ansi / ul 1998 safety of software in programmable … ul 1998 core requirements . copyright 2000...
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ANSI / UL 1998Safety of Software in
Programmable Components
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Product levelstandards and
regulations
ChangeManagement
SoftwareRisk Analysis
Verification,Validation, and
Test
Design for Safety
UL 1998 CORE REQUIREMENTS
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Software Risk AnalysisUL 1998, Section 3
• Risk Identification
• Initiating causes
• Software risk management
• Traceability
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ISO/IEC DIS 14971:Medical Devices – Application of risk management to medical devices
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Process Definition
UL 1998, Section 4• Defined inputs and outputs
• Integrated risk management
• Traceability
• Verification
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ISO/IEC 12207: Information technology – Software life cycle processes
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Design for Software Safety UL 1998
• Software Design
• Critical and Supervisory Sections
• Measures to Address Microelectronic Failure Modes
• Product Interfaces
• User Interfaces
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Design for Software Safety UL 1998
• Traceable
• Verifiable, testable, maintainable
• Defined interfaces
• Partitioning
• Initialization of variables to non-hazardous state
• Risk-addressed states and state transitions
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Design for Software Safety UL 1998
• Fault-handling• Redundant software
• Redundant hardware• Self diagnostic routines • Data integrity
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Verification UL 1998, Section 11
• Software Analysis• Software Testing
• Failure Modes and Stress Testing
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Software Testing
• Development & Post-release testing
• Test Cases traceable to Risk Analysis
• Traceable to the safety requirements
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Failure Mode & Stress Testing• Operator errors
• Microelectronic Hardware failure
• Error in data received from other sources
• Negative condition branch
• Out-of-range
• Boundary condition
• Type mismatched values for parameters
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Software Validation
FDA/CDRH’s Guidance for Industry: General Principles of Software Validation
“establishing [define, document, implement] by objective evidence that all software requirements have been implemented correctly and completely and are traceable to system requirements.”
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• Software Safety Plan
• Risk Analysis Approach and Results
• Configuration Management Plan
• Product Summary and User Documents
• System Architecture
Documentation
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• System and Software Requirements Specification
• System and Software Design Specification
• Verification, Validation and Test Plans
• Verification, Validation and Test Results
• Software Safety Reference Manual
Documentation
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Change ManagementUL 1998, Section 14
•Software shall contain a unique identifier.
•Changes or patches to a programmable electronic system shall not increase risk.
•Each time a change or patch is incorporated in the software, a new identifier shall be assigned.
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Off-The-Shelf (OTS) Software
UL 1998, Section 13
• Risks addressed • Identification of Version Release number
• List of known anomalies• Evidence of verification• Configuration Management plan
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UL 1998FDA Standards Recognition
• All medical devices containing software• 510(k), IDE, PMA, HDE
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FDA Submissions
SoftwareDocuments MINOR MODERATE MAJORSoftwareDescription SUBMIT SUBMIT SUBMITDevice HazardAnalysis SUBMIT SUBMIT SUBMIT
SRS SUBMIT SUBMIT SUBMITReleaseVersion No. SUBMIT SUBMIT SUBMIT
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FDA SubmissionsMinor / Moderate LOC
SUBMIT• UL 1998 compliance
DON’T SUBMIT• Architectural
Design*
• Design Specification*
• Traceability
• Validation
• Development*
• Revision History*
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Global Engineering Documents
TEL: (800) 845-7179
FAX: (303) 397-2740
e-mail: [email protected]
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