Product Safety

PRODUCT SAFETY Ing. Hana Věžníko á, Ph.D. Subjec „P oduc sa e y“ •The subjec con ains in o ma ion on he sys em o ensu ing he sa e y o p oduc s be o e hey a e placed on he ma ke . •Key p inciple: The p oduce s a e obliged o place on he ma ke only p oduc s which a e sa e. •The subjec applies o non- ood p oduc only. 1 Wha can be endange ed by he p oduc ? •P oduc use sa e y - dange o heal h o li e o use s. •Sa e y o o he s pe sons. •P ope y and li e o animals. •En i onmen . 2 How can he p oduc endange he use ? •Di ec haza ds, e.g. ul asound, lase beam, ho pa s, sha p edges, mo ing pa s, insu icien o unclea in o ma ion - inapp op ia e ins uc ions and subsequen inapp op ia e use o he p oduc . •Indi ec haza d, e.g. he ma e ials ma e ials ha emi oxic subs ances (child en lick hei oys - ph ala es, some glues in u ni e s elease he sol en s). 3 Damage o en i omen •P oduc s ha p oduces impe missible amoun s o ha m ul subs ances du ing i s ope a ion. •P oduc s con aining highly oxic subs ances ha con amina es he en i onmen due o imp ope disposal. •P oduc p oducing an unaccep able noise le el. 4 Damage o p ope y •The p oduc endange s i s su oundings due o he possibili y o i e o explosion. •Des uc ion o he p oduc du ing ope a ion and consequen damage o he building. •Subsequen damage caused by p oduc mal unc ion, eg non-compliance wi h se empe a u es, low a es, e c. 5 Is he e some p oduc wi hou dange by i s usage? •No, each p oduc can be dange ous. •The le el o dange can be di e en . •Exmple: spade – exca a o . 6 The main egula ion – Di ec i e 2001/95/EC •The pu pose o his Di ec i e is o ensu e ha p oduc s placed on he ma ke a e sa e: The p oduce s a e obliged o place on he ma ke only p oduc s which a e sa e. •The di ec i e dis ibu es all p oduc s o wo g oups: • he less dange ous p oduc s - all i s p o isions apply, • he mo e dange ous – only some p o isions a e alid. 7 DIRECTIVE 2001/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL o 3 Decembe 2001 on gene al p oduc sa e y •Each o i s p o isions shall apply in so a as he e a e no speci ic p o isions wi h he same objec i e in ules o Communi y law go e ning he sa e y o he p oduc s conce ned. 8 The main legisla i e documen s o unha monized p oduc s •Regula ion (EU) No 1025/2012 o he Eu opean Pa liamen and o he Council o 25 Oc obe 2012 on Eu opean s anda disa ion, amending Council Di ec i es 89/686/EEC and 93/15/EEC and Di ec i es 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC o he Eu opean Pa liamen and o he Council and epealing Council Decision 87/95/EEC and Decision No 1673/2006/EC o he Eu opean Pa liamen and o he Council Tex wi h EEA ele ance •COUNCIL DIRECTIVE o 25 June 1987 on he app oxima ion o he laws o he Membe S a es conce ning p oduc s which, appea ing o be o he han hey a e, endange he heal h o sa e y o consume s (87/357/EEC) 15 Di ec i e 2001/95/EC o he Eu opean Pa liamen and o he Council o 3 Decembe 2001 on gene al p oduc sa e y (Tex wi h EEA ele ance) •The Di ec i e aims a ensu ing ha each and e e y p oduc s placed on he ma ke a e sa e. •I applies o all he p oduc s which a e in ended o consume s o likely o be used by consume s e en i no in ended o hem, and a e supplied o made a ailable, whe he o conside a ion o no , in he cou se o a comme cial ac i i y, and whe he new, used o econdi ioned. •The egula ion includes de ini ions, esponsibili ies o pe sons and s a e au ho i ies and in o ma ion on he RAPEX sys em •EUR-Lex - 32001L0095 - EN - EUR-Lex (eu opa.eu) 16 Ca dinal de ini ions •‘p oduc ’ shall mean any p oduc — including in he con ex o p o iding a se ice —which is in ended o consume s o likely, unde easonably o eseeable condi ions, o be used by consume s e en i no in ended o hem, and is supplied o made a ailable, whe he o conside a ion o no , in he cou se o a comme cial ac i i y, and whe he new, used o econdi ioned. •This de ini ion shall no apply o second-hand p oduc s supplied as an iques o as p oduc s o be epai ed o econdi ioned p io o being used, p o ided ha he supplie clea ly in o ms he pe son o whom he supplies he p oduc o ha e ec •no e: An iques, a e collec i ely impo an i ems om a ious ields o ine a s, c a s, indus ial design o he his o y o echnology, which ha e no been p oduced o used o a long ime, and a e he e o e ela i ely a e. They a e usually made by hand o made in ac o ies made o na u al ma e ials, and a e o en a is ically and his o ically aluable. The Monumen s Ac se s a minimum age o 50 o an iques, bu due o apid changes in echnology and he ange o p oduc ion and ashion, his limi is s ill dec easing. 