How to get safety footwear. CE Marked

Transcription

1 How to get safety footwear CE Marked

2 EU regulatios set the stadard for the performace of PPE worldwide. The Europea Uio ad the Uited States of America are the world s largest safety footwear markets. Both have comprehesive legislatio coverig the workplace eviromet ad performace requiremets for safety footwear. Although other parts of the world have differet legislatio, the idustrial hazards are geerally very similar. Regardless of coutry, protective ad safety footwear ofte icorporates similar features, such as safety toecaps ad uder-foot protectio. More specialist footwear has bee developed to protect agaist other physical risks, such as cuttig by chaisaws, or evirometal hazards associated with chemicals, heat ad electricity. The Europea Persoal Protective Equipmet (PPE) Directive 89/686/EEC defies PPE as clothig ad equipmet desiged to be wor or held by a idividual for protectio agaist oe or more health ad safety hazards. A EC type-examiatio certificate is required for all types of safety footwear before products ca be placed o the EU market Sice the Directive became part of Europea law i 1995, suppliers of PPE i the Europea market have had to follow the appropriate approval procedure to CE mark their products. SATRA is oe of the leadig Notified Bodies for the CE markig of PPE iteded for the Europea market ad has bee ifluetial i the developmet of PPE-related test methods ad safety stadards. SATRA s testig ad certificatio services cover most areas of PPE from head protectio to safety footwear, ad early everythig i betwee. Europea Coucil Directive 89/686/EEC The Directive covers a rage of products, which it divides ito three categories. These are based o the risk, cosequeces ad severity of ijury likely to occur to someoe ot wearig adequate PPE. The procedures for demostratig compliace ad the ivolvemet of a Notified Body differ for each category. Simple desig PPE covers products that are claimed to provide protectio agaist miimal risks, with effects that are gradual ad ca be safely idetified by the user i good time. Products i this category (commoly called Category 1), washig-up gloves for example, are listed i the Directive. Category 1 PPE ca be self-certified by the maufacturer or Europea importer without the eed for thirdparty verificatio. The ivolvemet of a Notified Body is ot required. However, a eforcemet authority would expect to be able to examie a techical dossier backed up by appropriate test reports. Therefore, it is recommeded that records of some testig carried out by a idepedet test cetre be kept, to provide documetary evidece to support ay claims made about the product. Complex desig PPE (Category 3) covers products claimed to provide protectio agaist risks of mortal dager, or dagers that may seriously ad irreversibly harm the health of the user. Agai, a list of such products is detailed i the Directive. These products must be certified by a Notified Body ad are subject to iitial type examiatio ad cotiual productio checks. This category icludes footwear for fire fighters, for protectio agaist molte metal i foudries or for high voltage protectio. All other products (either simple or complex) fall ito a third category ofte called Itermediate desig or Category 2. These are products claimed to provide protectio agaist risks of severe ijury. A Notified Body must certify iitial examples of such products ad ay associated documetatio. Most safety footwear falls ito this category. Europea harmoised stadards As the Directive is a piece of geeral legislatio, it icludes health ad safety requiremets that must be take ito accout for all types of PPE. It does ot, however, detail how particular types of product should be tested. To support the Directive, the Europea Uio Commissio has madated the developmet of various product safety stadards through the Europea stadards agecy CEN (Comité Europée de Normalisatio). CEN has coveed a techical committee, refereced CEN/TC 161, to develop a series of harmoised Europea stadards for use i testig ad certificatio of foot ad leg protectio. These Europea stadards describe i detail how a particular type of product should be tested ad what performace is required to achieve a satisfactory pass. The tests developed

