Key A domestic wastewater 1 prefabricated septic tank B septic tank effluent 2 soil infiltration system C treated infiltrated effluent 3 packaged and/or site assembled domestic wastewate
Terms and definitions
For the purposes of this document, the terms and definitions given in EN 12566-3:2016,
EN 12566-6:2016, EN 16323:2014 and the following apply
3.1.1 tertiary treatment additional treatment process which results in further purification than that obtained by applying primary and secondary treatment
It is advisable to use specific expressions for treatment processes, such as nitrogen removal, phosphorus removal, polishing effects, and suspended solid removal, as tertiary treatment can sometimes be integrated with secondary treatment.
3.1.2 packaged unit prefabricated factory-built unit
3.1.3 site assembled unit unit composed of prefabricated components assembled on site coming from one manufacturer
3.1.4 biological processes processes in which the treatment is mainly carried out by micro-organism activity
3.1.5 physical processes processes in which the treatment is mainly carried out by using the physical properties of a media
3.1.6 chemical processes processes in which the treatment is mainly carried out by the addition of chemical agents
3.1.7 electrical processes processes in which the treatment is mainly carried out by the use of electricity
3.1.8 product family group of products in which, for the purpose of evaluation, the selected property(s) is/are similar for all products within the group
The definition of family encompasses products that share similar shapes, equipment, materials, and end-use conditions, ensuring a minimum level of hydraulic efficiency and structural performance across the entire range.
Note 2 to entry: The minimum level of performance (hydraulic efficiency and structural behaviour) are given by the test carried out on one model of the family
A tertiary treatment retrofit unit is designed to be installed within an existing package or site-assembled domestic wastewater treatment plant, adhering to the standards set by EN 12566-3 This unit enhances the capabilities of a secondary treatment system, ensuring improved wastewater management and compliance with environmental regulations.
EN 12566-6 or a pre-treated effluent filtration system in accordance with CEN/TR 12566-5
When a retrofit unit impacts the declared performance of an EN 12566–3 or EN 12566–6 unit, the entire system must undergo testing to ensure compliance with the applicable standard.
3.1.10 nominal designation expressed as an integer giving the maximum number of population equivalent appropriate to the plant
Symbols and abbreviated terms
The following symbols and abbreviations are used in this standard:
BOD5 (or BOD7) Biochemical oxygen demand at 5 days (or 7 days)
EPDM Ethylene Propylene Diene Monomer
Design
General
Tertiary treatment units shall be designed to be structurally stable with the expected loads for the intended use In addition, the units shall be durable, watertight and corrosion resistant
In the event of electrical, mechanical, or hydraulic malfunctions that may cause unit failure, an alarm must be installed to signal such issues The effectiveness of this alarm will be confirmed as outlined in Table A.2.
Overall dimensions
The overall dimensions of the prefabricated tertiary treatment unit (i.e height, width, length, diameters, etc.) shall be measured and declared together with a tolerance
Assessment of overall dimensions shall be done by measurement with accuracy of ± 0,5 % of the dimension.
Inlets, outlets, internal pipework and connections
The technical documentation must specify the nominal diameters for the inlet and outlet pipework of the prefabricated tertiary treatment unit It is essential that the hydraulic design, internal pipework, and connections are engineered to prevent any accidental back-flows, blockages, or surcharging during the plant's normal operation.
Inlet and outlet pipes shall be compatible with standardised pipe systems
Assessment of inlets, outlets, internal pipework and connections shall be done by measurement with accuracy of ± 0,5 % of the dimension.
Access
The prefabricated tertiary treatment unit shall be designed to restrict unauthorised access (e.g locking mechanism)
The unit's design must ensure accessibility for routine maintenance, including sampling, sludge removal, and cleaning A minimum opening dimension of 400 mm is required, whether in length for rectangular sections or diameter for circular sections However, for open units, access is not necessary.
For installation purposes of open units, there may be local regulations for maintenance access
NOTE 1 For installation purposes of open units, there may be local regulations for maintenance access
NOTE 2 The requirements to provide facility for the access of a person into the plant may depend on applicable regulations, valid in the member state for the intended end use conditions For example, the minimum dimension of the opening for the access of a person in EN 476 is 600 mm
Extension shafts, where applicable, and access covers of the prefabricated tertiary treatment unit shall be designed to be fit for purpose
The access dimensions shall be declared Assessment of access dimension shall be done by measurement with accuracy of 0,5 % of the dimension
The plant shall be designed to restrict unauthorized access by one of the following means: a) mass of the individual covers; b) securing feature; or c) locking accessory
Where a locking accessory or securing feature is used, it shall be designed so that the cover cannot be easily opened with objects readily accessible by children.
Load bearing capacity
For units not including a tank, load bearing capacity assessment is not required
The mechanical characteristics of tank materials, essential for calculating load-bearing capacity, must adhere to the test methods and values specified in EN 12566-3:2016, Annex D.
The prefabricated tertiary treatment units shall resist the loads resulting from handling, installation and use including desludging and maintenance, for their design life
When tested according to 5.1, the load bearing capacity is declared as:
— maximum allowed height of backfill (m);
— possibility to install the unit in water table or not, expressed as WET or DRY, respectively.
Tertiary treatment efficiency
For the purpose of determination of the tertiary treatment efficiency the tertiary treatment unit shall be determined by testing in accordance with Annex A
The tertiary treatment process significantly impacts BOD5, BOD7, COD, SS inlet concentrations, nitrogen parameters, and total phosphorus levels, and any such effects must be clearly reported.
All parameters relevant for the treatment process of upstream units according to EN 12566-3 or
EN 12566-6 shall be measured even if not declared by the manufacturer for CE-marking
The tertiary treatment efficiency shall be expressed in terms of tertiary treatment efficiency ratios with the indication of the organic load tested and the parameter to be reduced
In addition, the number of desludging procedures carried out during the test according to Annex A, shall be declared
Each tertiary treatment efficiency ratio shall be calculated according to 5.2.
Watertightness
The tertiary treatment unit shall be watertight It shall be tested according to 5.3
For units not including a tank, watertightness test is not required.
Power consumption
The power consumption of the unit shall be declared according to 5.4
The declared power consumption value shall be higher or equal to the measured value during the test in A.2.4.4.
Durability
General
The prefabricated tertiary treatment units, including all their internal components, shall be manufactured from materials that make them, from the durability aspects, suitable for use in a domestic wastewater environment
Materials of the other components of the unit (i.e filter material, pump, etc.) shall be in accordance with the specifications given by the manufacturer to the material/component supplier.
