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 specifies that these
products should meet essential safety requirements in terms of function,
sterility, material compatibility, marking, 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 1993 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 definition 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 device

which is intended to be totally or partially introduced, surgically or medically,
into the human body or by medical intervention into a natural orifice, and
which is intended to remain after the procedure;

Examples of products within the scope of the Directive include cardiac pacemakers,
neural stimulators and implantable infusion pumps and defibrillators and their
accessories.
Applicable to K0955: No, This directive only applies to an active implantable device.
Chiller is not an implantable device.

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:

New equipment intended for use in explosive atmospheres such as electrical components and
apparatus and machinery.

Separately 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) with 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 Requirements define technical measures for assessment and reduction of explosion risks.
The articles and other annexes define the certification procedures that manufacturers have to apply. These
procedures get stricter with more Notified Body involvement as the likelihood 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 with the Directive can bear the CE and Ex markings;
components do not bear the CE marking. Further markings form a code defining the category and
suitability for different types of explosive atmospheres. A Declaration of Conformity is required.
The ATEX equipment directive is linked to the ATEX Worker Directive 99/92/EC on employers' obligations
to protect workers from explosive atmospheres in work places.

Scope

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

electrical and non-electrical equipment capable of igniting the explosive atmosphere under normal or fault
conditions.
Separately supplied protective systems for fitting to equipment to control unavoidable explosions such as explosion
vents, suppression systems, etc.
safety devices, controlling devices and regulating devices contributing to the safe functioning of equipment and
protective systems such as gas detection systems that de-energise equipment.
components (items essential to the safe functioning of equipment and protective systems but with no autonomous
function) such as electrical components.
Products designed and manufactured for own use are not excluded from the requirements of the ATEX
Directive.
Equipment first used outside the European Union and imported after the 1 July 2003: The Directive applies
to equipment at the moment that it is placed on the European market; products manufactured outside the
European Union and successively imported (whether as new or as used equipment) must comply with the
directive. This duty is placed on the first importer into the Union market.

Applicable to K0955: No, This directive only applies to an active implantable device.
Chiller is not an implantable device.