Rakennustuotedirektiivin (89/106/EEC) artiklan 10, neuvoston direktiivi 21. joulukuuta 1988, mukaisesti notifioitu tuotehyväksyntälaitos EOTAN JÄSEN

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1 VTT Expert Services Oy PL VTT Puh Telekopio Rakennustuotedirektiivin (89/106/EEC) artiklan 10, neuvoston direktiivi 21. joulukuuta 1988, mukaisesti notifioitu tuotehyväksyntälaitos EOTAN JÄSEN Eurooppalainen tekninen hyväksyntä ETA-13/0625 European Technical Approval Kauppanimi: Trade name Hyväksynnän haltija: Holder of approval: Tuotetyyppi ja sen käyttötarkoitus: Generic type and use of construction product: Voimassaoloaika: Validity from/to Valmistuspaikka: Manufacturing plants: LAMI-ovet LAMI-doors Muovilami Oy Yrittäjäntie 5 FI Ähtäri Hygienia- ja puhdastilojen ovet Doors for hygienic and clean rooms From June 28, 2013 to June 27, 2018 Muovilami Oy Yrittäjäntie 5 FI Ähtäri Tämä hyväksyntä sisältää This European Technical Approval contains sivuja/liitteitä pages/annexes 11 sivua sisältäen yhden liitteen jossa 2 sivua 11 pages including one annex with two pages E TA Eurooppalainen tekninen hyväksyntäorganisaatio European Organisation for Technical Approvals

2 Page 2 of European Technical Approval ETA-13/0625 Issued on June 28, 2013 EEI LEGAL BASES AND GENERAL CONDITIONS 1. This European Technical Approval is issued by VTT Expert Services Ltd in accordance with: - Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of Member States relating to construction products 1, modified by the Council Directive 93/68/EEC 2, and Regulation (EC) N 1882/2003 of the European Parliament and of the Council 3, - - Laki rakennustuotteiden hyväksynnästä (230/2003) luvut 3 ja 10, Ympäristöministeriön asetus rakennustuotteiden hyväksynnästä 3 sekä Ympäristöministeriön antama valtuutuspäätös (19/629/2009). - Common Procedural Rules for Requesting, Preparing and the Granting of European Technical Approvals set out in the Annex of Commission Decision 94/23/EC 4 ; - Commonly agreed assessment method of May VTT Expert Services Ltd is authorised to check whether the provisions of this European Technical Approval are met. Checking may take place in the manufacturing plant(s). Nevertheless, the responsibility for the conformity of the products to the European Technical Approval and for their fitness for the intended use remains with the holder of the European Technical Approval. 3. This European Technical Approval is not to be transferred to manufacturers or agents of manufacturer other than those indicated on page 1; or manufacturing plants other than those indicated on page 1 of this European Technical Approval. 4. This European Technical Approval may be withdrawn by VTT Expert Services Ltd pursuant to Article 5 (1) of the Council Directive 89/106/EEC. 5. Reproduction of this European Technical Approval including transmission by electronic means shall be in full. However, partial reproduction can be made with the written consent of VTT Expert Services Ltd. In this case partial reproduction has to be designated as such. Texts and drawings of advertising brochures shall not contradict or misuse the European Technical Approval. 6. The European Technical Approval is issued by VTT Expert Services Ltd in English. This version corresponds to the version circulated within EOTA. Translations into other languages have to be designated as such. 1 Official Journal of the European Communities Nº L 40, , p Official Journal of the European Communities Nº L 220, , p Official Journal of the European Commission N L 284, , p Official Journal of European Communities Nº L 17, , p. 34

