Conformity assessment of pressure equipment

Pressure equipment falls under the harmonized area; these are specified products defined by Act No. 90/2016 Coll. (on the conformity assessment of specified products when placed on the market). The implementing regulation is Government Regulation No. 219/2016 Coll., which took effect on July 19, 2016. Directive No. 2014/68/EU (on the harmonization of the laws of the Member States relating to the making available on the market of pressure equipment) has also entered into full force. The

following applies to pressure equipment under Act No. 90/2016 Coll.:

Only products that meet the requirements of Act No. 90/2016 Coll. and the government regulation issued for its implementation (i.e., No. 219/2016 Coll.) and for which conformity has been assessed may be placed on the market.

After demonstrating conformity, the manufacturer is required, in cases specified by the Government Regulation, to draw up an EU Declaration of Conformity or another document confirming conformity and to affix the CE marking or another specified marking. The manufacturer is required to retain the technical documentation and the Declaration of Conformity to the extent and for the duration specified by the Government Regulation.

The manufacturer of pressure equipment shall provide, in the technical documentation, information regarding compliance with the material specifications under this Directive in one of the following ways:

If so provided by a government regulation, products may be put into service or used, including for the manufacturer’s own use, only if they meet the specified requirements and have been assessed for conformity. Pressure equipment and assemblies whose conformity has been assessed by the user’s testing laboratory must not bear the CE marking.

If a product complies with the requirements of European Union regulations harmonizing the conditions for placing products on the market that apply to the product, public authorities may not, from the perspectives governed by these regulations, prevent its supply to the market within the territory of the Czech Republic.

For the purposes of market surveillance, in cases where pressure equipment or an assembly is subject to several Union harmonization regulations, the information necessary to identify all relevant Union acts should be available in a single EU declaration
of conformity (which may take the form of a dossier consisting of the relevant individual declarations of conformity).

Ensuring the traceability of pressure equipment and assemblies throughout the supply chain helps to simplify and increase the effectiveness of market surveillance. An effective traceability system facilitates the task of market surveillance authorities in tracing economic operators who have placed non-compliant pressure equipment or assemblies on the market.

Member States shall not impede the placing on the market or putting into service of pressure equipment or assemblies covered by Directive 97/23/EC that comply with that Directive and were placed on the market before July 19, 2016.

Certificates and decisions issued by conformity assessment bodies under Directive 97/23/EC remain valid under this Directive.

Pressure equipment is a specified product defined by Act No. 22/1997 Coll., which falls within the harmonized area. Under Act No. 22/1997 Coll., the manufacturer or importer of pressure equipment is required to place only safe products on the market.

Pressure equipment must meet the technical requirements set forth in Annex No. 1 to Government Regulation No. 26/2003 Coll. (the so-called essential requirements). The essential requirements are considered to be met if the pressure equipment and assemblies comply with the safety requirements of harmonized Czech technical standards or, where applicable, foreign technical standards adopting harmonized European standards in the Member States of the European Union (Section 4a of Act No. 22/1997 Coll.). The CE marking is affixed to every pressure equipment or assembly that meets the requirements of this regulation, including conformity assessment procedures, and an EC Declaration of Conformity is attached to them. Directive No. 97/23/EC (on the approximation of the laws of the Member States relating to pressure equipment) has been transposed into Czech legislation as Government Regulation No. 26/2003 Coll. (laying down technical requirements for pressure equipment). This Directive was repealed by Directive No. 2014/68/EU on July 18, 2016 (Directive of the European Parliament and of the Council on the harmonization of the laws of the Member States relating to the making available on the market of pressure equipment).

The legal framework of Act No. 22/1997 Coll. does not provide sufficient scope for the proper transposition of directives developed in accordance with the principles of the New Legislative Framework; therefore, these directives must be transferred to the new Act on Conformity Assessment.

Directive 2014/68/EU has already been partially implemented in Government Regulation No. 26/2003 Coll., which is the implementing regulation for Act
No. 22/1997 Coll. on technical requirements for products. As of July 19, 2016, the new Directive 2014/68/EU must be fully implemented.

Government Regulation No. 26/2003 Coll. regulates the technical requirements for pressure equipment and assemblies with a maximum allowable pressure (PS) greater than 0.5 bar.
The following are considered pressure equipment:

• vessels,
• piping,
• safety and pressure equipment;
• components connected to pressure-bearing parts, such as flanges, sockets, couplings, supports, and lifting eyes.

Classification of
Pressure Equipment Pressure equipment is classified into Categories I through IV in accordance with Annex No. 2 to Government Regulation No. 26/2003 Coll., depending on the increasing degree of hazard. In the case of less hazardous equipment—equipment manufactured in accordance with the good engineering practice of a Member State of the European Union to ensure its safe use (These pressure equipment items or assemblies must be accompanied by instructions for use, and the pressure equipment or assemblies must bear a marking allowing identification of the manufacturer or its authorized representative and must not bear the CE marking.)

Chart 1	Chart 2	Chart 3
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Chart 7	Chart 8	Figure 9

Depending on the category determined in this manner, the manufacturer then selects one of the conformity assessment modules.

Safety equipment is generally classified in Category IV unless it is manufactured to protect specific pressure equipment.

Special provisions apply to assemblies. Assemblies are subject to this three-stage conformity assessment procedure:

1. each piece of equipment comprising the assembly shall be assessed in a manner appropriate to its category;
2. the assembly as a whole, consisting of various parts, shall be assessed (in terms of safe use, correct assembly, and safety during filling and emptying, i.e., in accordance with Sections 2.3, 2.8, and 2.9 of Annex I to Directive 97/23/EC) within the highest category applicable to the relevant equipment (with the exception of safety fittings, whose category is not taken into account when determining the category for this assessment);
3. protection of the assembly against exceeding permissible operating limits (i.e., in accordance with Sections 2.10 and 3.2.3 of Annex I to Directive 97/23/EC) shall be assessed within the highest category applicable to the equipment to be protected.

Pressure equipment or assemblies whose conformity has been assessed by a user testing laboratory must not bear the CE marking. The conformity assessment procedures used by user testing laboratories correspond to procedures A1, C1, F, and G, as described in Annex No. 3 to Government Regulation No. 26/2003 Coll.

Conformity Assessment
Procedures Before placing pressure equipment on the market, the manufacturer shall ensure the conformity assessment of each piece of equipment (Section 12(4) of the Act) using, at their discretion, one of the procedures set forth in Annex No. 3 to Government Regulation No. 26/2003 Coll., depending on the category of the pressure equipment (Section 3 and Annex No. 2 to Government Regulation No. 26/2003 Coll.).
When assessing conformity, a procedure for a higher category may be used, if available. For a description of the modules, see the nlfnorm portal.