Document Purpose

The purpose of this document is to specify which requirements in Quality Standards & Requirements that are classified as legal according to below set definition.

All requirements necessary to comply with to get safe products that minimize the risk of personal injuries requiring assistance from medical personnel are classified as being legal. This since they fall under General Product Safety Laws. The extent of the injury and the probability of the injury occurring needs to be evaluated. 

A requirement is considered as legal when the consequences of the requirement not being fulfilled can result in a personal injury requiring assistance from medical personnel based on foreseeable use and/or misuse. Cases of property damages are only falling under this definition when they have a reasonably foreseeable risk to lead to personal injuries requiring assistance from medical personnel. 

Bicycle Helmet Standards Europe

 

EN1078 is the European standard for helmets that regulates standards for pedal cyclists’ helmets,skateboard users helmets, and roller skate users’ helmets. This standard is identical to the British Standard BS EN1078 formulated in 1997 as well. Fulfilling the EN1078 standard means a helmet manufacturer has met the requirements of the European Personal Protective Equipment Directive (PPE; 89/686/EEC). 

EN1078 covers helmet production, taking field of vision, retention system features, and shock absorption features into consideration. The EN1078 standard uses flat and kerbstone test anvils, guided free-fall drop gadgets, impact energy criteria, impact velocity, retention system strength, and roll-off test. The retention system strength is tested through force applied dynamically.  

 

EN1080, on the other hand, is a certified standard for helmets for younger children. The EN1080 standard was drafted because of the increased number of fatal accidents that occurred on the playground when children played using playground equipment or tried to climb trees. These accidents were a result of children’s heads getting stuck in the playground equipment which would not have been the case without a helmet. As a result, the EN1080 standard was created. This standard allows a weaker retention system that releases on its own when a force greater than 90 newtons but less than 160 newtons is applied. A helmet cannot meet both EN1078 and EN1080 standards, it can only meet one of the two.

 

Sunglasses   

In Europe, sunglasses are considered to be personal protective equipment (PPE) and, therefore, subject to the requirements of the European regulation for personal protective equipment. This regulation places items of PPE into one of three categories, depending on the type of hazard that they are intended to protect against.

 

Sunglasses are listed as ‘Category I’ (the lowest category PPE). They can be self-certified and CE marked by the manufacturer after comparison of the appropriate technical documentation and confirmation that the performance of the product (both physical and optical) is satisfactory. Enforcement and customs authorities in European Member States may require this information.

 

A standard has been developed for sunglasses and sun glare filters. EN ISO 12312-1:2013+A1:2015 specifies performance properties for products intended for general social and domestic purposes, including driving. Photochromic types (that reversibly alter luminous transmittance under the influence of sunlight) are also included. However, it does not apply to eyewear for protection against radiation from artificial light sources, such as those used in solaria (tanning beds). Nor does it apply to ski goggles or sunglasses that have been medically prescribed for reducing exposure to solar radiation. ISO 12312 details methods to evaluate the general safety, optical properties and structural characteristics of afocal (plano) sunglasses and clip-ons, and sun glare filters. These include requirements for filters and complete sunglasses, and information to be supplied by the manufacturer. Reference is made to other eyewear standards (such as EN 166:2001 and EN 167:2001). These cover aspects of physical testing such as robustness and optical tests intended to check light transmission and distortion properties. Frames made of nickel are required to satisfy EN 16128:2015 – the test method for release of nickel from products in direct and prolonged skin contact.

 

There are five filter categories for sunglasses. Category 0 applies to photochromic lenses in the faded state (clear condition), with higher categories covering filters with greater light attenuation (reduction). Photochromic lenses are categorized as both 0 and a higher category, depending on their luminous (light) transmittance properties in the darkened state. Sunglasses suitable for driving need to conform to category 0, 1, 2, or 3 to allow sufficient visible light to pass and not adversely affect the recognition of traffic signals. In addition to evaluating luminous transmittance, tests are also carried out to evaluate the capability of the lens to filter out infrared and UV light.