17 Sa e p oduc •A "sa e p oduc " is a p oduc which, unde no mal o easonably o eseeable condi ions o use including du a ion and, whe e applicable, pu ing in o se ice, ins alla ion and main enance equi emen s, does no p esen any isk o only he minimum isks compa ible wi h he p oduc 's use, conside ed o be accep able and consis en wi h a high le el o p o ec ion o he sa e y and heal h o pe sons, aking in o accoun in pa icula i s cha ac e is ics, package and p esen a ion, special g oups o consume s (elde ly o young people) and e ec s on o he p oduc s. •kni e – blade, •i on - ho su ace 18 Nex de ini ion •‘dange ous p oduc ’ shall mean any p oduc which does no mee he de ini ion o ‘sa e p oduc ’ •‘se ious isk’ shall mean any se ious isk, including hose he e ec s o which a e no immedia e, equi ing apid in e en ion by he public au ho i ies •‘ ecall’ shall mean any measu e aimed a achie ing he e u n o a dange ous p oduc ha has al eady been supplied o made a ailable o consume s by he p oduce o dis ibu o 19 P oduce and dis ibu o •(i) he manu ac u e o he p oduc , when he is es ablished in he Communi y, and any o he pe son p esen ing himsel as he manu ac u e by a ixing o he p oduc his name, ade ma k o o he dis inc i e ma k, o he pe son who econdi ions he p oduc ; •(ii) he manu ac u e 's ep esen a i e, when he manu ac u e is no es ablished in he Communi y o , i he e is no ep esen a i e es ablished in he Communi y, he impo e o he p oduc ; •(iii) o he p o essionals in he supply chain, inso a as hei ac i i ies may a ec he sa e y p ope ies o a p oduc ; •‘dis ibu o ’ shall mean any p o essional in he supply chain whose ac i i y does no a ec he sa e y p ope ies o a p oduc ; 20 Responsibili y o pe son •I is he p oduce 's esponsibili y o place only sa e p oduc s on he ma ke . •P oduce s shall p o ide consume s wi h he ele an in o ma ion o enable hem o assess he isks inhe en in a p oduc h oughou he no mal o easonably o eseeable pe iod o i s use. •The p oduce has o ake p ecau iona y measu es agains hese isks which can be in o ma ion o consume s, ecall o p oduc s o wi hd awal p oduc s om he ma ke . •I p oduce s o dis ibu o s become awa e ha a p oduc is dange ous, hey mus in o m na ional au ho i ies and coope a e wi h hem. 21 Responsibili y o s a e au ho i ies •Membe S a es shall ensu e ha p oduce s and dis ibu o s comply wi h hei obliga ions unde his Di ec i e in such a way ha p oduc s placed on he ma ke a e sa e. •They shall es ablish o nomina e au ho i ies compe en o moni o he compliance o p oduc s wi h he gene al sa e y equi emen s. 22 Responsibili y o s a e au ho i ies •Membe S a es shall ensu e ha p oduce s and dis ibu o s comply wi h hei obliga ions unde his Di ec i e in such a way ha p oduc s placed on he ma ke a e sa e. •They shall es ablish o nomina e au ho i ies compe en o moni o he compliance o p oduc s wi h he gene al sa e y equi emen s. 23 Responsibili y o s a e au ho i ies •Membe S a es shall ensu e ha p oduce s and dis ibu o s comply wi h hei obliga ions unde his Di ec i e in such a way ha p oduc s placed on he ma ke a e sa e. •They shall es ablish o nomina e au ho i ies compe en o moni o he compliance o p oduc s wi h he gene al sa e y equi emen s. 24 CE Ma king Di ec i es and Regula ions 6. Cons uc ion P oduc s Regula ion –Regula ion (EU) No 305/2011 7. P essu e Equipmen Di ec i e –2014/68/EU 8. REACH – Regula ion (EC) No 1907/2006 9. RoHS – Res ic ion o Haza dous Subs ances – Di ec i e – 2011/65/EU 10. Was e Elec ical and Elec onic Equipmen Di ec i e – 2012/19/EU 11. ATEX Di ec i e – 2014/34/EU 12. Toy Di ec i e – 2009/48/EU 31 CE Ma king Di ec i es