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An end-user perspective on specifications
This article looks at the development of specifications and addresses the role of the end user in meeting obligations by using these specifications.
Although the emphasis is on European Standardisation work, the major driving force over the last ten years, the increasing role of international standardisation as the basis for worldwide specifications is also addressed. Development of European specifications
End users of workplace protective clothing in Europe which is classed as Personal Protective Equipment (PPE) need to understand the principal aspects and requirements of the Personal Protective Equipment Directive (89/686/EEC), the so called ‘product directive’, and increasingly also of the so called ‘use directive’ (89/656/EEC). These two Directives, published in 1989, set out, respectively, the mechanisms by which PPE such as protective clothing can be legally placed on the market and the responsibilities of the end-users to select the correct PPE and then use, maintain and withdraw it from service correctly. End users should therefore become familiar with the European specifications as EN standards, suffixed for example by BS in the UK, DIN in Germany and NF in France, which are applicable to protection against the hazards present in their workplace. These EN specifications are standards setting out performance requirements for specified laboratory tests and also sometimes design requirements, for example with respect to clothing.
The rationale behind the development of such EN standards, which began in 1989, was to assist the free movement of PPE items in Europe by setting one common set of requirements as minimum performance levels in the form of harmonised standards. Key to this objective was agreement on one EN method of test for a particular property in place of the then current situation of having different methods of test in, typically, the UK, France and Germany.
A unique status is attached to any published EN specification for PPE – this is the so called ‘presumption of conformity’ with the health and safety requirements set out in qualitative terms in the PPE product Directive, 89/686/EEC. This presumption means that an item of, say, clothing intended to protect against a specific hazard can be labelled with the CE Mark by the manufacturer and thus placed on the market if it complies with all the laboratory test requirements and any clothing design requirements set out in the appropriate EN specification. In terms of performance levels, EN specifications set minimum levels for each of the protective properties which the PPE item is judged to need if it is to provide sufficient protection when in new condition as placed on the market.
The real reason why end users must understand the EN specifications applicable to their workforce is because of the responsibilities which the PPE ‘Use’ Directive places upon employers. The first responsibility is to undertake a risk assessment so as to have a record of the hazards to which the wearer of the PPE may be subjected and then to relate this to the likelihood of being exposed to each hazard, i.e. the risk.
If the end-users are to make the most informed selection from CE-marked PPE on the market which complies with the EN specification and aligns with their risk assessment they also need to have an understanding of various further aspects of PPE. The first of these is that the link between the risk assessment and the performance requirement set out in the appropriate EN Specification may involve selecting the most appropriate level of EN performance. For example, some EN specifications for protective clothing offer a choice of several levels of protective performance against the specific hazard.
End users are clearly best able to deal with such a choice if they also have some knowledge in terms of the materials from which protective clothing can be manufactured.
Another ‘European only’ aspect of PPE selection relates back to the previously mentioned PPE ‘product’ Directive (89/686/EEC). This is the EC Type-Certification process which manufacturers have to undertake before they can place the CE mark on their PPE production items. For PPE which is of simple design that is intended to protect against hazards such as ‘weather conditions which are neither exceptional nor extreme, for professional use’, the manufacturer can self-certify the PPE. However, for PPE intended to protect against mortal danger or in other intermediate situations where the risks are not minimal, the manufacturer must obtain third party certification as an EC
Personal Protective Clothing
Type-Examination Certificate, issued by an organisation within the EU having the status of a Notified Body. This status has been given to some 50 organisations throughout Europe in the area of protective clothing certification via a scheme of national accreditation accepted by the European Commission.
The first such EC Type Examination Certificates were issued in 1993 and since July 1, 1995 this certification has been an obligatory requirement throughout the countries of the European Union.
The potential end user of PPE, whether it be ‘simple’ (Category I, self certified by the manufacturer), neither ‘simple’ nor ‘complex’ (Category II, certified by a Notified Body) or ‘complex’ (Category III, certified by a Notified Body to protect against mortal danger), must always request the appropriate documentation from the PPE supplier or manufacturer. The end user should therefore ask to see the manufacturer’s EC Type Examination Certificate if Category II or III PPE is needed as the outcome of the risk assessment.
