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Active Implantable Medical Devices Directive

Summary

This directive applies only to active implantable devices. To be classed as

such a device must rely on a power source not provided by the body or

gravity and be designed to be introduced into the body with the intention

to remain there following the procedure. The Directive species that these

products should meet essential safety requirements in terms of function

sterility material compatibility mar!ing user instructions and design

documentation. In addition there are requirements for type approval

production quality management clinical investigation and manufacturer

registration. The Directive came into force in "##$ and all equipment

within the scope must comply.

Scope

The Directive applies only to active implantable devices - all non active devices

medical devices are (or will be) covered under one of two other Directives - the

Medical Devices Directive and the (proposed) In Vitro Diagnostic Devices Directive.

The denition of an active implantable medical device given in the Directive is as

follows!

%active medical device%means any medical device relying for its

functioning on a source of electrical energy or any source of power other than

that directly generated by the human body or gravity"

%active implantable medical device%means any active medical devicewhich is intended to be totally or partially introduced# surgically or medically#

into the human body or by medical intervention into a natural orice# and

which is intended to remain after the procedure"

$%amples of products within the scope of the Directive include cardiac pacema&ers#

neural stimulators and implantable infusion pumps and debrillators and their

accessories.

'pplicable to *++! ,o# This directive only applies to an active implantable device.

hiller is not an implantable device.

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ATEX directive - Electrical and mechanical equipment for

use in explosive atmospheres

Summary

The ATEX Directive requires equipment and protective systems intended for explosive atmospheres to be

designed and manufactured to minimize the occurrence and limit the severity of accidental explosions.

It applies to

!e" #equipment$ intended for use in #explosive atmospheres$ such as electrical components and

apparatus and machinery.

%eparately supplied protective systems for controlling unavoidable explosions in explosive

atmospheres such as explosion vents& suppression systems& etc.

An #explosive atmosphere$ is a mixture of flammable substances 'gases& vapours& mists or dusts( "ith air&

under atmospheric conditions capable of causing a hazardous explosion if ignited.

#Equipment$ is equipment capable of igniting the explosive atmosphere under normal or fault conditions. It

is divided into electrical and non)electrical equipment.

The Essential *equirements define technical measures for assessment and reduction of explosion ris+s.

The articles and other annexes define the certification procedures that manufacturers have to apply. These

procedures get stricter "ith more !otified ,ody involvement as the li+elihood of an explosive

atmosphere increases 'that is& according to their category.( They also give requirements for governments

to implement and enforce the directive.

Equipment and protective systems that comply "ith the Directive can bear the -E and Ex mar+ings

components do not bear the -E mar+ing. /urther mar+ings form a code defining the category and

suitability for different types of explosive atmospheres. A Declaration of -onformity is required.

The ATEX equipment directive is lin+ed to the ATEX 0or+er Directive 112132E-on employers4 obligations

to protect "or+ers from explosive atmospheres in "or+ places.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:023:0057:0064:en:PDFhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:023:0057:0064:en:PDFhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:023:0057:0064:en:PDF

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Scope

This Directive applies to equipment and protective systems intended to operate within an explosive atmosphere:

electrical and non-electrical equipment capable of initin the explosive atmosphere under normal or fault

conditions!

"eparately supplied protective systems for fittin to equipment to control unavoidable explosions such as explosion

vents# suppression systems# etc!

safety devices# controllin devices and reulatin devices contributin to the safe functionin of equipment and

protective systems such as as detection systems that de-enerise equipment!

components $items essential to the safe functionin of equipment and protective systems but with no autonomous

function% such as electrical components!

5roducts designed and manufactured for 6o"n7 use are not excluded from the requirements of the &T'(

Directive!

Equipment first used outside the European 8nion and imported after the 9 :uly 3;;