3 EN ISO 20345/6/7 MARKING CODES EN ISO SB Toe protectio tested with 200J impact ad 15kN compressio force. EN ISO PB Toe protectio tested with 100J impact ad 10kN compressio force. EN ISO OB No toe protectio agaist mechaical hazards provided but must provide protectio to oe or more of the categories P, C, A, E, CI, AN, WR or HI as described below. CLASSIFICATIONS OF FOOTWEAR Class I Footwear made from leather ad other materials, excludig all-rubber or all-polymeric footwear. Class II All-rubber (etirely vulcaised) or all-polymeric (etirely moulded) footwear. Hybrid Class II footwear icorporatig aother material that exteds the upper. HRO Heat resistat outsole compoud tested at 300ºC P Peetratio resistat outsole tested at 1100 ewtos A Electrical resistace betwee foot ad groud of betwee 0.1 ad 1000 mega ohms C Electrical resistace betwee foot ad groud of less tha 0.1 mega ohms AN Akle protectio mea trasmitted force <10kN whe tested at 10J CR Cut resistat upper cut idex >2.5 CI Isulatio agaist the cold temperature drop less tha 10 C whe tested at -17 C HI Isulatio agaist heat temperature icrease less tha 22 C whe tested at 150 C E Eergy absorptio of the seat regio tested at 20 joules WRU Water resistat upper leather WR Water resistat footwear M Metatarsal protectio tested with 100J impact FO Oil-resistat outsole (applies to EN ISO oly) The followig short codes are for commoly used combiatios: S1 Footwear made from leather ad other materials excludig all-rubber or all-polymeric footwear + closed seat regio + SB + A + E + FO S2 S1 + WRU S3 S2 + P + cleated outsoles S4 All-rubber (etirely vulcaised) or all-polymeric (etirely moulded) footwear + SB + A + E S5 S4 + P + cleated outsoles. P1 Upper footwear made from leather ad other materials excludig all-rubber or all-polymeric footwear + closed seat regio + PB + A + E + FO P2 P1 + WRU P3 P2 + P + cleated outsoles P4 All-rubber (etirely vulcaised) or all-polymeric (etirely moulded) footwear + PB + A + E P5 P4 + P + cleated outsoles. O1 Footwear made from leather ad other materials excludig all-rubber or all-polymeric footwear + closed seat + A + E + FO O2 O1 + WRU O3 O2 + P + cleated outsoles O4 All-rubber (etirely vulcaised) or all-polymeric (etirely moulded) footwear OB + A + E O5 O4 + P + cleated outsoles. SRA Slip resistace o ceramic tile floor with SLS* SRB Slip resistace o steel floor with glycerol SRC Slip resistace o ceramic tile floor with SLS* ad o steel floor with glycerol. *SLS = Sodium lauryl sulphate solutio For further iformatio o CE certificatio please certificatio@satra.com

