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Quotes - Engineering - SalesPressure equipment rules for the European market
Any pressure equipment installed in the European Union or the wider European Economic Area falls under the Pressure Equipment Directive, 2014/68/EU. It is a law, not a design code: it sets the essential safety requirements a vessel must meet and the conformity assessment route the maker must follow, and it is satisfied by designing to a harmonized standard such as EN 13445 or to another recognized code, ASME included, with a demonstration that the essential requirements are met. The result is a CE mark on the nameplate, which is what allows the unit to be installed.
For a sanitary exchanger the process has three steps: classify the unit into a PED category from its pressure, volume and fluid, follow the assessment module that category allows, and mark it. Small units on water may fall below the thresholds entirely; a larger unit on steam will need a notified body involved. Knowing the category early avoids a redesign when the unit is already built.
Category I
- Self-assessed under module A
- Technical file and declaration of conformity
- CE mark, no notified body number
Categories II-IV
- Notified body takes part
- Design examination plus witnessed testing
- Four-digit notified body number beside CE
PED classification and assessment
Classification inputs
- PS: Maximum allowable pressure in bar; each side classified
- V: Volume in liters of the pressure chamber being classified
- Fluid group: Group 1 hazardous (flammable, toxic); Group 2 all others, including water and steam
- State: Gas or liquid at PS; steam and vapors count as gas
- Chart: PS times V plotted on the annex II table for the fluid and state
- Result: SEP, or category I, II, III or IV; the most severe chamber governs
Assessment and marking
- SEP: Sound engineering practice; no CE mark, maker's declaration only
- Category I: Module A, internal production control; CE mark, no notified body
- Category II: Module A2 or D1 or E1; notified body monitors or inspects
- Category III: Modules B plus D, E, F or C2, or H; type or design examination
- Category IV: Modules B plus D or F, G unit verification, or H1; full involvement
- Nameplate: CE mark, notified body number where applicable, PS, TS, V, year
Classify first; the category decides the paperwork
Taking a sanitary exchanger through PED
Classifying the unit
Each pressure chamber of the exchanger is classified on its own: the shell side and the tube side, and on a plate unit each fluid circuit. For each, take the maximum allowable pressure PS in bar gauge, the chamber volume V in liters, and decide the fluid group and state. Sanitary duty is nearly always Group 2: water, milk, juice, wort, glycol and steam are all Group 2. Steam counts as a gas. Multiply PS by V and read the category from the appropriate table in Annex II of the directive. The chamber with the highest category sets the category of the unit.
A small sanitary shell-and-tube unit with 6 bar plant water on one side and 3 bar product on the other, with a few liters per side, usually falls under sound engineering practice or category I. Put 10 bar steam in a large shell and the same unit lands in category II or III.
- Classify each side separately and take the highest
- Steam and vapor are gases for the table, which raises the category
- Fluid group is about the hazard of the fluid, not its cleanliness
Sound engineering practice and category I
Equipment below the category I threshold is designed and built to sound engineering practice: it must be safe, the maker keeps records, but no CE mark is applied and no notified body is involved. Category I is self-assessed under module A: the maker designs to the essential safety requirements, keeps a technical file, issues a declaration of conformity and applies the CE mark, again with no notified body. Many sanitary exchangers on water and low-pressure product fall here.
Categories II to IV and the notified body
From category II upward a notified body, an organization accredited by an EU member state, takes part. The modules describe how: monitoring the maker's quality system, examining the design, or inspecting the finished unit. For a one-off sanitary exchanger in category II or III the common route is a design examination of the drawings and calculations plus inspection and witnessed testing of the unit, after which the notified body's four-digit number goes on the nameplate beside the CE mark. Category IV applies to large steam vessels and is unusual on sanitary duty. The notified body also checks that materials comply, which for stainless means either an EN material grade with an EN 10204 3.1 certificate or a particular material appraisal for an ASTM grade.
PED and ASME on the same unit
A sanitary exchanger that ships to a European plant from a North American shop is commonly designed to ASME Section VIII and assessed under PED with ASME as the design code. The unit may carry both the U-stamp and the CE mark. The main points of friction are materials, where ASTM stainless grades need a particular material appraisal or a dual-certified EN equivalent; the hydrotest pressure, where PED uses 1.43 times PS against ASME's 1.3; and the technical file, which PED requires to be retained by the maker for ten years.
Specifying PED
Give the destination, the PS and TS each side, the fluids, and whether an ASME stamp is also required. The fabricator classifies the unit, names the module and the notified body if one is needed, and quotes the assessment as a line item. Call and talk it through with an engineer: 1-805-484-2992
Common FAQs
No. The CE mark is required for installation in the EU; the U-stamp is required in most US states. A unit installed in Europe needs the CE mark; a unit installed in the US needs the stamp. One that may be moved between them carries both.
No. Group 1 covers fluids classified as flammable, toxic, oxidizing or otherwise hazardous. Food products, water, steam and glycol are Group 2. High-proof ethanol in a distillery condenser can be Group 1.
An independent organization designated by an EU member state to carry out conformity assessment under the directive. Its four-digit number appears beside the CE mark on equipment it assessed.
The UK applies its own Pressure Equipment (Safety) Regulations, which mirror PED, with UKCA marking. Units for the UK are assessed under those rules; the technical work is the same.
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