3rd Edition 60601 1web Version

LNE / G-MED North America presents
IEC 60601-1 (Third Edition):

Prepare for Regulatory Questions presented by
Christophe Morellec Manager, Electrical Safety Activity, LNE Sebastien Hardy Manager, Active and External Use Medical Devices, LNE/G-MED
IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com
Presenter Bios / Contact Information

Christophe Morellec
Manager, Electrical Safety Activity, LNE
An experienced auditor and technical expert, Christophe led the implementation of the original electrical safety standard (IEC 60601-1) during his five years at LCIE the federal agency overseeing electrical industry testing in France.Now with LNE, Christophe regularly oversees testing for medical devices to the 60601-1 standard.
Sebastien Hardy
Manager, Active and External Use Medical Devices, LNE/G-MED
As Certification Project Manager, Sebastien has worked with many G-MED clients to assess compliance to the IEC 60601-1 standard. He is a regular presenter on topics related to EU Medical Device Directives, including standards for electrical medical devices.
Please submit your questions to gmedna@lne-gmed.com.

LNE/G-MED North America Contact Information: (301) 495-0477
Webinar Agenda
Main Differences in Third Edition Key Elements
Insulation Mechanical Hazards Construction
Notified Body Assessment

European Regulation (MDD / Essential Requirements) European Harmonized Standards
Impact of Changes During NB Assessment Link Between IEC 60601-1 and EN 62304
Main Differences in the Third Edition

The first major difference is the modification of the clause number
For example
In Edition 2 leakage current are in clause 19 In Edition 3 leakage current are in clause 8.7
To help us to make the link between this two editions IEC have written a technical report
IEC 62348/TR Ed 1
In this report, the link can be made easily in the two ways

Some collaterals standards are included in the new edition
IEC 60601-1-4 (programmable electrical medical systems) now clause 14 IEC 60601-1-1 (Medical electrical systems) now clause 16
Presence of normative Annex

For AP, APG product
Second parts was or will be modified too

For example IEC 60601-2-38 (electrical medical beds) Is now IEC 60601-2-52

Introduction of risk management file
According to ISO 14971- Application of risk management to medical devices Conclusion of test (pass / fail) could be dependent of the risk management file
Introduction of ESSENTIAL PERFORMANCE

performance necessary to achieve freedom from unacceptable RISK The manufacturer have to define essential performance.
New tests were added

Examples: impact test, fire classification for enclosure,

Alignment with basic IEC safety standards where possible eg:
IEC 60950-1: IT equipment - safety requirements IEC 60664: Insulation coordination within lowvoltage systems IEC 60990: Methods of measurement of touch current and protective conductor current
Reflects current advances in materials and technologies Caters for environmental effects on the Products (eg high altitude, pollution)

Reasons for Change to IEC 60601-1
More flexibility for design of new products Use of more readily available power sources saves cost Updating to keep pace with new technology Make IEC 60601-1 more user friendly and understandable Alignment with basic standards as required by IEC e.g. IEC 60664-1. Reduce spacings where these do not need to be so large Introduce the option for DC Dielectric Strength Testing.
Insulation
In Second Edition it was:
Clause 17 (separation) Clause 20 (dielectric strength) Clause 57.10 (creepage distances and air clearances)
In Third Edition it is:

Clause 8.5 (separation of parts) Clause 8.8 (Insulation) Clause 8.9 (creepage distances and air clearances)
Insulation
MOPPs and MOOPs
MOPP MOPP or MOOP? (providing protection for APPLIED PARTS or other ACCESSIBLE PARTS) MOOP
Manufacturers choice Subject to the IEC 60601-1 3rd Edition requirements for MOPPs Subject to the IEC 60601-1 3rd Edition requirements for MOOPs
IEC 60950
Insulation
Dielectric strength:
In Third Edition it is: (extract of table 6)
Insulation
Creepage distances and air clearances
interpolation is now permitted for creepage for both operator and patient for clearances interpolation is permitted above certain voltage limits for operator protection material group (CTI - Comparative Tracking Index) classification now brought in for operator protection pollution degree now brought in for operator protection mains transients (overvoltage category) now catered for in MOOPs
Insulation
Ed. 3 (example)
Insulation
Ed. 3
Insulation
Leakage current Measure a current between a part of the device and the earth Differentiates between PATIENT and OPERATOR EARTH LEAKAGE CURRENT TOUCH CURRENT PATIENT LEAKAGE CURRENT Total PATIENT LEAKAGE CURRENT
Insulation
In Ed.3
Mechanical Hazards
More Mechanical Hazards are covered by the new standard
Crushing Hazard Shearing Hazard Cutting or severing Hazard Entanglement Hazard Trapping Hazard Stabbing or puncturing Hazard Friction or abrasion hazard Expelled parts Hazard High pressure fluid ejection Hazard Falling Hazard Instability Hazard Impact Hazard Moving and positioning of patient Vibration and noise
Mechanical Hazards
Medical equipment with a Trapping zone (by inspection)
The Medical Equipment shall comply with the requirements of one or more of the following:
Gaps according to table 20 Safe distance (ISO 13852) Guards and protective measures Continuous activation
Mechanical Hazards
Gaps according to table 20 (Extract)
Mechanical Hazards
Vibration and noise
Audible acoustic energy (By test) Infrasound and ultrasound (By Risk Management file analysis) Hand transmitted vibration (By test)
Mechanical Hazards
Dynamic forces (Test)

