"Your Product Development in Safe Hands"

Glossary
Useful terminology and acronyms to aid clarity of meaning.

Glossary of Terms

Acronym

Term

Meaning

93/42/EEC

European Union Council Directive

Directive defining and classifying medical devices and procedures for CE marking conformance.

ANC

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.

CMMI

Capability Maturity Model Integration

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

DEF-Stan

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.

DICOM

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.

DSP

Digital Signal Processor

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

FPGA

Field Programmable Gate Array

Semiconductor device containing programmable logic components and programmable interconnects.

HL7

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

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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)

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ISO / IEC 12207: 1995

International Organization Standardization for a system of software life cycle processes updated in 2004. ISO/IEC 12207:2008-1 & -2 can also be applied to military software development and has been used to supersede standards such as MIL-STD-498.

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ISO 13485: 2003

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

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ISO 9001: 2000

International Organization Standardization certification for business quality management systems.

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ISO 26262

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

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IEC 60601

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

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IEC 62304

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

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ISO 14971 / EN 14971

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

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IEC 62366

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

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ISO/IEC 12207:2008

Standard for Systems and software engineering - software life cycle processes.

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IEC 61010-1 / EN 61010

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

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IEC 61508 / IEC 61508

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

iRMX

Intel RMX Operating System

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

LynxOS

Lynx Operating System

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

MIL STD

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.

MISRA

Motor Industry Software Reliability Association.

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

NIC

Network Interface Controller

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

R&D

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.

PACS

Picture Archival & Communication System

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

RIS

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.

RTOS

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.

SPICE

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

VxWorks Operating System

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