Industrial valves - Performance characteristics of thermoplastic valves when used as construction products

This document specifies performance requirements and means for evaluation of conformity for valves of thermoplastic material, by reference to product standards, for use in building and civil engineering applications for the delivery of liquid and gaseous fluids.It also contains information required for the purposes of regulatory marking.

Industriearmaturen - Anforderungen an die Gebrauchstauglichkeit von Armaturen aus Thermoplasten bei Verwendung als Bauprodukte

Dieses Dokument legt unter Verweisung auf Produktnormen Anforderungen an die Gebrauchstauglichkeit sowie Verfahren für die Konformitätsbewertung von Armaturen aus Thermoplasten fest, die in Bauwerken des Hoch- und des Tiefbaus für den Transport von flüssigen und gasförmigen Medien verwendet werden.
Es enthält außerdem Angaben, die für die vorgeschriebene Kennzeichnung erforderlich sind.
ANMERKUNG   Die Übereinstimmung mit den Konformitätsbewertungsverfahren in Abschnitt 5 und in Anhang ZA berechtigt zu der Annahme, dass in folgende Anlagen eingebaute Armaturen aus Thermoplasten für die CE Kennzeichnung geeignet sind:
-   Rohrleitungssysteme für Lieferung/Transport zu und Verteilung/Lagerung in Gebäuden;
-   Rohrleitungssysteme für das Beheizen/Kühlen von Gebäuden;
-   hinter dem externen Vorratsbehälter oder hinter dem letzten Druckregler außerhalb des Gebäudes;
-   Anlagen, die (gesetzlichen) Vorschriften über das Brandverhalten unterliegen/bzw. nicht unterliegen;
-   Anlagen für Gas und Brennstoff;
-   Anlagen für Wasser, das nicht für den menschlichen Gebrauch bestimmt ist.

Robinetterie industrielle - Caractéristiques de performance des appareils de robinetterie thermoplastiques utilisés comme produits de construction

En se référant aux normes de produit, le présent document spécifie des exigences de performance et des
moyens permettant d’évaluer la conformité des appareils de robinetterie en matériaux thermoplastiques
utilisés dans les bâtiments et le génie civil pour l’alimentation en fluides liquides et gazeux.
Il comporte également des informations requises pour les besoins du marquage réglementaire.
NOTE Pour information, il convient que les appareils de robinetterie en thermoplastiques conformes à la présente
Norme Européenne soient considérés comme appropriés pour des applications avec de l’eau potable soumises soit :
a) à la conformité à des réglementations nationales en vigueur dans le pays de destination prévu, qui peut comporter
des essais s’il s’agit de la démonstration de l’aptitude à l’emploi pour des applications en eau potable ;
b) à revêtement interne du produit et des essais correspondants si cela est exigé par les réglementations nationales
dans le pays de destination prévu.

Industrijski ventili - Zahteve glede primernosti uporabe ventilov iz plastomerov kot gradbenih elementov

General Information

Status
Published
Publication Date
19-Jun-2008
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
17-Jun-2008
Due Date
22-Aug-2008
Completion Date
20-Jun-2008

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Industrijski ventili - Zahteve glede primernosti uporabe ventilov iz plastomerov kot gradbenih elementovIndustriearmaturen - Anforderungen an die Gebrauchstauglichkeit von Armaturen aus Thermoplasten bei Verwendung als BauprodukteRobinetterie industrielle - Caractéristiques de performance des appareils de robinetterie thermoplastiques utilisés comme produits de constructionIndustrial valves - Performance characteristics of thermoplastic valves when used as construction products83.140.30Cevi, fitingi in ventili iz polimernih materialovPlastics pipes, fittings and valvesICS:Ta slovenski standard je istoveten z:EN 15389:2008SIST EN 15389:2008en01-september-2008SIST EN 15389:2008SLOVENSKI

STANDARD
SIST EN 15389:2008

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 15389May 2008ICS 91.140.70 English VersionIndustrial valves - Performance characteristics of thermoplasticvalves when used as construction productsRobinetterie industrielle - Caractéristiques de performancedes appareils de robinetterie thermoplastiques utiliséscomme produits de constructionIndustriearmaturen - Anforderungen an dieGebrauchstauglichkeit von Armaturen aus Thermoplastenbei Verwendung als BauprodukteThis European Standard was approved by CEN on 18 April 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36

B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 15389:2008: ESIST EN 15389:2008

