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CDRH
Center for Devices and Radiological Health, FDA
CE Marking
Approval marking for products being shipped into the 15 countries of the European Union. Products bearing the CE Marking represent that the product meets all applicable New Approach Directives.
Class I
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
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
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
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.
Competent Body
Certification organization appointed by EU member countries to legally assess products of manufacturers following the TCF route of compliance for meeting the EMC Directive.
CSA
Canadian Standards Association. Similar to Underwriters Laboratories in the U.S.
EC-European Community
Originally consisted of 12 member countries. Austria, Sweden and Finland did not join the EC (now the EU) until January 1, 1995.
EEA European Economic Area
The EEA includes EFTA and the EU, who have established mutual recognition of regulatory requirements within its boundaries.
EFTA European Free Trade Association
As of today, Norway, Iceland and Liechtenstein are the remaining EFTA countries. Austria, Finland and Sweden have joined the EU. Switzerland is not a member of the EFTA or the EEA. 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 Environmental Management and Audit System
An environmental standard that many EEA companies have implemented in their business.
EMC Directive
One of the EUs New Approach Directives covering Electromagnetic Compatibility. Provides protection (immunity) to electronic equipment from interference (emissions) from other electronic equipment. An example of interference would be when a television set produces electronic waves (fuzz) on the tube when a vacuum cleaner or blow dryer is running close by. Products needing to meet this directive had to do so by January 1, 1996.
EN 46000
The standard to which the Medical Notified Body will audit. Includes ISO 9000 (or EN 29000) and specific medical requirements.
EU European Union
A regional economic and political organization with a combined GDP of more than 7 trillion US Dollars and a population of 370 million. Its 15 members are Belgium, The Netherlands, Ireland, United Kingdom, Luxembourg, France, Portugal, Spain, Italy, Greece, Austria, Germany, Denmark, Sweden and Finland.
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.
Low Voltage Directive
One of the EUs New Approach Directives, mandated January 1, 1997. It applies to electronic equipment (including electrical apparatus or device) designed or adapted for use with voltage (in the case of alternating current) of nor 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 Directive
One of the EUs New Approach Directives, mandated January 1, 1995. This directive applies to machinery with interchangeable equipment or moving parts that may pose a mechanical hazard to the user.
Notified Body
Certification organization appointed by EU member countries to perform formal audits of products and quality systems for many of the EUs New Approach Directives. A Notified Body is appointed to a particular directive. For example, a Notified Body for the MDD may not necessarily be a Notified Body for the Low Voltage Directive as well. The names of all Notified Bodies are published in the Official Journal of the European Communities.
QS 9000
A quality standard written and mandated by the Big Three automakers (Chrysler, Ford and General Motors) for their first-tier supplies. Deadlines for meeting this standard are December 31, 1997 for General Motors and July 31, 1997 for Chrysler. Ford has not yet set a deadline.
Safe
According to the EUs New Approach Directive, safe means that when the system is installed, maintained and used for the purposes it is intended, there is no risk of it endangering the health of or of its being the cause 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 EMC Directive. The TCF includes a report or certificate issued by an EU appointed Competent 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.
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