Concrete, steel, PVC-U, PE, GRP, PDCPD and flexible sheets
For concrete, steel, PVC-U, PE, GRP, PDCPD tank and flexible sheets (i.e the parent material and the coatings, where relevant) the material shall comply with EN 12566-3:2016, 4.5.2 to 4.5.9, as appropriate.
Reaction to fire
General
When utilizing a prefabricated tertiary treatment unit, compliance with national fire reaction regulations is essential The fire performance of the unit must be classified according to EN 13501-1, either as Class A1, which does not require testing if it meets specific criteria, or as a class determined by testing the materials used in the unit.
NOTE In most cases Class E is considered to be sufficient as a minimum regulatory requirement for the reaction to fire performance of units used in buried (i.e underground) applications
In cases where a unit is not governed by national fire reaction regulations, it may be classified as either a specific class based on criteria a) or b), or labeled as "No Performance Determined" (NPD).
Units classified as Class A1 without the need for testing
The fire performance classification of a unit can be declared as Class A1 without testing if all materials used in the tank contain no more than 1% of uniformly distributed organic material, based on either mass or volume, whichever is more stringent.
Precast reinforced concrete and steel used in prefabricated tertiary treatment units typically contain organic materials at levels below 1% Due to their low combustibility, these materials can be classified as class A1 for fire performance without the need for testing Additionally, any external coatings applied to the tank's surface are made of inorganic materials, also classified as class A1, provided they have a thickness of at least 1.0 mm or a mass per unit area of 1.0 kg/m².
Units classified according to the test results
To assess the fire performance of a unit, all constituent materials, including any surface coatings, must be classified according to EN 13501-1 Only the lowest classification among these materials will be declared The classification for each material is determined through specific test methods outlined in the standards referenced in EN 13501-1.
A constituent material of a unit is defined as a material that can significantly influence the unit's fire reaction performance As outlined in EN 13501-1, this definition applies in specific circumstances.
— homogeneous unit: its material; or
A non-homogeneous unit is defined by its substantial component, which is a material that forms a significant part of the unit Specifically, a layer qualifies as a substantial component if it has a mass per unit area of at least 1.0 kg/m² or a thickness of at least 1.0 mm.
This article discusses the relevance of various materials used in tank construction, including unplasticised polyvinylchloride (PVC-U), polyethylene (PE), glass reinforced polyester (GRP-UP), polypropylene (PP), and polydicyclopentadiene (PDCPD) It also addresses containers made from flexible sheets such as HDPE, PP, PVC, or EPDM, with or without surface coatings.
Test specimens used for the test methods, applicable for this classification, shall be prepared according to EN 13501-1 and to the relevant standards referred therein.
Dangerous substances
National regulations on dangerous substances may require verification and declaration on release, and sometimes content, when construction products covered by this standard are placed on those markets
In the absence of European harmonized test methods, verification and declaration on release/content should be done taking into account national provisions in the place of use
An informative database on European and national regulations regarding dangerous substances can be found on the Construction website at EUROPA.
1) See Decision of the Commission 96/603/EC of 1996-10-04 (see OJEU L 267 of 1996-10-19), as twice amended by 2000/605/EC of 2000-09-26 ( see OJEU L 258 of 2000-10-12 ) and by 2003/424/EC of 2003-06-06 ( see OJEU L 144 of 2003-06-
Load bearing capacity
Generals
The mechanical characteristics of tank materials, essential for calculating load-bearing capacity, must adhere to the test methods and values specified in EN 12566-3:2016, Annex D.
For buried installation, the load bearing capacity of the prefabricated tertiary treatment unit (i.e of the tank of this unit) shall be established:
— either by calculation with the knowledge of basic data for material and loads (see 5.1.2);
— or by test directly on the tank of the unit (see 5.1.3)
When installing prefabricated tertiary treatment units with watertight extension shafts or in water tables, it is essential to consider the maximum installed depth's relevant loads and conduct tests or calculations to verify the unit's load-bearing capacity For units designed solely for non-buried conditions, their load-bearing capacity should be evaluated through calculations only.
For a unit with the container made of flexible sheets, the pit test only shall be used.
Load bearing capacity determined by calculation
One of the following two methods may apply:
— method 1: Indirect method usable for all materials by declaring the following parameters:
— geometrical data of the plant: e.g wall thickness, distance of ribs, shape;
— properties of the materials and components: All parameters given in chapter durability (see 4.5 and Annex D of EN 12566-3:2016)
The manufacturer shall provide in the installation instructions the height of backfill and the maximum height of water table for installation
— Method 2: Directly declaring the performance using the applicable Eurocode:
— Eurocode 2 (EN 1992-1-1) for concrete (where applicable);
— Eurocode 3 (EN 1993-1-1) for steel (where applicable)
The manufacturer will deliver calculation results in accordance with the relevant Eurocode, detailing the height of backfill and the feasibility of installing the plant on either a wet or dry site, along with the water table height measured from the plant's base.
When Method 1 is employed for assessing load-bearing capacity, the notified body verifies the product's dimensions and material properties In contrast, when Method 2 is utilized, the notified body validates the input data for calculations, reviews the calculations, and confirms the results of the Initial Type Test (ITT) report.
Calculation of backfill loads shall be carried out according to EN 12566-3:2016, 5.1.2.2
A vertical and a horizontal component of the hydrostatic loads shall be calculated according to
For pedestrian loads, a value of 2.5 kN/m² should be used in calculations when the backfill height (h) is 1 meter or less When the height exceeds 1 meter, pedestrian loads can be disregarded in calculations, as they are considered negligible compared to other loads.
Load bearing capacity determined by testing
The load bearing capacity of the prefabricated tertiary treatment unit shall be established by the crushing resistance or maximum load deformation according to EN 12566-3:2016, Annex C
The test results shall ensure that the load bearing capacity under the declared height of backfill is ensured
According to C.5 of EN 12566-3:2016, the unit must be installed following the manufacturer's specifications regarding the maximum allowable height of backfill, as well as the option to install the system in either wet or dry conditions.