EN 15389:2008 (E) 2 Contents Page Foreword..............................................................................................................................................................4 1 Scope......................................................................................................................................................5 2 Normative references............................................................................................................................5 3 Terms and definitions...........................................................................................................................6 4 Performance requirements...................................................................................................................6 4.1 Reaction to fire.......................................................................................................................................6 4.2 External pressure strength...................................................................................................................6 4.3 Mechanical strength: Internal pressure strength...............................................................................6 4.3.1 Determination of nominal pressure PN...............................................................................................6 4.3.2 Verification of pressure strength.........................................................................................................6 4.4 Dimensional tolerances........................................................................................................................6 4.5 Effectiveness: tightness (gas and liquid)............................................................................................7 4.6 Durability of valves................................................................................................................................7 4.7 Dangerous substances.........................................................................................................................7 4.8 Resistance to high temperature...........................................................................................................7 4.9 Safeguard against overloading of handle...........................................................................................7 4.10 Noise level..............................................................................................................................................7 5 Calculation and test methods...............................................................................................................7 5.1 Reaction to fire.......................................................................................................................................7 5.2 Determination of the nominal pressure PN for thermoplastics materials.......................................7 5.3 Internal pressure strength....................................................................................................................8 5.4 Dimensional tolerances........................................................................................................................8 5.5 Effectiveness: tightness gas and liquid..............................................................................................8 5.6 Durability................................................................................................................................................8 5.7 Safeguard against overloading of handle...........................................................................................8 6 Evaluation of conformity.......................................................................................................................8 6.1 General....................................................................................................................................................8 6.2 Initial type testing..................................................................................................................................9 6.2.1 General....................................................................................................................................................9 6.2.2 Initial type test requirements................................................................................................................9 6.3 Factory production control.................................................................................................................10 6.3.1 General..................................................................................................................................................10 6.3.2 FPC requirements................................................................................................................................11 6.3.3 FPC system requirements..................................................................................................................12 6.4 One-off products and products produced in very low quantities..................................................13 Annex A (normative)

Product standards for building and civil engineering applications for the delivery of liquid and gaseous fluids.................................................................................................15 Annex B (normative)

Standards for assessment of conformity for building and civil engineering applications for the delivery of liquid and gaseous fluids..............................................................16 Annex ZA (informative)

Clauses of this European Standard addressing the provisions of EU Construction Products Directive........................................................................................................17 ZA.1 Scope and relevant characteristics...................................................................................................17 ZA.2 Procedure for attestation of conformity of valves made of thermoplastic materials...................18 ZA.2.1 Systems of attestation of conformity................................................................................................18 ZA.2.2 EC Certificate and Declaration of conformity...................................................................................20 ZA.3 CE marking and labelling....................................................................................................................22 ZA.3.1 CE marking requirements...................................................................................................................22 SIST EN 15389:2008

EN 15389:2008 (E) 3 ZA.3.2 Simplified CE marking with reference to a web site........................................................................25 ZA.3.2.1 General...............................................................................................................................................25 ZA.3.2.2 Minimum rules for the proper use of a web site for CE marking information.............................26 Bibliography......................................................................................................................................................28

SIST EN 15389:2008

EN 15389:2008 (E) 4 Foreword This document (EN 15389:2008) has been prepared by Technical Committee CEN/TC 69 “Industrial valves”, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2008, and conflicting national standards shall be withdrawn at the latest by November 2008. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. SIST EN 15389:2008

EN 15389:2008 (E) 5 1 Scope This European Standard specifies performance requirements and means for evaluation of conformity for valves of thermoplastic material, by reference to product standards, for use in building and civil engineering applications for the delivery of liquid and gaseous fluids. It also contains information required for the purposes of regulatory marking. NOTE For information, thermoplastic valves in conformity with this European Standard should be considered suitable for drinking water applications subject to either: a) compliance with any national regulations in the country of intended destination, which can include testing if this is the demonstration of fitness for drinking water applications; b) internal coating of the Product and subsequent testing if required by the national regulations in the intended country of destination. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 13501-1, Fire classification of construction products and building elements — Part 1: Classification using data from reaction to fire tests EN 13823, Reaction to fire tests for building products — Building products excluding floorings exposed to the thermal attack by a single burning item EN ISO 3126, Plastics piping systems — Plastics components — Determination of dimensions (ISO 3126:2005) EN ISO 9001:2000, Quality management systems — Requirements (ISO 9001:2000) EN ISO 9080, Plastics piping and ducting systems — Determination of the long-term hydrostatic strength of thermoplastics materials in pipe form by extrapolation (ISO 9080:2003) EN ISO 12162, Thermoplastics materials for pipes and fittings for pressure applications — Classification and designation — Overall service (design) coefficient (ISO 12162:1995) EN ISO 16135:2006, Industrial valves — Ball valves of thermoplastics materials (ISO 16135:2006) EN ISO 16136:2006, Industrial valves — Butterfly valves of thermoplastic materials (ISO 16136:2006) EN ISO 16137:2006, Industrial valves — Check valves of thermoplastic materials (ISO 16137:2006) EN ISO 16138:2006, Industrial valves — Diaphragm valves of thermoplastic materials (ISO 16138:2006) EN ISO 16139:2006, Industrial valves — Gate valves of thermoplastic materials (ISO 16139:2006) EN ISO 21787:2006, Industrial valves — Globe valves of thermoplastic materials (ISO 21787:2006) ISO 9393-2:2005, Thermoplastics valves for industrial applications — Pressure test methods and requirements — Part 2: Test conditions and basic requirements SIST EN 15389:2008

