IEC TR 80002-3-2014 PDF

Full title and description

St IEC TR 80002-3-2014 — Medical device software — Part 3: Process reference model of medical device software life cycle processes (derived from IEC 62304). This Technical Report (TR) presents a process reference model (PRM) that describes life‑cycle processes, their purpose and measurable outcomes, aligned with IEC 62304:2006 and mapped to ISO/IEC 12207:2008; it is intended as guidance for consistent software life‑cycle practice rather than as a regulatory inspection or certification instrument.

Abstract

IEC TR 80002-3:2014 documents a Process Reference Model (PRM) for medical device software life‑cycle activities. It restates process names from IEC 62304:2006, defines the purpose and expected process outcomes, and provides mappings to ISO/IEC 12207:2008 to enable consistent terminology and alignment between standards. The report clarifies which outcomes are normative under IEC 62304 and which are derived from ISO/IEC 12207 guidance; it is explicitly not intended to replace IEC 62304 or to be used as the basis for regulatory certification.

General information

• Status: Withdrawn — withdrawal date 3 November 2023.
• Publication date: 4 June 2014.
• Publisher: International Electrotechnical Commission (IEC).
• ICS / categories: 11.040.01 (medical equipment in general); also listed with IT/healthcare application classification.
• Edition / version: Edition 1.0 (2014).
• Number of pages: 28 pages (official IEC webstore listing).

Scope

This TR is limited to the software life‑cycle processes described in IEC 62304:2006 and presents them as a process reference model: process names, purposes and measurable outcomes. It aligns those processes with ISO/IEC 12207:2008 (via mappings, notably in Annex B) and follows the presentation conventions of ISO/IEC 24774:2010. The document does not add regulatory requirements, address FDA guidance documents, nor cover software development tools; it is intended as explanatory guidance to support consistent implementation of IEC 62304 requirements.

Key topics and requirements

• Process Reference Model (PRM) describing life‑cycle process names, purpose statements and measurable process outcomes aligned with IEC 62304.
• Mapping between IEC 62304:2006 and ISO/IEC 12207:2008 to harmonize terminology and process outcomes (Annex B).
• Incorporation of software safety class considerations (A / B / C) consistent with IEC 62304 and identification of outcome implications by safety class.
• Coverage of core life‑cycle processes: planning, requirements analysis, architectural and detailed design, unit implementation & verification, integration & testing, system testing and release, plus maintenance, configuration management and problem resolution.
• Guidance-oriented material (informative) that clarifies relationships between standards and suggests measurable outcomes — not additional normative requirements for regulatory approval.

Typical use and users

Used by medical device software developers, quality and regulatory affairs professionals, process engineers, and consultants to interpret and implement life‑cycle process requirements from IEC 62304 in a way that is consistent with broader software life‑cycle process frameworks (ISO/IEC 12207). Also useful for trainers, authors of internal development procedures, and tool vendors seeking alignment with IEC/ISO process terminology. The TR is intended as guidance and context rather than as a compliance checklist for regulators.

Related standards

Key related standards and documents include: IEC 62304:2006 (Medical device software — Software life cycle processes) and its Amendment 1 (2015); IEC TR 80002-1:2009 (guidance on application of ISO 14971 to medical device software); ISO/IEC 12207:2008 (software life‑cycle processes) and ISO/IEC 24774:2010 (presentation of ISO/IEC life‑cycle processes); plus other parts of the 80002 series such as ISO/TR 80002-2:2017 (validation of software for medical device quality systems). Users should consult the current editions/amendments of IEC 62304 and relevant ISO standards for normative requirements.

Keywords

medical device software, software life cycle, process reference model, IEC 62304, ISO/IEC 12207, software safety classification, risk management, configuration management, software verification, technical report.

FAQ

Q: What is this standard?

A: IEC TR 80002-3:2014 is a Technical Report that provides a process reference model for medical device software life‑cycle processes (derived from IEC 62304) and shows mappings to ISO/IEC 12207 for alignment and clarity.

Q: What does it cover?

A: It covers descriptive guidance on life‑cycle processes (planning, requirements, design, implementation, verification, integration, testing, release, maintenance, configuration and problem resolution), process outcomes by safety class, and mappings to ISO/IEC 12207. It is informative guidance, not a replacement of IEC 62304.

Q: Who typically uses it?

A: Software developers, quality and regulatory personnel, process owners, consultants, and educators working on medical device software lifecycle processes and procedure alignment.

Q: Is it current or superseded?

A: IEC TR 80002-3:2014 was withdrawn on 3 November 2023 and is no longer an active IEC document; it should be treated as historical guidance. For current normative requirements consult IEC 62304 (including Amendment 1, 2015) and any later revisions or related IEC/ISO documents. Organizations should verify the latest editions or drafts of IEC 62304 and related TRs when establishing compliance activities.

Q: Is it part of a series?

A: Yes — it is part of the 80002 series of guidance on medical device software (for example IEC TR/ISO TR parts such as 80002-1 and 80002-2 provide complementary guidance on risk management and software validation for quality systems).

Q: What are the key keywords?

A: Medical device software, process reference model, IEC 62304, software life‑cycle, safety classification, ISO/IEC 12207, risk management, verification and validation, configuration management.