ANSI / UL 1998 Safety of Software in Programmable … UL 1998 CORE REQUIREMENTS . Copyright 2000...

ANSI / UL 1998Safety of Software in

Programmable Components

Product levelstandards and

regulations

ChangeManagement

SoftwareRisk Analysis

Verification,Validation, and

Design for Safety

UL 1998 CORE REQUIREMENTS

Software Risk AnalysisUL 1998, Section 3

• Risk Identification

• Initiating causes

• Software risk management

• Traceability

ISO/IEC DIS 14971:Medical Devices – Application of risk management to medical devices

Process Definition

UL 1998, Section 4• Defined inputs and outputs

• Integrated risk management

• Traceability

• Verification

ISO/IEC 12207: Information technology – Software life cycle processes

Design for Software Safety UL 1998

• Software Design

• Critical and Supervisory Sections

• Measures to Address Microelectronic Failure Modes

• Product Interfaces

• User Interfaces

• Traceable

• Verifiable, testable, maintainable

• Defined interfaces

• Partitioning

• Initialization of variables to non-hazardous state

• Risk-addressed states and state transitions

• Fault-handling• Redundant software

• Redundant hardware• Self diagnostic routines • Data integrity

Verification UL 1998, Section 11

• Software Analysis• Software Testing

• Failure Modes and Stress Testing

Software Testing

• Development & Post-release testing

• Test Cases traceable to Risk Analysis

• Traceable to the safety requirements

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

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.”

• Software Safety Plan

• Risk Analysis Approach and Results

• Configuration Management Plan

• Product Summary and User Documents

• System Architecture

Documentation

• 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

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.

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

UL 1998FDA Standards Recognition

• All medical devices containing software• 510(k), IDE, PMA, HDE

FDA Submissions

SoftwareDocuments MINOR MODERATE MAJORSoftwareDescription SUBMIT SUBMIT SUBMITDevice HazardAnalysis SUBMIT SUBMIT SUBMIT

SRS SUBMIT SUBMIT SUBMITReleaseVersion No. SUBMIT SUBMIT SUBMIT

FDA SubmissionsMinor / Moderate LOC

SUBMIT• UL 1998 compliance

DON’T SUBMIT• Architectural

Design*

• Design Specification*

• Traceability

• Validation

• Development*

• Revision History*

Global Engineering Documents

TEL: (800) 845-7179

FAX: (303) 397-2740

e-mail: global@ihs.com

THANK YOU FOR ATTENDING

FOR MORE INFORMATION CONTACT UL at :

software@ul.comOROR

telephone toll-free: 11--888888--857857--63816381

ANSI / UL 1998 Safety of Software in Programmable … UL 1998 CORE REQUIREMENTS . Copyright 2000...

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