— C.2.1 and C.2.2 of EN 12566-3:2016 (crushing resistance test), the height of backfill shall be the minimum of H1 or H2 calculated according to Table 1;
— C.4 of EN 12566-3:2016 (vacuum test), the height of backfill shall be the minimum of H1 or H2 calculated according to Table 2
Table 1 — Formulae for height of backfill calculation after crushing resistance test
F is the crushing load (kN);
S 1 is the horizontal surface of the plant (m 2 );
H W is the height of the groundwater table measured from the bottom of the plant (m);
H 1 is the height of backfill (m)
F is the crushing load (kN);
S 2 is the lateral surface of the plant (m 2 );
H W is the height of the groundwater table measured from the bottom of the plant (m);
H p is the height from the bottom to the top of the plant (m) (extension shaft excluded);
H 2 is the height of backfill (m)
Table 2 — Formulae for height of backfill calculation after vacuum test
H W is the height of the groundwater table measured from the bottom of the septic tank (m);
H 1 is the height of backfill (m)
P is the underpressure (kPa) (see
EN 12566–3:2016, C.4); f is the coefficient (see
H W is the height of the groundwater table measured from the bottom of the septic tank (m);
H p is the total height of the septic tank (m);
H 2 is the height of backfill (m)
For open prefabricated tertiary treatment unit, the pit test shall only be used (see example in Figure 3)
Figure 3 — Pit test for open unit
Tertiary treatment efficiency
For the purpose of determination of the tertiary treatment efficiency the tertiary treatment unit shall be determined by testing in accordance with Annex A
Each tertiary treatment efficiency ratio shall be calculated using the following formula:
R TT is the tertiary treatment efficiency ratio for a given parameter (e.g BOD5 or BOD7, Total P, Total N);
Pt i is the figure of the given parameter at the inlet of the tertiary treatment unit;
Pt o is the figure of the same given parameter at the outlet of the tertiary treatment unit.
Watertightness
For units including tank(s), the tank(s) shall be tested according to EN 12566-3:2016, Annex A, and meet the requirements of EN 12566-3:2016, 4.4
For open prefabricated tertiary treatment units, the watertightness test shall be done by filling the unit up to the maximum height after sealing the apertures.
Power consumption
The power consumption shall be measured during the test described in Annex A, expressed as the consumption for the normal operating conditions (nominal sequences of the test) in kWh/d
Assessment of power consumption shall be done by measurement with accuracy of ± 5 % of the result
6 Assessment and verification of constancy of performance – AVCP
General
The compliance of the small wastewater treatment plant with the requirements of this standard and with the performances declared by the manufacturer in the DoP shall be demonstrated by:
— determination of the product type;
— factory production control by the manufacturer, including product assessment
The manufacturer shall always retain the overall control and shall have the necessary means to take responsibility for the conformity of the product with its declared performance(s).
Type testing
General
Manufacturers must determine all performance characteristics outlined in this standard when declaring their respective performances, unless the standard allows for declarations without testing, such as utilizing existing data, CWFT, or conventionally accepted performance metrics.
Previous assessments conducted in line with this standard may be considered valid if they were executed using the same or a more stringent testing method, under the same AVCP system, and pertain to the same product or products with similar design, construction, and functionality, ensuring that the results are relevant to the product in question.
NOTE 1 Same AVCP system means testing by an independent third party, and for reaction to fire under the responsibility of a notified product certification body (only for products covered by system 1+ and 1)
For assessment purposes, products from the same manufacturer can be categorized into families, where the characteristics of one or more products are deemed representative of those same characteristics across all products within that family.
NOTE 2 Products may be grouped in different families for different characteristics
Reference to the assessment method standards should be made to allow the selection of a suitable representative sample
In addition, the determination of the product type shall be performed for all characteristics included in the standard for which the manufacturer declares the performance:
— at the beginning of the production of a new or modified small wastewater treatment plant (unless a member of the same product family); or
— at the beginning of a new or modified method of production (where this may affect the declared properties);
Changes in the design of small wastewater treatment plants, raw materials, component suppliers, or production methods must be reflected in the relevant characteristics This is essential whenever such changes significantly impact one or more of these characteristics, in accordance with the definition of a product family.
When components are utilized with predefined characteristics established by the manufacturer through assessments based on other product standards, there is no need for re-evaluation of these characteristics It is essential to document the specifications of these components.
Products with regulatory markings that comply with relevant harmonized European specifications are assumed to meet the performance claims stated in the Declaration of Performance (DoP) However, this assumption does not absolve small wastewater treatment plant manufacturers from their responsibility to ensure that the entire plant is properly manufactured and that all component products meet the declared performance values.
Test samples, testing and compliance criteria
The number of samples of small wastewater treatment plant to be tested/assessed shall be in accordance with Table 3
Table 3 — Number of samples to be tested and compliance criteria
Characteristic Requirem ent clause Assessment method Number of tests/ samples Compliance criteria
Overall dimensions 4.1.2 4.1.2 Each product of the family Dimensions Inlets, outlets and connections 4.1.3 4.1.3 Each product of the family Dimensions
Access 4.1.4 4.1.4 Each product of the family Dimensions
4.3 5.2 and Annex A Onea product from the family
Declared values for ratios for required parameters and desludging frequency during the test
7 Clause 7 Each product of the family Declared value (in m 3 /day) for the tested product
Check that the manufacturer’s scaling rules applicable to all products of the family exist
Maximum hydraulic volume per unit of time g
7 Clause 7 Each product of the family Declared value (in m 3 /unit of time) for the tested product
Check that the manufacturer’s scaling rules applicable to all products of the family exist
Nominal daily load of the declared parameter
7 Clause 7 Each product of the family Declared value (in kg/day) for the tested product
Check that the manufacturer’s scaling rules applicable to all products of the family exist
3:2016, Annex A Each unit in the product family Pass/fail
4.2 5.1.2 Oneb product from the family Declared design loadsc and value for the max depth of backfill (in m)
For assessment according to calculation method 1, calculation is not part of ITT
Load bearing capacity, tested 4.2 5.1.3 and
Oneb product from the family Declared valuec or e according to test result or “Pass/fail” d and value for the max depth of backfill (in m)
Power consumption 4.5 5.4 One unit of the family Declared value: power consumption (in kWh/d) during normal operating conditions (nominal sequences)
Durability f 4.6 4.6.1 to 4.6.2 - Declared value according to material used and test method or
Reaction to fire 4.7.2 - Each material Declared class A1 (CWT)
4.7.3 According to standards referred in 4.7.3
Declared the lowest class acc to
EN 13501–1 of the relevant material
As relevant according to the substances and the intended place of use
When selecting materials for testing, manufacturers should identify the worst-case product for tertiary treatment efficiency and load-bearing capacity based on scaling rules Typically, the smallest product is deemed the worst case for treatment efficiency, while the largest is considered for load-bearing capacity, both of which must be verified according to these rules Additionally, the loads at the maximum depth of backfill above the unit must be factored into tests or calculations Requirements and test methods should align with the material used for the tank, and state-of-the-art test methods must be applied to the materials and components, including corrosion protective coatings Finally, the worst-case scenario for maximum hydraulic flow should be quantified in litres per second (l/s) over a specified timeframe, such as 0.6 l/s in 15 minutes.