3 Page 3 of European Technical Approval ETA-13/0625 Issued on June 28, 2013 II SPECIFIC CONDITIONS OF THE EUROPEAN TECHNICAL APPROVAL 1. Definition of the product and intended use 1.1 Definition of the construction product LAMI hygiene and clean room doors are made of glass fibre reinforced polyester (GRP). Doors have a seamless, pressure moulded sandwich structure with a core of freon-free polyurethane with non-rebated edges. Hygiene and clean room doors can also have fire rated requirements. LAMI fire rated hygiene and clean room doors have seamless, pressure moulded sandwich structure with a core of special fireproof mineral fibre with non-rebated edges. The 2.5 mm smooth glass fibre reinforced polyester (GRP) forms a completely seamless cover even at the edges. The surface is a non-porous, hard and smooth 0.5 mm moulded gelcoat. The encapsulated door structure and smooth surfaces of LAMI doors make them waterproof and easy to clean and will not harbour dirt or bacteria. The surfaces can also withstand the strongest disinfectants and cleaning agents. Also wall and floor joints of LAMI GRP doors meet the requirements of water resistance, durability and hygiene. Doors are delivered In standard sizes between 295 mm mm and also manufactured in customized sizes, when necessary. The sizes for fire rated doors are according to the fire tests. Door frames are manufactured of aluminium, glass fibre reinforced polyester or stainless steel. Fire door frames are manufactured of glass fibre reinforced polyester with special fireproof mineral fibre as the core material and with integral intumescent fire seal and cold smoke seal or stainless steel frame with cold smoke seal or aluminium frame with cold smoke seal. Stainless steel and aluminium fire frames have cold smoke seal (EPDM rubber) in the frame and integral intumescent fire seal in the edges of the door leaf. In addition to standard hinges of corrosion and acid proof stainless steel lift-off hinges 120x34 or 110x34, LAMI hinges with hold open facility, LAMI hinges product code 2519 or non-hold open hinges, other hinges can be used as specified by client. Additional parts like ironmongeries, protection plates and/or vision panels can be used as specified by client. Vision panels can cover max. 60% of door leaf s area The hinges, ironmongeries, vision panels, other accessories and equipment for fire rated doors are according to the fire tests. Thresholds can be used as specified by client. Threshold options for fire rated doors are GRP fire threshold depth 95 mm or 135 mm or 8 mm gap at sill. In addition to standard seals of integral silicon seal in the frame or EPDM rubber seal in the frame, other seals are possible when necessary. Other special accessories and equipment installed on LAMI GRP doors can be used as specified by client. 1.2 Intended use LAMI hygiene and cleanroom GRP doors are specially designed for internal premises that require the properties of high hygiene, waterproof and moisture resistance and durability. The doors may also have fire door requirements. The impact resistance and smooth gelcoat surface endures detergents, disinfectants and other chemicals so the doors are extremely easy to keep clean.

4 Page 4 of European Technical Approval ETA-13/0625 Issued on June 28, 2013 Use areas include: - cleanrooms, laboratories, pharmaceutical industry - hospitals, nurseries and care centres - fresh food handling areas and cold stores (over +0) - food industry and supermarkets - restaurants and commercial kitchens - education and other public premises - indoor swimming halls, public baths, leisure centres, toilets, changing rooms and other wet - premises - veterinary centres - manufacturing premises and warehouses - other demanding premises The provisions and the verification and assessment methods included or referred to in this CUAP have been written based upon the assumed working life of 25 years of the product, provided that the product is subjected to appropriate installation, use and maintenance. These provisions are based upon the current state of the art and available knowledge and experience. Assumed working life means that, when an assessment following the CUAP provisions is made, and when working life has elapsed, the real working life may be, in normal use conditions considerably longer without major degradation affecting the Essential Requirements 1. The indications given as to the working life of the construction product cannot be interpreted as a guarantee given by the product manufacturer or his representative or the approval body issuing the ETA, but are regarded only as means for choosing the appropriate products in relation to the expected economically reasonable working life of the works.

5 Page 5 of European Technical Approval ETA-13/0625 Issued on June 28, Characteristics of product and methods of verification The methods of verification and characteristics of the Lami doors evaluated in this ETA are as follows: CUAP Table 1 ER2 Characteristic 2.2 Safety in case of fire Reaction to fire Resistance to fire Assessment of the characteristic NPD EI 2 15, EI 1 30, EI 2 30 or EI 1 60 According to table 1 in the Annex 1 ER 3 ER 4 ER 5 ER5 Durability 2.3 Hygiene, health and environment Dangerous substances No dangerous materials *) Influence of moisture No influence, Water absorption < 0,01 % Emissions, ISO and 6 TVOC. mg/m 2 h (as toluene equivalent C 6 C 16 ) Formaldehyde, mg/m 2 h Ammonia, mg/m 2 h Carcinogenes, mg/m 2 h (as toluene equivalent C 6 C 16 ) Cleanability/chemical resistance DIN , stress class A1 0,02 < 0,02 < 0,01 < 0, h chemical contact No influence on the surface (chlorine, blood, milk, hydrochloric acid 30 %, Sodium hydroxide, 50 %, paraffin, cooking oil, detergent, coffee, coca cola) 2.4 Safety in use Average depth of permanent dents 0,2 Impact strength, ISO 8271 mm and diameter 9,3 mm (falling height 3 m) Safety against personal injuries by No sharp edges or surface roughness contact Mechanical strength Vertical point load, EN No deflection (door width 990 mm) Resistance to repeated opening and closing openings to 60 angle, RTE 53860/97 No influence on the openability 2.5 Protection against noise Sound properties R W, EN 140-3, EN ISO Energy economy and heat retention Thermal transmittance W/m 2 K, pren Air permeability 2.7 Related aspects of serviceability Handled in points Cleanability, chemical resistance, influence of moisture, safety in use. According to table 2 in Annex 1 0,94 (one leaf door 900 x 2090 mm, door leaf thickness 40 mm) NPD *In addition of the specific clauses relating to dangerous substances contained in this European Technical Approval, there may be other requirements applicable to the products falling within its scope (e.g. transposed European legislation and national laws, regulations and administrative provisions). In order to meet the provisions of the Construction Products directive, these requirements need also to be compiled with, when and where they apply.