A safe working load (150kg min ) is dropped from a distance of 150mm above the seat area
Construction
The new items are:
Usability:
The manufacturer shall address in a usability engineering process the risk of poor usability (See IEC 60601-1-6)
Alarm system:
The manufacturer shall address in the risk management process the need for alarm systems, risks associated with operation or failure (See IEC 60601-1-8)
Construction
Requirements for fire enclosures equipment:
Alternative means of fault conditions test Flammability classification requirement, according to IEC 60695 standard series
for wire inside fire enclosure FV1or better Connector and printed circuit FV2 or better For enclosure
Requirement for opening in enclosure
Construction
Impact test:
Resistance of enclosure from impact to protect against unacceptable risk Impact with a mass of 500g, 50mm witch fall freely from 1.3 height or pendulum Not applicable to flat panel displays, platen glass of ME, to cathode ray tubes
Construction
Rough handling test for mobile equipment:
Ascending step shock 0,4m/S 40 mm, 3 times against a step Descending step shock 0,4m/S 40 mm, 3 times fall over a step Door frame shock 0,4m/S 40 mm, 3 times against vertical obstacle
Construction
Mould stress relief test:
On enclosure of moulded or formed thermoplastic materials Test at minimum 70C for 7h No shrinkage or distortion
How will Notified Bodies assess the IEC standards to European regulatory rules?
European Regulation (MDD / ER)

NBs Duty to review the Technical File
The devices must meet the essential requirements (ER) set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned. (Art. 3 MDD 93/42/EEC)
For the Medical Device designed For all the products coming from the production line.
CE Mark is the tangible proof your product complies with ERs. (Conformity declared by the manufacturer through the Declaration of Conformity)
CE0459 identifies the intervention of LNE/G-MED IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

Essential Requirements
1. Annex I of MDD 93/42/EEC enumerates a set of 13 ERs 2. Objective: Duty of manufacturer to answer to ERs to ensure that:
The MD will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient. The MD is compatible with a high level of protection of health and safety

Examples of ERs related to the design
ERs # 9. Construction and environmental properties (combination /connection with other devices must be safe and must not impair the specified performances; the risks of reciprocal interference with other devices must be minimized; the risks of fire or explosion must be minimized)

Examples of ERs related to the design
ERs #12. Requirements for medical devices connected to or equipped with an energy source
(Repeatability, reliability and performance of Electronic Programmable Systems; Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations; minimize the risks of creating electromagnetic fields; Protection against electrical, mechanical and thermal risks). 12.1a For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.
European Harmonized Standards

Solution to answer completely or partially to ERs List of Harmonized standards published through the Official Journal (EN .).
The Standard Committees/organization must indicate the Essential Requirements associated to a particular standard.

Include one or several MDD Essential Requirements, for one or several categories of proucts
Deployment: Done by the manufacturer, at all the level of the organization (Design, manufacturing, final inspection, Testing, ...) Done by the NB when it is appointed to assess the product according to Annexes III, II.4 or IV MDD) Application of Harmonized Standards (HS) not mandatory, remains voluntary: If applied then they give presumption of conformity to applicable ERs If not then necessity for the manufacturers to justify and to make explicit the selected equivalent alternative methods.

