IEC TR 62348:2012

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

IEC/TR 62348:2012(E) which is a technical report, provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012. This technical report also provides a tool to assist users of IEC 60601-1 to trace requirements between the third edition and their source in the documents that form the basis of the third edition; principally the second edition as amended. This report is intended to be used by:
- those who must align standards based on the second edition of IEC 60601-1 with the third edition as amended;
- manufacturers of medical electrical equipment or medical electrical systems; and
- health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems. This second edition cancels and replaces the first edition published in 2006. The second edition retains the mapping that traces the requirements of IEC 60601-1:2005 and its Amendment A1:2012 (Edition 3.1) from their source in the documents that relate to IEC 60601-1:1998 and its amendments (Edition 2.2). The second edition adds an assessment of the impact of the most significant changes in Amendment 1:2012.

General Information

• Status: Published
• Publication Date: 11-Dec-2012
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JMT 1 - TC 62/SC 62A/JMT 1
• Current Stage: PPUB - Publication issued
• Start Date: 15-Mar-2013
• Completion Date: 12-Dec-2012

Relations

• Revises: IEC TR 62348:2006 - Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended <a href ="http://www.iec.ch/webstore/freepubs/iec62348{ed1.0}b.pdf">FREE DOWNLOAD</a>
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC/TR 62348 ®
Edition 2.0 2012-12
TECHNICAL
REPORT
colour
inside
Assessment of the impact of the most significant changes in Amendment 1 to
IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the
previous edition
IEC/TR 62348:2012(E)
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IEC/TR 62348 ®
Edition 2.0 2012-12
TECHNICAL
REPORT
colour
inside
Assessment of the impact of the most significant changes in Amendment 1 to

IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the

previous edition
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XD
ICS 11.040 ISBN 978-2-83220-548-8

– 2 – TR 62348 © IEC:2012(E)
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 9
4 Assessment of the changes in Amendment 1:2012 . 9
5 Changes impacting many users of the standard . 13
5.1 Updated normative references (Clause 2) [Moderate impact] . 13
5.2 Definition and rationale for EXPECTED SERVICE LIFE (Definition 3.28 and
rationale for 4.4) [Moderate impact] . 13
5.3 Restructuring of RISK MANAGEMENT (Subclause 4.2) [Significant impact] . 13
5.4 Application of ESSENTIAL PERFORMANCE (Subclause 4.3) [Significant impact] . 13
5.5 Revision to the concept of equivalent safety (Subclause 4.5) [Significant
impact] . 14
5.6 Requirements for parts that contact the PATIENT (Subclause 4.6) [Significant
impact] . 14
5.7 Steady-state measurement of input of the ME EQUIPMENT or ME SYSTEM
(Subclause 4.11) [Moderate impact] . 14
5.8 Simultaneous fault testing (Subclause 5.1) [Moderate impact] . 14
5.9 SUPPLY MAINS test characteristics (Subclause 5.5 a)) [Significant impact] . 15
5.10 Humidity preconditioning (Subclause 5.7) [Significant impact] . 15
5.11 Actuating mechanisms (Subclause 5.9.2.3) [Moderate impact] . 15
5.12 Legibility of markings (Subclause 7.1.2) [Moderate impact] . 15
5.13 Identification of ME EQUIPMENT, parts and ACCESSORIES (Subclauses 7.2.1
and 7.2.4) [Significant impact] . 15
5.14 Marking of fuses, THERMAL CUT-OUTS and OVER-CURRENT RELEASES
(Subclause 7.3.4) [Moderate impact] . 15
5.15 Marking of stand-by control (Subclause 7.4.2) [Moderate impact] . 15
5.16 Use of safety signs (Subclause 7.5) [Moderate impact] . 16
5.17 General requirements for ACCOMPANYING DOCUMENTS (Subclause 7.9.1)
[Significant impact] . 16
5.18 Disposal of waste (Subclause 7.9.2.15) [Moderate impact] . 16
5.19 Unique version identification (Subclauses 7.9.2.19 and 7.9.3.1) [Moderate
impact] . 16
5.20 Disclosure of ESSENTIAL PERFORMANCE (Subclause 7.9.3.1) [Significant
impact] . 16
5.21 Change to the fundamental rule of protection against electric shock
(Subclause 8.1 b)) [Moderate impact] . 16
5.22 Use of Y capacitors as a MEANS OF PROTECTION (Subclauses 8.5.1.2 and
8.5.1.3) [Moderate impact] . 16
5.23 Requirements for impedance and current-carrying capabilities (Subclause
8.6.4) [Moderate impact] . 17
5.24 Allowable values of LEAKAGE CURRENTS that can flow in a FUNCTIONAL EARTH
CONDUCTOR (Subclause 8.7.3) [Substantial impact] . 17
5.25 Measurement of the EARTH LEAKAGE CURRENT and current in functional earth
connection (Subclause 8.7.4.5) [Moderate impact] . 17
5.26 Clarification of the insulation to be tested (Subclause 8.8.1) [Significant
impact] . 17

