Gap Analysis Between the Second and
Third Editions of IEC 60601-1
(IEC 60601-1; Medical Electrical Equipment Part 1: General
Requirements for Basic Safety and Essential Performance)
Sept 2012
Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
TABLE OF CONTENTS
Abstract ............................................................................................. 3
Abbreviations .................................................................................... 4
Market Trends/Challenges ................................................................ 5
Solution ............................................................................................. 6
Best Practices ................................................................................. 10
Common Issues .............................................................................. 11
Conclusion....................................................................................... 12
References ...................................................................................... 13
Author Info ....................................................................................... 13
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Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
Abstract
The International Electrotechnical Commission (IEC) is a worldwide
organization
for
standardization
comprising
all
national
electrotechnical committees. International standard IEC 60601-1
has been prepared by subcommittee 62A, common aspects of
electrical equipment used in medical practice. The third edition of
the standard was published in 2005, and this cancels and replaces
the second edition published in 1988.
This standard IEC 60601-1, 3rd edition, applies to the basic safety
and
essential
performance
of
MEDICAL
ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. Few new
clauses have been introduced, and amendments have been made
to some of the existing clauses. For instance, under Clause 9,
subclause 9.2.2.4 dealing with GUARDS and protective measures
has been newly introduced in the third edition. At the same time,
subclause 9.4.2.2 in the third edition “Instability excluding transport”
has been amended by modifying subclauses 24.1, 24.3 c), 24.3,
24.3 Indent 1 and 24.3 Indent 2 from the second edition of IEC
60601-1.
This Whitepaper focuses on the gaps between the two editions of
nd
rd
IEC 60601-1, viz., 2 and 3 editions which affect the Mechanical,
Electrical and Electromechanical standards of any medical devices.
This paper provides an approach to close the gaps which exist
between the above said editions of IEC 60601-1.
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3
Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
Abbreviations
Sl.
No.
Acronyms
Full Form
1
IEC
International Electrotechnical Commission
2
IFU
Instruction For Use
3
UL
Underwriters Laboratories Inc
4
TR
Technical Report
5
ISO
International Organization for
Standardization
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4
Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
Market Trends/Challenges
“… the speed of upgrade to the
higher version of the standard
will make a huge difference
commercially”
Medical devices need to comply with certain standards to ensure
safety of the patients and other users. IEC 60601-1 establishes the
standard with respect to basic safety and essential performance. As
the technology evolves, there have been considerable changes
happening in the medical device industry. In order to ensure that the
standards do not become outdated due to technology and market
changes, they have been upgraded based on post-market studies,
case studies, market risk, product failure, etc.
rd
IEC 60601-1 3 edition cancels and replaces the second edition
published in 1988, its Amendment 1 (1991) and Amendment 2
(1995). In the market, any product requiring compliance with IEC
rd
60601-1 needs to comply with this 3 edition of IEC 60601-1. As
many clauses have either been changed, updated or added, it is not
a simple task for a device which was previously compliant to the
second edition to claim compliance to the third edition.
In the current market trend, it is obvious that for a product to
successfully withstand and overcome competition, the speed of
upgrading to the higher version of the standard will make a huge
difference commercially.
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Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
Solution
rd
“…the gaps can be closed
through re-inspecting the
device, updating the IFU
documents, Risk management
file and by performing
verification testing.”
As we know IEC 60601-1 3 edition cancels and replaces the
second edition published in 1988, its Amendment 1 (1991) and
Amendment 2 (1995). HCL Technologies has derived an approach
for finding the gaps in the clauses between the two versions of the
standard. This process has different stages, viz. understanding,
categorization, clause comparisons between editions of standard,
actual gaps, applicability, compliance check, and the efforts to
bridge the gaps.
Understanding
A clear understanding of the product and its functions is required
before attempting to ensure its compliance with any standard. This
will speed up the analytical process and enhance the clarity of the
final decision while doing the actual gap analysis.
For example, Clause 9.4.2.4 IEC 60601-1 Third Edition states,
“Casters and Wheels.” If the researcher is familiar with the product,
he can identify whether there are casters and wheels in the system
and easily make a decision.
Categorization
Categorization separates the clauses with respect to their
properties, like mechanical, electrical and electromagnetic. Some of
the clauses belong to both mechanical and electrical categories.
Once the system is well understood and categorized properly, the
researcher can focus on the specific needs of compliance and
proceed further.
For example, a few clauses from IEC 60601-1 Third Edition have
been shown below indicating their categorization:
Clause
Standard Phrase
Category
7.7
Colours of the insulation of conductors
Electrical
9.4.2.3
Instability from horizontal and vertical forces
Mechanical
15.1
Arrangements of controls and indicators of ME
Electrical and
EQUIPMENT
Mechanical
17
Electromagnetic compatibility of ME
EQUIPMENT and ME SYSTEMS
Electromagnetic
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Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
Clause comparisons between editions of standard
The important step toward ensuring product compliance with the
new edition of the standard is a comparison of the clauses between
the two editions. This will reflect the changes in the same clause
between the editions of the standard. This could be the same, an
amendment or introduction of a new clause.
For example, a few clauses from IEC 60601-1 Third Edition have
been shown below indicating their comparison:
Clause
Standard Phrase
Comparisons
7.2.15
Cooling conditions
Same
7.2.16
Mechanical stability
Amended
7.2.18
External pressure source
New clause introduced in the 3rd edition
Gaps
As we compare the clauses across the editions, the gaps become
obvious and clear. This step will provide a clear understanding of
the gaps and the area to be focused.