Test reports
Test reports documenting the determination of the product type must be retained by the manufacturer for a minimum of 10 years following the last production date of the associated small wastewater treatment plant.
Shared other party results
A manufacturer can leverage product type determination results obtained from another source, such as another manufacturer or a product developer, to support their own performance declaration for a product that shares the same design, dimensions, raw materials, constituents, and manufacturing methods, as long as certain conditions are met.
— the results are known to be valid for products with the same essential characteristics relevant for the product performance;
The other party responsible for determining the product type has agreed to provide the manufacturer with the test results and report necessary for product type determination This includes essential information about the product's performance characteristics, as well as details regarding production facilities and the production control process relevant for Factory Production Control (FPC).
— the manufacturer using other party results accepts to remain responsible for the product having the declared performances and he also:
The product must maintain the same performance characteristics as the one evaluated for product type determination, ensuring no significant differences in production facilities or the production control process compared to the original product.
A copy of the product type determination report must be maintained, which includes essential information for verifying that the product is manufactured in accordance with the same design, using identical raw materials, components, and manufacturing methods.
Cascading determination of the product type results
Certain construction products are provided by companies known as "system houses," which supply some or all components to an assembler The assembler then manufactures the finished product in their factory based on an agreement.
A system house, legally established for manufacturing or assembling products, can assume responsibility for defining the product type based on key characteristics of an end product This end product is then manufactured or assembled by other companies in their own facilities.
The system house must provide an "assembled product" that includes components produced by itself or by other manufacturers This product will undergo a type determination process, and the resulting product type report will be made accessible to the assemblers, who are the actual manufacturers responsible for the product being marketed.
In addressing this situation, the cascading determination of product type should be included in the technical specifications, particularly for characteristics that involve the participation of a notified product certification body or a notified test laboratory.
The product type report obtained by the system house from a notified body can be utilized for regulatory marking by assemblers without needing to re-engage a notified body for the determination of essential characteristics that have already been tested, as long as certain conditions are met.
The assembler produces a product using the same combination of components and assembly methods as specified in the product type report obtained by the system house If the report is based on a component combination that does not accurately represent the final market-ready product, or if the assembly deviates from the system house's instructions, the assembler must submit the finished product for a new product type determination.
— the system house has notified to the manufacturer the instructions for manufacturing/assembling the product and installation guidance;
The manufacturer is responsible for ensuring the product is assembled correctly, following the provided manufacturing and assembly instructions, as well as the installation guidance communicated by the system house.
A written agreement, such as a contract or license, must clearly outline the responsibilities and liabilities of both the component producer (system house) and the assembler of the finished product.
The manufacturing and assembly instructions, along with installation guidance provided by the system house, are essential components of the assembler's Factory Production Control system and play a crucial role in the formulation of the product type report.
The assembler must maintain documented evidence that the combination of components and manufacturing methods used align with the product type report obtained by the system house It is essential for the assembler to keep a copy of this determination report for reference.
The assembler is responsible for ensuring that the product meets the declared performance standards, encompassing both its design and manufacture This responsibility remains intact regardless of any agreements made with the system house regarding liability under private law, particularly when the assembler affixes the regulatory marking to the product.
Factory production control
General
The manufacturer shall establish, document and maintain an FPC system to ensure that the products placed on the market comply with the declared performance of the essential characteristics
The FPC system will include established procedures, routine inspections, and assessments to effectively manage and control raw materials, components, equipment, the production process, and the final product.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic manner in the form of written policies and procedures
This factory production control system documentation aims to establish a shared understanding of performance evaluation, ensuring that the required product standards are met It facilitates the effective operation of the production control system, allowing for thorough checks on product performance Ultimately, factory production control integrates operational techniques and measures necessary for maintaining compliance with the declared essential characteristics of the product.
In case the manufacturer has used shared or cascading product type results, the FPC shall also include the appropriate documentation as foreseen in 6.2.4 and 6.2.5.
Requirements
The manufacturer must ensure the effective implementation of the FPC system according to the product standard It is essential to document the tasks and responsibilities within the production control organization and maintain this documentation regularly.
The roles and responsibilities of personnel involved in managing, executing, or verifying work that impacts product consistency must be clearly defined This is especially crucial for those tasked with initiating preventive measures against product inconsistencies, addressing issues when they arise, and identifying and documenting problems related to product consistency.
Personnel involved in tasks that impact product performance must possess the necessary education, training, skills, and experience, with proper records maintained to ensure their competence.
In each factory the manufacturer may delegate the action to a person having the necessary authority to:
— identify procedures to demonstrate constancy of performance of the product at appropriate stages;
— identify procedures to correct instances of non-constancy
The manufacturer must create and maintain up-to-date documentation for factory production control (FPC) that aligns with the product and manufacturing process The FPC system should instill confidence in the product's consistent performance by preparing documented procedures and instructions that meet technical specifications, effectively implementing these procedures, recording operations and their outcomes, and utilizing the results to address deviations, rectify non-conformities, and, if needed, revise the FPC to eliminate the causes of performance inconsistencies.
In subcontracting scenarios, the manufacturer must maintain overall control of the product and ensure access to all necessary information to meet responsibilities as outlined by this European standard.
When a manufacturer outsources any aspect of a product's design, manufacturing, assembly, packing, processing, or labeling to a subcontractor, the subcontractor's Factory Production Control (FPC) may be considered relevant for the specific product.
The manufacturer who subcontracts all of his activities may in no circumstances pass the above responsibilities on to a subcontractor
Manufacturers with a Factory Production Control (FPC) system that meets the EN ISO 9001 standard and adheres to the current European standard are deemed to fulfill the FPC requirements outlined in Regulation (EU) No 305/2011.