TR 62348 © IEC:2012(E) – 3 –
5.27 Spacing for one MEANS OF OPERATOR PROTECTION for a WORKING VOLTAGE of
25 V r.m.s. (Table 16) [Moderate impact] . 17
5.28 Measurement of CREEPAGE DISTANCES AND AIR CLEARANCES (Subclause 8.9.4)
[Moderate impact]. 17
5.29 Spillage on ME EQUIPMENT and ME SYSTEMS (Subclause 11.6.3) [Moderate
impact] . 17
5.30 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS (Subclause
11.6.6) [Moderate impact] . 18
5.31 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT or
ME SYSTEM (Subclauses 11.8 and 16.8) [Significant impact] . 18
5.32 Emissions, deformation of ENCLOSURE or exceeding maximum temperature
(Subclause 13.1.2) [Significant impact] . 18
5.33 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) (Subclause 14.1)
[Moderate impact]. 18
5.34 Design and implementation (Subclause 14.9) [Moderate impact] . 18
5.35 PEMS VALIDATION (Subclause 14.11) [Moderate impact] . 18
5.36 Mechanical strength (Subclause 15.3.1) [Moderate impact] . 18
5.37 Actuating parts of controls of ME EQUIPMENT (Subclause 15.4.6.1 b)
[Moderate impact]. 19
5.38 Limitation of movement (Subclause 15.4.6.2) [Moderate impact] . 19
5.39 Transformers (Subclause 15.5.1.1) [Moderate impact] . 19
5.40 Overload test (Subclause 15.5.1.3) [Moderate impact] . 19
5.41 Dielectric strength (Subclause 15.5.2) [Moderate impact] . 19
5.42 Construction of transformers used to provide separation as required by 8.5
(Subclause 15.5.3) [Significant impact] . 19
5.43 Resistors bridging a MEANS OF PROTECTION (Rationale for Subclause 4.8)
[Moderate impact]. 19
6 Changes impacting particular users of the standard . 20
6.1 ME EQUIPMENT intended to receive power from other equipment (Subclause
7.2.5) [Significant impact] . 20
6.2 ME EQUIPMENT or ACCESSORIES supplied sterile (Subclauses 7.2.17 and
7.9.2.18) [Moderate impact] . 20
6.3 ME EQUIPMENT supplied from an external pressure source (Subclause 7.2.18)
[Moderate impact]. 20
6.4 Mass of MOBILE ME EQUIPMENT (Subclause 7.2.21) [Significant impact] . 20
6.5 General requirements for the instructions for use when the PATIENT is an
OPERATOR (Subclause 7.9.2.1) [Moderate impact] . 20
6.6 ME EQUIPMENT emitting radiation (Subclause 7.9.2.17) [Moderate impact] . 20
6.7 ME EQUIPMENT with DEFIBRILLATION-PROOF APPLIED PARTS (Subclause 8.5.5.1
a)) [Significant impact] . 21
6.8 Energy reduction test for ME EQUIPMENT with DEFIBRILLATION-PROOF APPLIED
PARTS (Subclause 8.5.5.2) [Significant impact] . 21
6.9 Measurement of LEAKAGE CURRENT for sterile equipment (Subclause 8.7.1 b))
[Moderate impact]. 21
6.10 Isolation of PERMANENTLY INSTALLED ME EQUIPMENT from the SUPPLY MAINS
(Subclause 8.11.1) [Moderate impact] . 21
6.11 Protective measures (Subclause 9.2.2.4.4) [Moderate impact] . 21
6.12 Continuous activation (Subclause 9.2.2.5) [Moderate impact] . 22
6.13 Speed of movement(s) (Subclause 9.2.2.6) [Moderate impact] . 22
6.14 Unintended movement (Subclause 9.2.3.1) [Significant impact] . 22
6.15 Overtravel end stops (subclause 9.2.3.2) [Moderate impact] . 22
6.16 Overbalancing from horizontal and vertical forces (Subclause 9.4.2.3 a))
[Significant impact] . 22

– 4 – TR 62348 © IEC:2012(E)
6.17 Movement over a threshold (Subclause 9.4.2.4.3) [Significant impact] . 22
6.18 Instability of MOBILE ME EQUIPMENT in transport position (Subclause
9.4.3.1 c)) [Moderate impact] . 22
6.19 Instability of MOBILE ME EQUIPMENT on an incline surface and in other than
transport position (Subclause 9.4.3.2 a)) [Moderate impact] . 22
6.20 Instability of MOBILE ME EQUIPMENT from lateral forces in other than transport
position (Subclause 9.4.3.2 b)) [Significant impact] . 22
6.21 Acoustic energy and vibration (Subclause 9.6.1) [Moderate impact] . 22
6.22 Audible acoustic energy measurements (Subclause 9.6.2.1) [Moderate
impact] . 23
6.23 Static forces due to loading from persons (Subclause 9.8.3.2) [Moderate
impact] . 23
6.24 Dynamic forces due to loading from persons (Subclause 9.8.3.3) [Moderate
impact] . 23
6.25 ME EQUIPMENT not intended to produce diagnostic or therapeutic X-radiation
(Subclause 10.
...