 

 

Personal Eye Protection

Protective eyewear is tested to meet a specific set of standards and is marked according to its protective ability. Although there are many standards for safety eyewear depending on its purpose, all eyewear intended for use in the workplace must meet a core European standard: EN 166:2001.

What is EN166?

 

EN 166:2001 is the European standard covering the requirements for protective eyewear. It is closely linked to EN 167:2001and EN 168:2001 which specify the optical and non-optical test methods.

EN 166 specifies the minimum requirements for a range of performance tests. This standard contains a set of requirements referred to as ‘basic requirements’, which may be regarded as mandatory.

 

When is safety eyewear needed?

 

Eye protection is required whenever there could be a risk to the eyes. The EN 166 standard of eyewear isn’t limited to the workplace.

Protective eyewear is diverse and is designed to counter a variety of risks such as splatter, impact and light filtration. UV rays from the sun is one of the biggest risks to the eyes.

To protect the eye from foreign objects, such as dust particles, caustic fluids, radiochemicals or metal swarf shavings, suitable eye protection should be selected and worn where applicable.

Eyewear is one of the most common forms of PPE and one of the most versatile. Where there is a potential hazard, eye protection should be worn even if there is no immediate, presentable risk. Some injuries are immediate, but others can be gradual as a result of lengthened exposure to sunlight, for example.

 

Face masks 

 

European standard EN 14683:2019+AC:2019 Medical face masks are classified as Type I and Type II according to bacterial filtration efficiency, whereby Type II is further divided (Type II and IIR) according to whether or not the mask is splash resistant. The 'R' signifies splash resistance. Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements3 . 

 

• Level One: Low barrier protection. Only for general use, not used for aerosols, spray or fluids.
• Level Two: Moderate barrier protection. Use for low to moderate levels of aerosols, spray and/or fluids.
• Level Three: Maximum barrier protection. Use for high risk of fluid, spray and/or fluids.

 

Key Testing Metrics:

 

Masks are tested to five key performance criteria:

• Bacterial Filtration Efficiency: measures and tests the bacteria filtered out by the mask (larger than three microns).
• Particulate Filtration Efficiency: measures and tests the particles filtered out by the mask (larger than one micron).
• Fluid Resistance: evaluates and tests the resistance of the face mask to the penetration of approximately 2 mL of synthetic blood at a high velocity. Based on visual evidence, the mask either passes or fails the test.
• Breathability: tests the resistance of the face mask to a controlled airflow driven at the mask. Lower breathing resistance results indicate a higher level of comfort for the user.
• Flammability: tests the time required for an exposed flame to proceed up the mask material at a distance of five inches. Normal flammability is known as Class One.

 

The more resistance the mask offers to any of these criteria, the higher the grade, and thus the higher the protection. Higher protection masks are more suited to surgery or working with chemicals, however, will not protect against vapors, which will need a respirator.

 

• Mouth and respiratory protection must be CE marked
• Personal protective equipment category III must bear the CE marking with the Notified Body's four-digit ID number. Respiratory protection eg shall be marked CE0000
• The Declaration of Conformity, or an URL where it can be downloaded, should be included with the product. The DoC must be in Swedish or English
• The products must be accompanied by a user manual in Swedish or English 
• The manufacturer must have provided mouth and respiratory protection with type number, serial number or other identification mark. If this is not possible due to the size or nature of the personal protective equipment, the information must be placed on the packaging or in a accompanying document
• Contact information to the current manufacturer and importer must be on the mouth and respiratory protection, alternatively on the packaging or in the accompanying document
• EU Type-Examination Certificate: Only for categories II and III.
• To be able to sell Category II or III personal protective equipment, the manufacturer must compile technical documentation for the protection and submit a prototype for EU type control to a Notified Body. A Notified Body is an independent organization with the expertise to assist and monitor the manufacturers' work to verify that the products placed on the market comply with the EU / EEA rules. The notified body reviews the technical documentation and tests the product, usually with the help of a harmonized standard. If the protection complies with the requirements of the Personal Protective Equipment Regulation, the notified body issues an EU Type-Examination Certificate.

