IEC 82304-1:2016 PDF

Name: IEC 82304-1:2016 — Health software — Part 1: General requirements for product safety
SKU: IEC 82304-1:2016
Price: 35 EUR
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Health software — Part 1: General requirements for product safety

Название (английский):

IEC 82304-1:2016

Health software — Part 1: General requirements for product safety

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 26
Дата публикации:: 31 октября 2016 г.
Издание:: IEC IS 82304 edition 1 version 1
ICS:: 35.080

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Описание (английский):

IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты IEC

Overview

IEC 82304-1:2016 - Health software - Part 1: General requirements for product safety - is an international joint IEC/ISO standard that defines safety and security requirements for software-only health products intended to run on general computing platforms (i.e., without dedicated hardware). The standard focuses on manufacturer responsibilities across the entire software lifecycle: design, development, validation, installation, maintenance and disposal. It clarifies scope (software-only products), limits (embedded software in dedicated medical devices is out of scope), and the need for documented processes to assure product safety.

Key topics and technical requirements

Risk management: All health software requires a risk management process; software that can contribute to hazardous situations must have risk controls to prevent or reduce harm.

Software life-cycle processes: Requirements reference and build on established software development practices (see IEC 62304) to ensure consistent development, verification and maintenance.

Verification and validation (V&V): The standard requires plans, documented verification of requirements, and validation of intended use, including validation reports and re-validation after significant changes.

System and use requirements: Manufacturers must define and verify product use requirements, system requirements, and manage updates and changes.

Identification and accompanying documentation: Products must include identification, instructions for use, and technical descriptions to support safe deployment.

Post-market activities: Obligations include software maintenance, post-market communication, re-validation, decommissioning and disposal processes.

Security and safety alignment: Emphasis on safety and security as complementary requirements for health software products placed on the market.

Practical applications

Use IEC 82304-1 when developing, releasing or maintaining health-related software products such as clinical decision-support apps, patient self-care apps, telehealth software, and software-as-a-medical-service offerings that run on standard PCs, tablets, or smartphones.

Apply the standard to create compliant development policies, V&V plans, risk assessments, user instructions, and post-market surveillance programs.

Helpful for preparing technical documentation for regulators, purchasers, or certification bodies and for aligning product development with recognized safety expectations.

Who should use this standard

Software manufacturers and product managers of health apps and clinical software

Software engineers, QA and validation teams

Regulatory affairs, clinical safety officers, procurement specialists and conformity assessment bodies

Engineers integrating third‑party health software into care pathways

Related standards

IEC 62304 (software life-cycle processes) - referenced for development processes

IEC 60601 series - for combined products where software is part of a physical medical device

Keywords: IEC 82304-1, health software, medical device software, software lifecycle, risk management, product safety, software validation, post-market surveillance, IEC 62304.

IEC 82304-1:2016 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards

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