IEC TR 62296:2003

Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements

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 equippment; - test houses and others responsible for assessment of compliance with IEC 60601-1, and - those developing subsequent editions of IEC 60601-1. The recommendations in the first edition of IEC/TR 62296 have been considered in preparing the third edition of IEC 60601-1. If and when additional recommendations are developed by IEC/SC 62A/WG 14 and published as amendments to this technical report, these will also be considered for incorporation into the third edition through the amendment/revision process.

General Information

• Status: Published
• Publication Date: 17-Mar-2003
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 22-Jan-2009

Relations

• Revised: IEC TR 62296:2009 - Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
• Effective Date: 05-Sep-2023

Standards Content (Sample)

TECHNICAL IEC
REPORT
TR 62296
First edition
2003-03
Considerations of unaddressed safety aspects
in the Second Edition of IEC 60601-1
and proposals for new requirements
Etudes des aspects de sécurité non énoncés
dans la seconde édition de la CEI 60601-1
et propositions de nouvelles prescriptions

Reference number
IEC/TR 62296:2003(E)
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the

60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.

Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,

edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the

base publication incorporating amendment 1 and the base publication incorporating

amendments 1 and 2.
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thus ensuring that the content reflects current technology. Information relating to
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TECHNICAL IEC
REPORT
TR 62296
First edition
2003-03
Considerations of unaddressed safety aspects
in the Second Edition of IEC 60601-1
and proposals for new requirements
Etudes des aspects de sécurité non énoncés
dans la seconde édition de la CEI 60601-1
et propositions de nouvelles prescriptions

 IEC 2003  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail]  Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale
XB
International Electrotechnical Commission
Международная Электротехническая Комиссия
For price, see current catalogue

– 2 – TR 62296  IEC:2003(E)
CONTENTS
FOREWORD . 4

INTRODUCTION .5

1 Scope and object . 6

1.1 Scope . 6

1.2 Object. 6

2 Recommendations . 6

2.1 Summary of all recommendations prepared by SC 62A/WG 14 . 6
2.2 Recommendation sheets. 9
2.2.1 Separation: Reliability of component impedance . 9
2.2.2 Separation: Non-complying CREEPAGE DISTANCE and AIR CLEARANCES .10
2.2.3 Mains supply transformers: Overload test .11
2.2.4 Mains supply transformers: Short circuit and overload tests .12
2.2.5 CREEPAGE DISTANCE and AIR CLEARANCES: Values.13
2.2.6 Dielectric strength.14
2.2.7 Failure of components: Evidence of reliability .15
2.2.8 ENCLOSURES and protective covers .16
2.2.9 INTERNALLY POWERED EQUIPMENT: 110 % of the maximum supply voltage.17
2.2.10 CREEPAGE DISTANCES and AIR CLEARANCES: Values under 1 mm .18
2.2.11 Separation: Secondary circuit impedance limit LEAKAGE CURRENT .19
2.2.12 ENCLOSURES and PROTECTIVE COVERS: Lampholder/switching device .20
2.2.13 Fixing, prevention of maladjustment: Torque test .21
2.2.14 Batteries not intended to be changed by OPERATOR: Lithium batteries .22
2.2.15 Excessive temperatures: Ambient temperatures.23
2.2.16 Continuous LEAKAGE CURRENTS: Different SUPPLY MAINS.24
2.2.17 ENCLOSURE and protective covers: EQUIPMENT in ambulances .25
2.2.18 Dielectric strength: Voltages appearing from external sources .26
2.2.19 Testing switch mode power supply units (SMPSU) .27
2.2.20 Failure of an electrical component: Time periodicity for detection.29
2.2.21 Environmental conditions: Compliance paragraph .30
2.2.22 Limitation of voltage and/or energy: Capacitance .31
2.2.23 LEAKAGE CURRENTS: Presence of 45 kΩ resistor in Figure 21.32