There is no standardised format required by the European Commission but the actual Certificate will be a one or two page document stating the name and address of the manufacturer and/or his authorised representative, the PPE item description, identifying code and design drawing, the EN specification with which it complies and the name, address and identification number of the Notified Body. There should also be a cross reference to any related test report on the detailed assessment of the PPE item and of the manufacturer’s technical file.
However the certificate is presented, the end user should be able to see the test report from the Notified Body setting out the requirements of the EN specification against the performance values achieved by the PPE item. By this means the end user will be able to assess the margin of compliance achieved by the PPE items against the minimum requirements of the EN Specifications. Thus various competing items can be compared by the end user and, inevitably, related to value for money. As stated earlier, some EN Specifications also set design criteria for PPE: this is the case with protective clothing for molten metal splash – a design compliance assessment by the Notified Body should also be available to the end user.
In addition to the EC Type-Examination documentation, the end user should see all relevant information on various aspects relating to the use of the PPE being offered. This list of aspects upon which information must be provided is set out in Annex II, Clause 1.4 of the PPE Directive 89/686/EEC and includes storage, use, cleaning, maintenance, servicing, disinfection, performance in technical tests (i.e. ENs in this context) and the obsolescence deadline.
In addition, and a difficult issue for both end users and manufacturers, ‘PPE subject to ageing’, see Annex II, Clause 2.4 of 89/686/EEC, should be supplied either with an obsolescence or withdrawal from use date or number of cleaning cycles allowable. If the manufacturer is unable to give an undertaking with regard to the useful life of PPE, notes must provide all the information necessary to enable the purchaser or user to establish a reasonable obsolescence date.
This ‘in use’ aspect of PPE provision is clearly very important; no PPE should be worn which has, or may have, a level of performance which falls below the level set for new PPE in the EN used to achieve certification and allow application of the CE mark. PPE subject to ageing must include potentially many types of protective clothing, certainly ones which may become thinner by abrasion and/ or lose some protective surface treatment via a cleansing process.
Increasingly, user information is being added to by the provision of test data on items withdrawn from use after various, preferably documented, cycles of use and cleansing. This is so that a snapshot audit of in-use performance can be obtained and used as criteria for prediction of lifespan. Such a testing programme is probably most relevant for protective clothing providing chemical penetration resistance or flame retardancy via a surface treatment – damage to protective clothing in the form of cuts, tears and even serious abrasion should be identified by a programme of documented inspection.
A further aspect of the European PPE Directive 89/686/EEC is that the increasing availability of specific EN performance standards means that there are not now many classes of PPE, in terms of type of item or hazard they claim to protect against, for which an EN does not exist. Because of these EN’s presumption of conformity with the health and safety requirements of this Directive, the PPE certification process and selection process would appear to become more straightforward with the passage of time since 1995.
There is, however, a crucial point about EN specifications: They are not obligatory and are thus only one way, albeit the preferred way, by which a manufacturer can obtain an EC type examination certificate for an item of Category II or Category III PPE. This is because the Health and Safety requirements set out in the 89/686/EEC Directive only require that the technical specification used meets the appropriate health and safety requirements. Thus a manufacturer can choose to not apply, or only partially apply, the harmonised EN standards or cannot apply them in whole or part because they do not exist (and may never exist for some very specialised end use situations).
Personal Protective Clothing
Manufacturers who choose, or have to choose, this so called Technical File route must submit their technical specification and certification request to a Notified Body in the usual way but the first task of the Notified Body is to check if the technical specification does comply with the health and safety requirements of Directive 89/686/EEC in terms of both the protective properties to be assessed and the levels of protection set for each property. If the Notified Body is satisfied with the technical specification it then progresses, as in the case of use of an EN specification, to check if the PPE item submitted does meet the chosen specification.