and Regula ions 13.Radio Equipmen Di ec i e – 2014/53/EU 14.Rec ea ional C a Di ec i e – 2013/53/EU 15.Ac i e Implan able Medical De ices Di ec i e – 90/385/EEC 16.Explosi e o Ci il Use Di ec i e – 93/15/EEC 17.Noise Emission in he En i onmen Di ec i e – 2000/14/EC 18.Gas Appliances Di ec i e – 2009/142/EC 19.Li s Di ec i e – 2014/33/EU 20.Py o echnic Di ec i e – 2007/23/EC 21.Measu ing Ins umen s Di ec i e – 2004/22/EC 32 One o mo e di ec i e/ egula ion can apply o a single p oduc •Machine y (such as packaging machines, me al p esses, mixe s, d ills e c), o example may be co e ed by (among o he s): •Machine y Di ec i e (2006/42/EC) •EMC Di ec i e (2014/30/EU) •Elec ical equipmen (such as ligh ing, powe adap e s), o example may be co e ed by (among o he s): •Low Vol age Di ec i e (2014/35/EU) •EMC Di ec i e (2014/30/EU) •RoHS Di ec i e (2011/65/EU) •Elec onic equipmen (such as compu e s, ables, sma phones), o example may be co e ed by (among o he s): •EMC Di ec i e (2014/30/EU) •Low Vol age Di ec i e (2014/35/EU) •Radio Equipmen Di ec i e (2014/53/EU) •RoHS Di ec i e (2011/65/EU) 33 Do my p oduc s need CE ma king? •The e is no au ho i y ha p o ides a p oduc lis s o nomencla u e ha names he p oduc s ha equi e CE. •Recommended me hod: •The CE ma king is equi ed only o ce ain p oduc s in ended o be sold in he coun ies o he Eu opean Economic A ea (EEA) •The CE ma king is equi ed only o p oduc s o which a CE ma king di ec i e o egula ion has been adop ed 34 P oduc s ha do no equi e CE •Chemicals •Pha maceu icals •Cosme ics •Foods u s •P oduc s no co e ed by he Eu opean CE ma king di ec i es may s ill all wi hin he scope o o he EU o na ional legisla ion. I no CE di ec i e o egula ion applies, he Gene al P oduc Sa e y Di ec i e (2001/95/EC) may apply. This Gene al P oduc Sa e y Di ec i es equi es ha p oduc s a e sa e, bu is does no equi e any ma king. 35 The di ec i es and ha monized s anda ds •Di ec i es se ou he essen ial equi emen s, w i en in gene al e ms. They limi legisla i e ha monisa ion o a numbe o essen ial equi emen s ha a e o public in e es . •Essen ial equi emen s de ine he esul s o be a ained, o he haza ds o be deal wi h, bu do no speci y he echnical solu ions o doing so. •The p ecise echnical solu ion may be p o ided by a s anda d o by o he echnical speci ica ions o be de eloped in acco dance wi h gene al enginee ing o scien i ic knowledge laid down in enginee ing and scien i ic li e a u e a he disc e ion o he manu ac u e . •Eu opean Ha monized s anda ds p o ide he de ailed echnical in o ma ion o mee he essen ial equi emen s. The e o e, ha monized s anda ds a e linked o he essen ial equi emen s in he di ec i es. This p ocess is called ha moniza ion 36 Fo example: TOY •Toys p oduc s designed o in ended o use by child en unde 14 yea s o age a e co e ed unde he Toy Sa e y Di ec i e and, as such, need o be CE ma ked. In o de o comply wi h he di ec i e, besides p epa ing all he ele an documen a ion such as Decla a ion o Con o mi y and echnical ile, you oys shall also comply wi h he EN 71 s anda ds: •He e a e some example o EN 71 s anda ds: •EN 71-1: Mechanical and physical p ope ies •EN 71-2: Flammabili y •EN 71-3: Speci ica ion o mig a ion o ce ain elemen s •I you a e planning o impo elec onic oys, you shall comply wi h bo h EN 71 and EN 62115 s anda ds. 37 Ha monized s anda ds o GPSD •The EU’s Gene al P oduc Sa e y Di ec i e co e s “any p oduc …which is in ended o consume s o likely, unde easonably o eseeable condi ions, o be used by consume s e en i no in ended o hem, and is supplied o made a ailable, whe he o conside a ion o no , in he cou se o a comme cial ac i i y, and whe he new, used o econdi ioned.” •The Commission o he Eu opean Union (EU) has published an upda ed lis o s anda ds ha can be used o demons a e compliance wi h he essen ial equi emen s o i s Di ec i e 2001/95/EC, ela ed o gene al p oduc sa e y. •h ps://eu -lex.eu opa.eu/legal-con en /EN/TXT/PDF/?u i=CELEX:52017XC0811(14)& om=EN •These s anda ds a e in ended o ce ain p oduc s only. The di ec i e GPSD applies o many o he p oduc s. 38 Technical