BRITISH STANDARD BS EN 12094 2 2003 Fixed firefighting systems — Components for gas extinguishing systems — Part 2 Requirements and test methods for non electrical automatic control and delay devices[.]
General design
Pilot container valves and their actuators, utilized exclusively in non-electrical automatic control and delay devices, must be tested in accordance with prEN 12094-4 However, the vibration, temperature, corrosion, stress corrosion, and operational reliability tests should adhere to the specifications outlined in this European Standard.
Pneumatic-powered components must be designed to prevent any leakage from pilot lines that could impact the operation of downstream components.
4.1.2 All materials shall be resistant to media with which they come into contact.
4.1.3 The component shall be designed so that the function cannot be adversely affected by ageing or environmental influences.
4.1.4 Non-metallic materials and elastomers shall be selected to be stable and not alter their performance over the working life recommended by the manufacturer.
The component's delay time can be adjusted up to 60 seconds through either continuous or step adjustments, with a maximum increment of 5 seconds for the latter Additionally, the component will feature physical protection to deter tampering, such as a locked door or protective cover, along with clear indicators to signal any unauthorized adjustments to the settings.
The setting and the operation of the non-electrical delay devices shall not be affected by other components like fire detection and alarm devices.
4.1.6 The component shall be powered using any of the following sources of energy
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4.1.7 Components powered by pneumatic energy shall be specified by the manufacturer for a working pressure according to Table 1.
CO2 stored in high-pressure cylinder 140
CO2 stored in low-pressure cylinder 25
Non liquefied inert gas (e.g nitrogen) pressure in the container delivering the control energy at 50 o C
Pneumatic energy regulated by a pressure reducing valve as specified by the manufacturer
The manufacturer must define the energy supply capacity and identify any additional devices, such as alarm sounders, that utilize the same energy source, along with the maximum number of these devices that can be connected.
4.1.9 If the component incorporates a pneumatic actuator, the manufacturer shall specify nominal, maximum and minimum values for the pressure supply.
4.1.10 If the component incorporates a mechanical powered actuator, the manufacturer shall specify the weights and the drop distance.
When a component includes an electrically powered actuator, the manufacturer must provide the nominal, maximum, and minimum voltage and current specifications Additionally, these electrical actuators should be designed for continuous duty operation.
4.1.12 If the component incorporates a pyrotechnic powered actuator, the manufacturer shall specify:
minimum all-fire current and its minimum duration and the form of the signal; and
maximum storage time under specified storage conditions; and
maximum life time under stand-by conditions (50 ° C and 70 % relative humidity)
Manufacturers must provide data demonstrating that the failure rate of the device in the energy transfer path does not exceed 1 in 10,000 at the recommended firing current Additionally, actuators must achieve the required power output after a 90-day aging test at a temperature of (90 + 2)°C Furthermore, the power output of the actuator at the end of its service life, as recommended by the manufacturer, should be at least three times greater than what is necessary to operate the valve under the most challenging conditions.
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Connection threads
Connection threads shall comply with International Standards or European Standards for threads, e.g ISO 7-1 or
Signal processing and indication
The component shall be capable of receiving, processing, transmitting and indicating signals separately for each flooding zone.
It shall carry out the following functions in accordance with 5.4: a) Receive and process the triggering signal from
1) non-electrical special fire detector, and/or
2) manual triggering device, and/or
3) electrical control device, and/or
4) appropriate electrical delay device in connection with electrical special fire detectors, and/or
The control and indicating equipment of an automatic fire detection system must be initiated by automatic or manual fire detectors and ensure that the extinguishing release signal activates only after the alarm has sounded and any applicable delay has passed It should transmit an un-delayed triggering signal for other functions, prevent alarm silencing during the flooding period unless protected against unauthorized operation, and allow for a delay in the extinguishing release signal if a non-electrical delay device is present Additionally, it must control the flooding time for low-pressure CO2 systems and enable secondary flooding initiated manually after the initial discharge, with alarms sounding The system should clearly indicate its quiescent, activated, and disabled states and transmit the released condition information to the control and indicating equipment as necessary.
System delay
The system delay for discharge shall not exceed 15 s, when tested in accordance with 5.5.
The system delay for alarms shall not exceed 5 s, when tested in accordance with 5.5.