Standards used to Demonstrate Conformity of Electromedical Devices
Few years ago:
ISO 13485(96): Quality System assessment versus 20 chapters EN 1441: Risk analysis for medical products IEC 601-1, IEC 601-2-xx: Safety of products checked versus specific hazard (mechanical, )
Today:
ISO 13485 (03) based on process approach including risk management throughout product realization (clause 7.1) ISO 14971: Risk management including residual risks evaluation IEC 601-1 Ed 3 ( 4.2): Requirements to established a risk management process complying with ISO 14971. ISO 62304: Introduction of this new standard to improve the validation of software

Current Status of IEC Standards
IEC 601-x-x series published as European Harmonized standard to presume compliance to essential requirements: IEC 601-1-2 for ER # 9.2 , 12.5 IEC 601-1-4 for ER # 12.1, Standards used as a common language between manufacturers, Notified Bodies, Test labs, Recognition of testing made by accredited test labs, recognition between test labs.
IEC 60601-1 (Third Edition)
Impact of changes during NB assessment
Impact of Changes During NB Assessment

Calendar
New IEC 60601 standard Ed 3 published in Dec. 05. Second edition will become obsolete in June 2012 if there is no particular standard 60601-2-XX is applicable to the Medical Device. If a particular standard applies to MD then Manufacturer should wait promulgation of harmonized IEC 601-2-xx Ed 3.

IMPACT for Manufacturers:
Major QMS difference compared to the 2nd Ed.: Refers several times to Risk Management File (RMF). Impact:
Deploy a specific RMF for each product, in compliance with ISO 14971 requirements and covering all the items required by IEC 60601-1 3rd Edition. For the R&D activities, necessity to established an efficient interface between Regulatory Affairs and Design team(s). Deploy a Coherent Approach based on the Technical state of the art, the information raised in the field, Analysis of information information derived from previous similar designs
As long as the Ed. 3 of particular standard are not promulgated, the manufacturers still need to comply with Ed. 2 but necessity to start to work on the new edition upstream from this promulgation.

IMPACT on Assessors (Testing Laboratory) The terminology Unacceptable Risk is used as a criteria several times in the new edition, to determine: The tests who need to be performed. The acceptance criteria for the tests. Testing Laboratories need to have a good technical expertise associated to a good clinical knowledge of medical device under test. Need to be trained on ISO 14971 approach, requirements The documentation review is reinforced, beyond the realization of technical testing. Deeper discussion/debate between the Laboratory and the manufacturer

IMPACT for Notified Bodies
Risk Management File already constituted an important document of CE Technical File. It becomes one of the key documents with the introduction of 3rd Edition. During the Design Process review, a particular attention shall be paid to the choices and alternative solutions used by the manufacturer during the Design verification [demonstration of conformity to ERs], alternative solutions documented in the RMF. Recognition and Acceptance of IEC Test Reports will be based on the simultaneous and detailed review of test report and RMF.
All of the actors are impacted

As long as the collateral and particular standard Ed 3 are not promulgated . Some processes need to be adjusted by each actor Training Nevertheless, even if the standards and our practices are evolving, the initial goal and target remain identical: . All Medical Devices must offer a high level of protection of health and safety of patients, users or, where applicable, other persons.
Link Between IEC 60601-1 and EN 62304

IEC 60601-1:1988 + Amendment IEC 60601-1:2005 Section 14 IEC 62366:2008 ISO 14971:2007 IEC 62304:2006 ISO 13485:2003 IEC 60601-1-4:1999
IEC 60601-1-6:2006

Major Differences between Art. 14 IEC 60601-1 and EN 62304:
EN 62304 does not cover software validation. PEMS validation is a system level activity and is outside the scope of this standard. Art 14.6.1 requires: When compiling the list of know and foreseeable hazards, the manufacturer shall consider those hazards associated with software and hardware aspects of the PEMS including those associated with network/data coupling, . This Requirement for network/data coupling is not included in EN 62304.
Major Differences between Art. 14 IEC 60601-1 and EN 62304: Independance of personnel performing the verification is not included in EN 62304. It is considered covered in ISO 13485.

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LNE / G-MED North America presents

IEC 60601-1 (Third Edition):

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

Presenter Bios / Contact Information

Please submit your questions to gmedna@lne-gmed.com.

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

Notified Body Assessment

Main Differences in the Third Edition

Main Differences in the Third Edition

Presence of normative Annex

Second parts was or will be modified too

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

Main Differences in the Third Edition

Introduction of ESSENTIAL PERFORMANCE

New tests were added

Main Differences in the Third Edition

Main Differences in the Third Edition

In Third Edition it is:

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

Gaps according to table 20 (Extract)

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

Dynamic forces (Test)

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

European Regulation (MDD / ER)

European Regulation (MDD / ER)

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

European Regulation (MDD / ER)

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

European Regulation (MDD / ER)

European Harmonized Standards

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

European Harmonized Standards

European Harmonized Standards

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

European Harmonized Standards

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

IEC 60601-1 (Third Edition)

Impact of changes during NB assessment

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

Impact of Changes During NB Assessment

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

Impact of Changes During NB Assessment

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

Impact of Changes During NB Assessment

Impact of Changes During NB Assessment

IEC 60601 (Third Edition) LNE / G-MED North America www.LNE-America.com

All of the actors are impacted