Testing and Certification
Many predominant industries in the Middle East such as petrochemical, construction, telecommunications, as well as oil and gas utilities, require extensive use of PPE.
When sourcing PPE, the now familiar CE symbol (a manufacturer’s declaration that the product complies with EU legislation) together with the associated user information leaflets can be used as guidance to suitable equipment. Moreover, with European industry being a significant user of PPE, manufacturers of PPE in the Middle East are increasingly looking to gain approval of their products for sale in Europe. European Union regulations often set the standard for the performance of Personal Protective Equipment (PPE) worldwide. Much of what is detailed below is relevant to all types of PPE, not just safety footwear, with only the intricacies of the product testing differing.
The European Union and the United States of America are the world’s largest safety footwear market. Both have comprehensive legislation covering the workplace environment and performance requirements for safety footwear. Although other parts of the world have different legislation, the industrial hazards are generally very similar. Regardless of country, protective and safety footwear often incorporates similar features, such as safety toecaps and under-foot protection. More specialist footwear has been developed to protect against other physical risks, such as cutting by chainsaws, or environmental hazards associated with chemicals, heat and electricity.
The European Personal Protective Equipment (PPE) Directive 89/686/EEC defines PPE as clothing and equipment “designed to be worn or held by an individual for protection against one or more health and safety hazards”. Since the Directive became part of European law in 1995, suppliers of PPE in the European market have had to follow the appropriate approval procedure to CE mark their products.
European Council Directive 89/686/EEC
The Directive covers a range of products, which it divides into three categories. These are based on the risk, consequences and severity of injury likely to occur to someone not wearing adequate PPE. The procedures for demonstrating compliance and the involvement of a Notified Body differ for each category.
‘Simple’ design PPE covers products that are claimed to provide protection against minimal risks, with effects that are gradual and can be safely identified by the user in good time.
Products in this category (commonly called Category 1), washing-up gloves for example, are listed in the Directive. Category 1 PPE can be ‘self-certified’ by the manufacturer or European importer without the need for third-party verification. The involvement of a Notified Body is not required. However, an enforcement authority would expect to be able to examine a technical dossier backed up by appropriate test reports. Therefore, it is recommended that records of some testing carried out by an independent test centre be kept, to provide documentary evidence to support any claims made about the product.
‘Complex’ design PPE (Category 3) covers products claimed to provide protection against risks of mortal danger, or dangers that may seriously and irreversibly harm the health of the user. Again, a list of such products is detailed in the Directive. These products must be certified by a Notified Body and are subject to initial type examination and continual production checks. This category includes footwear for fire fighters, for protection against molten metal in foundries or for high voltage protection.
All other products (neither simple nor complex) fall into a third category often called ‘Intermediate’ design or Category 2. These are products claimed to provide protection against risks of severe injury. A Notified Body must certify initial examples of such products and any associated documentation. Most safety footwear falls into this category.
European harmonised standards
As the Directive is a piece of general legislation, it includes health and safety requirements that must be taken into account for all types of PPE. It does not, however, detail how particular types of product should be tested. To support the Directive, the European Union Commission has mandated the development of various product safety standards through the European standards agency CEN (Comité Européen de Normalisation). CEN has convened a technical committee to develop a series of harmonised European standards for use in testing and certification of foot and leg protection.
These European standards describe in detail how a particular type of product should be tested and what performance is required to achieve a satisfactory pass. The tests developed for the various standards are designed to assess products against the requirements of the PPE Directive for the risks of the particular activity for which they are to be used. The European Commission reviews these standards and, if they are found suitable, they become officially harmonised throughout Europe, and receive a ‘presumption of conformity’ for the parts of the Directive detailed in Annex ZA of each standard. The publication of the standard is also mentioned in the official journal of the EU. Hence, when starting the CE marking process, it is necessary to review Annex ZA of any harmonised standard to be used, to ensure that all relevant clauses of the Directive are addressed.
Harmonised standards are not the only means of demonstrating compliance with the PPE Directive. A manufacturer can use any technical specification as long as it can be shown to satisfy the relevant basic health and safety requirements (BHSR) of the PPE Directive essential safety requirements. However, if a harmonised standard is available for the particular product being examined, there should be a sound technical argument if it is not used. In certain areas, such as niche or leading edge products, there may still be no harmonised standards available. In such cases a technical specification detailing how compliance is to be demonstrated must be produced and used. SATRA has certified a number of products where harmonised standards or satisfactory national standards do not exist and has produced a series of SATRA standards (referred to as ‘M’ Documents) to cover them.