Function at ambient temperatures
The component is designed to function effectively within an ambient temperature range of 0 °C to +50 °C or -20 °C to +50 °C, as verified by tests outlined in sections 5.4 and 5.6 Additionally, any measured deviation in delay time, and if relevant, the extinguishing period, must remain within ±10% of the specified time.
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Internal pressure
The component shall not show any deterioration, when tested in accordance with 5.7.
Strength
Mechanically powered parts of components shall show no deterioration and shall correctly function, when tested in accordance with 5.8.
Operational reliability
There shall be no deterioration of performance, when a component is tested in accordance with 5.9.
Corrosion
The component shall operate satisfactorily when tested in accordance with 5.4.3 after being subjected to the corrosion test in accordance with 5.10.
Stress corrosion
Any copper alloy part under permanent pressure used in the component shall not crack, when tested in accordance with 5.11.
Vibration
When tested in accordance with 5.12 the components shall not operate or be damaged during conditioning and shall operate satisfactorily after conditioning.
Pneumatic energy supply using pilot containers
Pilot containers must provide pneumatic energy for components and devices, including alarm systems, with tests conducted as per section 5.13 in conjunction with these devices The reserve capacity for pneumatic energy should be at least five times the amount needed for a release cycle, plus an additional amount for the alarm equipment, accommodating the maximum number of sounders specified by the manufacturer, and lasting for a minimum of 30 minutes, if applicable.
CO2, the contents of the pilot pressure containers, where used, shall be at least 500 g.
CO2 pilot containers shall be continuously monitored using a weighing device according to EN 12094-11.
The content of a pilot container filled with air or inert gas shall be continuously monitored by a pressure gauge according to EN 12094-10 or a weighing device according to EN 12094-11.
The pilot containers shall be dedicated exclusively for the gas extinguishing installation.
Operating force
All signal or function transmissions must exert a force that is at least double the required force for proper component operation, while pyrotechnic devices must achieve a force that is at least triple the necessary amount, as tested according to section 5.14.
Functional reliability
4.14.1 When the component is triggered by electrical means, there shall be no deterioration of performance, when tested in accordance with 5.15.2, 5.15.3, 5.15.4 and 5.15.5 The component shall operate at 85 %, 100 % and
The electrical devices shall be specified for continuous duty.
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Pneumatic powered components must demonstrate consistent performance when tested according to sections 5.15.2, 5.15.3, 5.15.4, and 5.15.5 These components are required to function effectively at the manufacturer's specified nominal, maximum, and minimum pressure levels.
Gravity-powered components must maintain performance standards as outlined in sections 5.15.2 to 5.15.5 It is essential that the free travel of the travel weight is unobstructed, ensuring a minimum clearance of 50 mm beyond the fully operated position.
Springs must operate as the primary driving force in the component, allowing for unrestricted full travel without any obstruction Additionally, performance should remain consistent and unaffected when evaluated according to section 5.15.6.
When triggered by pyrotechnic means, the component must show no deterioration when tested according to sections 5.15.2, 5.15.3, 5.15.4, and 5.15.5 Additionally, it should function at the minimum specified current of the pyrotechnic device.
Safety classification
The component must be designed to meet EN 60529 standards, specifically class IP 44 Additionally, any switch and monitoring equipment installed externally should comply with class IP 65, while solenoid coils should adhere to class IP 55, and pyrotechnic devices must meet class IP X7 requirements.
Test facility
Ensure that the entire functionality of the component is verified, excluding the actuation of pilot containers, without discharging the extinguishing media If required, special provisions, such as a connection for a pneumatic energy supply, should be implemented for testing purposes.
Documentation
4.17.1 The manufacturer shall prepare and maintain documentation.
The documentation submitted to the testing authority must include a general description of the equipment, detailing its features and functions, as well as a comprehensive technical specification.
1) the information as given in 4.1;
To ensure compatibility with other system components, it is essential to provide sufficient information regarding mechanical, electrical, or software integration Additionally, clear installation and mounting instructions, along with comprehensive operating and maintenance guidelines, are crucial If applicable, routine testing instructions should also be included to facilitate proper functionality.
The manufacturer is required to prepare, maintain, and submit comprehensive documentation, unless supply conditions prevent this, which includes a detailed description of the overall mechanical design.
1) main parts of components and their tasks;
2) way in which the parts interact; b) component lists;
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This documentation shall also comprise details of any sub-components.