For example there is now an ISO (International Organisation for Standardisation) Specification for protective clothing for wildland firefighting. Because it is not published as an EN ISO it does not carry automatic presumption of conformity with the 89/686/EEC Directive. End users in Europe do want to be supplied with protective clothing which complies with the detailed and end use specific requirements of this standard so Notified Bodies are asked to check its content against the appropriate health and safety requirements in the PPE Directive.
As a consequence, protective clothing certified on the basis of using this ISO Specification (ISO 15384:2003) is in use. Provisional EN specifications, known as prENs, are also sometimes used for EC Type Certification. Again the Notified Body has to be satisfied as a first step that the health and safety requirements have been met. Examples here are where the development of the final EN has been slow. For example prEN13034 (Chemical Protective Clothing) and prEN13911 (Hoods for Firefighters).
A final aspect of the PPE certification process relevant to end users is the requirement in the 89/686/EEC for Category III PPE such as for firefighters to be subject to factory production control procedures via a Notified Body. The application of such a procedure should become apparent to an end user initially because of the addition to the CE-mark label on the PPE item of a 4 digit number, this being the ID number of the Notified Body which has undertaken the FPC procedure, not the ID number of the Notified Body which has undertaken the EC Type Certification process!
What this number signifies is that the manufacturer has an approved ISO 9000 based quality management system for the manufacture of the Category III PPE concerned or has been subjected to a production quality monitoring programme undertaken by the Notified Body. End users should ask manufacturers for evidence of this additional check on the PPE they are proposing to acquire.
Many people have been closely involved in the EN standards creation process; some, such as the author, since its initiation in 1989. To date for example, under the scope of CEN Technical Committee 162 ‘Protective Clothing including hand and arm protection and life jackets’, the 12 Working Groups have produced some 110 standards, of which approximately 75 are specifications, the remainder being test methods and one being a Technical Report – TR 14560:2003 ‘Guidelines for selection, use, care and maintenance of protective clothing against heat and flame’ and thus of particular interest to end users of this class of protective clothing.
There are also about 65 EN standards either being revised or still being developed as first editions under the scope of this Technical Committee. There are another 10 CEN Technical Committees dealing with all other standardisation in the field of PPE.
Development of International Specifications
This work is undertaken by ISO, the International Organisation for Standardisation, based in Geneva. Prior to the advent of the European PPE Directive in 1989, ISO had published a number of test methods for PPE, including some for protective clothing. When CEN, the Committee for European Normalisation, began its work on PPE standards in 1989, it became apparent that there needed to be an agreement between CEN and ISO to encourage working together to avoid duplication of effort.
The resulting Vienna Agreement attempts to do this by requiring either CEN or ISO to lead work items so that, ideally, the outcome is one harmonised EN ISO standard for a particular type of PPE which includes methods of test which are also arrived at by the same process and thus also EN ISO standards. An example of progress along this route is that some test methods which were originally EN or ISO are now EN ISO. Likewise specifications which were published in the first instance as ENs may become EN ISOs.
Where the process is confusing is that there will always be a change from an EN standard number to a different EN ISO number (see later for examples); this is because, rightly ISO is the future for worldwide standards development as it is not regionally based like CEN (or NFPA or ASTM in the United States).
If a performance specification is to be an EN ISO, it has to include an Annex ZA setting out how it complies clause by clause with the health and safety requirements set out in European Directive 89/686/EEC. While this directive has no jurisdiction with respect to use of PPE outside of Europe, such a list could be argued to be giving extra authority to a standard in the minds of users outside of Europe. Indeed some such users have extra confidence in an item of PPE if it has gone through the procedures required by the European Directive to achieve certification.
An advantage that an ISO lead gives to the PPE standards development process is that a wider choice of test methods, expertise and ideas can be available. This should lead to ‘better’ standards in the long term provided that the genuine need to recognise regional differences in working practices is applied. To date there are some 15 ISO standards in the field of protective clothing which are not EN ISOs and may be different from the EN standard.
Some specific standards for protective clothing
1. Heat and flame protective clothing
EN469:1995 – Protective Clothing for Firefighting. This is being revised in CEN and can be expected as EN469:2004 if the final draft passes the voting process in Europe.
