DEFINITIONS

The CE label

The CE label certifies that basic demands have been met. The CE label must determine a minimum safety standard for technical products in the domestic market and thus contribute to free traffic of goods in Europe. The CE label prevents each European country from issuing individual regulations for technical products.

Companies with the CE label have the advantage that they obtain access to the whole of the domestic market, without having to apply for individual permits from 27 national authorities.

The CE label signifies the manufacturer's responsibility towards the product. With the CE label, he declares that his product complies with all regulations and that its validity has been harmonised with all EU countries as far as his product is concerned. The manufacturer is obliged to carry out a conformity evaluation for products manufactured in the EU, provide technical documentation, submit the EG conformity declaration and attach the CE label to the product.

The CE label shows that the product complies with the safety requirements of the relevant guidelines. The legal principles of CE labelling is comprehensively regulated in the so-called "New Legislative Framework". The harmonised regulations for individual product groups are recorded in the EU guidelines.

GMP-compliant

Good Manufacturing Practise
Guidelines for ensuring the quality of production processes and conditions. It guarantees production quality and compliance with health authority marketing stipulations.

 

EX-zone protection

GDevices can be used in areas that potentially face the risk of gas or dust explosions. Explosion protection for equipment means using constructive measures to prevent high surface temperatures, or the generation of sparks, that could cause combustion during operation.

The EX-symbol shows the device group and category system.
The device group defines whether the device can be used underground (I) or in other areas (II). The device category shows which technical demands must be met by equipment in the particular EX-zone.

In areas at risk of gas explosions, the various explosive sub-groups are differentiated. The gases are classified according to the risk they pose.

LKE products can be used in Zones 1 / 2 and 21 / 22.

Zone 1: this is an area in which a hazardous, potentially explosive atmosphere may occasionally be present during normal operation. Only Category 1 equipment may be used in this zone.                          

Zone 2: this is an area in which a hazardous, potentially explosive atmosphere is rare and is only present temporarily. Category 1 and 2 equipment may be used in this zone.

Zone 21: this is an area in which dusts are occasionally present during normal operation. Only Category 21 equipment may be used in this zone.

Zone 22: in this area, a hazard caused by swirling dust is unlikely during normal operation, or only occurs rarely or temporarily. Only Category 21 and 22 equipment may be used in this zone.

ATEX

ATmosphère EXplosible
Stipulates that the operating safety of equipment and protective systems must be guaranteed in potentially explosive areas.


The 94/9/EG directive is the new European regulation for equipment in potentially explosive areas. It defines the general protective aims (protection of persons and assets).

According to the ATEX directive 94/9/EC, categories 1 to 3 are assigned. The letter "G" stands for Gas, "D" stands for dust. Equipment Protection Levels (EPL) are defined in the IEC 60079-0 as well as in the permit according to the IECEx scheme.


A major difference to the previously valid law is that, for the first time, non-electrical equipment must now also be certified for use in potentially explosive areas. The directive has been binding since July 2003 for all explosion-protected equipment brought into circulation within the European Union.

What is QHD?

QHD
is a two-level testing system for the hygienic structure and cleanability of components, machines and plants for germ-free or sterile applications. (Evidence that the basic principles of hygiene compliant constructions have been observed and easy cleaning is assured).

In Level 1,
the producer refers to the fulfilment of the requirements in the QHD manual, and documents which regulations have been observed during construction.

In Level 2, which may take place in addition to Level 1, the producer can prove cleanability by means of a rapid test. This test can either be carried out by trained personnel at the producer’ s premises using testing equipment that meets the requirements or by an authorised, independent laboratory.

The QHD producer can then document the hygiene-oriented structure and cleanability of components and plant for the first level, or both levels, of QHD with their own certificate.

This QHD self-certification by the producer is product-related. The manufacturer declares, with this, that he has complied with the current state of technology as far as the requirements written in the guidelines are concerned, and that he has conformed to hygiene compliant construction methods.