IEC 62304 –

medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...

software –

software life cycle A software release life cycle is the sum of the stages of development and maturity for a piece of computer software ranging from its initial development to its eventual release, and including updated versions of the released version to help impro ...

processes is an

international standard international standard is a technical standard developed by one or more international standards organizations. International standards are available for consideration and use worldwide. The most prominent such organization is the International Or ...

published by the

International Electrotechnical Commission The International Electrotechnical Commission (IEC; in French: ''Commission électrotechnique internationale'') is an international standards organization that prepares and publishes international standards for all electrical, electronic and r ...

(IEC). The standard specifies life cycle requirements for the development of

medical software Medical software is any software item or system used within a medical context, such as:reducing the paperwork, tracking patient activity * standalone software used for diagnostic or therapeutic purposes; * software embedded in a medical device (of ...

and software within medical devices. It has been adopted as national standards and therefore can be used as a

benchmark Benchmark may refer to: Business and economics * Benchmarking, evaluating performance within organizations * Benchmark price * Benchmark (crude oil), oil-specific practices Science and technology * Benchmark (surveying), a point of known elevatio ...

to comply with regulatory requirements.

Implications of IEC 62304 for software

The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (

software of unknown pedigree SOUP stands for software of unknown (or uncertain) pedigree (or provenance), and is a term often used in the context of safety-critical and safety-involved systems such as medical software. SOUP is software that has not been developed with a known ...

or provenance). The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.

General requirements

Quality management system A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). I ...

* Risk management *

Software safety classification Software installed in medical devices is assessed for health and safety Occupational safety and health (OSH), also commonly referred to as occupational health and safety (OHS), occupational health, or occupational safety, is a multidiscipli ...

Software development process

* Software development planning * Software requirements analysis * Software architectural design * Software detailed design * Software unit implementation and verification * Software integration and integration testing * Software system testing * Software release

Effect of safety classification on required development process documentation

Software maintenance process

* Establish software maintenance plan * Problem and modification analysis * Modification implementation

Software risk management process

* Analysis of software contributing to hazardous situations * Risk control measures * Verification of risk control measures * Risk management of software changes * Security and reliability through

software quality In the context of software engineering, software quality refers to two related but distinct notions: * Software functional quality reflects how well it complies with or conforms to a given design, based on functional requirements or specification ...

Software configuration management process

* Configuration identification * Change control * Configuration status accounting

Software problem resolution process

* Prepare problem reports * Investigate the problem * Advise relevant parties * Use change control process * Maintain records * Analyse problems for trends * Verify software problem resolution * Test documentation contents

References

External links

* #62304 Regulation of medical devices Software development process Medical software {{software-stub