All weighing, measuring and testing equipment shall be calibrated and regularly inspected according to documented procedures, frequencies and criteria
Regular inspection and maintenance of all manufacturing equipment are essential to prevent inconsistencies in the production process due to use, wear, or failure These inspections and maintenance activities must follow the manufacturer's written procedures, with records kept for the duration specified in the manufacturer's FPC procedures.
All incoming raw materials and components must have documented specifications, along with an inspection scheme to ensure compliance When using supplied kit components, their performance consistency must align with the relevant harmonized technical specifications.
Each individual small wastewater treatment plant must be identifiable and traceable to its production origin Manufacturers are required to implement written procedures that ensure regular inspections of the processes involved in affixing traceability codes and markings.
The manufacturer shall plan and carry out production under controlled conditions
The manufacturer shall establish procedures to ensure that the stated values of the characteristics he declares are maintained The characteristics, and the means of control, are:
Table 4 — Minimum frequency of FPC testing for the tertiary treatment units
Characteristic Test method or verification Minimum frequency of test/check
Overall dimensions 4.1.2 1/100 units or minimum
1/week Inlets, outlets and connections 4.1.3 1/100 units or minimum
1/week Tertiary treatment efficiency ratios Check list of product components Each finished product (tertiary treatment unit) Watertightness EN 12566–3:2016, Annex A 1/200 units or minimum
1/month Load bearing capacity Check there are no changes to raw materials and components Each reception of raw material and components
Power consumption Check list of product components Each reception of raw material and components Durability Check there are no changes to raw materials Each reception of raw material
Reaction to fire Check list of raw materials Each reception of raw material and components
Release of dangerous substances As relevant according to the substances and the intended place of use
Each reception of raw material and components
NOTE 1 If the performance (e.g using the “NPD” option) for certain characteristic is not declared, the corresponding parts of the test plan do not need to be performed
NOTE 2 It is understood that the week and the month are production week or production month
The manufacturer must establish documented procedures for handling non-compliant products, ensuring that all incidents are recorded as they happen These records should be maintained for the duration specified in the manufacturer's written guidelines.
If a product does not meet the acceptance criteria, the regulations for non-compliant products will be enforced Immediate corrective actions will be implemented, and any non-compliant products or batches will be isolated and clearly identified.
Once the fault has been corrected, the test or verification in question shall be repeated
All control and test results must be accurately documented, including the product description, manufacturing date, adopted test method, test results, and acceptance criteria, all signed by the responsible individual.
Any control results that do not comply with this European standard must have documented corrective measures taken to address the issue, such as conducting additional tests, modifying the manufacturing process, or discarding or rectifying the product.
The manufacturer shall have documented procedures that instigate action to eliminate the cause of non-conformities in order to prevent recurrence
The manufacturer shall have procedures providing methods of product handling and shall provide suitable storage areas preventing damage or deterioration.
Product specific requirements
The FPC system shall address this European Standard and ensure that the products placed on the market comply with the declaration of performance
The FPC system will incorporate a product-specific FPC that outlines the necessary procedures to ensure product compliance at various stages This includes controls and tests to be conducted before and during manufacturing, as specified in the FPC test plan, as well as verifications and tests on finished products, also following the frequency established in the FPC test plan.
When a manufacturer relies solely on finished products, the processes outlined in section b) will ensure that the product achieves a compliance level equivalent to that of a product subjected to Factory Production Control (FPC) during its manufacturing.
When a manufacturer conducts certain production processes in-house, it can lead to a reduction in operations categorized under b), which may be partially substituted with those under a) Typically, the greater the extent of production handled by the manufacturer, the more operations under b) can be replaced by those under a).
In any case the operation shall lead to an equivalent level of compliance of the product as if FPC had been carried out during the production
NOTE Depending on the specific case, it can be necessary to carry out the operations referred to under a) and b), only the operations under a) or only those under b)
The operations mentioned pertain to the intermediate states of products during manufacturing, including adjustments to machines and measuring equipment The selection of controls and tests, along with their frequency, should be determined by factors such as the product type and composition, the complexity of the manufacturing process, and the sensitivity of product features to variations in manufacturing parameters.
The manufacturer must create and keep records that demonstrate the sampling and testing of production These records should clearly indicate if the production meets the specified acceptance criteria and must be retained for a minimum of three years.
Initial inspection of factory and of FPC
For fire reaction assessments in systems 1+, 1, and 2+, an initial inspection of the factory and the Factory Production Control (FPC) must be conducted once the production process is complete and operational It is essential to evaluate the factory and FPC documentation to ensure compliance with the requirements outlined in sections 6.3.2 and 6.3.3.
During the inspection, it is essential to confirm that all necessary resources for achieving the product characteristics outlined in the European standard are properly implemented Additionally, it must be ensured that the FPC procedures align with the FPC documentation and are effectively followed Finally, the product must be verified to comply with the type samples, ensuring that its performance meets the Declaration of Performance (DoP) requirements.
All sites conducting final assembly or testing of the product must be evaluated to ensure compliance with specified conditions If the FPC system encompasses multiple products, production lines, or processes, and the general requirements are confirmed for one, there is no need to reassess these requirements for others within the same system.
All assessments and their results shall be documented in the initial inspection report.
Continuous surveillance of FPC
For fire reaction systems 1+, 1, and 2+, the Fire Protection Certificate (FPC) must undergo surveillance every five years This surveillance involves reviewing the FPC test plans and production processes for each product to identify any changes since the last assessment The importance of these changes will also be evaluated.
Checks shall be made to ensure that the test plans are still correctly implemented and that the production equipment is still correctly maintained and calibrated at appropriate time intervals
Records of tests and measurements conducted during production and on finished products must be reviewed to confirm that the obtained values align with those of the samples used for product type determination, ensuring appropriate actions are taken for any non-compliant products.
Any changes to the product, production process, or FPC system that may impact the declared product characteristics must lead to a reassessment of all affected performance characteristics This reassessment should follow the product type determination process outlined in section 6.2.1.
Where relevant, a re-assessment of the factory and of the FPC system shall be performed for those aspects, which may be affected by the modification
All assessments and their results shall be documented in a report
6.3.7One-off products, pre-production products (e.g prototypes) and products produced in very low quantity
The small wastewater treatment plant will undergo assessment for its one-off production, with prototypes evaluated prior to full-scale manufacturing Additionally, products created in extremely limited quantities, specifically not exceeding one unit, will also be subject to this evaluation process.