ISO 11613:2000 – Protective Clothing for Firefighting. This is a combination in one document of EN 469:1995 and NFPA 1971 from a similar date. It is intended to be revised as the basis for all of the PPE items which are required for ‘conventional’ firefighting via the work of a new ISO Committee. The number should remain unaltered.
Both of these standards set performance requirements for protective properties such as flame resistance and heat protection, they also set design criteria. An objective of the revision of EN 469 is to offer 2 levels of heat protection so as to take account of various ambient conditions and firefighting techniques.
EN 470-1:1995 – Protective Clothing for Welders. This is also being revised and will become EN IS0 11611-note new ISO number. It currently sets performance requirements for a weld droplet test and flammability behaviour and also has detailed design criteria (to prevent weld spatter being trapped in turnups, etc). A unique aspect to BS EN 470:1995 is that it contains a note as to the dangers of UV radiation from welding processes in the context of potential skin cancer.
EN 531:1995 – Protective Clothing for industrial workers exposed to heat. This is a complex performance specification providing a choice of several levels of heat protection and molten metal splash protection as distinct from welding spatter. It sets design criteria for molten metal splash protective garments similar to those for welders clothing. It is also being revised and will become EN ISO 11612, another new number to remember!
2. Chemical protective clothing
This class of protective clothing is divided into 6 types depending upon its purpose. Examples are: EN 943-2:2002 – Performance requirements for gas-tight (Type 1 equipment) protective clothing for emergency teams. EN 465:1995 – As above but for spray-tight connections between different parts of the clothing (Type 4 equipment). EN 466:1995 – As above but for liquid-tight connections (Type 3 equipment). prEN 13034:2002 – As above but suits for limited protective performance against liquid chemicals. This is an example of a very slow process towards an EN – the previous draft was dated 1997. Various related but often different ISO standards exist.
3. Protective clothing against foul weather, wind and cold
ENV 342:1998 – Protective Clothing against cold. This is a provisional standard in that it is not accepted universally in Europe. A revision under the same EN number is intended to lead to full EN status shortly.
ENV 343:1998 – Protective Clothing against foul weather. This is likewise going through a revision process intended to upgrade its status.
No one actually plans to create an ENV so fortunately there are no other examples currently in the protective clothing field.
4. High visibility warning clothing
EN 471:1994 – High Visibility warning clothing. This standard sets performance requirements for the fluorescent and retroreflective tape materials used in such garments. It also offers 3 levels of visible area of these materials in a garment and sets requirements for where the retro-reflective bands must be situated. A revision as EN 471:2003 is about to be publishedonly minor changes have been introduced.
To conclude, there has been an enormous amount of effort put in to all aspects of PPE provision since 1989 which should lead to International Standards being increasingly available. Such standards do drive PPE innovation via new materials and new designs because they are performance based rather than composition based – surely a good basic philosophy. If more effort is put into in-use performance monitoring, reductions in injuries should occur because PPE will be withdrawn at the correct time. Better and more consistent risk assessment procedures can play a key role by ensuring that the correct new PPE is selected.
Further information
British Standards Institution, Customer Services: To purchase current UK and European Standards in relation to particular products
British Standards Institution 389 Chiswick High Road, London, W4 4AL Tel: +44 (0) 208 996 9000 · Fax: +44 (0) 208 996 7400 www.bsi-global.com
Health and Safety Executive: Supply copies of the regulations and guidance notes
HSE Information Services Caerphilly Business Park, Caerphilly, United Kingdom CF83 3GG Infoline: Tel: +44 (0) 8701 5455 · Fax: +44 (0) 2920 859260 [email protected] Neil Sorensen has been actively involved in the development and application of EN and ISO standards for protective clothing for many years. He currently leads UK input via BSI to standards development for fire protective clothing. He is also certification manger at BTTG, Manchester, UK, a leading textile related testing and certification organisation
Published: 10th Oct 2003 in Health and Safety International
