Paper

BY USE OF PUBLISHED STANDARDS OR ALTERNATIVE TECHNICAL SPECIFICATIONS

Foreword

The EU Personal Protective Equipment Directive affects some 42 industries across the EU and EFTA states. It provides the foundations upon which a series of harmonised European standards can be prepared, preventing barriers to free-passage of protective equipment between Member States. The situation where no standards exist by which PPE can be assessed, or where an interim stage exists whilst such standards are being prepared, is allowed for within the provisions of the Directive.

This paper provides brief explanations of the various methods, mechanisms and procedures by which manufacturers or their agents in the EU/EFTA Member States can bring PPE products into conformity with the requirements of the Directive using available, published standards or other, alternative technical specifications. It describes the legal requirements and provides, from first hand experience, a model for achieving EC Type-Examination certification of PPE products.

Introduction

The EU Personal Protective Equipment (PPE) Directive (89/686/EEC) was published on December 21, 1989 and came into force on July 1, 1995. It defines PPE as “any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards” and defines three distinct categories of PPE:

Simple design (or “Category 1”) - “where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerned, the effects of which, when they are gradual, can be safely identified by the user in good time”. An exhaustive list of examples is provided by the Directive, including gardening and kitchen gloves and thimbles.

Intermediate design (or “Category 2”) - any product not described within the exhaustive listings for Category 1 and Category 3 products.

Complex Design (or “Category 3”) - PPE “intended to protect against mortal danger or against dangers which may seriously and irreversibly harm the health, the immediate effects of which the designer assumes the user cannot identify in sufficient time”. An exhaustive list of examples is provided by the Directive, including respiratory devices, fall-arrest devices and clothing for use in extremely low and extremely high temperatures.

Intermediate and Complex Design PPE must be type-examined by a European Notified Body and issued with EC Type-Examination certificates. In the case of Simple Design PPE, however, the manufacturer or his agent in the EU may declare that the PPE meets the requirements of Annex 2 of the Directive, and self-certify the PPE.

Responsibility rests with the manufacturer, or his agent in the EU, to ensure that the products he markets comply with the requirements of the Directive, and that PPE products are correctly categorised. In the UK, responsibility for enforcement of the Directive’s provisions falls to County Council Trading Standards Departments.

The PPE Directive - Purpose

The primary purpose the PPE Directive is to prevent or remove barriers to trade between EU and EFTA member states caused by the existence of conflicting national standards for personal safety equipment. The Directive provides the foundations and motivation for the development of an extensive series of harmonised European standards (EN = European Norm); responsibility for the preparation of which falls to the Comite Europeen de Normalisation (European Committee for Standardization) - CEN - under a series of mandates issued by the European Commission.

Basic Health and Safety Requirements and the function of standards

Annex 2 of the PPE Directive provides an exhaustive list of basic health and safety requirements, and PPE must meet all relevant requirements before it can be said to conform with the Directive and may carry the CE (Conformite Europeen = European Conformity) mark (relevant in that, for instance, football shin pads would be expected to provide protection against physical injury (clause 3.3) but would not be expected to prevent drowning (clause 3.4).

Where there is a harmonised European standard for a PPE type (for instance: EN 1078 : 1997 - “Helmets for pedal cyclists and for users of skateboards and roller skates”), the standard will already address all relevant Annex 2 requirements for that product type. Products satisfying all the requirements of the standard may therefore carry the CE mark.

Where no standard exists, however, a manufacturer must show that the evaluation process which the PPE product has undergone does satisfy all relevant Annex 2 requirements. This means that the product technical file will list all the test methods and/or EN, ISO, national or other standards which have been used in order to evaluate the protective performance of the PPE (and comprising an “alternative technical specification”), and show how these methods and standards satisfy the relevant clauses of Annex 2 of the Directive. This process is known as “marking against the Directive”.

Obviously, marking against the Directive can be a very difficult and highly laborious process, with extensive research work and possibly developmental testing to be conducted; whereas the availability of a European standard removes much of the guesswork from the product certification procedure.

Product technical files

A product technical file is required for all PPE. Simply; this document must uniquely identify the product, including the materials and manufacturing methods used in its construction. Notified Bodies will normally issue helpful guidelines to first-time applicants upon request.

The availability of a harmonised European standard makes product technical file preparation a much simpler and easier process than is the case when working to an alternative technical specification, since in the latter case the file must describe the test protocol in detail, and the relevant clauses of Annex 2 of the Directive which are addressed by the protocol.