For type assessment, the provisions of 6.2.1, 3rd paragraph apply, together with the following additional provisions:
— in case of prototypes, the test samples shall be representative of the intended future production and shall be selected by the manufacturer;
— on request of the manufacturer, the results of the assessment of prototype samples may be included in a certificate or in test reports issued by the involved third party
The FPC system for one-off products and those produced in very low quantities must guarantee that there are adequate raw materials and components for production Relevant provisions regarding these materials will be applied as necessary Additionally, the manufacturer is required to keep records that enable product traceability.
For prototypes intended for series production, it is essential to conduct an initial inspection of the factory and the FPC prior to the commencement of production or the implementation of the FPC This assessment will evaluate key factors to ensure readiness for mass manufacturing.
During the initial assessment of the factory and Factory Production Control (FPC), it is essential to verify that all necessary resources for achieving the product characteristics outlined in the European standard are available Additionally, it must be ensured that the FPC procedures, as per the FPC documentation, are effectively implemented and adhered to in practice Furthermore, procedures should be established to demonstrate that the factory's production processes can consistently produce a product that meets the requirements of the European standard, ensuring that the final product is identical to the samples used for verifying compliance with this standard.
Once series production is fully established, the provisions of Clause 6.3 shall apply
For the application of this standard, a population equivalent relates to design value of 60 gBOD5/d and
The nominal designation of the tertiary treatment unit shall be designed as:
— the hydraulic daily flow Q N (m 3 /d) in nominal conditions, and the maximum hydraulic volume per unit of time;
The daily load of the unit under nominal conditions is measured for the specified parameters, including BOD5, BOD7, COD, SS, total phosphorus, and total nitrogen, expressed in kilograms per day (kg/d).
EXAMPLE 1,4 m 3 /d, 0,7 m 3 /15 min and 0,02 kg/d of total phosphorus
Marking
Each prefabricated tertiary treatment unit must be clearly labeled with essential information, including the manufacturer's details, product identification, and the European Standard number EN 12566-7 Additionally, it should specify the nominal designation, conditions of use, date of manufacture, laboratory name, test report number (if applicable), and electrical supply requirements (if necessary).
Where regulatory marking provisions require information on some or all items listed in this clause, the provisions of this clause concerning those common items are deemed to be met.
Technical information accompanying the unit
The following technical information shall accompany each prefabricated tertiary treatment unit: a) manufacturer and product identification; b) the number of this standard, i.e EN 12566-7; c) information required when describing the unit:
1) overall dimensions of the product;
2) tank: material (type) and coating (type and thickness) where applicable;
3) the volume or the amount of sludge production under nominal conditions; d) scaling rules used to define the product family;
The scaling rules are established by the manufacturer to validate the product selection for the ITT Additionally, details regarding the characteristics of the prefabricated tertiary treatment unit are provided.
1) nominal designation of the tertiary treatment unit (see Clause 5);
NOTE 2 This information could be accompanied by the equivalence in terms of total population (PT) in the place of intended use of the unit
2) tertiary treatment efficiency ratios with the indication of the load tested, the parameter to be reduced and the range of ambient air temperature during the test;
3) power consumption of the unit in normal operating conditions (nominal sequences) if applicable;
5) load bearing capacity expressed as: i) maximum allowed height of backfill (m); ii) possibility to install the product in a water table or not, expressed as WET or DRY, respectively;
The determination method for this characteristic, whether through calculation or testing, depends on the tank material Additionally, any impact of the tertiary treatment process on BOD5, BOD7, COD, and SS must be disclosed It is also essential to include installation, operation, and maintenance procedures, the date of manufacture, and the corresponding test report numbers.
Other technical information may be provided
Where regulatory marking provisions require information on some or all items listed in this clause, the requirements of this clause concerning those common items are deemed to be met.
Installation instructions
The manufacturer shall supply installation instructions with each tertiary treatment unit, written in the language accepted in the country in which the plant is to be installed
• contain comprehensive data for the installation of plants and all operating conditions including pipes connections, electrical connections and commissioning and start-up procedures;
• cover all installation conditions, including any limitation due to the effect of ambient temperature;
When considering the installation of the product, it is crucial to evaluate the worst-case site conditions, including the height of backfill and the potential for installation in either a wet or dry water table.
This European Standard specifies that the products are not designed to withstand vehicle loads If these products are to be utilized in locations where vehicle loads may occur, it is essential to implement measures that prevent direct transfer of the vehicle load to the plant.
The installation instructions shall contain details of sitting, requiring that the plant when installed has ready access for maintenance, particularly desludging equipment
The manufacturer shall describe any ventilation requirements where applicable.
Operation manual
The operation manual contains survey, service check and maintenance instructions
Each tertiary treatment unit will come with an operation manual tailored for nominal conditions These instructions will be provided in the official language of the Member State where the unit is to be installed and utilized.
— process description and identification of potential malfunction risks;
— detailed information about the service of technical components;
— frequency of replacement for internal components including any filtration media;
— guidance for the disposal and/or reuse of the waste materials
The manufacturer shall write clear safety instructions so the operator shall pay attention that nobody falls in the plant during the maintenance
Tertiary treatment efficiency test procedure
Preliminary requirements
General
The process type shall be identified as one or more of the following: biological, physical, chemical or electrical
Before testing starts the following information shall be provided:
— process design specifications including a complete set of drawings and supporting calculations;
— installation and operation requirements of the tertiary treatment unit;
— mechanical, electrical and structural safety.
Installation and commissioning
The unit shall be installed and commissioned in accordance with the manufacturer's instructions
Tertiary treatment retrofit unit(s) shall be tested with a tank provided by the manufacturer simulating the conditions of use
Test conditions, including environment and wastewater temperatures, and compliance with the manufacturer's operating manual, shall be monitored and recorded.
Operation procedures during testing
Routine maintenance, desludging (where applicable) and operation shall be in accordance with the manufacturer's operating instructions All maintenance work shall be recorded.
Data to be monitored
It is essential to continuously monitor the following data: a) daily hydraulic flow; b) parameters such as BOD5 or BOD7, COD, and SS for both influent and effluent, which indicate the potential impact of the process on non-declared parameters and provide conditions for unit usage; c) the parameters specified by the manufacturer in the nominal designation must be measured for both influent and effluent.