 

High Visibility Clothing

EN ISO 20471 is an international standard that imposes requirements on visible workwear for employees in high-risk areas. Using the right safety workwear is important and must be prioritized. Even if working in areas where visibility is important only takes place during a short part of the working day. EN ISO 20471 is divided into three classes, in accordance to the risk zone you work in and to how well the product is able to protect the employee. It is the visibility requirement – and thus the requirement for the area consisting of reflectors and fluorescent materials – that determines which class you need to choose. In all products, the reflecting ability of all reflectors fulfills what previously corresponded to class 2.

 

 

CLASS 1

Class 1 high-visibility clothing can be used in situations with a low risk of collisions and accidents. Class 1 high- visibility clothing is not suitable for work on public roads, but is suitable for work in full or partial daylight within a company’s premises. Maximum traffic speed 30 km/h.

CLASS 2

Class 2 work clothing provides good visibility for roadworks, courier services and twilight work. Class 2 high- visibility clothing is suitable for work on public roads with a maximum traffic speed of 50 km/h.

CLASS 3

Class 3 high-visibility clothing is mandatory when working in the dark. Visible at traffic speeds up to 90 km/h. This optimum visibility greatly reduces the risk of accidents. 

 

EN 13356 Visibility Accessories for Non-professional Use

This standard relates to products intended to be worn or carried by individuals to make them more conspicuous to other road users under low light levels. The products use retro-reflective material only. 

There are 3 types of products that are covered by this standard which are Type 1 – free hanging, Type 2 – removable, or Type 3 – mounted. These can be flexible or rigid. This standard gives requirements for the photometric performance and minimum areas of the retro-reflective material.

EN 1150 Visibility Clothing for Non Professional Use

 

This standard gives details of the requirements for high visibility clothing for nonprofessional use. 

 

Hearing protection

 

EN 352 standards explained

 

The first 3 parts of EN352 cover the basic requirements of hearing protection and define the passive performance requirements. This includes the requirements for size, materials and construction.

 

The instructions for EN 352 testing methods are not included within these 3 basic parts, instead they refer to another standard, EN 13819. EN 13819 details the testing methods common to all types of hearing protectors covered by EN 352, and come in 2 parts: 1) Physical test methods and 2) Acoustic test methods.

 

Another standard mentioned in EN 352 is EN 458, which covers selection, use, care and maintenance of hearing protectors.

 

To meet the EN352 standards, hearing protection is tested in the following areas (subject to product type):

 

• Materials and construction
• Sizing and adjustability
• Cup rotation
• Headband force 
• Cushion pressure
• Resistance to damage when dropped
• Change in headband force
• Resistance to leakage
• Ignitability
• Minimum attenuation
• Marking
• Information supplied by the manufacturer

 

EN 352-1:2002 - Hearing protectors - Ear muffs

Ear muffs tested in accordance with EN 352-1:2002 must be labeled with the standard number, manufacturer and model identification. Where required, there should also be indication for the orientation of the ear muff e.g. ‘TOP’ and/or ‘LEFT’ and ‘RIGHT’.

 

• Materials and construction

Any materials used to make the product that will come into contact with the skin must be non-staining and not likely to cause skin irritation, allergic reaction or other adverse effects on health. The device must be free from sharp edges to be considered safe for use, and cleaning and disinfection methods specified should not cause damage or impairment to the hearing protection.  

 

• Size and adjustability

This is tested to ensure that ear defenders are suitable for the range of head sizes designated by the manufacturer. With EN 352-1:2002 compliant products you should expect an adequate fit.

 

• Cup rotation

Hearing protectors are measured to assess whether or not the rotation of the cups is sufficient. There must be enough rotation for wearers to adjust the device to achieve the best fit.

 

• Headband force

There should be no excessive force on the wearer’s head.

 

• Cushion pressure

There should be no excessive pressure on the wearer’s head.

 

• Resistance to damage when dropped

For this test, the ear protection product is dropped from a specified height onto a solid steel plate. If part of the product cracks or breaks then it will fail the test.

 

• Change in headband force

After the tests above have been completed, headbands are subjected to flexing for 1000 cycles, before being conditioned in a water bath at 50°C for 24 hours. Once complete the headband force is measured a second time. A maximum deviation between the 2 measurements determines whether it passes.

