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The Journal for Employee Protection
The Journal for Employee Protection
by Dave McKeown, SATRA
Hearing protection is vital for many people in a wide range of industries around the world. In fact, in many situations it is critical in protecting an individual’s hearing. Worldwide, approximately 900 million people suffer with some form of hearing loss. Many of these cases could have been prevented with the correct use of adequate hearing protection.
Most industrialised nations have some form of occupational noise legislation. For instance, in the UK the ‘Control of Noise at Work Regulations’, based on a European directive, provides minimum health and safety requirements. These regulations set out the action values and exposure limit values at which employers must act. At a daily or weekly exposure level of 80dB(A)/135dB(C) peak or more, the employer must provide information and training to staff and make hearing protection devices available. At 85dB(A)/137dB(C)peak and above, the employer must take reasonable action to try to reduce the noise in the workplace by using engineering controls or administrative methods. If the noise cannot be reduced in this way, hearing protection devices become mandatory. There is also an exposure limit value of 87dB(A)/140dB(C)peak’, above which no worker can be exposed to.
However, it is not only in the workplace where people are exposed to harmful noise levels. Music venues, nightclubs and shooting ranges are just a few of the places at which these noise levels are regularly exceeded.
Hearing protection can be found in many different forms, whether standard ear-muff or ear-plug designs (known as ‘passive devices’) or more complex models incorporating electronic systems which react differently in varied noise environments, known collectively as ‘active devices’.
The performance of models in their passive state is dependent on several factors. The depths of the cups which enclose the ears, the headband force and the acoustic absorption of liners are just a few of the variables contributing to the performance of earmuffs, while size, fit and construction material generally govern the effectiveness of earplugs.
“the slightest break in a seal around an earplug or the cushion of an earmuff will reduce the attenuation”
However, the protection provided by any device will be compromised if it is poorly fitted or incorrectly worn – even the slightest break in a seal around an earplug or the cushion of an earmuff will reduce the ‘attenuation’ (noise reduction) provided by the hearing protection. Because of this, it is important that wearers are shown how to correctly fit and use their hearing protection.
Before a hearing protection product can be placed on the market in Europe, it must be tested and certified. This is because it falls under the scope of the Personal Protective Equipment Regulation 425/2016. Furthermore the regulation categorises hearing protection PPE as complex or category 3 which means that following a type examination, bulk production must be checked by a notified body at regular intervals, usually annually.
The wide range of hearing protection types available is reflected by the number of European Standards governing this testing. The EN 352 series of standards is currently comprised of eight parts, which cover the general requirements of each type of hearing protector. For example, parts one and two relate to passive earmuffs and earplugs respectively. Part three sets out the requirements of earmuffs attached to industrial safety helmets, and the final five parts cover active devices – including level-dependent, active noise reduction and audio input devices.
The testing scheme differs for each type of device. However, each of them must undergo physical and acoustics testing plus testing to ensure the innocuousness of the materials used, as well as a review of product marking and wearer information.
Attention is also drawn to standards EN 352-9 and EN 352-10 that are currently in draft form for public comment and are expected to be published later in 2019.
The draft standards FprEN 352-9 (Audio input ear plugs) and prEN 352-10 (Entertainment audio ear plugs) are under the final stages of development for testing of earplugs with audio input. The first, FprEN 352-9, is similar to EN 352-6 but for earplugs instead of earmuffs. The second, prEN352-10, is similar to EN 352-8, but for earplugs instead of earmuffs. During the drafting of these standards a critical development was the drafting of a third draft document, FprEN 13819-3:2018, which defines the test procedures for products covered by parts 9 & 10.
The document FprEN 352-9 “Hearing protectors – Safety requirements – Part 9 – Earplugs with safety-related audio input” is applicable to earplugs that include an electrical audio input facility or circuit for safety-related communication. The audio signal can be transmitted through cables or wirelessly e.g. by Bluetooth. It specifies requirements on construction, design, performance, marking and user information related to the inclusion of the safety-related audio input. Earplugs with safetyrelated audio input are designed to enable users to hear speech and warning signals, while providing attenuation of external sound. They may be selected for use in a number of different environments, for example in air traffic communication, in the police forces, in the broadcasting and entertainment industries.