3) other parameters may be specified for declaration;
The following parameters must be documented: ambient air temperature, influent and effluent temperatures, total power consumption of the unit (if applicable), influent and effluent pH values, influent and effluent conductivity, dissolved oxygen concentration, sludge production (if applicable), chlorine concentration (if applicable), and any other relevant parameters.
Test procedure
Time for establishment
The time needed for establishment of biomass and stability of the process, shown in Table A.1 as the X- value (in weeks), shall be indicated.
Influent characteristics
The influent shall be equivalent to a secondary treated effluent coming from units according to
EN 12566-3 or effluent coming from units according to EN 12566-6; it may also be effluent coming from installation according to CEN/TR 12566-5
The influent characteristics shall be those declared by the manufacturer (see Clause 7) The concentration of different influent parameters shall be declared as a mean value with tolerance.
Daily flow pattern for testing
The unit will function at the nominal hydraulic daily flow rate, Q N, measured in cubic meters per day, along with the daily flow pattern that includes the maximum hydraulic flow rate specified by the manufacturer.
The daily flow used for testing purposes shall be measured, recorded and declared.
Test procedure
Routine monitoring shall take place throughout the period of the test procedure The test schedules listed in Table A.1 shall apply
Regular measurements must be conducted at both the inlet and outlet of the unit during each sequence The sequence order can be adjusted, but it is essential to include a "Nominal load sequence" following every stress period.
When more than one process for a given system is declared, the test to be performed shall be the longest test in relation to the processes declared
After desludging (where applicable) a period of one day shall be allowed for recovery before the programme of tests and sampling is continued
Processes Biological Physical Chemical Electrical
Length of test (in weeks) Xa + 16 Xa + 16 Xa + 8 Xa + 8
Nominal load with power breakdown 2 3 2 3 1 3b 1 3
Total 16 17 16 17 8 14 8 14 a X is the time for process establishment or process adjustment X is declared by the manufacturer b Chemical dosing should recommence automatically after a power failure c No influent d This is a way of validating the functionality of the alarm
The hydraulic daily flow shall be adjusted in order to establish the extra load during 48 h, as shown in Table A.2, at the start of the first week overloading phase
A power breakdown test will be conducted to simulate a loss of electric power or mechanical failure for 24 hours on the unit equipment, while ensuring that the influent input is maintained in accordance with the daily flow pattern.
When there is optional electrical discharge equipment, the test shall be done with this equipment
Where applicable, the power energy consumption of the unit shall be measured and expressed in KWh/d:
— for the complete duration of the test;
— for the four nominal sequences (value to be declared)
The results will be calculated by dividing the total energy consumption in kilowatt-hours (kWh) by the total measurement duration, which includes both the overall test duration and the total duration of the four nominal sequences measured in days.
Influent and effluent sampling
Regular samples will be collected at both the inlet (influent) and outlet (effluent) of the unit being tested These samples will consist of flow-based composites over a 24-hour period, following the schedule outlined in Table A.1.
Sample analysis
Samples will be analyzed following the applicable ISO, EN ISO, or EN standard methods, and the report will include references to the testing analysis (refer to Annex C).
Concentrations shall be determined for each declared parameter
The mean value of ratios for all nominal sequences, both with and without power breakdown, will be calculated for each declared parameter The report will include the individual treatment efficiency values for underloading and overloading sequences.
Test report
The test report must include essential information such as the specifics of the tested unit, including its nominal daily load and maximum hydraulic volume per unit of time Additionally, it should provide details on the unit's conformity with the pre-testing information and present the data collected during testing, particularly as outlined in section A.2.4.
1) the temperature: liquid phase and ambient air during the test;
The average efficiency ratios for parameters to be minimized during nominal sequences, along with the individual efficiency ratios for both underloading and overloading, are analyzed in conjunction with the tested organic load.
3) data to describe the effects on the treatment process of upstream units according to
The EN 12566-3 and EN 12566-6 standards require comprehensive documentation of maintenance and repairs conducted during the testing phase, including desludging frequency and volume removed Additionally, it is essential to report electrical power consumption throughout the test period and during the four nominal sequences Any issues, whether physical or environmental, encountered during testing must be documented, along with any deviations from the manufacturer's maintenance guidelines Furthermore, details regarding any physical deterioration of the unit, such as clogging behavior, should also be included in the report.
B.1 biological processes processes in which the treatment is mainly carried out by microorganism activity
Note 1 to entry: These processes are mostly used for the reduction of COD, BOD, SS and nitrogen parameters
EXAMPLE Biological filtration with or without vegetation (sand, gravel, peat, activated carbon, other media filtration)
B.2 Physical processes involve treatments that primarily utilize the physical properties of a medium These methods are predominantly employed for the reduction of suspended solids (SS) and phosphorus.
EXAMPLE Physical filtration (sand, gravel, peat, activated carbon, other media), cartridge and drum membranes, reverse osmosis, ultra-filtration
B.3 chemical processes processes in which the treatment is mainly carried out by the addition of chemical agents
Note 1 to entry: These processes are mostly used for the reduction of SS, phosphorus
EXAMPLE Dosing with ozone, dosing with iron or aluminium derivatives for flocculation
B.4 electrical processes processes in which the treatment is mainly carried out by the use of electricity
Note 1 to entry: These processes are mostly used for the reduction of microorganisms
Chemical analysis should be done using methods specified in the relevant EN, EN ISO and/or ISO standards Examples are given in Table C.1
Ammonium nitrogen ISO 5664 or ISO 6778 or ISO 7150-1 or EN ISO 11732 or EN
ISO 14911 Kjeldahl nitrogen EN ISO 11905-1 or EN 12260 or EN 25663
Nitrate EN ISO 10304-1 or EN ISO 13395
Phosphorus EN ISO 6878 or EN ISO 15681-2 or EN ISO 11885
Clauses of this European Standard addressing the provisions of the EU
ZA.1 Scope and relevant characteristics
This European Standard has been prepared under Mandate M/118 “Wastewater engineering products” given to CEN by the European Commission and the European Free Trade Association
When this European standard is referenced in the Official Journal of the European Union (OJEU), the clauses outlined in this annex are deemed to fulfill the requirements of the applicable mandate under Regulation (EU) No 305/2011.
