Basic Safety, Basic Safety, Essential Essential

Performance, and Performance, and EMC EMC Frank O’Brien

www.obcompman.com

TopicsTopics

IEC 60601-1, 3IEC 60601-1, 3rdrd edition, pre-FDIS edition, pre-FDIS text:2004-04text:2004-04Medical electrical equipment – Medical electrical equipment – Part 1: General requirements for Part 1: General requirements for basic basic safety and essential performancesafety and essential performance BackgroundBackground Basic Safety, Essential PerformanceBasic Safety, Essential Performance Risk Management ProcessRisk Management Process New Requirements of InterestNew Requirements of Interest

Electrical, Mechanical, ThermalElectrical, Mechanical, Thermal

TopicsTopics

IEC  60601 1 2:2001 + A1:2004-09IEC  60601 1 2:2001 + A1:2004-09Medical electrical equipment – Medical electrical equipment – Part 1-2: General requirements for Part 1-2: General requirements for safety –safety –Collateral standard: Collateral standard: Electromagnetic compatibilityElectromagnetic compatibility – – Requirements and testsRequirements and tests Overview of changesOverview of changes EMC essential performanceEMC essential performance

Jurisdictional AuthorityJurisdictional Authority

22ndnd edition in use edition in use IEC 60601-1:1988 + A1:1991 + A2:1995IEC 60601-1:1988 + A1:1991 + A2:1995

Forms the basis for national/regional Forms the basis for national/regional consensus standard in all major consensus standard in all major medical device marketsmedical device markets

Including US, Europe, Japan, Canada, Including US, Europe, Japan, Canada, Australia/New Zealand, South Korea, China, Australia/New Zealand, South Korea, China, BrazilBrazil

SC62A Working GroupsSC62A Working Groups

WG 5: Ergonomics and graphical symbolsWG 5: Ergonomics and graphical symbols WG 11: Medical electrical systems WG 11: Medical electrical systems WG 14: Testing to General Safety Standard WG 14: Testing to General Safety Standard WG 15: Risk managementWG 15: Risk management WG 16: Electrical hazardsWG 16: Electrical hazards WG 17: Mechanical hazards WG 17: Mechanical hazards WG 18: Overheating, fire protection and WG 18: Overheating, fire protection and

otherother WG 22: Programmable electrical medical WG 22: Programmable electrical medical

systems (PEMS)systems (PEMS)

Release ScheduleRelease Schedule

Aug Aug 20042004

National Committees voted to National Committees voted to circulate 2CDV as FDIS, (with 1400 circulate 2CDV as FDIS, (with 1400 comments) comments)

Apr Apr 20052005

Comments resolved, FDIS text Comments resolved, FDIS text submitted for editing check and submitted for editing check and French translation. Work begins on French translation. Work begins on aligning Particulars and Collateralsaligning Particulars and Collaterals

Sep(?) Sep(?) 20052005

FDIS circulated for final vote and FDIS circulated for final vote and typographical comments.typographical comments.

Dec(?) Dec(?) 20052005

33rdrd Edition circulated. Jurisdictions Edition circulated. Jurisdictions with Authority work to adopt with 3 with Authority work to adopt with 3 to 5 year(?) transitionto 5 year(?) transition

IEC 60601-1, Collaterals, IEC 60601-1, Collaterals, ParticularsParticulars

Collateral Standards

Particular Standards

Requirements for specific technologies and/or hazards

Requirements for specific equipment types

60601-2-2 High

Frequency

Surgical Equipme

nt

60601-2-1

Medical Electron Accelerat

ors

60601-2-38

Electrically

Operated Hospital

Beds

60601-2-50

Infant Photother

apy Equipmen

t

General Standard60601-1

60601-1-2

EMC60601-

1-3Radiati

on Protecti

on

60601-1-6

Usability

60601-1-8

Alarms

Collaterals Inserted into Collaterals Inserted into General StandardGeneral Standard

IEC 60601-1, 3rd

Edition

IEC 60601-1-4, PEMS (software

)

Clause 14

IEC 60601-1-

1, Systems

Clause 16

Scope, Clause 1.1Scope, Clause 1.1

““Applies to the BASIC SAFETY and Applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL MEDICAL ELECTRICAL EQUIPMENT and MEDICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS”ELECTRICAL SYSTEMS”