4.17.4 All documentation normally supplied by and specified by the manufacturer for use by the end user shall be supplied with the device and constitute part of the supply.
Test conditions
The components shall be tested assembled as recommended for installation by the manufacturer The tests shall be carried out at a temperature of (25 + 10) °C, except when otherwise stated.
The tolerance for all test parameters is 5 %, unless otherwise stated.
Test samples and order of tests
Three samples shall be used for the tests The order of tests shall be as shown in Table 2.
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Test order for Tests sample A sample B sample C
Corrosion
The function test in accordance with 5.4.3 shall be carried out after each of the following tests:
A visual and measurement check shall be made to determine that the test samples correspond to the description in the drawings, parts lists, description of functions, operating and installation instructions.
5.4.1 The test relates to the requirements of 4.3 and 4.5.
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The component will be activated through standard methods, such as a manual control device It is essential to test the function and document the flooding time for CO2 low-pressure systems Testing for these components will involve an extinguishing period of 30 seconds, 120 seconds, and 240 seconds, with each cycle repeated 10 times.
5.4.3 The delay time shall be set to 30 s and the discharge time to 120 s, if applicable The function shall be tested 10 times and the actual times shall be recorded.
The test relates to the requirements of 4.4.
In optimal configurations as specified by the manufacturer, non-electrical automatic control devices, such as alarm sounders and actuators, must activate even under adverse energy supply conditions like low temperatures The response time from a manual control device or specialized fire detector to the actuator should be within 15 seconds, while alarm sounders must trigger within 5 seconds.
The test relates to the requirements of 4.5.
The test sample shall be conditioned at (50 ± 2)°C for at least 4 h Then the cycle as described in 5.4.2 shall be carried out 10 times at (50 ± 3) °C.
The test sample shall be conditioned at (- 20 ± 2) °C or (0 ± 2) °C for at least 4 h Then the cycle as described in
5.4.2 shall be carried out 10 times at – 20°C or 0°C.
The test relates to the requirements of 4.6.
Pressurised parts shall be connected to a suitable pressure supply (hydraulic or pneumatic) All ports shall be blocked.
The pressure shall be increased to 1,5 times the working pressure and shall be maintained for 5 min.
The component shall be depressurised and the function test shall be carried out in accordance with 5.4.3.
This test relates to the requirements of 4.7.
For mechanically powered parts the function shall be tested with 1,5 times the maximum operating force.
After the above test the function shall be tested in accordance with 5.4.3.
This test relates to the requirements of 4.8.
The following test cycle shall be carried out 500 times:
The nominal working pressure of ± 10% must be applied to the inlet port of a pressurized part assembly.
CO2, air or nitrogen or the nominal force shall be applied in the case of mechanically powered devices; b) the device shall be operated by normal means.
After the above test the function shall be tested in accordance with 5.4.3.
5.10.1 The test relates to the requirements of 4.9.
5.10.2 The sample in its normal mounting position shall be subjected to a sulphur dioxide test in accordance with IEC 60068-2-42, test Kc.
The test procedure generally described in IEC 60068-2-42, test Kc shall be used, except that the conditioning shall be as described below.
The following conditions shall be applied:
5.10.3 Immediately after conditioning the sample shall be subjected to a drying period of 16 h at 40 o C, maximum
Samples should be maintained at 50% relative humidity and allowed to recover for 1 to 2 hours under standard atmospheric conditions Following this recovery, the samples must undergo a functional test as specified in section 5.4.3 and be thoroughly inspected for any mechanical damage, both externally and internally.
Vibration
The function test in accordance with 5.4.3 shall be carried out after each of the following tests:
A visual and measurement check shall be made to determine that the test samples correspond to the description in the drawings, parts lists, description of functions, operating and installation instructions.
5.4.1 The test relates to the requirements of 4.3 and 4.5.
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The component will be activated through standard methods, such as a manual control device Testing of the function is essential, and for CO2 low-pressure systems, the flooding time must be documented A test will be conducted on components for CO2 low-pressure systems with extinguishing periods of 30 seconds, 120 seconds, and 240 seconds, with a total of 10 cycles performed.
5.4.3 The delay time shall be set to 30 s and the discharge time to 120 s, if applicable The function shall be tested 10 times and the actual times shall be recorded.
The test relates to the requirements of 4.4.
