE CURRENTS: Different SUPPLY MAINS
35	2.2.17 ENCLOSURE and protective covers: EQUIPMENT in ambulances
36	2.2.18 Dielectric strength: Voltages appearing from external sources
37	2.2.19 Testing switch mode power supply units (SMPSU)
39	2.2.20 Failure of an electrical component: Time periodicity for detection
40	2.2.21 Environmental conditions: Compliance paragraph
41	2.2.22 Limitation of voltage and/or energy: Capacitance
42	2.2.23 LEAKAGE CURRENTS: Presence of 45 kΩ resistor in Figure 21
43	2.2.24 Humidity preconditioning treatment: Exception from requirement
44	2.2.25 Dielectric strength: EQUIPMENT containing floating circuits
45	2.2.26 General requirements for tests: Measurement uncertainty
46	2.2.27 CREEPAGE DISTANCES and AIR CLEARANCES: Interpolated values
47	2.2.28 Overheating: Change of load resistance
48	2.2.29 Mains operated EQUIPMENT with additional power source: Integrity of externalprotective earth
49	2.2.30 Rechargeable batteries: No OPERATOR/USER maintenance
50	2.2.31 Isolation from the SUPPLY MAINS: Symbol for single pole switch
51	2.2.32 Sequence of testing: Clause 52 before Clause 19
52	2.2.33 SINGLE FAULT CONDITION: ENCLOSURE LEAKAGE CURRENT from INTERNALLY POWEREDEQUIPMENT
53	2.2.34 Marking on the outside of EQUIPMENT: Type and rating of fuses
54	2.2.35 Excessive temperatures: APPLIED PARTS not intended to supply heat
55	2.2.36 Mains supply transformers: Use of PTCs as protective devices
56	2.2.37 Components and general assembly: Reliability of components
57	2.2.38 Definition of APPLIED PART: EQUIPMENT worn by PATIENTS
58	2.2.39 Construction: Triple insulated winding wire
59	2.2.40 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test versus CREEPAGEDISTANCES and AIR CLEARANCES
60	2.2.41 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test versus CREEPAGEDISTANCES and AIR CLEARANCES – POWER SUPPLY CORDS
61	2.2.42 ACCOMPANYING DOCUMENTS: on CD-ROM or electronic file format
62	2.2.43 INTERNAL ELECTRICAL POWER SOURCE: Requirements for lithium batteries
63	2.2.44 Dielectric strength: Differences between B-d and B-e
64	2.2.45 Excessive temperatures: Thermocouple instead of resistance method
65	2.2.46 Mains fuses and OVER-CURRENT RELEASEs: Fuses in CLASS II EQUIPMENT
66	2.2.47 Plug in power supply
67	2.2.48 Connecting cords between EQUIPMENT parts: Other applications
68	2.2.49 MULTIPLE PORTABLE SOCKET-OUTLET
69	2.2.50 Separation, DEFIBRILLATION-PROOF APPLIED PART: multiple APPLIED PARTS
70	2.2.51 Separation, APPLIED PART: Hand held flexible shafts
71	2.2.52 Protective earthing: No-load voltage of 6 V maximum
72	2.2.53 Foot-operated control devices: Protection against entry of liquids
73	2.2.54 Mains supply transformers
74	2.2.55 Dielectric strength: Reliability of components to bridge A-a2 and B-a
75	2.2.56 Dielectric strength: A-e in switch mode power supply units (SMPSU)
76	2.2.57 Dielectric strength: Connection of 12 V dc negative side to enclosure
77	2.2.58 Dielectric strength: Voltages appearing on SIP/SOP
78	2.2.59 APPLIED PART: EQUIPMENT without APPLIED PART
79	2.2.60 Scope: Other than MEDICAL ELECTRICAL EQUIPMENT in contact with the body of aperson
80	2.2.61 Markings: AC symbol
81	2.2.62 Interruption of power supply: Characteristics of interruption
82	2.2.63 Reference voltage: Different reference voltages in the same circuit
83	Bibliography
85	Index of Terms

Published By	Publication Date	Number of Pages
AAMI	2009	86


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Standard Title	AAMI/IEC TIR62296:2009 – Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements
Published Code	AAMI
Publication Date	2009
Pages Count	86

AAMI TIR62296 2009

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