Overview of product approvals

EC Declaration of Conformity and CE marking regarding the compliance with safety and quality standards

Manufacturers must control whether the marketed products comply with the applicable product-specific directives of the European Community (EC Directives), in particular with the basic safety requirements. The manufacturer itself is responsible for the control of the conformity, unless EC Directives require to involve a “notified body“, e.g. accredited test centres.

Depending on the product, different EC Directives are applicable, e.g.:

• PED – Pressure Equipment Directive
• ATEX – Product directive for the use in explosive areas
• EMC – Electromagnetic Compatibility Directive

To give you an example, here are some brief explanations regarding the PED Pressure Equipment Directive:

For pressure gauges, the Pressure Equipment Directive of the European Union 92/23/EC is to be applied.

But the issuance of an EC Declaration of Conformity by pressure gauge manufacturers is only required starting from a measuring range of >200 bar. Such devices may then also be marked with CE marking. No CE marking may be applied to pressure gauges <200 bar.

Pressure bearing components such as pressure gauge cocks, pressure gauge valves, siphons and chemical seals up to a connection of DN<25 are products covered by the directive 2/17 §3.3 and subject to the provisions of the „Good Engineering Practice“. No EC Declaration of Conformity and CE marking may be made for these products.

GOST-R Certificate of Conformity and marking
regarding the compliance with safety and quality standards

With just a few exceptions, JAKO products are GOST-R certified and thus meet the requirements for their importinto countries of the Russian Federation. If required by the customer, the respective proof is provided by attaching a certified copy of the original certificate. GOST-R certifications are considered an important quality property not only in Russia or the states of the former Soviet Union, but also in many Eastern and Southeastern European countries.

The GOST-R Certificate of Conformity is valid as proof that all applicable GOST standards for the respective product are met.

The publisher of the GOST standards (comparable with the German DIN or the American ANSI) exists since 1925 and, with headquarters in Moscow, is under the control of the Government of the Russian Federation.  

Currently, there is a certification obligation for goods that are imported into the Russian Federation. The technical contents of this certification obligation are comparable with the CE marking or the ISO and DIN certifications. As Russia does not recognise or only partially recognises the afore mentioned quality standards and norms as such, the conformity of the products to be exported with the Russian standards and regulations must be controlled and certified.

Only notified bodies are allowed to control and issue GOST-R certificates.GOST certificates often are a mandatory element of the required export documents for the Russian customs authorities. For manufacturers holding a one or three-years series certificate, it is sufficient to attach a certified copy of the original certificate.

EC Declaration of Conformity and CE as well as Ex marking
regarding the compliance with safety standards in explosive areas

ATEXis a widely used synonym for the ATEX Directives of the European Community. The term ATEX is derived from the French abbreviation for ATmosphère EXplosible. Currently, there are two directives in the area of explosion prevention and protection:

• the ATEX Product Directive 94/9/EC  - applicable to the manufacturer, e.g. JAKO
• the ATEX User Directive 1999/92/EC – applicable to the plant operator

Both directives are interacting. While the one directive describes how plant operators are to identify their potentially explosive atmospheres, categorise these in hazard zones and set measures for explosion prevention and protection, the other directive sets out how electrical and some non-electrical equipment is to be tested and what conditions it must meet, allowing it to be operated in the respective hazard zones.

ATEX Product Directive 94/9/EC:

The ATEX Product Directive 94/9/EC (unofficially also referred to as “ATEX 95“ because of the relevant art. 95 of the EC treaty on the free movement of goods) of the European Parliament and Council on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres stipulates the rules for the marketing of products used in potentially explosive atmospheres. For the first time, this Directive also included the non-electrical equipment. Thus e.g. rotating couplings may pose ignition risks due to impermissibly high heating.

The purpose of the Directive is to protect people working in potentially explosive atmospheres. Annex II of the Directive contains basic health and safety requirements that must be complied with by the manufacturer and provenwith respective EC Declaration of Conformity procedures.

Since 30 June 2003, only equipment, components and protective systems may be marketed that meet the ATEX Product Directive 94/9/EC.

The classification distinguishes between “equipment” and “components”:

• “Equipment“ means machines, apparatus, fixed or mobile devices, control components and instrumentations thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy and/or the processing of material and which are capable of causing an explosion through their own potential sources of ignition.
   
• “Components“ means any item essential to the safe functioning of equipment and protective systems but with no autonomous function.

ATEX conformity assessment or type examination for JAKO measuring instruments

JAKO dial pressure gauges and dial thermometers without electrical transmitters are mechanical measuring devices without electrical components and sources of ignition as defined by EN 1127-1.

The only potential source of ignition is electrostatically charged dust. This alone, however, does not constitute a prerequisite for being subject to the EC Directive 94/4/EC.

Therefore, no EC Declaration of Conformity and EX markingis required for these products.

ATEX User Directive 1999/92/EC:

The ATEX User Directive 1999/92/EC (also unofficially referred to as „ATEX 137“ because of the relevant art. 137 of the EC treaty) concerns the minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres. This Directive contains basic safety requirements to be implemented by the operator/employer. These include:

• Prevention or limitation of the formation of explosive atmospheres (primary explosion protection)
• Avoidance of effective ignition sources (secondary explosion protection)
• Mitigation of the effects of a potential explosion to a harmless degree (tertiary explosion protection or explosion mitigation measures)
   

SIL2 manufacturer’s declaration as proof for the functional safety risk
of individual components and/or complete systems

The term Safety Integrity Level (SIL) is defined by the standard IEC 61508 (General functional safety) and the standard IEC 61511 (Functional safety in the process industry) as measure for the functional safety in process industry. In sensitive areas, e.g. in energy supply, the safety risk in the event of system failure or failure of individual system components is identified according to this standard. For this purpose, suppliers of system parts or components must carry out and provide a SIL assessment for the individual system components to be supplied. Component manufacturers then have to determine the random failure behaviour of the individual components, e.g. of an inductive contact pressure gauge, on the basis of a FMEDA (Failure Modes, Effects and Diagnostic Analysis). In this process, also statistical values of the individual components and their functional connections are jointly assessed.

FDA approval as proof for health-friendly materials

The Food and Drug Administration (FDA) is the USA’s government agency for food and drug safety. On customer request and depending on the application requirements, JAKO exclusively uses FDA approved materials and substances for the production of the measuring instruments, e.g. FDA approved paraffin oil as fluid damping in dial instruments.

Certificate of conformity and marking
as proof for a hygiene-compatible product and/or machine design

The European Hygienic Engineering & Design Group (EHEDG) is a community of experts made up of machine and component manufacturers, experts from the food industry as well as research institutes and health authorities. The organisation was founded in 1989 with the purpose to raise the awareness of hygiene in the processing and packaging of foodstuffs.

The key task of the EHEDG is to contribute to the hygiene-compatible construction and design in all areas of food production and thus to ensure safe food production. The EHEDG continues to promote the European legislation and its call for the hygienic handling, processing and packaging of foodstuffs with the aid of hygiene-compatible machines as well as in a hygienic environment (EC Directive 2006/42/EC for machines, EN 1672-2 and EN ISO 14159 for hygienic requirements).