In optimal configurations as specified by the manufacturer, non-electrical automatic control devices, such as alarm sounders and actuators, must activate even under challenging energy supply conditions like low temperatures The response time from a manual control device or specialized fire detector to the actuator should be within 15 seconds, while alarm sounders must trigger within 5 seconds.
The test relates to the requirements of 4.5.
The test sample shall be conditioned at (50 ± 2)°C for at least 4 h Then the cycle as described in 5.4.2 shall be carried out 10 times at (50 ± 3) °C.
The test sample shall be conditioned at (- 20 ± 2) °C or (0 ± 2) °C for at least 4 h Then the cycle as described in
5.4.2 shall be carried out 10 times at – 20°C or 0°C.
The test relates to the requirements of 4.6.
Pressurised parts shall be connected to a suitable pressure supply (hydraulic or pneumatic) All ports shall be blocked.
The pressure shall be increased to 1,5 times the working pressure and shall be maintained for 5 min.
The component shall be depressurised and the function test shall be carried out in accordance with 5.4.3.
This test relates to the requirements of 4.7.
For mechanically powered parts the function shall be tested with 1,5 times the maximum operating force.
After the above test the function shall be tested in accordance with 5.4.3.
This test relates to the requirements of 4.8.
The following test cycle shall be carried out 500 times:
The nominal working pressure, with a tolerance of ± 10%, must be applied to the inlet port of a pressurized part assembly.
CO2, air or nitrogen or the nominal force shall be applied in the case of mechanically powered devices; b) the device shall be operated by normal means.
After the above test the function shall be tested in accordance with 5.4.3.
5.10.1 The test relates to the requirements of 4.9.
5.10.2 The sample in its normal mounting position shall be subjected to a sulphur dioxide test in accordance with IEC 60068-2-42, test Kc.
The test procedure generally described in IEC 60068-2-42, test Kc shall be used, except that the conditioning shall be as described below.
The following conditions shall be applied:
5.10.3 Immediately after conditioning the sample shall be subjected to a drying period of 16 h at 40 o C, maximum
Samples should be maintained at 50% relative humidity and allowed to recover for 1 to 2 hours under standard atmospheric conditions Following this recovery, the samples must undergo a functional test as specified in section 5.4.3 and be thoroughly inspected for any mechanical damage, both externally and internally.
The test relates to the requirements of 4.10.
For this test, complete samples or portions of samples will be utilized A properly sized container with a capillary tube vent, having a known capacity, is required The aqueous ammonia solution must have a specific weight of 0.94 kg/l ± 2% Each liter of container volume should be filled with (10 ± 0.5) ml of the solution.
The sample must be degreased prior to testing and exposed to a moist atmosphere of ammonia and air for 10 days at a temperature of (34 ± 2)°C Additionally, the samples should be placed (40 ± 5) mm above the liquid level.
After testing, the samples shall be cleaned and dried and subjected to careful visual examination To make cracking clearly visible, the liquid penetration method shall be used.
After the above test the function shall be tested in accordance with 5.4.3.
This test relates to the requirements of 4.11.
The sample shall be attached to a vibration table using fixing materials provided by the manufacturer.
The sample will undergo sine-wave vibration across all three axes, with frequencies ranging from 10 Hz to 150 Hz The frequency will be increased uniformly at a rate of one octave every 30 minutes Vibration acceleration will be set at 0.2 g for frequencies between 10 Hz and 50 Hz, and at 0.5 g for frequencies from 50 Hz to 150 Hz.
The sample shall not operate during the test caused by the vibrations No deterioration or detachment of parts shall
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After the above test the function shall be tested in accordance with 5.4.3.
Functional reliability
The function test in accordance with 5.4.3 shall be carried out after each of the following tests:
A visual and measurement check shall be made to determine that the test samples correspond to the description in the drawings, parts lists, description of functions, operating and installation instructions.
5.4.1 The test relates to the requirements of 4.3 and 4.5.
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The component will be activated through standard methods, such as a manual control device Its functionality will be tested, and for CO2 low-pressure systems, the flooding time will be documented Testing for these components will involve extinguishing periods of 30 seconds, 120 seconds, and 240 seconds, with each cycle repeated 10 times.
5.4.3 The delay time shall be set to 30 s and the discharge time to 120 s, if applicable The function shall be tested 10 times and the actual times shall be recorded.
The test relates to the requirements of 4.4.