2.2.24 Humidity preconditioning treatment: Exception from requirement .33
2.2.25 Dielectric strength: EQUIPMENT containing floating circuits.34
2.2.26 General requirements for tests: Measurement uncertainty.35
2.2.27 CREEPAGE DISTANCES and AIR CLEARANCES: Interpolated values .36
2.2.28 Overheating: Change of load resistance.37
2.2.29 Mains operated EQUIPMENT with additional power source: Integrity of
external protective earth .38
2.2.30 Rechargeable batteries: No OPERATOR/USER maintenance.39
2.2.31 Isolation from the SUPPLY MAINS: Symbol for single pole switch .40
2.2.32 Sequence of testing: Clause 52 before Clause 19 .41
2.2.33 SINGLE FAULT CONDITION: ENCLOSURE LEAKAGE CURRENT from
INTERNALLY POWERED EQUIPMENT.42
2.2.34 Marking on the outside of EQUIPMENT: Type and rating of fuses.43
2.2.35 Excessive temperatures: APPLIED PARTS not intended to supply heat.44

TR 62296  IEC:2003(E) – 3 –
2.2.36 Mains supply transformers: Use of PTCs as protective devices.45

2.2.37 Components and general assembly: Reliability of components.46

2.2.38 Definition of APPLIED PART: EQUIPMENT worn by PATIENTS.47

2.2.39 Construction: Triple insulated winding wire .48

2.2.40 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test

versus CREEPAGE DISTANCES and AIR CLEARANCES.49

2.2.41 Cord anchorages/ Cord guards: In mobile unit with APPLIANCE

COUPLER.50

2.2.42 ACCOMPANYING DOCUMENTS: on CD-ROM or Electronic File Format .51

2.2.43 INTERNAL ELECTRICAL POWER SOURCE: Requirements for lithium

batteries .52
2.2.44 Dielectric strength: Differences between B-d and B-e.53
2.2.45 Excessive temperatures: Thermocouple instead of resistance method .54
2.2.46 Mains fuses and OVER-CURRENT RELEASEs: Fuses in CLASS II
EQUIPMENT .55
2.2.47 Plug top power supply.56
2.2.48 Connecting cords between EQUIPMENT parts: Other applications .57
2.2.49 MULTIPLE PORTABLE SOCKET-OUTLET .58
2.2.50 Separation, DEFIBRILLATION-PROOF APPLIED PART: multiple APPLIED
PARTS.59
2.2.51 Separation, APPLIED PART: Hand held flexible shafts .60
2.2.52 Protective earthing: No-load voltage of 6 V maximum .61
2.2.53 Foot-operated control devices: Protection against entry of liquids .62
2.2.54 Mains supply transformers .63
2.2.55 Dielectric strength: Reliability of components to bridge A-a and B-a .64
2.2.56 Dielectric strength: A-e in switch mode power supply units (SMPSU) .65
Bibliography.66
Index of defined terms.67

– 4 – TR 62296  IEC:2003(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
CONSIDERATIONS OF UNADDRESSED SAFETY ASPECTS

IN THE SECOND EDITION OF IEC 60601-1 AND

PROPOSALS FOR NEW REQUIREMENTS

FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International
Organization for Standardization (ISO) in accordance with conditions determined by agreement between the
two organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this technical report may be the subject of
patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
The main task of IEC technical committees is to prepare International Standards. However,
a technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example “state of the art”.
IEC 62296, which is a technical report, has been prepared by subcommittee 62A: Common
aspects of electrical equipment used in medical practice, of IEC technical committee 62:
Electrical equipment in medical practice.
The text of this technical report is based on the following documents:

Enquiry draft Report on voting
62A/398/CDV 62A/414/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
The committee has decided that the contents of this publication will remain unchanged
until 2005. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
TR 62296  IEC:2003(E) – 5 –
INTRODUCTION
At the Sydney meeting in August 1994, IEC subcommittee (SC) 62A established a procedure

under which working group (WG) 14 would develop recommendations regarding problems of

interpretation or application of IEC 60601-1. WG 14 is made up of experts with particular

expertise in testing according to the requirements of IEC 60601-1. Many of the experts on

WG 14 are employed by test houses with a long history of applying IEC 60601-1 to MEDICAL

ELECTRICAL EQUIPMENT. While the National Committee members of SC 62A nominate these

experts, their recommendations were not to be formally adopted through any official voting

procedure. To reinforce this process, the Subcommittee specifically directed that the

following note appear on every page of the resulting informational circular:

IMPORTANT NOTE:
...