6 Page 6 of European Technical Approval ETA-13/0625 Issued on June 28, Evaluation and attestation of conformity and CE marking 3.1 System of attestation of conformity According to the decision of the European Commission on the system 1 or 3 of attestation of conformity applies. System 1 concern the use as fire and/smoke compartmentation doors in and on escape routes. This system of attestation of conformity 1 is defined as follows: (a) (b) Tasks for the manufacturer: (1) Factory production control; (2) Further testing of samples taken at the factory in accordance with a prescribed test plan; Tasks for the Notified Body: (3) Initial type testing of the product (4) Initial inspection of factory and of factory production control 5) continuous surveillance, assessment and approval of factory production control. This system of attestation of conformity 3 is defined as follows: System 3: declaration of conformity of the product by the manufacturer on the basis of: (a) Tasks for the manufacturer: (1) Factory production control; (b) Tasks for the approved body: (2) Initial type testing of the system; Note: Approved bodies are also referred to as "notified bodies" 3.2 Responsibilities Tasks of the manufacturer Factory production control The manufacturer shall exercise permanent internal control of production. 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, including the records of results performed. This production control system shall insure that the product is in conformity with this European technical approval. The manufacturer may only use initial constituent materials stated in the technical documentation of this European technical approval. The factory production control shall be in accordance with the "Control plan (xx, 2013) relating to the European technical approval ETA-13/0xxx issued on xx, 2013 which is part of the technical documentation of this European technical approval. The "Control plan" is laid down in the context of the factory production control system operated by the manufacturer and deposited at VTT Expert Services Ltd. The results of factory production control shall be recorded and evaluated in accordance with the provisions of the "Control plan" 5.

7 Page 7 of European Technical Approval ETA-13/0625 Issued on June 28, 2013 The records shall include at least the following information: Controls of incoming raw materials, like raw materials of GRP, aluminium profiles, strips,, other components (appearance, dimensions, material certificates) Controls of appearance and dimensions of the doors, profiles and strips Control of out going delivery (comparison of request with the content of sending) Handling of reclamations Other tasks for the manufacturer The manufacturer shall provide a technical data sheet and an installation instruction with the following minimum information: Technical data sheet: a) Field of application Installation Instructions: a) Steps to be followed b) Procedure in case of retrofitting The manufacturer shall, on the basis of a contract, involve a body which is approved for the tasks referred to in section 3.1 in the field of the product in order to undertake the actions laid down in section For this purpose, the "control plan" referred to in sections and shall be handed over by the manufacturer to the approved body or bodies involved. The manufacturer shall make a declaration of conformity, stating that the product is in conformity with the provisions of this ETA and shall mark the product with CE mark according to the clause Tasks of the notified bodies Initial type testing of the product The results of the tests performed as part of the assessment for the European Technical Approval can be used unless there are changes in the production, product or plant. In such cases, the necessary initial type testing has to be agreed between the approval body and notified body Initial inspection of the factory and factory production control The Notified Body shall ascertain that, in accordance with the control plan, the factory and the factory production control are suitable to ensure continuous and orderly manufacturing of the components according to specifications mentioned in clause 2 of this ETA, The notified body shall retain the essential points of its actions referred to above and state the results obtained and conclusions drawn in a written report. The notified certification body involved by the manufacturer shall issue an EC certificate of conformity stating the conformity with the provisions of this ETA, Continuous surveillance assessment and approval of the factory and factory production control The appropriate part of the control plan states the information on the properties which have to be controlled by the notified body involved. The frequency of this task should be once a year.