The document FprEN 352-10 “Hearing protectors – Safety requirements – Part 10 – Entertainment audio earplugs” is applicable to earplugs that provide reproduced sound for entertainment purposes. They may be designed with an electrical audio input, with built-in broadcast receivers or with other built-in wireless receivers such as Bluetooth, or they may be part of a complete system composed of transmitters and receiving audio earplugs. This document specifies requirements on construction, design, performance, marking and user information relating to the inclusion of the entertainment audio facility. Entertainment audio earplugs may use a wired or wireless system through which audio entertainment can be relayed. They may incorporate a radio receiver set or music player for entertainment or allow audio input from external devices. They also offer the possibility to communicate warning signals or messages. The product standards impose a limitation on the reproduced sound pressure level at the ear.
One of the first physical tests undertaken in the testing scheme is a materials and construction assessment. This confirms that the device is free from sharp edges, is safe for use and that any cleaning and disinfection methods specified cause no damage or impairment to the hearing protection.
A sizing assessment is also required, to ensure that the product is suitable for the range of head sizes designated by the manufacturer. The majority of devices are classified as ‘medium’ size range, which should fit the vast majority of the population. However, products can be classed as ‘small’ or ‘large’, and must be clearly labelled so before they are placed on sale. During this test, a range of fitting rigs, moulded headforms and size gauges are used to ensure that the products can meet specified test dimensions and so provide an adequate fit for the consumer.
For earmuffs, cup rotation is assessed to confirm that the cups can be rotated sufficiently so that the wearer can find the most comfortable position. Headband force and cushion pressure are also measured to ensure that there is no excessive pressure upon the head from the combination of cushions and headband.
Resistance to damage is evaluated by dropping the hearing protection from a specified height onto a solid steel plate. If any part of the sample cracks or breaks, the device will fail the test, and will most probably require redesign and resubmission for testing. This testing can also optionally be conducted at -20°C for devices which are designed for use in colder environments.
The durability of headbands or standby mechanisms, which allows helmet-mounted earmuffs to be returned to the position which they occupy while not in use, are also tested if they are incorporated into the device. This is gauged by placing the cups of the product onto a pair of plates which oscillate between a minimum and maximum separation distance. The process continues for 1,000 cycles to replicate the action of a wearer fitting and removing the device or activating the standby mechanism.
Conditioning then takes place in the form of water immersion for 24 hours. As an option, this can be conducted with the headband under stress which is applied using a parallel spacer placed between the cushions of the device. Once complete, the change in headband force is measured for a second time, with a maximum deviation between the two measurements providing the pass criterion.
“a range of fitting rigs, moulded headforms and size gauges are used to ensure that the products can meet specified test dimensions”
If earmuffs with fluid filled cushions are under test, resistance to leakage must be assessed. A vertical load of 28±1 Newtons is applied to the cushion for 15 minutes, and any leakage caused will constitute a test failure.
The final physical test, which is undertaken for all types of hearing protection, is an ignitability assessment. A steel rod heated, to around 650ºC is applied to the device. If any part ignites or continues to glow after the removal of the rod, the device fails the ignition test.
Microphones are housed in cavities in the sides of the fixture to replicate the position of the ears. The testing is normally conducted in an acoustic tunnel, with a loudspeaker at one end, and acoustically absorbent foam at the other and along the length of the tunnel. This creates an ‘anechoic’ effect, meaning that generally sound waves striking the sides and the end of the tunnel are absorbed rather than reflected, thus allowing a ‘plane progressive sound wave’ (moving in one direction only, with no reflections from side walls or ends) to propagate along the tunnel. It is worth noting that this test sets no limit on the minimum attenuation which should be achieved. It is designed to assess the difference in the attenuation values between ten samples of the same earmuff model, in order to ensure that there is not a major variation in performance.
The subjective attenuation test uses human subjects to assess the performance of a hearing protection device, and does require a minimum attenuation value to pass the test. The results of these tests are published for the model when it is placed on sale and supplied to wearers. This test measures the ‘threshold of hearing’ – the lowest sound pressure level perceivable by the ear – of 16 human test subjects, with and without the hearing protection worn. The performance of the model is calculated from these values.
