"Your Product Development in Safe Hands"

Useful terminology and acronyms to aid clarity of meaning.

Glossary of Terms





European Union Regulation

EU Regulation of medical devices replacing the medical device directive (MDR).


European Union Regulation

EU Regulation of In Vitro Diagnostic Devices replacing the In Vitro Diagnostic Directive.


European Union Council Directive

Directive defining and classifying medical devices and procedures for CE marking superseded by mDR.


European Union Council Directive

Directive defining and classifying in vitro diagnostic devices and procedures for CE marking superseded by IVDR.


Active Noise Cancellation, sometimes referred to ANR (Active Noise Reduction)

The technology of cancelling out sound waves by generating an inverse wave sound to neutralise the unwanted noise. There are various techniques for this including feedforward, feedback or combined.


Capability Maturity Model Integration

Created by the Software Engineering Institute (SEI) as a process improvement approach in product development.


UK Defence Standardisation

Standards for working on UK MOD related projects such as DEF Stan 00-56 for Safety Management Requirements for Defence Systems or 59-41 for Electromagnetic Compatibility.


Digital Imaging and Communications in Medicine

The industry standard for radiological image communications, an application-layer protocol that resides at the top several layers of the Open System Interconnect (OSI) reference model for data communications.


Digital Signal Processor

Specialised microprocessor designed specifically for digital signal processing in real time.


Field Programmable Gate Array

Semiconductor device containing programmable logic components and programmable interconnects.


Hospital Level 7

The ANSI standard for information interchange between foreign systems in the healthcare industry. The "7" refers to the fact that the protocol is designed to address the 7th layer of the International Standards Organization's Open System Interconnect mode


Imaging Modalities

Types of medical imaging systems. The best known and most common are X-Ray, CT (Computed Tomography), MRI (Magnetic Resonance Imaging), Ultrasound, NM (Nuclear Medicine) and PET (Positron Emission Tomography)


ISO / IEC 12207

Systems and software engineering standard for Software life cycle processes that defines process for monitoring controlling and improving software development.


ISO 13485

International Organization Standardization certification for quality management systems specifically for medical devices and related systems.


ISO 9001

International Organization Standardization certification for business quality management systems.


ISO 26262

ISO 26262 defines functional safety for automotive equipment applicable throughout the lifecycle of all automotive electronic and electrical safety-related systems.


IEC 60601

A series of standards that detail the requirements for electrical safety for devices coming into contact with patients.


IEC 62304

Standard for Medical device software - software life cycle processes and production control software.


ISO 14971 / EN 14971

Standard for Medical devices - application of risk management to medical devices.


IEC 62366

Standard for Medical devices - Application of usability emgineering to medical devices.


IEC 61010

Standard for safety requirements for electrical equipment for measurement, control and laboratory use.


IEC 61508 / IEC 61508

Standard for Functional safety of electrical, electronic and programmable electronic safety-related systems.


Intel RMX Operating System

Real time computer operating system provided by Intel for x86 microprocessors.


Lynx Operating System

Popular real time Unix computer operating system supported on a range of microprocessors.


Military Standards for US Department of Defence

Standards for working on US Defence related projects such as MIL-STD-498 for Software development and documentation.


Motor Industry Software Reliability Association.

Guidelines for the creation and application of safe, reliable software within vehicles.


Network Interface Controller

Hardware device used to interface computer devices to an Ethernet network.


Picture Archival & Communication System

Industry accepted term used to identify a radiological image storage and distribution system based on film-less communications technology.


Research and Development

Research into the development of new technology products. In the context of this web-site this relates to product electronics and software. Development is the application of engineering and management skills to design and implement a product or sub-system.


Radiology Information System

A system that provides the information management features that hospital Radiology departments need for daily business. Typically includes patient tracking, billing and administrative programs and also may include clinical features.


Real-Time Operating System

A class of operating system intended for real-time applications. Both open source and proprietary systems are available ranging from high level systems such as VxWorks, Windows CE or LynxOS to more device specific systems from device vendors.


Software Process Improvement and Capability determination

An international initiative to support the development of international standards for software processes assessment. Also covers standards for component models for simulations.


VxWorks Operating System

Popular real time computer operating system supported on a range of microprocessors.