gap analysis between the second and third editions of iec ... · iec 60601-1 3rd edition cancels...

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)

S e p t 2 0 1 2

Gap Analysis between the second and third editions of IEC 60601-1 | Sept 2012

© 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.

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



3

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

IEC 60601-1, viz., 2nd

and 3rd

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.



4

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



5

Market Trends/Challenges

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.

IEC 60601-1 3rd

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

60601-1 needs to comply with this 3rd

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.

“… the speed of upgrade to the

higher version of the standard

will make a huge difference

commercially”



6

Solution

As we know IEC 60601-1 3rd

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

EQUIPMENT

Electrical and

Mechanical

17 Electromagnetic compatibility of ME

EQUIPMENT and ME SYSTEMS Electromagnetic

“…the gaps can be closed

through re-inspecting the

device, updating the IFU

documents, Risk management

file and by performing

verification testing.”



7

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

Phrase

Gap with respect to previous edition

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 2nd

edition, 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;



8

Clause Standard Phrase Applicability Justification

9.3 HAZARD associated

with surfaces, corners

and edges

Yes Hazard with respect to user

interface need to be removed

from the system

9.8.3 Strength of patient or

operator support or

suspension systems

No There is no patient support

feature directly attached with this

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

standards are referred IEC 60601-1: 2005, 3rd

edition, Technical

report TR 62348: 2006-05, 1st edition and UL 60601-1: 2003 2

nd

edition. See Fig.1



9

Mechanical Gap Analysis on IEC 60601-1 3rd

edition (US

market)

Fig 1: Process flowchart



10

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.

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.

“…bridging the gap can be

done with 100% perfection by

adopting our technique, which

is easy, time saving and highly

effective”



11

Common Issues

Applicability of the proposed solution needs to be verified with

experts with the needed expertise.

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.

“….needs careful evaluation

and testing by experts before

clearing the product for

compliance”



12

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.

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.

“…our method simplifies the

entire process”



13

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.

Hello, I’m from HCL’s Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers.

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About HCL

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