Conformity assessment procedure for simple pressure vessels

Requirements effective April 20, 2016:

Simple pressure vessels fall within the harmonized scope; they are specified products as 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. 119/2016 Coll., which took effect on April 20, 2016.

A simple pressure vessel manufactured in series (according to Government Regulation No. 119/2016 Coll.) is considered to be any welded vessel designed to withstand an internal overpressure greater than 0.5 bar, intended for containing air or nitrogen, which is not exposed to a flame, and:

- whose parts and assemblies affecting the strength of the vessel under pressure are made of either unalloyed stainless steel, unalloyed aluminum, or non-hardened aluminum alloys.

The vessel consists

either a cylindrical section of circular cross-section closed at the ends by domed or flat heads coaxial with the cylindrical section, or
two coaxial domed heads.

Its maximum allowable pressure does not exceed 30 bar, and the product of this pressure and the vessel’s volume (P·V) does not exceed 10,000 bar.

The minimum permissible temperature is not lower than -50 °C, and the maximum permissible temperature is:

for steel vessels, not higher than 300 °C; and
for vessels made of aluminum or aluminum alloys, not higher than 100 °C.

Only products that meet the requirements of Act No. 90/2016 Coll. and the government regulations issued for its implementation (i.e., Government Regulation No. 119/2016 Coll.) and for which conformity has been assessed may be placed on the market.
Government Regulation No. 119/2016 Coll. sets out in Annex 1 the essential safety requirements for simple pressure vessels for which the product of PS.V exceeds 50 bar.L. Compliance with the essential technical requirements is demonstrated through conformity assessment procedures.

If a vessel complies with harmonized standards or parts thereof that apply to such vessels and for which references have been published in the Official Journal of the European Union, it is presumed to be in conformity with the essential technical requirements covered by those standards or parts thereof.

To demonstrate conformity, the manufacturer is required to draw up an EU Declaration of Conformity and affix the CE marking (and other specified markings). The manufacturer is required to retain the technical documentation and the Declaration of Conformity to the extent and for the duration specified in Government Regulation No. 119/2016 Coll.

If a container is subject to multiple European Union harmonization regulations requiring the preparation of an EU Declaration of Conformity, a single EU Declaration of Conformity shall be prepared referring to all such regulations, including references to their publication (this may take the form of a file comprising declarations of conformity issued for individual regulations).
By drawing up the EU Declaration of Conformity, the manufacturer becomes responsible for the vessel’s compliance with the requirements set forth in this Government Regulation No. 119/2016 Coll

. Identification of economic operators (i.e., traceability)
Economic operators shall, at the request of the supervisory authority, identify all economic operators who supplied them with a vessel or to whom they supplied a vessel for a period of 10 years after the vessel was supplied to them and for a period of 10 years after they supplied the vessel.

Transitional Provisions
Vessels that meet the requirements of Government Regulation No. 20/2003 Coll., laying down technical requirements for simple pressure vessels, may continue to be placed on the market and put into service provided they were placed on the market before April 20, 2016. Certificates issued by notified bodies pursuant to Government Regulation No. 20/2003 Coll. remain valid under Government Regulation No. 119/2016 Coll.

Member States shall not prevent the placing on the market or putting into service of vessels covered by Directive 2009/105/EC that comply with that Directive and were placed on the market before April 20, 2016. Certificates issued by approved inspection bodies under Directive 2009/105/EC remain valid under this Directive. Union

safeguard procedure concerning vessels that are compliant but nevertheless pose a risk
If a Member State finds that, although a vessel complies with this Directive, it poses a risk to the health or safety of persons, domestic animals, or property, it shall require the relevant economic operator to take all appropriate measures to ensure that the vessel in question, if placed on the market, no longer poses that risk, or to withdraw it from the market or from circulation within a period that the Member State may specify and that is proportionate to the nature of the risk. The economic operator shall ensure that corrective action is taken in respect of all affected vessels that it has supplied throughout the Union. The Member State shall immediately inform the Commission and the other Member States thereof.

Conformity assessment procedures pursuant to Government Regulation No. 119/2016 Coll. and Directive No. 2014/29/EU