EN 15389:2008 (E) 6 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 nominal size DN numerical designation of the size of a component, other than a component designated by thread size, which is a convenient round number approximately equal to the manufacturing dimension in millimetres (mm) NOTE This can apply to either the internal diameter (DN/ID) or external diameter (DN/OD). 3.2 nominal outside diameter dn specified diameter, in millimetres, assigned to a nominal size 3.3 nominal pressure PN numerical designation used for reference purposes related to the mechanical characteristics of the component of a piping system NOTE For plastic piping systems conveying water it corresponds to the maximum continuous operating pressure in bar, which can be sustained with water at 20 °C for thermoplastics and 35 °C for thermosetting materials, based on the minimum design coefficient. 4 Performance requirements 4.1 Reaction to fire Where subject to regulatory requirements, the product shall be tested and classified in accordance with 5.1. 4.2 External pressure strength The external pressure strength of pressure piping systems is deemed to be satisfied by the internal pressure strength as given in 4.3. 4.3 Mechanical strength: Internal pressure strength 4.3.1 Determination of nominal pressure PN For thermoplastics materials the internal pressure strength of thermoplastics valves shall be determined in accordance with 5.2 and shall be declared by the manufacturer as nominal pressure PN. 4.3.2 Verification of pressure strength The verification of the internal pressure strength of thermoplastics valves shall be in accordance with 5.3. 4.4 Dimensional tolerances The manufacturer shall declare the dimensional tolerances for thermoplastics valves and their connection dimensions by reference to the relevant specific European Product Standard as given in Annex A. Dimensions shall be measured in accordance with 5.4 and shall be within the specified tolerances. SIST EN 15389:2008

EN 15389:2008 (E) 7 4.5 Effectiveness: tightness (gas and liquid) Thermoplastics valves shall be tested in accordance with 5.5. No leakage shall occur during the test period. 4.6 Durability of valves Thermoplastics valves meeting the requirements of this European Standard are deemed to have a reasonable economic working life. NOTE The valves are expected to last at least the lifetime of the network where they are installed. If the nature of the fluid is different from water or this fluid or water has a higher temperature than 20 °C, de-rating the pressure shall be in accordance with the following European Standard, as appropriate to the valve type: EN ISO 16135 to EN ISO 16139 and EN ISO 21787. 4.7 Dangerous substances Materials used in products shall not release any dangerous substances in excess of the maximum permitted levels specified in a relevant European Standard for the material or permitted in the national regulations of the member state of destination. NOTE Attention is drawn to NOTE 1 and NOTE 2 in ZA.1. 4.8 Resistance to high temperature The resistance to high temperature shall be taken from the tabulated values listed in 4.3 of the valve product standards as given in EN ISO 16135:2006 to EN ISO 16139:2006 and EN ISO 21787:2006, as applicable. 4.9 Safeguard against overloading of handle The safeguard against overloading of handle shall be tested in accordance with 5.7. 4.10 Noise level The noise emission is dependent on the flow conditions in the pipe system; the manufacturer shall declare the maximum designed flow velocity for the pipe system in which his valve is tested and which is the basis of his declaration. The limitation shall be published in the relevant operating instruction. NOTE The measurement of noise emission is a regulatory requirement in some, but not all, member states of the European Economic Area (EEA). 5 Calculation and test methods 5.1 Reaction to fire Classification shall be in accordance with EN 13501-1. If a higher classification than class E is required, testing shall be performed in accordance with EN 13823.