In optimal configurations as specified by the manufacturer, non-electrical automatic control devices, such as alarm sounders and actuators, are designed to activate even under challenging energy supply conditions, like low temperatures The response time from a manual control device or specialized fire detector to the actuator should be within 15 seconds, while alarm sounders must trigger within 5 seconds.
The test relates to the requirements of 4.5.
The test sample shall be conditioned at (50 ± 2)°C for at least 4 h Then the cycle as described in 5.4.2 shall be carried out 10 times at (50 ± 3) °C.
The test sample shall be conditioned at (- 20 ± 2) °C or (0 ± 2) °C for at least 4 h Then the cycle as described in
5.4.2 shall be carried out 10 times at – 20°C or 0°C.
The test relates to the requirements of 4.6.
Pressurised parts shall be connected to a suitable pressure supply (hydraulic or pneumatic) All ports shall be blocked.
The pressure shall be increased to 1,5 times the working pressure and shall be maintained for 5 min.
The component shall be depressurised and the function test shall be carried out in accordance with 5.4.3.
This test relates to the requirements of 4.7.
For mechanically powered parts the function shall be tested with 1,5 times the maximum operating force.
After the above test the function shall be tested in accordance with 5.4.3.
This test relates to the requirements of 4.8.
The following test cycle shall be carried out 500 times:
The nominal working pressure, with a tolerance of ± 10%, must be applied to the inlet port of a pressurized part assembly.
CO2, air or nitrogen or the nominal force shall be applied in the case of mechanically powered devices; b) the device shall be operated by normal means.
After the above test the function shall be tested in accordance with 5.4.3.
5.10.1 The test relates to the requirements of 4.9.
5.10.2 The sample in its normal mounting position shall be subjected to a sulphur dioxide test in accordance with IEC 60068-2-42, test Kc.
The test procedure generally described in IEC 60068-2-42, test Kc shall be used, except that the conditioning shall be as described below.
The following conditions shall be applied:
5.10.3 Immediately after conditioning the sample shall be subjected to a drying period of 16 h at 40 o C, maximum
The sample should be maintained at 50% relative humidity, followed by a recovery period of 1 to 2 hours under standard atmospheric conditions After this recovery phase, the sample will undergo a functional test as specified in section 5.4.3 and will be examined for any mechanical damage, both externally and internally.
The test relates to the requirements of 4.10.
For this test, complete samples or portions of samples will be utilized A properly sized container with a capillary tube vent, having a known capacity, is required The aqueous ammonia solution must have a specific weight of 0.94 kg/l ± 2% Each liter of container volume should be filled with (10 ± 0.5) ml of the solution.
The sample must be degreased prior to testing and exposed to a moist atmosphere of ammonia and air for 10 days at a temperature of (34 ± 2)°C Additionally, the samples should be placed (40 ± 5) mm above the liquid level.
After testing, the samples shall be cleaned and dried and subjected to careful visual examination To make cracking clearly visible, the liquid penetration method shall be used.
After the above test the function shall be tested in accordance with 5.4.3.
This test relates to the requirements of 4.11.
The sample shall be attached to a vibration table using fixing materials provided by the manufacturer.
The sample will undergo sine-wave vibration across all three axes, ranging from 10 Hz to 150 Hz, with a uniform frequency increase of one octave every 30 minutes The vibration acceleration will be set at 0.2 g for frequencies between 10 Hz and 50 Hz, and at 0.5 g for frequencies from 50 Hz to 150 Hz.
The sample shall not operate during the test caused by the vibrations No deterioration or detachment of parts shall
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After the above test the function shall be tested in accordance with 5.4.3.
The test relates to the requirements of 4.12.
Under the manufacturer's maximum configuration, including alarm sounders, actuators, and connected pipe volume, the component must activate five times even in the most challenging energy supply conditions, such as low temperatures Following this cycle, the alarm sounders are required to operate for a minimum of 30 minutes if they are connected to the same energy source.
After the above test the function shall be tested in accordance with 5.4.3.
The test relates to the requirements of 4.13 The complete component shall be tested to verify compliance with the requirements of 4.13 using a suitable test procedure applicable to the component design.
5.15.1The tests relate to the requirements of 4.14.
5.15.2 Electrical triggered components shall be triggered five times with nominal, maximum and minimum specified voltage.
5.15.3 Pneumatic powered components shall be triggered five times supplied with the minimum, nominal and maximum specified pressure.
