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A Glossary of
Regulatory Terms

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ATEX 94/9/EC
One of the European Union (EU) New Approach Directives.  The Equipment and Protective Systems intended for use in potentially explosive atmospheres is commonly referred to as the ATEX Directive.

CDRH
Center for Devices and Radiological Health, FDA

CE Marking
Certification mark for products being shipped into the 27 countries of the European Union.  Products bearing the CE Marking represent that the product meets all applicable 'New Approach' Directives.

Class I / Medical Devices Directive
General unpowered (non-active) devices which do not penetrate the body or non-surgically invasive devices for transient use (less then 60 minutes). Some low risk, powered (active) devices for patient support or examination.

Class IIa / Medical Devices Directive
Generally non-hazardous active therapeutic and diagnostic devices. Low risk, surgically invasive devices for transient use or short term use (up to 30 days).

Class IIb / Medical Devices Directive
Generally potentially hazardous active therapeutic and diagnostic devices (e.g. X-ray sources). Higher risk surgically invasive devices for transient or short term use. Surgically invasive devices for long term or implantable (non-active) use (not more than 30 days).

Class III / Medical Devices Directive
All devices which make contact with the heart, central circulatory system or central nervous system. All long term invasive or implantable devices which have biological effect on the body or are absorbed into it.

CSA
Canadian Standards Association. Similar to Underwriters Laboratories (UL) in the U.S.

EC European Community
This refers to either the 'European Community' or to the 'European Commission', an independent institution that represents and upholds the interests of the European Union as a whole.

EEA European Economic Area
The EEA refers to the European Economic Area which consists of the European Union and all the EFTA countries except Switzerland who have established mutual recognition of regulatory requirements within its boundaries.

EFTA European Free Trade Association
As of today, the EFTA members are Iceland, Liechtenstein, Norway and Switzerland. On October 21, 1991, the EC and EFTA reached an agreement that included the principles of free movement of goods, services, capital and people.

EMAS Eco-Management and Audit Scheme
Is a voluntary initiative designed to improve companies environmental performance.

EMC Directive 2004/108/EC
One of the European Union (EU) 'New Approach' Directives.  The EMC Directive applies to an extensive range of equipment  encompasing electrical and electronic appliances, systems and installations.  The main objective of the Directive is to guarantee the free movement of equipment and to create an acceptable Electromagnetic environment in the Community. 

EN 46000
Is the harmonised standard for quality assurance in medical device manufacture.

EU European Union
The European Union (EU) is a political and economic union of 27 member states. For a full list of member states click here

European Commission
One of the European Unions Institutions. The Commission is responsible for proposing policy and legislation. It is the guardian of all European Treaties and Laws and can initiate action against Member States which do not comply with EU rules.

ISO International Organization for Standardization
A worldwide federation of national standard bodies, founded in Geneva, Switzerland in 1946.

ISO 14000 Known also as BS 7750
It is an international standard covering environmental issues and concerns, such as air emissions, water discharge, wastes, noise, odor, etc.

ISO 9000
Series of international standards that form the foundation and framework for an effective management system within any type of business.

IVD - In Vitro Diagnostic Devices 98/79/EC
One of the European Union (EU) 'New Approach' Directives.  The Directive covers devices used in vitro for the examination of a specimen derived from the human body, including reagents, instruments and specimen receptacles.

Low Voltage Directive (LVD) 2006/95/EC
One of the European Union (EU) 'New Approach' Directives.  It applies to electronic equipment (including electrical apparatus or device) designed or adapted for use with voltage (in the case of alternating current) of not less than 50 volts nor more than 1,000 volts or (in the case of direct current) of not less than 75 volts nor more than 1,500 volts.

Machinery Safety Directive (MSD) 98/37/EC
One of the European Union (EU) 'New Approach' Directives.  Machinery is described as "an assembly of linked parts or components, at least one of which moves joined together for a specific application".

Medical Devices Directive (MDD) 93/42/EEC
One of the European Union (EU) 'New Approach' Directives.  This came into effect on January 1, 1995 and has been enforced since June 15, 1998.

Notified Body
Notified Bodies are appointed by National Government Authorities in each European Member State.  The principal role of a Notified Body is to offer services for conformity assessment on the conditions set out in the 'New Approach' Directives in support of CE Marking.  This normally means assessing the manufacturers conformity to the essential requirements listed in each directive.  The full list of Notified bodies is published in the Official Journal of the European Union (OJEU).

NRTL
Nationally Recognized Testing Laboratories.  The testing laboratories test products and certify if they pass standards tests.

OJEU - Official Journal of the European Union
This is the publication in which all contracts from the public sector which are valued above a certain threshold must be published.

QS 9000
A quality standard written and mandated by the "Big Three" automakers (Chrysler, Ford and General Motors). It was introduced to the industry in 1994.  All suppliers to the automotive industry need to implement a QS9000 system.

Radio & Telecommunications Terminal Equipment Directive (R&TTE) 1995/5/EC
One of the European Union (EU) 'New Approach' Directives.  With the exception of a few categories of equipment, the R&TTE Directive applies to all equipment that uses the radio frequency spectrum.  It also applies to all terminal equipment attached to public telecommunication networks.

Safe
According to the EUs New Approach Directive, safe means that when the machinery or safety component is properly installed and maintained and used for the purposes for which it is intended there is no risk of its endangering the health of or of its being the cause or occasion of death or injury to persons or, where appropriate, to domestic animals or damage to property.

TCF Technical Construction File
One of the conformity assessment routes for meeting the requirements of the Radio & Telecommunications Terminal Equipment Directive (R&TTE). The TCF includes a report or certificate issued by an EU appointed Notified Body.

TF Technical File
For most New Approach Directives, a Technical File is used to demonstrate compliance. This documentation generally contains a description of the apparatus, test reports, and design drawings and specification, etc.

UL
Underwriters Laboratories Inc. (UL) is a U.S. for-profit privately owned and operated product safety testing and certification organization. 

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