5.2 Determination of the nominal pressure PN for thermoplastics materials For thermoplastics materials the nominal pressure PN shall be determined as follows: a) determine the σLPL value in accordance with EN ISO 9080. Data provided by either the compound manufacturer or the product manufacturer shall be taken into account; SIST EN 15389:2008

EN 15389:2008 (E) 8 b) classify the material (MRS) in accordance with EN ISO 12162; c) determine the PN for a chosen pipe series (SDR series) in accordance with ISO 9393-2:2005, Clauses 5 and 6. 5.3 Internal pressure strength Internal pressure strength testing shall be in accordance with ISO 9393-2:2005, Clauses 5 and 6. 5.4 Dimensional tolerances Shall be measured in accordance with EN ISO 3126. 5.5 Effectiveness: tightness gas and liquid The leak tightness of thermoplastics valves shall be tested in accordance with ISO 9393-2:2005, Clause 7. 5.6 Durability Thermoplastics Valves conforming with the requirements of this document and with a declared nominal pressure, which is determined according to 5.2 of this European Standard, shall be deemed to be durable for a reasonable economic working life. 5.7 Safeguard against overloading of handle The Safeguard against overloading of handle shall be tested in accordance with 4.6.5 of the valve product standards as given in Annex A, as applicable. 6 Evaluation of conformity 6.1 General The conformity of thermoplastics valves with the requirements of this European Standard and with the declared values (including classes) shall be demonstrated by:  initial type testing;  factory production control by the manufacturer, including product assessment. For the purposes of testing, valves may be grouped into families, where it is considered that the results for one or more characteristics from any product within the family are representative for the same characteristics for all products within that family. A product may be in more than one family for different characteristics. For type testing the following family groups apply. a) Size groups for valves as given in Table 1. SIST EN 15389:2008

EN 15389:2008 (E) 9

Table 1 — Size groups Range of nominal diameters, dn Size group for thermoplastics material 1 DN ≤ 50 2 50 < DN ≤ 300 3 300 < DN

b) Type groups for valves as given in Table 2. Table 2 — Type groups Fitting group Type of valves 1 Ball valves 2 Diaphragm valves

3 Butterfly valves 4 Other valves

6.2 Initial type testing 6.2.1 General Type tests shall be carried out on new products and whenever there is a change in design, in material and/or in production method, other than routine in-process adjustment and extension of the product range (see Table 3). A change of supplier of a material or stabiliser does not lead to a change in performance if the chemical composition remains the same. Material modifications within limits may be considered as a not change of material. The limits are as defined in the relevant material standards given in Annex B. For tests previously performed in accordance with the provisions of the standards listed in Annex A, as applicable, (same product, same characteristic(s), same test method, same system of attestation, etc.) the results may be taken into account. All characteristics given in Clause 4 shall be subject to calculation and/or initial type testing. 6.2.2 Initial type test requirements The initial type testing of the characteristics according to Clause 4 shall be performed in accordance with the sampling procedure given in Table 3. SIST EN 15389:2008

EN 15389:2008 (E) 10

Table 3 — Type testing of valves Testing relevant to a Essential characteristics Requirement Clause of this European Standard I M E Sampling procedure (minimum sampling) Acceptance Reaction to fire 4.1 + + — Once/compound or formulation b see classification in EN 13501-1 External pressure strength 4.2 + + + See internal pressure strength Pass/fail Mechanical strength: Internal pressure strength 4.3 + + + One diameter/size group/ valve type group/compound or formulation Pass/fail Dimensional tolerances 4.4 + — + Once/size/valve/compound or formulation Pass/fail Effectiveness: tightness gas and liquid 4.5 + + + One diameter/size group/ valve type Pass/fail Durability of valves 4.6 + + + Once/compound or formulation By the classification of the long-term strength performance Dangerous substances 4.7 +

— See notes in Table ZA.1

Pass/fail Resistance to high temperature 4.8 + + + One diameter/size group/ valve group Declared values Safeguard against overloading of handle 4.9 + — + One diameter/size group/ valve group Pass/fail Noise level 4.10 + — + One diameter/size group/ valve group Noise emission declared as decibels a I is initial type test in case of new system;

M is change of material;
E is extension of the product range with new size group or fitting group.

+ denotes testing relevant for the characteristic-occurrence-combination. b In case of single burning item (SBI) test the vertical part is size 110 and the horizontal part size 40, which is then representative for all dimensions.