A model for achieving EC Type-Examination certification of PPE products

Based on personal experience with several types of PPE product, this section deals with the processes and mechanisms involved in developing products to meet the requirements of either a published European standard (EN) or an alternative technical specification.

As stated in the section on product technical files, the availability of a harmonised European standard makes progress on that particular aspect of an application for EC Type-Examination far simpler than situations where an alternative technical specification is required to be written.

There have been several occasions, most notably with football player’s shin pads and back protectors for motorcyclists, where in the absence of an EN it has been necessary to develop a technical specification alongside collection of test data from prototype products.

This has resulted in a lengthy and sometimes costly game of “leapfrog” for the manufacturer concerned - who, after all, is acting as both guinea pig and pioneer in the process - as a series of prototype samples are produced, each incorporating new materials or combinations thereof, in order to reach an end point where the threat faced by the user of the PPE is reduced to an acceptable minimum by the intervention of the PPE product.

Continuing to use football shin pads and motorcycle back protectors as typical examples: medical evidence was readily available to suggest the level at which the maximum force transmitted by the product should be set to significantly reduce injuries. Evidence is not always so readily available, however, with regard to the impact forces which might be experienced. In this regard, a decision had to be made to set the impact forces at a level which products could be expected to reduce to the level established by medical evidence so far as currently-available materials and technology permit.

The design of the PPE - particularly the area of the user which the PPE product was required to cover in light of medical opinion - also has to be addressed. Again, during a combined product/technical specification development programme, this process can also become a game of technological leapfrog; with changes to the original product having to be implemented in order to arrive at an end design which satisfies the requirements of the Directive. In the case of motorcyclists’ back protectors, new medical opinion concerning the need for increased protection to the scapulae (shoulder blades) required an extensive redesign of the cutting knives for the manufacturer concerned. It was an investment which paid off for the company concerned, however, as their product became the first in the marketplace to achieve EC Type Approval and enjoyed significant sales in Scandinavia alone.

Stage 1 - Testing of materials

This process is described in detail above for cases where no standard is available. Where a standard is available, however, it is merely a case of testing materials, or combinations thereof, until a specification is found which will meet the requirements of the standard. An example might be a cycle helmet with polycarbonate shell and expanded polystyrene foam liner. To meet the requirements of the standard this product may, for instance, require a change to a thicker shell and an increased density lining.

Stage 2 - Testing of construction

This is particularly relevant in the case of some protective clothing - motorcyclists’ clothing, for example. Whilst leather or textile outer shell materials may have adequate protective performance, abrasion-resistance, tear resistance and cut-resistance being examples; these properties will be completely irrelevant in an accident if the materials or methodology used in the assembly of the garment are inadequate.

Stage 3 - Data

Stages 1 and 2 will yield the data required to determine the specification of the finished product. If the results are unacceptable, further testing of amended/revised materials and/or construction will be necessary.

Stage 4 - Design process and preparation of product technical file

With the specification for both materials and construction methodology established, the design process comes into play. Whilst the components in isolation may have the required protective performance, this does not guarantee the finished product will adequately protect (see above comments on football players’ shin pads and motorcyclists’ back protectors).

An EN will provide details of design requirements which are mandatory and those which are not permitted (for example; features which might actually cause or increase the risk of injury). EN 1078 (“Helmets for pedal cyclists and for users of skateboards and roller skates”) provides useful examples. It provides detailed specifications for the required user field of vision provided by the helmet; it states that helmets should have low weight, be ventilating, be easy to put on and take off, be useable with spectacles and not significantly interfere with the ability of the user to hear traffic noise. Finally, in this series of examples, adjustment and fastening mechanisms are not permitted to be green (presumably since use of a colour associated internationally with “safety” or “proceed” might encourage a well-meaning passer-by to remove the helmet of a casualty with a serious head or neck injury).

During this process the product technical file will also be prepared, although it is far from unknown for these documents to be amended throughout the remaining stages of the EC Type-Examination process.

Stage 5 - Manufacture of prototype products

These are the samples which will be evaluated for EC Type-Examination, and will be manufactured to the specification determined as a result of analysis of all data generated by earlier testing. At this stage, manufacturers may decide to provide staff training in new manufacturing methodology, so that full production of type-approved products can commence on receipt of certification.