4 Safety footwear may be tested for cotact heat resistace Govermets ad otified to the Europea Commissio o the basis of their ability to carry out the examiatios ad tests required for markig of PPE. They must be idepedet, impartial ad have a high level of professioal idemity isurace. There are curretly aroud 110 Notified Bodies throughout Europe 105 i EU Member States ad 5 i EFTA coutries (all i Switzerlad ad Norway). These are all subject to routie surveillace at regular itervals. It is possible to idetify which Notified Body has certified a product as the body s ame, address ad uique umber must be displayed o the accompayig user iformatio. Represetatives from the Notified Bodies meet regularly to esure that stadards ad legislatio are applied uiformly across Europe. These groups are usually referred to as Vertical ad Horizotal Groups. 1. Examiig the desig documetatio (referred to as the techical file) to esure first that the product satisfies all the relevat sectios from the list of basic health ad safety requiremets give i Aex II of the PPE Directive; ad secodly, that the product is adequately described through the use of diagrams ad lists givig the source of all materials. 2. Carryig out a series of tests ad examiatios o the products to esure they meet the claimed performace levels. This may be carried out to harmoised Europea stadards or, if required, the maufacturer ad Notified Body ca use a agreed techical specificatio. The test reports are the added to the techical file. If EC type-examiatio is successful, a certificate is issued by the Notified Body to prove the item s coformity. For itermediate products, this is effectively the ed of the Notified Body s ivolvemet ad the certificate holder becomes resposible for esurig that subsequet productio remais the same as the model examied by the Notified Body. Productio checks I additio to iitial type examiatio of the prototype model, Complex desig PPE is subject to checks by a Notified Body to esure that productio versios of the item cotiue to comply with the sample that was approved by the EC type examiatio. It should be oted, however, that the Notified Body that carries out the Article 11 assessmet eed ot be the same as the Notified Body that carried out the origial type approval. The maufacturer or authorised represetative ca choose oe of two methods for the Notified Body to use whe checkig the coformity of ogoig productio: Article 11A (Product Moitorig) This ivolves the Notified Body selectig ad removig radom samples of maufactured items of PPE which are the tested by methods such as those used i the origial EC type-examiatio to esure cotiuig compliace. Article 11B (Quality System Moitorig) The Notified Body visits the maufacturig site to check that the quality systems used by the EC type-examiatio It is madatory for suppliers of Complex ad Itermediate desig PPE to have iitial examples of their products assessed by a Europea Notified Body such as SATRA. This process, called EC type-examiatio, checks the desig ad documetatio of a prototype or iitial example of a item of PPE to esure it is fit for its iteded use ad satisfies the BHSR of the Directive. This assessmet is based o the claims made about the product i the user iformatio ad is achieved by: A protective toecap beig subjected to a compressio test

5 Europea legislatio also covers a umber of restricted chemical substaces, therefore SATRA also eeds to cofirm the product does ot cotai ay of these before a certificate ca be issued. Restricted substace legislatio icludes: EC Directive 2002/61/EC Azo Colourats (Dyes) EC Directive 1999/51/EC Petachloropheol (PCP) EC Directive 94/27/EC Nickel Resistace to radiat heat is a importat property for some types of safety footwear maufacturer are capable of eablig cosistet productio of the certified product. SATRA uses quality maagemet system auditors registered with the Iteratioal Register of Certified Auditors (IRCA) for this work. Both Article 11A ad 11B assessmets are carried out o a regular basis while that item of PPE remais i productio. Step by step guide to CE markig with SATRA 1. It is essetial that maufacturers have access to copies of the stadards associated with their particular products ad familiarise themselves with the requiremets. If they do t, it is more difficult to maufacture products that are likely to be immediately suitable. We recommed you obtai a copy of the Natioal Legislatio that eacts the Europea PPE Directive, as this is the legislatio that cotrols the placig of PPE o the Europea Market. Copies of documets ca be purchased from SATRA ( testmethods@satra.com). 2. We recommed that products are desiged takig ito accout the requiremets of the product stadard(s). This souds obvious, but we still see may istaces where a product has bee made first ad the legislative requiremets cosidered later. With may stadards there are a umber of optioal properties, so it is importat at this stage to decide what category of protectio is required. Maufacturers may also wish to commissio some limited experimetal tests to idetify ay potetial desig problems. 3. Where the ivolvemet of a Notified Body is required, the maufacturer or authorised represetative eeds to make a formal applicatio for EC typeexamiatio. Amogst other thigs, this will cofirm the ame of the orgaisatio the certificate should be issued to, the product idetifiers ad the product test specificatio. Ideally the applicatio form should be accompaied by the techical file ad product samples. A basic template of a techical file is available o request for member compaies. 4. The Notified Body assessor will eed to cofirm that appropriate tests have bee carried out. SATRA has some of the most extesive testig facilities i the world ad may cliets also require us to test their products. 5. I additio to performace testig agaist the specific product stadard, EC type-examiatio agaist the PPE Directive also requires a assessmet of iocuousess cofirmatio that the product will ot harm those who come ito cotact with it, icludig the wearer. At its simplest this may be a check that there are o sharp edges or poits. Products also eed to be assessed agaist EN ISO 13688:2013 Geeral requiremets for clothig; also see Aex 17 of REACh. Curret guidace is uderstood to be that the CE mark sigifies compliace with all relevat legislatio. Therefore compliace with Azo Dye, PCP or Nickel directives (via atioal legislatio) is madatory. 6. I additio to cofirmatio of the product s physical attributes, EC typeexamiatio also icludes assessmet of a techical dossier, called the techical file. This should iclude: Name ad address of the maufacturer. EU authorised represetative (if relevat). Product specificatios (drawigs, photographs ad costructio details). Raw material specificatios (icludig the full postal address of the supplier). Quality cotrol ad test facilities used at the maufacturig plat. Product markig (artwork of the iformatio to be affixed to the product). Copy of user iformatio sheet. Details of how the product complies with Aex II of EC Directive 89/686. Details of how the certificate holder iteds to comply with Article 11 of EC Directive 89/686*. Test reports (especially those beig used to support the EC typeexamiatio). [* Complex desig products oly] 7. SATRA will assess the techical file ad if ecessary, request ay additioal iformatio eeded to satisfy the miimum requiremets. Whe the file is cosidered to be satisfactory, a EC type-examiatio certificate is produced.