Test reports shall be kept by the manufacturer for at least 10 years after discontinuation of the product. 6.3 Factory production control 6.3.1 General The manufacturer shall establish, document and maintain an FPC system to ensure that the products placed on the market conform to the stated performance characteristics. The FPC system shall consist of procedures, regular inspections and tests and/or assessments and the use of the results to control raw and other incoming materials or components, equipment, the production process and the product. If the manufacturer has the component designed, manufactured, assembled, packed, processed and labelled by subcontracting, FPC of the original manufacturer may be taken into account. However, where subcontracting takes place, the manufacturer shall retain the overall control of the component and ensure that SIST EN 15389:2008

EN 15389:2008 (E) 11 he receives all the information that is necessary to fulfil his responsibilities according to this European Standard. The manufacturer who subcontracts all of his activities may in no circumstances discharge himself of his responsibilities to a subcontractor. 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 production control system documentation shall ensure a common understanding of conformity evaluation and enable the achievement of the required component characteristics and the effective operation of the production control system to be checked. Factory production control therefore brings together operational techniques and all measures allowing maintenance and control of the conformity of the component with its technical specifications. Its implementation may be achieved by controls and tests on raw materials and constituents, processes, manufacturing equipment and finished components, including material properties in components, and by making use of the results thus obtained. The results of inspections, tests or assessments requiring action shall be recorded, as shall any action taken. The action to be taken when control values or criteria are not met shall be recorded and retained for the period specified in the manufacturers FPC procedures. The specifications of all incoming raw materials and components shall be documented, and the inspection scheme for ensuring their conformity shall be established. Manufacturers operating a quality system, which conforms to or is no less stringent than the relevant requirements of EN ISO 9001 and which is made specific to products covered by this European Standard shall be deemed to satisfy the FPC requirements of this European Standard. 6.3.2 FPC requirements The FPC of the characteristics according to Clause 4 shall be performed in accordance with the sampling procedure given in Table 4. SIST EN 15389:2008

EN 15389:2008 (E) 12 Table 4 — Factory production control of valves Essential characteristics Requirement clause of this European Standard Test method Sampling procedure (minimum sampling) Acceptance Reaction to fire 4.1 Identification of compound or formulation Once/batch See classification in EN 13501-1 External pressure strength 4.2 See internal pressure strength See internal pressure strength Pass/fail Mechanical strength: Internal pressure strength 4.3 Assembly control and/or final inspection Once/batch

Pass/fail Dimensional tolerances 4.4 EN ISO 3126 or according to the manufacturers quality plan Once/batch Pass/fail Effectiveness. tightness gas and liquid 4.5 Indirect testing: see dimensional tolerances Once/batch Pass/fail Durability of valves 4.6 Indirect testing: see internal pressure strength, and check of compound or formulation

Once/batch Pass/fail
Dangerous substances 4.7 See notes in Table ZA.1 See notes in table ZA.1

Pass/fail Resistance to high temperature 4.8 Identification of compound or formulation Once/batch Tabulated values Safeguard against overloading of handle 4.9 Identification of compound or formulation Once/batch Pass/fail Noise level 4.10 Identification of compound or formulation Once/batch Noise emission declared as decibels

6.3.3 FPC system requirements 6.3.3.1 Personnel The responsibility, authority and the relationship between personnel that manages, performs or verifies work affecting product conformity, shall be defined. This applies in particular to personnel that need to initiate actions preventing product non-conformities from occurring, actions in case of non-conformities and to identify and register product conformity problems. Personnel performing work affecting product conformity shall be competent on the basis of appropriate education, training, skills and experience for which records shall be maintained. 6.3.3.2 Equipment All weighing, measuring and testing equipment necessary to achieve, or produce evidence of, conformity shall be calibrated or verified and regularly inspected according to documented procedures, frequencies and criteria. Control of monitoring and measuring devices shall comply with the appropriate clause of EN ISO 9001:2000. SIST EN 15389:2008

EN 15389:2008 (E) 13 All equipment used in the manufacturing process shall be regularly inspected and maintained to ensure use, wear or failure do not cause inconsistency in the manufacturing process. Inspections and maintenance shall be carried out and recorded in accordance with the manufacturer’s written procedures and the records retained for the period defined in the manufacturer's FPC procedures. 6.3.3.3 Design process The factory production control system shall document the various stages in the design of the products, identify the checking procedure and those individuals responsible for all stages of design. During the design process itself, a record shall be kept of all checks, their results, and any corrective actions taken. This record shall be sufficiently detailed and accurate to demonstrate that all stages of the design phase, and all checks, have been carried out satisfactorily. Compliance with EN ISO 9001:2000, 7.3 shall be deemed to satisfy the requirements of this sub-clause. 6.3.3.4 Raw materials and components The specifications of all incoming raw materials and components shall be documented, as shall the inspection scheme for ensuring their conformity. The verification of conformity of the raw material with the specification shall be in accordance with EN ISO 9001:2000, 7.4.3. 6.3.3.5 In-process control The manufacturer shall plan and carry out production under controlled conditions. Compliance with EN ISO 9001:2000, 7.5.1 and 7.5.2 shall be deemed to satisfy t

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