Assessing a subject’s threshold of hearing requires extremely low background noise levels. These noise levels are so low that they are expressed in negative decibels. To achieve such a quiet environment, a specially-designed location is required, such as:
These chambers are designed to insulate against sound travelling through their walls, and use a heavyduty construction of two independent wall structures separated by a cavity and acoustically-absorbent insulation. ‘Anechoic’ means that an extremely high percentage of sound inside the chamber is absorbed by the walls and ceiling, which are covered with foam wedges that absorb acoustic energy over a wide range of frequencies.
Attenuation ratings awarded to hearing protection devices are denoted using ‘Simplified Noise level Reduction’ (also referred to as ‘Single Number Rating’, or SNR), ‘High-Medium-Low’ (HML) and ‘octave band values’. These are different ways to quantify the performance of the device in question. SNR provides a single attenuation value based on the subjective attenuation tests. Theoretically, this value can be subtracted from measured external noise levels in order to estimate the noise level at the ear, beneath the hearing protection. However, it should be noted that this method does not provide any information as to how much protection is provided in different frequency ranges, which is why the HML rating system is also required.
HML provides further detail, allowing the attenuation provided to be assessed across high, medium and low frequency ranges. This is particularly useful if a person is subjected to narrow band noise rather than broadband noise, as it allows a more accurate assessment of the noise level at the ear.
Marking of the device and the information provided to wearers also needs to be inspected. This involves a review of the supplied user manuals and an examination of the final product to ensure that the correct markings are present, and that the required information is supplied to users, as specified in the relevant European standard.
The protection provided by protective devices will be compromised if they are poorly fitted or incorrectly worn – even the slightest break in a seal around an earplug or the cushion of an earmuff will reduce the ‘attenuation’ (noise reduction) provided by the hearing protection. Because of this, it is important that wearers are shown how to correctly use their hearing protection and this is especially important when fitting ear muffs to helmets.
With regards to EN352-3:2002 the term “model” refers to the earmuffs plus the helmet they were tested with. This pairing of earmuff and helmet is referred to in the standard as the basic combination. However often it is possible to attach the same earmuffs to different helmets. Such combinations are referred to as supplementary combinations and the testing of such combinations is also covered by EN 352-3:2003.
Additional testing on supplementary combinations is required and includes the range of mechanical tests including headband force. Depending on the level of headband force achieved by the supplementary combination and comparing this to the headband force of the basic combination will indicate whether the supplementary combination also requires acoustic testing.
Without testing there is no guarantee that fitting earmuffs to a completely different helmet, i.e. a helmet not tested as one of the supplementary combinations, will provide sufficient protection. The combination thus created will not have a valid CE mark. Users especially need to be aware that they cannot simply remove earmuffs from the approved helmet and attach them to a different helmet. Suppliers and manufacturers should be aware of this potential misuse by users and provide sufficient information (e.g. to select only earmuff helmet combinations that have been tested?) in the marking and information leaflet provided to wearers.
Any materials used in the manufacture of the device which will come into contact with the skin must be confirmed as being non-staining, and not likely to cause skin irritation, allergic reaction or any other adverse effect on health. The physical testing schedule is designed to replicate the day-to-day physical demands which will be put upon the hearing protection, and to ensure that the device is fit for purpose.
The type examination of PPE requires notified bodies to inspect the marking of the device and the information provided to wearers. This involves a review of the supplied user manuals and an examination of the final product to ensure that the correct markings are present, and that the required information is supplied to users, as specified in the relevant European standard. In the case of helmet mounted earmuffs tested according to EN 352-3:2002 the information should include the list of helmets that the earmuffs have been tested with and approved for use with.
Dave McKeown, SATRA
How SATRA can help?
SATRA has two Notified Bodies, one in the UK and another in the Irish Republic, and has a team of experts on hand to help you through
the process of the testing and type examination according to the requirements of the PPE Regulation. SATRA is also able to carry out the module C2 checks on samples from bulk production as specified in PPE regulation, or, alternatively, module D quality management system audits in the manufacturing facility.
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