5.15.4 Gravity powered components shall be triggered five times at the specified drop distance.
5.15.5 Components which are triggered by pyrotechnic means shall be tested 10 times with the minimum specified current.
5.15.6 Spring powered components shall be triggered five times with the specified pre-loading.
The component must display essential information, including the manufacturer's or supplier's name or trademark, model designation, applicable working pressure, identifying marks or codes such as serial or batch numbers for tracking manufacturing details, and the temperature range.
The marking shall be non-detachable, non-flammable, permanent and legible.
Where the requirements of ZA.3 give the same information as above, the requirements of this clause 6 have been met.
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General
The compliance of the component with the requirements of this European Standard shall be demonstrated by:
factory production control by the manufacturer.
The manufacturer, whether a natural or legal entity, is responsible for placing a component on the market under their own name Typically, the manufacturer designs and produces the component independently Alternatively, they may subcontract the design, manufacturing, assembly, packing, processing, or labeling of the component Additionally, they have the option to assemble, pack, process, or label pre-made products.
that the initial type testing in accordance with this European Standard is initiated and carried out (where relevant, under the control of a product certification body); and
that the component continuously complies with the initial type testing samples, for which compliance with this European Standard has been verified.
He shall always retain the overall control and shall have the necessary competence to take the responsibility for the component.
The manufacturer is entirely accountable for ensuring that each component meets all applicable regulatory standards If the manufacturer utilizes components that have already been verified for compliance, such as those with CE marking, they are not obligated to conduct a new evaluation However, if the components have not been previously validated for conformity, the manufacturer must perform the necessary assessments to demonstrate compliance.
Initial type testing
7.2.1 Initial type testing shall be performed to demonstrate conformity with this European Standard.
All characteristics given in clause 4 (except 4.17) shall be subject to this initial type testing, except as described in 7.2.3 to 7.2.5.
In the event of modifications to the component or production method that could impact the specified properties, initial type testing is required This testing must cover all characteristics listed in clause 4, excluding 4.17, that may be altered by the modification, unless otherwise specified in clauses 7.2.3 to 7.2.5.
Tests conducted in accordance with this standard may be considered valid if they were performed using the same or a more stringent test method, under the same attestation of conformity system, and on components of similar design, construction, and functionality, ensuring that the results are relevant to the component in question.
NOTE Same system of attestation of conformity means testing by an independent third party under the control of a product certification body.
Components can be categorized into families based on shared characteristics or representative test results Consequently, it is not necessary to test every component within a family for initial type testing.
If the component's characteristics have already been validated in accordance with prEN 12094-4 and EN 60529, no additional assessment is necessary to confirm compliance with this European Standard.
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In the context of prototypes and third-party certification, the manufacturer is responsible for selecting the samples, not the third party During the initial factory inspection and production control, it is confirmed that the component consistently meets the standards of the initial type testing samples.
7.2.7 If the technical documentation of the test samples does not give a sufficient basis for later compliance checks, a reference sample (identified and marked) shall remain available for this purpose.
7.2.8 Any initial type testing and its results shall be documented in a test report.
Factory production control (FPC)
The manufacturer shall establish, document and maintain an FPC system to ensure that the components placed on the market conform with the stated performance characteristics.
When a manufacturer outsources the design, production, assembly, packaging, processing, and labeling of a component to a subcontractor, the subcontractor's FPC can be considered However, the manufacturer must maintain overall control of the component and ensure they obtain all necessary information to meet their obligations under the European Standard It is crucial to note that a manufacturer cannot absolve themselves of responsibility by subcontracting all activities.
FPC is the permanent internal control of production exercised by the manufacturer.
Manufacturers must systematically document all elements, requirements, and provisions through written policies and procedures This documentation of the production control system is essential for ensuring a shared understanding of conformity evaluation, facilitating the achievement of necessary component characteristics, and enabling effective monitoring of the production control system's operation.
Factory production control integrates operational techniques and measures to ensure that components meet technical specifications This process involves conducting controls and tests on measuring equipment, raw materials, manufacturing processes, machines, and finished products By analyzing the results obtained from these evaluations, manufacturers can maintain and verify the conformity of material properties in components.
The FPC system should fulfil the requirements as described in the following clauses of EN ISO 9001:2000, where applicable:
The FPC system may be part of a Quality Management system, e.g in accordance with EN ISO 9001.
address this European Standard; and
ensure that the components placed on the market conform with the stated performance characteristics.