Terminology, Clauses Terminology, Clauses 3.63, 3.643.63, 3.64

ME EquipmentME Equipment ““Having an APPLIED PART [or Having an APPLIED PART [or

detecting/transmitting energy with] detecting/transmitting energy with] PATIENT and … intended … to diagnose, PATIENT and … intended … to diagnose, treat or monitor; or to compensate or treat or monitor; or to compensate or alleviate disease, injury or disability”alleviate disease, injury or disability”

Includes necessary ACCESSORIESIncludes necessary ACCESSORIES

ME SystemME System ““Combination of equipment at least one of Combination of equipment at least one of

which is ME EQUIPMENT”which is ME EQUIPMENT”

Terminology, Clauses Terminology, Clauses 3.10, 3.273.10, 3.27

Basic SafetyBasic Safety ““Freedom from unacceptable RISK Freedom from unacceptable RISK

directly caused by HAZARDS when ME directly caused by HAZARDS when ME EQUIPMENT is used in NORMAL and EQUIPMENT is used in NORMAL and SINGLE FAULT CONDITION”SINGLE FAULT CONDITION”

Essential PerformanceEssential Performance ““Performance necessary to achieve Performance necessary to achieve

freedom from unacceptable RISK”freedom from unacceptable RISK” Would absence or degradation of function Would absence or degradation of function

result in unacceptable risk?result in unacceptable risk?

Terminology, Clauses Terminology, Clauses 3.39, 3.102, 3.383.39, 3.102, 3.38

Hazard: “potential source of harm”Hazard: “potential source of harm” Risk = Probability * SeverityRisk = Probability * Severity Harm: “physical injury or damage to Harm: “physical injury or damage to

health or property”health or property”

HazarHazardd

HarHarmm

Risk

ISO 14971

Risk Management Process, Risk Management Process, Clause 4.1, 4.2, 4.7Clause 4.1, 4.2, 4.7

“…“…requirements shall apply in NORMAL requirements shall apply in NORMAL USE and reasonably foreseeable misuse”USE and reasonably foreseeable misuse”

““A RISK MANAGEMENT PROCESS A RISK MANAGEMENT PROCESS complying with ISO 14971 shall be complying with ISO 14971 shall be performed”performed” Residual RISK must be acceptableResidual RISK must be acceptable

““ME Equipment shall … be SINGLE ME Equipment shall … be SINGLE FAULT SAFE” (free of unacceptable RISK FAULT SAFE” (free of unacceptable RISK under SINGLE FAULT CONDITION)under SINGLE FAULT CONDITION)

Risk Management Risk Management Process, 4.3Process, 4.3

““Manufacturer identifies which Manufacturer identifies which functions … are Essential functions … are Essential Performance”Performance” Determined by manufacturer’s policy Determined by manufacturer’s policy

for Risk acceptabilityfor Risk acceptability ““Collateral and Particular Standards Collateral and Particular Standards

[aligned with 3[aligned with 3rdrd edition] are expected edition] are expected to identify specific Essential to identify specific Essential Performance,” Annex A, 3.27Performance,” Annex A, 3.27

Risk Management Risk Management ProcessProcess

When desired, in many cases, still a test When desired, in many cases, still a test standard with pass/fail criteriastandard with pass/fail criteria Can presume acceptable risk with compliance Can presume acceptable risk with compliance

with Clauses containing verifiable with Clauses containing verifiable requirementsrequirements

Annex A, Guidance and Rationale, Clause 4.2Annex A, Guidance and Rationale, Clause 4.2

22ndnd Edition was foremost a test standard Edition was foremost a test standard with pass/fail criteriawith pass/fail criteria When desired, allowed risk analysis to When desired, allowed risk analysis to

evaluate alternative constructions offering evaluate alternative constructions offering “equivalent degree of safety”, Clause 3.4“equivalent degree of safety”, Clause 3.4

Risk Management Risk Management ProcessProcess

A formal Quality System is NOT requiredA formal Quality System is NOT required A quality system facilitates dealing with risk A quality system facilitates dealing with risk

management in a systematic waymanagement in a systematic way PEMS requires a Development Life CyclePEMS requires a Development Life Cycle

An explanatory note to Clause 14.4 references IEC An explanatory note to Clause 14.4 references IEC 62304, (under development), which requires q-system62304, (under development), which requires q-system