Before EC Type-Examination certificates can be issued, the manufacturer must satisfy the Notified Body that an acceptable quality control system is in place to ensure that all examples of full production PPE are manufactured to a specification identical to that of the approved “type”. Provision of exploded assembly diagrams and step-by-step instructions to manufacturing staff has previously been found to help prevent errors and misunderstandings. Such training aids can be discussed, revised if necessary and then implemented, ensuring that all recipients have had adequate opportunity to provide input and to fully absorb what they are required to do. A requirement for sampling of products and for dealing with non-conformances must be established.

ISO 9000 accreditation of the manufacturer is not a prerequisite for issue of certificates, but it does substantially reduce the quantity of text required to describe the manufacturer’s quality control systems.

Stage 6 - Independent evaluation

At this stage the finished prototype(s) will possibly be subjected to a full test regime (although data generated from stages 1 and or 2 may count towards the final test report) and be evaluated according to all other relevant requirements of Annex 2.

Ergonomic performance will be evaluated. Is the product comfortable to use? Can it be fitted to the wearer easily? Does it make the wearer uncomfortably hot during the activity for which it is designed. Can the user perform associated activities whilst wearing the PPE (for example; does a motorcycle suit permit the user to walk, as well as to ride their motorcycle?). Does it permit the use of other PPE which might be needed in order to protect other parts of the body during the activity (for example; do shin pads permit ankle height boots to be worn?). These are typical of the issues which may have been identified and which will need to be addressed.

The sizing and labelling of the product will be assessed. Does the PPE fit the size of wearer indicated by the size label? Are the labels satisfactorily informative? Does the manufacturer's information to the user satisfy the requirements of the EN/Annex 2 of the Directive? Does the product technical file uniquely identify the PPE which is being evaluated?

Stage 7 - The test report

If a prototype product has satisfied all test, design, ergonomics and documentation requirements, a positive test report will be issued. Even if a test report is issued with some non-conformances noted, the manufacturer may submit a revised prototype which satisfactorily addresses those points, and receives a supplementary report which confirms that the revised product fully satisfies the relevant requirements.

Stage 8 - Certification

Test houses and Notified Bodies may be independent of each other, they may be one and the same organisation, or a Notified Body may subcontract testing to a test house. This will make no difference to the validity of the EC Type-Examination certificate(s) finally issued, although it is possible for a manufacturer to “shop around” and make some savings. Even the industry handling the EC Type-Examination process is a competitive marketplace!

The Notified Body will require a copy of a positive test report and the product technical file. These will be inspected to ensure that everything is in order.

The Notified Body will generally issue certificates for a product which has been tested at any reputable test house; against the requirements of either a harmonised European standard or an acceptable alternative technical specification. In the second case, the Notified Body assumes considerably more responsibility for ensuring that the PPE product satisfies Annex 2 of the Directive, since it is the Notified Body which ultimately is underwriting the alternative technical specification used.

Once certificates are issued, the manufacturer may attach the CE mark to the models subject of the certification and technical file. The goods may then be freely marketed throughout the EU and EFTA member states.

CONCLUSION: Cost of process and benefits

As stated above, manufacturers who are developing a technical specification whilst simultaneously developing a product stand to face higher costs for achieving type approval than would be the case if an EN was available. The costs of testing will be determined by a number of factors; not least the number of tests to be conducted, the duration of any given test regime and the complexity of the test methodology.

For some product types the test regime may be quite short and simple, and therefore very inexpensive. For example; a test against the requirements of EN 420 : 1994 “General requirements for gloves”, clause 4.4.2 (“Determination of pH value”), using the test method described in ISO 4045 : 1977, might cost as little as £50.00 at current rates. For other product types the costs might be more significant - as in the case of a full series of tests against EN 1078, where the cost will be in the region of £1000.00 to £1300.00 - for still other PPE types, with extremely complicated test regimes, the cost could rise to several thousands of pounds. Any of the above costs would be compounded by a need to re-specify and re-test prototypes following a non-conformance.

Although the purpose of the PPE Directive is most certainly not to assist marketing of CE marked products, the fact is that manufacturers can enjoy a competitive advantage, for a time, if they are the first in their market to achieve product certification; and no less a body than the British Standards Institution has asked why manufacturers shouldn’t market their products’ superiority.

The simple fact remains, however, that if a product is designed or intended to provide personal protection then it is PPE and must conform with the requirements of the Directive. Any commercial benefits are secondary to the primary requirement of compliance with EU law, as adopted into national law.

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