Product	Module Conformity Assessment Module	Description of Module
PS.V greater than 50 bar.L	prior to manufacture	EU type examination (Module B)	Conformity to harmonized standards: At the manufacturer’s discretion: 1. assessment of the adequacy of the vessel’s technical design through examination of the technical documentation and supporting evidence without testing a specimen (Module B – design type), or 2. assessment of the adequacy of the vessel’s technical design through review of the technical documentation and supporting evidence and testing of a prototype of the complete vessel that is representative of the intended production (Module B – production type)
PS.V greater than 50 bar.L	prior to manufacture	EU type examination (Module B)	Non-compliance with hEN, or only partial compliance: the manufacturer shall submit for testing a prototype of the complete vessel that is representative of the intended production, along with technical documentation and other supporting documents for the review and assessment of the suitability of the vessel’s technical design (Module B – production type)
PS.For capacities greater than 3,000 bar·L
,
	prior to placing on the market	: Module C1—	conformity to type based on internal production control and supervised testing of vessels (Module C1)
PS.V does not exceed 3,000 bar·L but is greater than 200 bar.L:		Module C1 Module C2	At the manufacturer’s discretion: 1. conformity to type based on internal production control and supervised testing of vessels (Module C1), or 2. conformity to type based on internal production control and supervised inspections of vessels at random intervals (Module C2)
PS.V does not exceed 200 bar.L, but is greater than 50 bar.L,		module C1 module C	At the manufacturer’s discretion: 1. conformity to type based on internal production control and supervised testing of vessels (module C1), or 2. conformity to type based on internal production control (module C)

A) Vessels for which the product of PS.V exceeds 50 bar.L.

When placing vessels on the market

, the manufacturer

shall ensure that these vessels are designed and manufactured in accordance with the essential requirements (as per Annex 1 of Government Regulation No. 119/2016 Coll.), prepare technical documentation (as per Annex 2), and carry out or have carried out the relevant conformity assessment procedure (as per Section 9, and in more detail in Annex 2 of Government Regulation No. 119/2016 Coll.).
If compliance with the essential requirements has been demonstrated, the manufacturer shall draw up an EU declaration of conformity and affix the CE marking and inscriptions in accordance with Annex 3 to Government Regulation No. 119/2016 Coll. The manufacturer shall keep the technical documentation and the EU declaration of conformity for a period of 10 years from the date the vessel is placed on the market.
The vessel or its manufacturer’s label must bear at least the following information:

maximum allowable pressure
(PS in bar)

maximum allowable temperature
(Tmax in °C)

minimum allowable temperature
(Tmin in °C)

vessel capacity
(V in L)

name, trade name or
trademark and address of the manufacturer

type and serial number or batch
designation of the vessel

The manufacturer shall also ensure that clear and comprehensible instructions for use and safety information in the Czech language are provided with the vessels.
The manufacturer shall conduct tests on samples of containers placed on the market and other necessary investigations, and, where necessary, keep records of complaints, non-compliant containers, and containers withdrawn from circulation, and shall keep distributors informed of these activities on an ongoing basis.

The authorized representative

shall keep the EU declaration of conformity and technical documentation available to the supervisory authority for 10 years from the date the container was placed on the market.

Before placing the vessel on the market,

the importer

shall ensure that the manufacturer has carried out the relevant conformity assessment procedure, prepared the technical documentation, affixed the CE marking and the required inscriptions to the vessel, and that the manufacturer has fulfilled the traceability requirements (i.e., type and serial number or batch identification allowing for their identification, contact address). The importer shall ensure that the containers are accompanied by instructions for use and safety information in the Czech language.
The importer shall retain a copy of the EU Declaration of Conformity for the supervisory authority’s records for a period of 10 years from the date the container is placed on the market and shall ensure the submission of the technical documentation.
The importer shall indicate on the container (or in the accompanying document) their name, trade name, or trademark and contact address.
The importer shall conduct tests on samples of containers placed on the market and other necessary investigations, and, where necessary, keep records of complaints, non-compliant containers, and containers withdrawn from circulation, and shall keep distributors informed of these activities on an ongoing basis.

Before placing a vessel on the market,

the distributor

shall verify that the vessel bears the CE marking, is provided with the required inscriptions, is accompanied by the required documents, instructions for use, and safety information, and that the manufacturer and importer have fulfilled their traceability obligations.

B) Vessels with a product of PS.V is 50 bar.L or less

The manufacturer

shall ensure that the vessels are designed and manufactured in accordance with the good engineering practice of a Member State of the European Union and bear the markings specified in Annex No. 3 to Government Regulation No. 119/2016 Coll. The vessel or its manufacturer’s label must bear at least the following information:

maximum allowable pressure
(PS in bar)

maximum allowable temperature
(Tmax in °C)

minimum allowable temperature
(Tmin in °C)

vessel capacity
(V in L)

name, trade name or trademark
, and the manufacturer’s address

;

the type and serial number or batch
designation of the vessel

. The manufacturer shall also ensure that clear and comprehensible instructions for use and safety information in the Czech language are provided with the vessels.

The importer

shall ensure that the containers are designed and manufactured in accordance with the good engineering practice of an EU Member State, are marked in accordance with Annex 3, and that the manufacturer fulfills the traceability requirements (i.e., type and serial number or batch designation enabling their identification, contact address). The importer shall ensure that the containers are accompanied by instructions for use and safety information in the Czech language.

The distributor

shall verify that the container bears the required markings and is accompanied by instructions for use and safety information, and that the manufacturer and importer have fulfilled their traceability obligations.