UL 1998-2004 Standard for Software in Programmable Components - Revision 1

Abstract: Available
Author: Stan Magee CCP (Ret.)
Cover: Available
Customer Set for this product: Medical devise and Solar power devices firms
Format: Word® (To save money, click here for our PDF version)
ISBN Numbers: 978-0-9716087-9-5 / 0-9716087-9-2
Language: English
Page count of document: 86
Provider: SEPT
Sample Pages: Available
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $330.00
Product Details

The experts at SEPT have revised this checklist to reflect revision 1 to this major software engineering document:

  • The ANSI/UL 1998 standard is focused toward application-specific, non-networked software in a programmable component embedded in a product for which a failure may result in injury to persons.
  • A general software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software.
  • The Checklist provides an easy-to-use classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews.

It provides information on:

1. Risk Analysis
2. Process Definition
3. Qualification of Design, Implementation and Verification Tools
4. Software Design
5. Critical and Supervisory Section of Software
6. Measures to Address Microelectronic Hardware Failure Modes
7. Product Interface
8. User Interface
9. Software Analysis and Testing
10. Documentation
11. Off-the-Shelf (OTS) Software.
12. Software Changes and Document Control 14. Documentation
13. Identification

This product supports these Software Engineering processes

  • Configuration Management
  • Design
  • Documentation
  • Integration
  • Life Cycle
  • Maintenance And Operation
  • Quality
  • Safety
  • Verification And Validation

Customers of this product:

  • Gen-Probe
  • Hewlett-Packard
  • Iradimed Corporation
  • Marathon Engine Systems
  • MicroPlanet
  • Preferred-mfg.
  • Royal Philips Electronics
  • Simex
  • W&H Dental Work

Note: “International Standards (ISO) define the best of practices for Medical Device and Software firms in producing a quality product. This checklist that SEPT produces will ensure that all of the best of practices are adhered to.”

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