6 8. SATRA returs the techical file (but keeps a copy) together with the EC typeexamiatio certificate. These should be kept i a safe place (ideally i a Europea office) as the relevat Europea eforcemet authorities may eed to see them as part of ay ivestigatios if there is a problem i the future. 9. The certificate holder must draw up a EC Declaratio of Coformity; a writte commitmet to maufacture the products i exactly the same way as the model that was type approved. Ay chages to subsequet productio should be discussed with ad reviewed by the Notified Body, or the certificate may o loger be valid. 10. Products ca ow be maufactured ad placed o the Europea market provided that: The desig remais uchaged. The products are marked i accordace with the techical file. The products are supplied with user iformatio as detailed i the techical file. 11. I the case of complex desig products, maitai ogoig compliace i accordace with oe of the two Article 11 routes. It is importat to remember that the EC type examiatio certificate remais the property of the Notified Body. Although we caot prevet orgaisatios supplyig product to the market, we ca withdraw the certificate if we have sufficiet grouds to cosider it is beig abused i some way. Notified Bodies such as SATRA carry out a crucial role i assessig PPE products facilitatig Europea trade by esurig safety ad cosistecy of applicatio through harmoised Europea stadards ad the PPE Directive requiremets. This provides cosumers with a measure of cofidece that products have bee assessed agaist recogised stadards or other specificatios by a idepedet third party, which is itself assessed for competece. It is importat to remember that, with the exceptio of complex category products, where the same Notified Body has bee omiated to carry out additioal resposibilities to periodically assess ogoig productio, a Notified Body does ot see the vast majority of PPE produced after iitial type examiatio. Resposibility for esurig cosistet productio i accordace with the iitial type examiatio lies with the certificate holder. EN ISO 20345/6/7 Categories of protectio The curret Europea footwear stadards are: Safety footwear: EN ISO 20345:2011 Protective footwear: EN ISO 20346:2014 Occupatioal footwear: EN ISO 20347:2012 The trough test from ENO ISO assesses water resistace markig code W R Impact tests are carried out at 200J ad 100J eergy (EN ISO ad EN ISO respectively Forestry footwear: EN ISO 17249:2013 Footwear agaist chemicals: EN 13832:2006 Parts 1-3 Firefighters footwear: EN 15090:2012 Footwear agaist molte metal: EN 20349:2010 Electrically isulatig footwear: EN 50321:2000 Footwear for motorcyclists: EN 13634:2015 These all refer to EN ISO for details of the test procedure. The three mai footwear product stadards (EN ISO 20345/6/7) iclude a rage of optioal tests each with a associated markig code; see box. The umber of samples required to carry out testig to these stadards depeds o a umber of factors, as test specimes must be cut from the upper/outsole/isole area. Factors affectig how may samples are required iclude the umber of upper materials preset ad the shape ad size of the various upper paels. However, provided the desig of the upper is relatively simple with oly oe upper material ad a limited umber of seams, the followig samples should be sufficiet: 4 pairs of footwear i the smallest size from the rage to be produced 4 pairs of footwear i the largest size from the rage to be produced 4 pairs of footwear of a size from the middle of the size rage A4 cuttigs of upper ad liig materials.