For example,
Clause
Standard
Gap with respect to previous edition
Phrase
5.9.2.1
Test finger
1) Testing mass changed from 40kg to 45kg in 3rd edition
2) Tolerances on the test finger changed in 3rd edition
(Eg: Tolerance for linear dimension above 25mm is ±0.2
in 2ndedition, but ±0.3 in 3rd edition)
Applicability
The above topics are common to all categories of clauses, like
mechanical, electrical and electromagnetic. Now this stage is
project-specific. For example, if a mechanical engineer wants to find
the mechanical gaps of his device, he can use only the mechanical
clause as applicable.
For example, if applicability checking is done against a Cryocare
system;
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Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
Clause
9.3
9.8.3
Standard Phrase
HAZARD associated
Applicability
Yes
Justification
Hazard with respect to user
with surfaces, corners
interface need to be removed
and edges
from the system
Strength of patient or
No
There is no patient support
operator support or
feature directly attached with this
suspension systems
system
Compliance check
This is a critical stage and needs expert knowledge in the relevant
area to check and ensure product compliance. This can be done
through inspecting the device, validation and verification of all
parameters mentioned in the relevant clause, verifying the clause
with respect to existing IFU documents and the risk management
file and doing formal testing.
Effort to bridge the gaps
If the product fails to comply with the standard in the previous stage,
i.e., compliance check, it has to go through the next crucial stage,
viz., bridging the gaps. This section basically covers the mitigation
needed to close the gaps. After the necessary design modifications
are carried out in the device with respect to the mitigation plan, the
gaps can be closed through re-inspecting the device, updating the
IFU documents, risk management file and by performing verification
testing.
For example, process of doing mechanical gap analysis is shown
below:
Mechanical Gap Analysis (US market)
Mechanical Gap Analysis: the process of finding the gaps in
mechanical properties between the second and third editions of
each clause of IEC 60601-1 standard. Some clauses belong to only
mechanical and some clauses pertain to mechanical as well as
electrical properties. For completing this gap analysis, the following
rd
standards are referred IEC 60601-1: 2005, 3 edition, Technical
st
nd
report TR 62348: 2006-05, 1 edition and UL 60601-1: 2003 2
edition. See Fig.1
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Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
rd
Mechanical Gap Analysis on IEC 60601-1 3
market)
edition (US
Fig 1: Process flowchart
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Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
Best Practices
The process of adopting the third edition of IEC 60601-1 is gaining
importance now in the market. Each manufacturer has begun to
adopt his own technique to comply with the third edition of the
standard. HCL Technologies has developed a unique process,
checklist and template to ensure product compliance with respect to
medical safety and essential performance.
“…bridging the gap can be
done with 100% perfection by
adopting our technique, which
is easy, time saving and highly
effective”
This process of bridging the gap can be done with 100% perfection
by adopting our technique, which is easy, time saving and highly
effective.
As the new edition contains existing clauses, amended and new
clauses, this technique will help in identification and ensuring
compliance for different products.
In this process, most of the steps are common for different products.
Hence, we can use the same process sheet for checking the
compliance of different products which are required to comply with
this standard.
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Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
Common Issues
Applicability of the proposed solution needs to be verified with
experts with the needed expertise.
“….needs careful evaluation
and testing by experts before
clearing the product for
compliance”
While making efforts to close the gaps inspection, testing and
documentation of the processes are mandatory. The process needs
experts in each area to visualize and verify the problem and find
suitable means for compliance with the standard.
In order to comply with the IEC 60601-1 standard, a device needs to
comply with other standards as well. For instance, clause 7.2.17
“Protective Packaging” requires ISO 780 and ISO 15223
compliance.
The major issue here is design modification, if required. Sometimes
it will lead to redesign the product entirely. After making design
modifications for compliance, the entire process should be verified
and validated. The challenge here is the cost required to carry out
the needed modifications.
Another challenging area is the compliance of interface devices.
Sometimes, to make a decision, more than one expert may be
required. There may be new unexpected changes in the properties
of the device while carrying out changes in the interface unit. This
needs careful evaluation and testing by experts before clearing the
product for compliance.
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Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
Conclusion
The process outlined above envisages an efficient and simple way
for any product to comply with the third edition of IEC 60601-1.
Though there are different methods available in the market, our
method simplifies the entire process. It is time saving and
economical. This process has already been successfully
implemented for a few products where gap analysis has been done.
“…our method simplifies the
entire process”
Because HCL Technologies has vast experience in the medical
domain, and is knowledgeable about multiple standards, including
medical safety standards, and has good infrastructure for design
verification and validation, there is no doubt that HCL can provide
the support necessary to complete better gap analysis projects.
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Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012
References
1. IEC 60601-1 : 2005 3rd Edition .,Medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance
2. UL 60601-1 : 2003 Medical Electrical Equipment, Part 1:
General requirements for Safety
3. TR 62348 :2006-05 Mapping between the clauses of the
third edition of IEC 60601-1 and the 1988 edition as
amended
4. ISO780:1997 ; Packaging -- Pictorial marking for handling of
goods
Author Info
Mr. Bhen Jose is a Mechanical Engineer with
Masters in CAD and has 11 years of experience
in various domains like Medical, Automobile and
Heavy machinery. He is presently working as a
Senior Technical Lead in HCL Technologies
Ltd, Chennai.
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