FDA QSR requires a q-system w/design controlsFDA QSR requires a q-system w/design controls Where a documented design/development process Where a documented design/development process

exists, it shall incorporate the risk mgt processexists, it shall incorporate the risk mgt process ISO 14971, Clause 3.2ISO 14971, Clause 3.2

Risk control•Option analysis•Implementation•Residual risk evaluation/Overall risk acceptance

Risk analysisRisk analysis•Intended use/intended purpose identification•Hazard identification•Risk estimation

Risk evaluationRisk evaluation•Risk acceptability decisions

Post-production informationPost-production information•Post-production experience•Review of risk management experience

Risk Management Risk Management ProcessProcess

Ris

k a

ssess

men

t

Ris

k m

an

ag

em

en

t

ISO 14971

Figure 1

Risk RegionsRisk Regions

Negligible

Marginal

Critical Catastrophic

Incredible

Improbable

Remote

Occasional

Probable

Frequent Intolerab

leALARP

As Low As Reasonably Practicable

Broadly Acceptable

Probabil

ity

Severity

Example based onISO 14971, Fig E.1

Development Life Cycle Development Life Cycle ProcessProcess

(facilitates risk mgt, not (facilitates risk mgt, not required)required)1.Requirem

ents, Analysis,

Specifications

7. Systems Test

6. Integration

Test

5. Module Test

4. Implementa

tion

3. Detailed Design,

Specification

2. Top-Level Design,

Specification

Verification

Verification

Validation

On

goin

g R

isk

An

alysis

Veri

ficati

on

of

Ris

k

Con

trols

Example based on Fig H.2 (PEMS)

New Requirements of New Requirements of InterestInterest

Use of ITE (computer) Power Supplies Use of ITE (computer) Power Supplies acceptable withacceptable with ME Systems, Clause 16, Annex IME Systems, Clause 16, Annex I

If ITE in patient environment, separation If ITE in patient environment, separation transformer is possible solutiontransformer is possible solution

ME Equipment, Clause 8.5, 4.6ME Equipment, Clause 8.5, 4.6 Accessible surfaces are unlikely to contact Accessible surfaces are unlikely to contact

PATIENTPATIENT 2 MEANS OF OPERATOR PROTECTION (MOOP)2 MEANS OF OPERATOR PROTECTION (MOOP)

Compliance with Leakage Current limits, Compliance with Leakage Current limits, Clause 8.7Clause 8.7 5/10 mA Earth, 100/500 uA Touch, (NC/SFC)5/10 mA Earth, 100/500 uA Touch, (NC/SFC)

New Requirements of New Requirements of InterestInterest

New TRAPPING ZONE mitigation New TRAPPING ZONE mitigation optionsoptions Gaps, 9.2.2.2, Table 20Gaps, 9.2.2.2, Table 20 Safety Distances, 9.2.2.3, ISO 13852Safety Distances, 9.2.2.3, ISO 13852 Guards, and Protective Measures, Guards, and Protective Measures,

9.2.2.49.2.2.4 Includes collision detection systemsIncludes collision detection systems

Continuous Activation, 9.2.2.5Continuous Activation, 9.2.2.5

New Requirements of New Requirements of InterestInterest

Reduced TENSILE Reduced TENSILE SAFETY FACTORS, SAFETY FACTORS, Clause 9.8, Table Clause 9.8, Table 2121 Material TENSILE Material TENSILE

STRENGTH and all STRENGTH and all external forces are external forces are quantifiable and quantifiable and accurateaccurate

Safety Factors Safety Factors reduced by 37.5% reduced by 37.5% (e.g. from 4 to 2.5)(e.g. from 4 to 2.5)

New Requirements of New Requirements of InterestInterest

Maximum allowable Maximum allowable surface surface temperatures are temperatures are time dependent, and time dependent, and increased, Clause increased, Clause 11.1, Tables 23 and 11.1, Tables 23 and 2424 Example from Table Example from Table