7 for the various stadards are desiged to assess products agaist the requiremets of the PPE Directive for the risks of the particular activity for which they are to be used. The Europea Commissio reviews these stadards ad, if they are foud suitable, they become officially harmoised throughout Europe, ad receive a presumptio of coformity for the parts of the Directive detailed i Aex ZA of each stadard. The publicatio of the stadard is also metioed i the official joural of the EU. Hece, whe startig the CE markig process, it is ecessary to review Aex ZA of ay harmoised stadard to be used, to esure that all relevat clauses of the Directive are addressed. Harmoised stadards are ot the oly meas of demostratig compliace with the PPE Directive. A maufacturer ca use ay techical specificatio as log as it ca be show to satisfy the relevat basic health ad safety requiremets (BHSR) of the PPE Directive. However, if a harmoised stadard is available for the particular product beig examied, there should be a soud techical argumet if it is ot used. I certai areas, such as iche or leadig edge products, there may still be o harmoised stadards available. I such cases a techical specificatio detailig how compliace is to be demostrated must be produced ad used. SATRA has certified a umber of products where harmoised stadards or satisfactory atioal stadards do ot exist ad has produced a series of SATRA specificatios (referred to as M Documets) to cover them. Typically the tests ecessary to certify a item of PPE cover all of the followig four mai categories: 1. Iocuousess: This usually icludes some quatitative tests, such as measurig the quatity of trace toxic substaces i the product or its raw materials. It may also ivolve a subjective assessmet for ay parts of the product that may cause ijury, such as sharp edges. 2. Ergoomics: Usually a small-scale practical wear trial which ivolves the wearer carryig out a rage of movemets typical of ormal Footwear for use i foudry applicatios to protect aaist molte metals is i the Complex PPE category use ad reportig ay restrictios or discomfort caused by the PPE. 3. Protective coverage: Particularly importat for products such as impact protectors. Miimum dimesios are specified, which are usually depedet o the size of the iteded wearers, ad the area of coverage is ofte checked agaist a stadard template. 4. Protective qualities: A rage of physical laboratory tests to mimic accidet scearios, such as measuremet of resistace to impact, peetratio, cuttig, burig ad the flow of electricity. Durig the developmet of CEN stadards (ENs), idividual EU member states are prohibited from workig o their ow stadards (this process is formally referred to as stadstill ). This esures that all ew stadards produced for products covered by the PPE Directive do ot differ sigificatly betwee EU member states. For istace, safety footwear desiged ad sold i Germay should be tested to the same stadard as a similar product desiged i Frace or the UK. CEN stadards are achievig widespread acceptace worldwide. A umber of coutries outside Europe have take advatage of the progress beig made uder the PPE Directive either by usig the relevat ENs or modifyig them slightly to meet their ow requiremets. May Europea stadards also form the basis of stadards produced by the Iteratioal Stadards Orgaisatio (ISO). Others are developed joitly betwee CEN ad ISO uder the Viea Agreemet, which is iteded to help reduce duplicatio of effort. The curret safety footwear stadards EN ISO through to EN ISO are a good example of this. The role of Notified Bodies Notified Bodies, such as SATRA, are Europe-based orgaisatios that have bee appoited by Member State Safety footwear is widely used i the costructio idustry

8 SATRA Techology Cetre, Wydham Way, Telford Way, Ketterig, Northamptoshire, NN16 8SD, Uited Kigdom Tel: +44 (0) Fax: +44 (0)