8 Page 8 of European Technical Approval ETA-13/0625 Issued on June 28, 2013 The notified body shall retain the essential points of its actions referred to above and state the results obtained and conclusions drawn in a written report. In cases where the provisions of this ETA and its control plan are no longer fulfilled the certification body involved shall withdraw the certificate of conformity and inform VTT Expert Services Ltd without delay. 3.3 CE-marking The CE-marking 6 shall be affixed on the packaging or on the delivery tickets put into the packages. The symbol CE shall be accompanied by the following additional information: the name and address of the producer (legal entity responsible for the manufacture) the last two digits of the year in which the CE marking was affixed the number of the European Technical Approval, ETA-13/0625 Properties of the door 4. Assumptions under which the fitness of the product for the intended use was favourably assessed 4.1 Manufacturing The European technical approval is issued for the product on the basis of agreed information deposited with VTT Expert Services Ltd, which identifies the product that has been assessed and judged. Changes to the product or production process, which could result in this deposited information being incorrect, should be notified to VTT Expert Services Ltd before the changes are introduced. VTT Expert Services Ltd will decide whether or not such changes affect the ETA and consequently the validity of CE-marking on the basis of the ETA and if so whether further assessment or alterations to the ETA, shall be necessary. 4.2 Installation LAMI doors are intended to be used only in applications that fulfil the criteria of the clause 2. Installation work shall be performed according to the instructions of the manufacturer. Special attention shall be paid to the instructions concerning installation instructions of the manufacturer and restrictions connected to use as fire/smoke door. 5 The "control plan" is a confidential part of the European technical approval and only handed over to approved body or bodies involved in the procedure of attestation of conformity. See section Notes on the CE-marking are stated in Guidance Paper D of the European Commission CE-marking under the Constructions products Directive, Brussels 01 January 2002

9 Page 9 of European Technical Approval ETA-13/0625 Issued on June 28, Indications to the manufacture 5.1 Packaging transport and storage Transport and storage of the components of the doors shall be according to the instructions of the manufacturer. Doors are transported and stored so that they do not get dirty. 5.2 Use, maintenance and repair The use and maintenance instructions are included in each delivery. On behalf of VTT Expert Services Ltd Espoo June 28, 2013 Tiina Ala-Outinen Service Manger Liisa Rautiainen Assessment Manager

10 Page 10 of European Technical Approval ETA-13/0625 Issued on June 28, 2013 Table1. Fire resistance classification of the Lami doors Annex 1 (1/2) Door type KMS 24 double door Without threshold KMS 12 single leaf door Without threshold KMS 25 double door Without threshold KMS12 single leaf door With vermiculite threshold KAS 12 single leaf door Fire resistance class acc. EN EI 1 60 concrete or concrete wall EI 1 60 EI 2 30 EI 1 30 EI 2 15 KMS 12 EI 2 30 KRS 12 EI 2 30 Door sizes Frame width 2319 mm Frame height 2080 mm Width of GRP frame 45 mm and depth 95 mm Door leaves with 4 steel hinges (Roca industry) Frame width 1195 mm Frame height 2080 mm Width of GRP frame 45 mm and depth 95 mm Door leave with 4 steel hinges (Roca industry) Frame width 2519 mm Frame height 2480 mm Width of GRP frame 45 mm and depth 95 mm Door leaves with 4 steel hinges (Roca industry) Frame width 1195 mm Frame height 2092 mm Width of GRP frame 45 mm and depth 95 mm Door leave with 4 steel hinges (Roca industry) Frame width 1210 mm Frame height 2090 mm Width of 2 mm thick Al profile with mineral wool frame 45 mm and depth can be regulated Door leave with 4 steel hinges (Roca industry) Frame width 1195 mm Frame height 2080 mm Width of GRP frame 45 mm and depth 95 mm Door leave with 4 steel hinges (Roca industry) Two with Pyrostop glass glazed apertures 760 x 210 mm and 510 x 210 mm (height x width) in the door leaf Frame width 1242 mm Frame height 2105 mm Width of 1.5 mm thick stainless steel with mineral wool profile frame 45 mm and depth can be regulated Door leave with 4 steel hinges (Roca industry)

11 Page 11 of European Technical Approval ETA-13/0625 Issued on June 28, 2013 Table2. Sound insulation properties of Lami doors Door type Sound insulation, R W db KMS10 single leaf door 23,7 Door sizes Frame width 1000 mm Frame height 2100 mm Door thickness 40 mm (GRP surfaces 2,5, + 2,5 mm and 35 mm PUR insulation) GRP threshold, EPDM tightening strips in frame and threshold

Rakennustuotedirektiivin (89/106/EEC) artiklan 10, neuvoston direktiivi 21. joulukuuta 1988, mukaisesti notifioitu tuotehyväksyntälaitos EOTAN JÄSEN

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