2424 Applied Parts > 41 C Applied Parts > 41 C

need to be disclosed need to be disclosed in IFUin IFU

APPLIED APPLIED PARTPART

Maximum Maximum TemperaturTemperatur

e, Ce, C

Contact Contact for time tfor time t

PlasticPlastic

t < 1 mint < 1 min 6060

1 min 1 min << t t < 10 min< 10 min

4848

10 min < 10 min < tt

4343

EMC, IEC 60601-1-EMC, IEC 60601-1-2:20012:2001

Became effective in Europe in Nov Became effective in Europe in Nov 2004 (DOW)2004 (DOW)

Many changesMany changes

Major Changes to IEC Major Changes to IEC 60601 1 2:200160601 1 2:2001

Emissions exemption deleted;Emissions exemption deleted; New requirements for Harmonic New requirements for Harmonic

emissions and Flicker for class B;emissions and Flicker for class B; Allowance for ITE;Allowance for ITE; Extensive disclosure documentation Extensive disclosure documentation

requirements;requirements; Labeling;Labeling;

Major Changes to IEC Major Changes to IEC 60601 1 2:200160601 1 2:2001

New Immunity requirements:New Immunity requirements: Conducted 150 kHz to 80 MHz;Conducted 150 kHz to 80 MHz; Radiated extended to 2.5 GHz;Radiated extended to 2.5 GHz; ESD – 6 kV contact;ESD – 6 kV contact; EFT & Burst – 2 kV power lines; 1 kV signal EFT & Burst – 2 kV power lines; 1 kV signal

lines;lines; Surge – 2 kV line to gnd; 1 kV line to line; Surge – 2 kV line to gnd; 1 kV line to line; Voltage dips and interruptions;Voltage dips and interruptions; Magnetic Fields – 3A/m.Magnetic Fields – 3A/m.

ESD exemption;ESD exemption;

Major Changes to IEC Major Changes to IEC 60601 1 2:200160601 1 2:2001

Performance and safety based – Passing at Performance and safety based – Passing at reduced levels is no longer allowed if function reduced levels is no longer allowed if function is associated with Essential Performance;is associated with Essential Performance;

Extensive compliance criteria;Extensive compliance criteria; Compliance required during and after a test;Compliance required during and after a test; Essential Performance determination;Essential Performance determination; Applies to Systems and may require risk Applies to Systems and may require risk

analysis;analysis; Non-medical electrical equipment may be Non-medical electrical equipment may be

exempt.exempt.

IEC 60601-1-2, IEC 60601-1-2, Amendment1:2004-09Amendment1:2004-09

Removes Definition and Capitalization Removes Definition and Capitalization from Essential Performance termfrom Essential Performance term Allows the developing interpretation in IEC Allows the developing interpretation in IEC

60601-1 to drive the application in 60601-1-2 60601-1 to drive the application in 60601-1-2 rather than the other way aroundrather than the other way around

““essential performance is identified … essential performance is identified … and and discloseddisclosed by manufacturer,” Clause by manufacturer,” Clause 3.201.23.201.2 Annex GGG, Guidance for identification of Annex GGG, Guidance for identification of

essential performance, refers to draft 3essential performance, refers to draft 3rdrd editionedition

EMC Essential EMC Essential PerformancePerformance

““IMMUNITY TEST LEVELS represent normal IMMUNITY TEST LEVELS represent normal use environment,” Clause 36.202.1.ause environment,” Clause 36.202.1.a

““During Immunity testing, each function During Immunity testing, each function associated with essential performance is associated with essential performance is tested,” Clause 36.202.1.ctested,” Clause 36.202.1.c

During Immunity testing, compliance criteria During Immunity testing, compliance criteria for essential performance is specified in for essential performance is specified in Clause 36.202.1.jClause 36.202.1.j ““Shall be able to provide identified essential Shall be able to provide identified essential

performance and remain safe”performance and remain safe”

SummarySummary

IEC 60601-1, 3IEC 60601-1, 3rdrd Ed. expected in Dec Ed. expected in Dec 2005(?)2005(?) National/regional versions mid-late 2006(?)National/regional versions mid-late 2006(?) Older versions withdrawn, mid-late 2009-2011(?)Older versions withdrawn, mid-late 2009-2011(?)

Risk Management Process RequiredRisk Management Process Required Can presume acceptable risk with verifiable Can presume acceptable risk with verifiable

requirementsrequirements Essential Performance RequiredEssential Performance Required

No unacceptable risk from loss of functionNo unacceptable risk from loss of function EMC essential performance is disclosedEMC essential performance is disclosed