 

• Resistance to leakage

This is specifically for ear muffs with fluid-filled cushions. A vertical load of 28±1 Newtons is applied to the cushion for 15 minutes and any leakage caused will constitute a test failure.

 

• Ignitability

A steel rod heated to around 650°C is applied to the hearing protection device. If any part ignites or continues to glow after the removal of the rod then the device will fail the ignition test. 

 

 

• Minimum attenuation

The minimum attenuation value must be recorded for EN 352-1 compliant ear muffs. This is the lowest sound pressure level perceivable by the ear of 16 human test subjects with and without the hearing protection worn. It is then possible to calculate the performance of the model from these values.

 

 

EN 352-2:2002 - Hearing protectors - Ear plugs

 

The second section of the EN352 standards, EN 352-2:2002, specifies the constructional, design, performance and marking requirements for EN 352 compliant ear plugs. This includes specification for the sound attenuation of the ear plugs, measured in accordance with EN 24869-1.

 

Ergonomic aspects of the ear plugs are addressed by taking into account the interaction between the wearer, device and, where possible, the working environment in which the device is likely to be used.

 

The markings for EN 352-2 may only appear on the packaging; these include the standard number, manufacturer and model identification. In addition to these markings the packaging for EN 352-2 ear plugs should also state whether they are disposable or reusable, have fitting instructions, include the nominal size of formable plugs (ranging from 5-14mm), and custom molded ear plugs should have LEFT/RIGHT differentiation.

 

Ear plugs are tested for many of the properties outlined above in EN 352-1:

 

• Sizing and adjustability
• Materials and construction
• Resistance to damage when dropped
• Ignitability
• Minimum attenuation

 

There are, however, some small differences to testing methods in EN 352-2. Custom molded ear plugs are not tested for sizing and adjustability, and with reusable ear plugs, the method of cleaning and disinfection specified is assessed to ensure it causes no significant alteration to the acoustic performance or to the material and construction properties.  

 

EN 352-3:2002 - Hearing protectors - Ear muffs attached to a safety helmet

 

The third section deals with the specific requirements for ear muffs attached to industrial safety helmets. In EN 352-3 products are tested for all properties mentioned in the EN 352-1 section, as well as specific testing methods for helmet mounted ear defenders.

 

The markings to be included on EN 352-3 ear muffs are the standard number, manufacturer and model identification, as well as indication of orientation where required e.g. ‘TOP’ and/or ‘LEFT’ and ‘RIGHT’.

 

EN 352 Parts 4 to 8

 

From part 4 onwards, the EN352 series deals with the safety requirements and testing methods for additional functions built into hearing protectors. An example of this is a ‘level dependent’ function, covered in EN 352-7. Level dependent ear plugs are designed to provide restoration of external sounds, while also providing attenuation of sound at high sound pressure levels. Other additional functions include active noise reduction and audio communications.

 

You can see the full list of additional hearing protection functions covered by EN 352 below:

 

• EN 352-4:2001 - Hearing protectors - Level dependent ear muffs 
• EN 352-5:2002 - Hearing protectors - Active noise reduction ear muffs 
• EN 352-6:2002 - Hearing protectors - Ear muffs with electrical audio input
• EN 352-7:2002 - Hearing protectors - Level dependent ear plugs
• EN 352-8:2008 - Hearing protectors - Entertainment audio ear muffs

 

How to choose hearing protection

 

When you are looking for fit-for-purpose ear protection, look out for the EN 352 markings. EN 352 certification will ensure they have been tested in accordance with European standards, and therefore possess all of the properties required for effective and reliable hearing protection.

 

Before a decision is made, however, you will need to work out the particular employee’s daily or weekly noise exposure, measuring the noise level of each task they are required to carry out and how much time is spent on the task. This can be done with a professional decibel meter (sound level meter)

 

Single Number Rating (SNR) is required to maintain compliance. Every hearing protection product will come with an SNR, and this allows you to compare the protection offered by different products in order for you to make the best decision. The higher the SNR level, the more protection the product gives.

 

Here are the SNRs required to remain compliant at various noise levels: