comparison of the use of iso 31000, iso 14971 and ......iso 31000 iso 14971 stamp accident...

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Risk analysis of complex medical devices: Comparison of the use of ISO 31000, ISO 14971 and STAMP/STPA for microprocessor-controlled prostheCc knees Rögnvaldur J. Saemundsson University of Iceland Svana Helen Björnsdóttir Reykjavik University Helga Einarsdóttir Reykjavik University Páll Jensson Reykjavik University European STAMP Workshop and Conference 2017 Reykjavik, September 13-15

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Page 1: Comparison of the use of ISO 31000, ISO 14971 and ......ISO 31000 ISO 14971 STAMP Accident “Occurrence or change of a particular set of circumstances” Undefined “An undesired

Risk analysis of complex medical devices: ComparisonoftheuseofISO31000,ISO14971andSTAMP/STPAfor

microprocessor-controlledprostheCcknees

Rögnvaldur J. SaemundssonUniversity of Iceland

Svana Helen BjörnsdóttirReykjavik University

Helga EinarsdóttirReykjavik University

Páll JenssonReykjavik University

European STAMP Workshop and Conference 2017Reykjavik, September 13-15

Page 2: Comparison of the use of ISO 31000, ISO 14971 and ......ISO 31000 ISO 14971 STAMP Accident “Occurrence or change of a particular set of circumstances” Undefined “An undesired

Background

Page 3: Comparison of the use of ISO 31000, ISO 14971 and ......ISO 31000 ISO 14971 STAMP Accident “Occurrence or change of a particular set of circumstances” Undefined “An undesired

The challengeUSEU

FDAGMPMDD

EssentialRequirements

QualitySystemRegulation

EN13485QualityManagementSystems

EN62304SofwareLife-cycle

EN62366UsabilityEngineering

EN14971RiskManagement

EUHarmonizedStandards

EN60601-1ElectricalSafety

For complex medical devices ISO/EN 14971 does not cover EU regulators’ essential requirements and is complemented by other standards and a periodic audit process.

Page 4: Comparison of the use of ISO 31000, ISO 14971 and ......ISO 31000 ISO 14971 STAMP Accident “Occurrence or change of a particular set of circumstances” Undefined “An undesired

Objective

• Compare the risk analysis process of ISO 14971, ISO 31000 and STAMP/STPA

• How are the differences relevant to risk management of complex medical devices?

Page 5: Comparison of the use of ISO 31000, ISO 14971 and ......ISO 31000 ISO 14971 STAMP Accident “Occurrence or change of a particular set of circumstances” Undefined “An undesired

GeneralISO 31000 ISO 14971 STAMP

Guidelines Guidelines (harmonized standard) Method

Page 6: Comparison of the use of ISO 31000, ISO 14971 and ......ISO 31000 ISO 14971 STAMP Accident “Occurrence or change of a particular set of circumstances” Undefined “An undesired

Core conceptsISO31000 ISO14971 STAMP

Accident

“Occurrenceorchangeofa

particularsetofcircumstances”

Undefined

“Anundesiredandunplannedeventthatresultsinaloss

(includinglossofhumanlifeorinjury,propertydamage,

environmentalpollutionandsoon)”

Harm Undefined

“Physicalinjuryordamagetothehealthofpeople,ordamageto

propertyortheenvironment”

Undefined

Differences in nomenclature

Page 7: Comparison of the use of ISO 31000, ISO 14971 and ......ISO 31000 ISO 14971 STAMP Accident “Occurrence or change of a particular set of circumstances” Undefined “An undesired

Risk AnalysisISO 31000 ISO 14971 STAMP/STPA

Generic and abstract model

Manufacturer selects appropriate methods

Systematic approach (STPA)

Manufacturer defines acceptable risks Importance of communication and documentation

Page 8: Comparison of the use of ISO 31000, ISO 14971 and ......ISO 31000 ISO 14971 STAMP Accident “Occurrence or change of a particular set of circumstances” Undefined “An undesired

ConclusionsHow are the differences relevant to risk management of complex medical devices?

• STAMP/STPA provides a more systematic approach to analyse risks originating from interaction between the components of a complex system.

• STAMP/STPA designed to address risks through design.

• Is STAMP/STPA more cost effective for regulatory compliance?