VDE 0750-101 E DIN EN 62304 2018-06 PDF

Full title and description

STB VDE 0750-101 E DIN EN 62304:2018-06 — Health software / Medical device software — Software life-cycle processes. German/English draft national adoption (E‑DIN) of EN/IEC 62304 describing software life‑cycle requirements for software that is a medical device or an integral/embedded part of a medical device; this draft extended the scope toward “health” software but was issued as a draft and later withdrawn.

Abstract

This document sets out the processes, activities and tasks required for the safe development, maintenance and decommissioning of medical/health software. It defines a lifecycle framework (planning, requirements, design, implementation, verification, release, maintenance, problem resolution and configuration management) and requires integration with risk management practices so that software-related hazards are identified, assessed and controlled. The draft noted an expanded application to health software beyond strictly regulated medical devices, and retained the IEC/EN 62304 approach of software safety classification (Classes A, B, C) and controls for SOUP (software of unknown pedigree/provenance).

General information

• Status: Withdrawn (draft national adoption withdrawn; did not become a final published replacement). For current normative text see DIN EN 62304 (VDE 0750-101) 2016 edition and IEC 62304:2006 + Amendment 1:2015.
• Publication date: 2018-06-01 (June 2018; draft issued 2018-05-18 / published as E DIN EN 62304:2018-06 draft in June 2018).
• Publisher: DIN / VDE (VDE Verlag) — DKE/VDE national committee (DKE/UK 811.3) responsible for the German version.
• ICS / categories: 11.040.01 (Medical equipment); 35.240.80 (Health informatics / IT applications in healthcare).
• Edition / version: E DIN EN 62304:2018-06 (draft national adoption, designation STB VDE 0750-101).
• Number of pages: 190 pages (draft document length).

Scope

The standard covers software life‑cycle requirements for software that is itself a medical device or an integral/embedded part of a medical device, and (per the 2018 draft text) intended to be applicable more broadly to “health” software products. It addresses lifecycle processes from planning, requirements and architecture, through implementation, verification and validation, to release, post‑market maintenance and problem resolution. It does not replace device-level validation and final release requirements for a complete medical device; those remain the responsibility of the overall device manufacturer and applicable regulatory rules.

Key topics and requirements

• Software life‑cycle process model: planning, development, verification, release, maintenance and retirement.
• Software safety classification (Classes A, B, C) based on potential to contribute to hazardous situations and patient harm.
• Risk management integration — linkage with ISO 14971-based risk processes and documentation of risk controls for software hazards.
• Requirements engineering, traceability and rigorous verification/validation practices to demonstrate conformance.
• Configuration management, change control, build/release management and versioning.
• Management of SOUP (software of unknown or uncertain pedigree/provenance) including rationale and testing strategy.
• Maintenance, problem resolution and post‑market support processes (incident handling, corrective actions).
• Documentation and records required for regulatory evidence (plans, design history, test reports, trace matrices, risk files).
• Guidance on qualification of personnel, review activities and supplier controls.
• Interfaces to related topics: usability (IEC 62366), product safety for health apps (EN/IEC 82304-1) and cybersecurity considerations where applicable.

Typical use and users

Used by medical device manufacturers and suppliers (including SaMD developers), software engineers, quality and regulatory affairs teams, notified bodies and testing laboratories. Also used by consultants and auditors to assess software lifecycle compliance, and by product managers and risk engineers to structure development and post‑market activities for medical and health‑related software.

Related standards

IEC 62304 (base international standard) and IEC 62304:2006 + Amendment 1:2015 consolidated; ISO 14971 (risk management for medical devices); IEC/TR 80002-1 (guidance on applying ISO 14971 to software); IEC 62366 (usability engineering); EN / IEC 82304-1 (health software product safety); ISO 13485 (medical device quality management); IEC 60601 series (where software is part of electrical medical equipment); various cybersecurity and software engineering guidance documents used alongside 62304.

Keywords

IEC 62304, EN 62304, VDE 0750-101, STB, medical device software, health software, software life cycle, software safety classification, SOUP, risk management, ISO 14971, verification, validation, configuration management, post-market maintenance.

FAQ

Q: What is this standard?

A: This designation refers to the German draft national adoption (E DIN) of EN/IEC 62304 published as STB VDE 0750-101 E DIN EN 62304 in June 2018. IEC/EN 62304 defines software life‑cycle requirements for medical device software and the draft attempted to broaden applicability to “health” software.

Q: What does it cover?

A: It covers processes and requirements for planning, development, verification, release, maintenance and decommissioning of software used as or in medical/health devices, including software safety classification, integration with risk management, management of SOUP, documentation and traceability requirements.

Q: Who typically uses it?

A: Medical device manufacturers, SaMD developers, software and systems engineers, regulatory and quality professionals, notified bodies, test labs, and consultants responsible for software lifecycle compliance and evidence generation.

Q: Is it current or superseded?

A: The specific E DIN EN 62304:2018-06 draft (STB VDE 0750-101) was withdrawn and did not become a final, active replacement. For current normative requirements refer to DIN EN 62304 (VDE 0750-101) published as the 2016 edition and to IEC 62304:2006 with Amendment 1:2015 (the consolidated international text). If you need to confirm which national edition is currently in force for certification or regulatory submissions, check the latest national standards catalogue or your national standards body for the up‑to‑date status.

Q: Is it part of a series?

A: Yes. IEC/EN 62304 is part of the family of medical device software and safety standards and is commonly used with ISO 14971 (risk management), IEC 62366 (usability), EN/IEC 82304-1 (health software product safety) and supplemental IEC technical reports (for example IEC/TR 80002 series) that provide application guidance.

Q: What are the key keywords?

A: Medical device software, health software, software life cycle, IEC 62304, VDE 0750-101, risk management, SOUP, software safety class, verification and validation, configuration management.