Typically the tests necessary to certify an item of PPE cover all of the following four main categories:
- Innocuousness: This covers some quantitative tests, such as measuring the quantity of trace toxic substances in the product or its raw materials but also often includes a subjective assessment for any parts of the product that may cause injury, such as sharp edges.
- Ergonomics: Usually a small-scale practical wear trial which involves the wearer carrying out a range of movements typical of normal use and reporting any restrictions or discomfort caused by the PPE
- Protective coverage: Particularly important for products such as impact protectors. Minimum dimensions are specified, which are usually dependent on the size of the intended wearers
- Protective qualities: A range of physical laboratory tests to mimic accident scenarios, such as measurement of resistance to impact, penetration, cutting, burning and the flow of electricity
During the development of CEN standards (ENs), individual EU member states are prohibited from working on their own standards (this process is formally referred to as ‘standstill’). This ensures that all new standards produced for products covered by the PPE Directive do not differ significantly between EU member states. For instance, safety footwear designed and sold in Germany should be tested to the same standard as a similar product designed in France or the UK.
CEN standards are achieving widespread acceptance worldwide. A number of countries outside Europe have taken advantage of the progress being made under the PPE Directive either by using the relevant ENs or modifying them slightly to meet their own requirements. Many European standards also form the basis of standards produced by the International Standards Organisation (ISO). Others are developed jointly between CEN and ISO under the ‘Vienna Agreement’, which is intended to help reduce duplication of effort. The new safety footwear standards EN ISO 20344-7 are a good example of this.
The role of Notified Bodies is to carry out certain duties under the Directive. They must be independent, impartial and have a high level of professional indemnity insurance. There are currently over 100 Notified Bodies throughout Europe. These are all subject to routine surveillance at regular intervals. It is possible to identify which Notified Body has certified a product as the body’s name, address and unique number must be displayed on the accompanying user information. Representatives from the Notified Bodies meet regularly to ensure that standards and legislation are applied uniformly across Europe. These groups are usually referred to as Vertical and Horizontal Groups.
EC type examination
It is mandatory for suppliers of Complex and Intermediate design PPE to have initial examples of their products assessed by a European Notified Body such as SATRA. This process, called EC type examination, checks the design and documentation of a prototype or initial example of an item of PPE to ensure it is fit for its intended use and satisfies the BHSR of the Directive. This assessment is based on the claims made about the product in the user information and is achieved by:
- Examining the design documentation (referred to as the technical file) to ensure first that the product satisfies all the relevant sections from the list of basic health and safety requirements given in Annex II of the PPE Directive; and secondly, that the product is adequately described through the use of diagrams and lists giving the source of all materials
- Carrying out a series of tests and examinations on the products to ensure they meet the claimed performance levels. This may be carried out to harmonised European standards or, if required, the manufacturer and Notified Body can use an agreed technical specification. The test reports are then added to the technical file. If EC type examination is successful, a certificate is issued by the Notified Body to prove the item’s conformity. For intermediate products, this is effectively the end of the Notified Body’s involvement and the certificate holder becomes responsible for ensuring that subsequent production remains the same as the model examined by the Notified Body
In addition to initial type examination of the prototype model, Complex design PPE is subject to checks by a Notified Body to ensure that production versions of the item continue to comply with the sample that was approved by the EC type examination. It should be noted, however, that the Notified Body that carries out the Article 11 assessment need not be the same as the Notified Body that carried out the original type approval. The manufacturer or authorised representative can choose one of two methods for the Notified Body to use when checking the conformity of ongoing production:
Article 11A (Product Monitoring) – This involves the Notified Body selecting and removing a random sample of manufactured items of PPE which are then tested by methods used in the original EC type examination to ensure continuing compliance.
Article 11B (Quality System Monitoring) – The Notified Body visits the manufacturing site to check that the quality systems used by the manufacturer are capable of enabling consistent production of the certified product. SATRA uses quality management system auditors registered with the International Register of Certified Auditors (IRCA) for this work.
Both Article 11A and 11B assessments are carried out on a regular basis while that item of PPE remains in production.