This annex deals with the CE marking of the prefabricated tertiary treatment unit plants intended for the uses indicated in Table ZA.1 and shows the relevant clauses applicable
This annex has the same scope as in Clause 1 of this standard related to the aspects covered by the mandate and is defined by Table ZA.1
Table ZA.1 — Scope and relevant characteristics
Construction products: Kits and elements for wastewater treatment plants (prefabricated tertiary treatment units)
Intended use: To be used outside buildings for faecal water and organic effluent for a population up to 50 PE
Essential characteristic Requirement clauses in this standard
The reaction to fire classification ranges from A1 to F, where materials can be classified without testing (CWT) or declared based on the lowest class material according to EN 13501–1, utilizing the specified test methods.
Effectiveness of treatment, as: tertiary treatment efficiency:
— tertiary treatment efficiency ratios and/or
The results of the tests conducted in accordance with section 5.2 and Annex A are presented as tertiary treatment efficiency ratios (in %) along with the specified organic load parameters, including BOD 5, BOD 7, and COD, for each tested load.
— number of desludging 4.3 - a) Tested according to Annex A, and b) Expressed as an integer
— Power consumption 4.5 a) Tested according to Annex A, and b) Expressed in kWh/d
Treatment capacity, as: nominal designation:
− nominal load for the parameter to be reduced, and
7 - Designated according to Clause 7 and expressed in kilograms of parameter to be reduced per day (kg/d)
− nominal hydraulic daily flow ( Q N ) 7 - Designated according to Clause 7 and expressed in cubic metres of secondarily treated effluent per day (m 3 /d)
− maximum hydraulic flow 7 Designated according to Clause 7 and expressed in cubic metres per unit of time
Watertightness 4.4 - Tested according to 4.4 a and EN 12566–3:2016, Annex A, and expressed as “Pass” or “Fail”
Release of dangerous substance 4.8 - As relevant, according to 4.8
The load bearing capacity is defined by crushing resistance and maximum load deformation, calculated in accordance with section 5.1.2 and EN 12566-3:2016, Annex D, or tested as per Annex C This capacity is expressed as the maximum allowable height of backfill (in meters) and indicates whether the installation site is wet or dry, denoted as WET with the maximum height of the water table measured from the base of the plant, or DRY.
Durability 4.6 - Tested according to 4.5.2 to 4.5.9 (as appropriate) of EN
12566-3:2016 and expressed as “Pass” or “Fail”
In Member States where there are no regulatory requirements for essential product characteristics related to its intended use, the declaration of product performance for these characteristics is not mandatory.
Manufacturers marketing their products in these Member States are not required to assess or disclose the performance of their products concerning essential characteristics They can utilize the "No performance determined" (NPD) option in the information accompanying the CE marking and in the declaration of performance.
ZA.2 Procedure of attestation of conformity of prefabricated tertiary treatment unit
The AVCP system for prefabricated tertiary treatment units, as outlined in Table ZA.1, was established by EC Decision 97/464/EC on June 27, 1997, and amended by EC Decision 2004/663/EC on September 20, 2004 Table ZA.2 details the intended uses and corresponding performance levels or classes for these systems.
Table ZA.2 — System(s) of AVCP
Product Intended use Level(s) or class(es) Attestation of conformity systems
Kits and elements for wastewater treatment plant To be used outside buildings for faecal water and organic effluent
For all use(s) when subject to regulations on reaction to fire A1*, A2*, B*, C*
System 1: See Regulation (EU) No 305/2011 (CPR) Annex V, 1.2
System 3: See Regulation (EU) No 305/2011 (CPR) Annex V, 1.4
System 4: See Regulation (EU) No 305/2011 (CPR) Annex V, 1.5
Products and materials that undergo a distinct stage in the production process can enhance their fire reaction classification, such as through the incorporation of fire retardants or the reduction of organic materials.
** Products/ materials not covered by footnote (*)
Products and materials classified as A1 under Decision 96/603/EC, as amended, do not require testing for fire reaction.
NOTE Tertiary treatment units belong to the family of products indicated under product in Table ZA.2
The AVCP for the prefabricated tertiary treatment unit in Table ZA.1 must follow the procedures outlined in Tables ZA.3 to ZA.5, based on the applicable clauses of the relevant European Standards The responsibilities of the notified body will be confined to the essential characteristics specified in Annex III of the relevant mandate and those that the manufacturer chooses to declare.
Table ZA.3 — Assignment of evaluation of AVCP tasks for prefabricated tertiary treatment units under system 1 a
Tasks Content of the task AVCP clauses to apply
Factory production control (FPC) All essential characteristics of Table ZA.1 relevant for the intended use which are declared 6.3.1, 6.3.2, 6.3.3,
Further testing of samples taken at factory according to the prescribed test plan
Task for the notified testing laboratory
Determination of the product-type on the basis of type testing (based on sampling carried out by the manufacturer), type calculation, tabulated values or descriptive documentation of the product
All essential characteristics of Table ZA.1 relevant for the intended use which are declared except reaction to fire 6.2
Initial inspection of factory and of FPC Reaction to fire 6.3
Continuous surveillance, assessment and evaluation of FPC
Reaction to fire 6.3 a For products covered by footnote (*) of Table ZA.2
Table ZA.4 — Assignment of AVCP tasks for prefabricated tertiary treatment units under system
Tasks Content of the task AVCP clauses to apply
Tasks for the manufacturer Factory production control (FPC) All essential characteristics of Table ZA.1 relevant for the intended use which are declared 6.3
Tasks for a notified testing laboratory
Determination of the product-type on the basis of type testing (based on sampling carried out by the manufacturer), type calculation, tabulated values or descriptive documentation of the product
All essential characteristics of Table ZA.1 relevant for the intended use which are declared 6.2 a For products covered by footnote (**) of Table ZA.2
Table ZA.5 — Assignment of AVCP tasks for prefabricated tertiary treatment units under system
Tasks Content of the task AVCP clauses to apply
Factory production control (FPC) encompasses all key characteristics outlined in Table ZA.1 that are pertinent to the intended use, as declared in section 6.3 The determination of the product type is based on type testing, which includes sampling conducted by the manufacturer, type calculations, tabulated values, or descriptive documentation of the product.
All essential characteristics of Table ZA.1 relevant for the intended use which are declared 6.2 a For products covered by footnote (***) of Table ZA.2
ZA.2.2 Declaration of performance (DoP)
The manufacturer draws up the DoP and affixes the CE marking on the basis of the different AVCP systems set out in Annex V of the Regulation (EU) No 305/2011:
In case of products under system 1
— the factory production control and further testing of samples taken at the factory according to the prescribed test plan, carried out by the manufacturer; and