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The FPC system must incorporate a specific FPC or Quality plan that outlines procedures for demonstrating component conformity at various stages This includes controls and tests to be conducted before and during manufacturing at specified frequencies, as well as verifications and tests on finished components, also according to established frequencies.
When finished components are utilized by the manufacturer, the processes outlined in section b) will ensure that the component achieves a conformity level equivalent to that obtained through standard FPC during production.
When a manufacturer conducts parts of the production process independently, it can reduce the operations typically required under category b) and substitute them with those under category a) Generally, a higher degree of self-conducted production allows for more operations under b) to be replaced by those under a) Regardless of the approach taken, the operations must ensure that the component achieves a conformity level equivalent to that obtained through standard Factory Production Control (FPC) during production.
NOTE Depending on the specific case, it may 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 focus on the intermediate states of components, as well as the manufacturing machines, their adjustments, and measuring equipment The selection of controls, tests, and their frequency is determined by factors such as the type and composition of the component, the complexity of the manufacturing process, and the sensitivity of component features to variations in manufacturing parameters.
The manufacturer must maintain records that demonstrate the sampling and testing of production, clearly indicating whether it meets the established acceptance criteria, and these records should be kept for a minimum of ten years In cases where components do not meet acceptance measures, non-conforming product procedures must be followed, requiring immediate corrective action, isolation, and proper identification of the non-conforming components or batches After addressing the issue, the relevant tests or verifications must be repeated.
All control and test results must be accurately documented, including the component description, manufacturing date, adopted test method, test results, and acceptance criteria, all signed by the responsible individual If any control result fails to meet the requirements of the European Standard, the records must also detail the corrective actions taken, such as conducting additional tests, modifying the manufacturing process, or discarding or repairing the component.
7.3.3.3 Individual components or batches of components and the related manufacturing documentation shall be completely identifiable and retraceable.
7.3.4 Initial inspection of factory and FPC
Initial inspections of the factory and the FPC typically occur while production is ongoing and the FPC is actively implemented However, these inspections can also be conducted prior to the commencement of production and the practical application of the FPC.
7.3.4.2 The following shall be assessed to verify that the requirements of 7.3.2 and 7.3.3 are fulfilled:
The factory assessment must confirm that all necessary resources for meeting the component characteristics outlined in this European Standard are available or will be available Additionally, it should ensure that the FPC procedures, as detailed in the FPC documentation, are being implemented and adhered to in practice.
The component must comply with the initial type testing samples verified against the European Standard Additionally, it is essential to determine if the Factory Production Control (FPC) system is integrated into a Quality Management System that adheres to EN ISO 9001 standards This system should be certified and undergo annual surveillance by a recognized certification body, which is a member of the European Co-operation for Accreditation and has signed the Multilateral Agreement (MLA).
All manufacturing facilities where final assembly or testing of components occurs must be evaluated to ensure compliance with specified conditions A single assessment can encompass multiple components, production lines, or processes If the Factory Production Control (FPC) system applies to various components and meets the general requirements, then the detailed verification of the FPC requirements for one component can serve as a representative for others.
Assessments conducted under this standard can be considered if they pertain to the same conformity attestation system and involve the same component or components with similar design, construction, and functionality, ensuring that the results are relevant to the component in question.
NOTE Same system of attestation of conformity means inspection of FPC by an independent third party under the control of a product certification body.
7.3.4.5 Any assessment and its results shall be documented in a report.
7.3.5.1 All factories which have been assessed according to 7.3.4 shall be re-assessed once a year, except as stated in 7.3.5.2.
In this case each FPC assessment shall verify a different component or production process, where applicable.
7.3.5.2 If the manufacturer provides proof of continuing satisfactory operation of his FPC system the frequency of the re-assessment may be reduced to once every four years.
NOTE 1 Sufficient proof can be the report of a certification body, see 7.3.4.2 d).
If the Quality Management system aligns with EN ISO 9001 and is effectively implemented and maintained, as confirmed by initial assessments and ongoing QM audits, it indicates that the relevant aspects of the integrated Factory Production Control (FPC) are adequately addressed Consequently, this ensures that the manufacturer's operations are well-regulated, allowing for a reduction in the frequency of special FPC surveillance assessments.
7.3.5.3 Any assessment and its results shall be documented in a report.