Step by step guide to CE marking
1. It is essential that manufacturers have access to copies of the standards associated with their particular products and familiarise themselves with the requirements. If they don’t, it is more difficult to manufacture products that are likely to be immediately suitable. We recommend you obtain a copy of the National Legislation that enacts the European PPE Directive, as this is the legislation that controls the placing of PPE on the European Market.
2. Products should be designed taking into account the requirements of the product standard(s). With many standards there are a number of optional properties, so it is important at this stage to decide what category of protection is required. Manufacturers may wish to commission some limited experimental tests to identify any potential design problems.
3. Where the involvement of a Notified Body is required, the manufacturer or authorised representative needs to make a formal application for EC type examination. Amongst other things, this will confirm the name of the organisation the certificate should be issued to, the product identifiers and the product test specification. Ideally the application form should be accompanied by the technical file and product samples.
4. The Notified Body assessor will need to confirm that appropriate tests have been carried out.
5. In addition to performance testing against the specific product standard, EC type examination against the PPE Directive also requires an assessment of innocuousness – confirmation that the product will not harm those who come into contact with it, including the wearer. At its simplest this may be a check that there are no sharp edges or points. European legislation also covers a number of restricted chemical substances.
Restricted substance legislation includes:
- EC Directive 2002/61/EC – Azo Colourants (Dyes)
- EC Directive 1999/51/EC – Pentachlorophenol (PCP)
- EC Directive 94/27/EC – Nickel
6. In addition to confirmation of the product’s physical attributes, EC type examination also includes assessment of a technical dossier, called the ‘technical file’. This should include:
- Name and address of the manufacturer
- EU authorised representative (if relevant)
- Product specifications (drawings and construction details)
- Raw material specifications (including the full postal address of the supplier)
- Quality control and test facilities used at the manufacturing plant
- Product marking (artwork of the information to be affixed to the product)
- Copy of user information sheet
- Details of how the product complies with Annex II of EC Directive 89/686
- Details of how the certificate holder intends to comply with Article 11 of EC Directive 89/686*
- Test reports (especially those being used to support the EC type examination)
[* Complex design products only]
7. SATRA will assess the technical file and if necessary request any additional information needed to satisfy the minimum requirements. When the file is considered to be satisfactory, an EC type examination certificate is produced.
8. The technical file is returned together with the EC type examination certificate. These should be kept in a safe place (ideally in a European office) as the relevant European enforcement authorities may need to see them as part of any investigations if there is a problem in the future.
9. The certificate holder must draw up an EC Declaration of Conformity; a written commitment to manufacture the products in exactly the same way as the model that was type approved. Any changes to subsequent production should be discussed with and reviewed by the Notified Body, or the certificate may no longer be valid.
10. Products can now be manufactured and placed on the European market provided that:
- The design remains unchanged
- The products are marked in accordance with the technical file
- The products are supplied with user information as detailed in the technical file
11. In the case of complex design products, maintain ongoing compliance in accordance with one of the two Article 11 routes.
The current European footwear standards include:
- Safety footwear: EN ISO 20345:2004 + A1: 2007
- Protective footwear: EN ISO 20346:2004 + A1: 2007
- Occupational footwear: EN ISO 20347:2004 + A1: 2007
- Forestry footwear: EN ISO 17249:2004
- Toe caps and penetration resistant inserts EN 12568: 1998
- Electrically insulating footwear EN 50321: 2000
- Footwear against chemicals: EN 13624
- Firefighters’ footwear: EN 15090:2006
- Motorcyclists Footwear EN 13634: 2002
These all refer to EN ISO 20344 for details of the test procedure.
The three main footwear product standards (EN ISO 20345/6/7) include a range of optional tests each with an associated marking code; see box. The number of samples required to carry out testing to these standards depends on a number of factors, as test specimens must be cut from the upper/outsole/insole area. Factors affecting how many samples are required include the number of upper materials present and the shape and size of the various upper panels. However, provided the design of the upper is relatively simple with only one upper material and a limited number of seams, the following samples should be sufficient:
- 4 pairs of footwear in the smallest size from the range to be produced.
- 4 pairs of footwear in the largest size from the range to be produced.
- 4 pairs of footwear of a size from the middle of the size range.
For more information on Safety Footwear visit http://www.osedirectory.com/product.php?type=health&product_id=18
Published: 01st May 2009 in Health and Safety Middle East