s anda ds Technical s anda ds a e ine i able ools ha can help o p o ide p oduc sa e y. The S anda ds can ul ill a numbe o asks: •ensu e he quali y and sa e y o p oduc s and/o se ices •achie e compa ibili y be ween p oduc s and/o componen s •access ma ke s and sell o cus ome s in o he coun ies •sa is y you cus ome s’ expec a ions and equi emen s • educe cos s, elimina e was e and imp o e e iciency •comply wi h ele an legisla ion including EU egula ions •gain knowledge abou new echnologies and inno a ions 39 S anda diza ion •Law egula es he de elopmen o s anda ds, hei use and en o cemen . •The s anda diza ion p ocess in EU is conce ned by EU Regula ion on Eu opean S anda diza ion 1025/2012. (REGULATION (EU) No 1025/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL o 25 Oc obe 2012 on Eu opean s anda disa ion) •The p ima y objec i e o s anda diza ion is he de ini ion o olun a y echnical o quali y speci ica ions wi h which cu en o u u e p oduc s, p oduc ion p ocesses o se ices may comply. S anda diza ion can co e a ious issues, such as s anda diza ion o di e en g ades o sizes o a pa icula p oduc o echnical speci ica ions in p oduc o se ices ma ke s whe e compa ibili y and in e ope abili y wi h o he p oduc s o sys ems a e essen ial. 40 Applica ion o ha monisa ion legisla ion •Union ha monisa ion legisla ion applies when he p oduc is placed on he ma ke and o any subsequen ope a ion which cons i u es making a ailable un il i eaches he end-use . •Union ha monisa ion legisla ion applies o all o ms o selling. A p oduc o e ed in a ca alogue o by means o elec onic comme ce has o comply wi h Union ha monisa ion legisla ion when he ca alogue o websi e di ec s i s o e o he Union ma ke and includes an o de ing and shipping sys em. •The Union ha monisa ion legisla ion applies o newly manu ac u ed p oduc s bu also o used and second- hand p oduc s impo ed om a hi d coun y when hey en e he Union ma ke o he i s ime •Union ha monisa ion legisla ion applies o inished p oduc s. •A p oduc which has been subjec o impo an changes o o e hauls aiming o modi y i s o iginal pe o mance, pu pose o ype may be conside ed as a new p oduc . The pe son who ca ies ou he changes becomes hen he manu ac u e wi h he co esponding obliga ions. 47 Which P oduc s A e Co e ed By The ATEX Di ec i e (2014/34/EU)? •The ATEX Di ec i e applies o equipmen and p o ec i e sys ems in ended o use in po en ially explosi e a mosphe es. Sa e y de ices, con olling de ices, and egula ing de ices in ended o use ou side po en ially explosi e a mosphe es bu equi ed o o con ibu ing o he sa e unc ioning o equipmen and p o ec i e sys ems wi h espec o he isks o explosion a e also co e ed by he scope o his Di ec i e. •Acco ding o his Di ec i e, ‘equipmen ’ means machines, appa a us, ixed o mobile de ices, con ol componen s and ins umen a ion he eo and de ec ion o p e en ion sys ems which, sepa a ely o join ly, a e in ended o he gene a ion, ans e , s o age, measu emen , con ol and con e sion o ene gy and/o he p ocessing o ma e ial and which a e capable o causing an explosion h ough hei own po en ial sou ces o igni ion. 48 Which P oduc s A e Co e ed By The ATEX Di ec i e (2014/34/EU)? •‘P o ec i e sys ems’ means de ices o he han componen s o he equipmen de ined abo e which a e in ended o hal incipien explosions immedia ely and/o o limi he e ec i e ange o an explosion and which a e sepa a ely placed on he ma ke o use as au onomous sys ems. 49 Which P oduc s A e No Co e ed By The ATEX Di ec i e (2014/34/EU)? •a) medical de ices in ended o use in a medical en i onmen ; •(b) equipmen and p o ec i e sys ems whe e he explosion haza d esul s exclusi ely om he p esence o explosi e subs ances o uns able chemical subs ances; •(c) equipmen in ended o use in domes ic and non- comme cial en i onmen s whe e po en ially explosi e a mosphe es may only a ely be c ea ed, solely as a esul o he acciden al leakage o uel gas; •(d) pe sonal p o ec i e equipmen co e ed by Council Di ec i e 89/686/EEC o 21 Decembe 1989 on he app oxima ion o he laws o he Membe S a es ela ing o pe sonal p o ec i e equipmen ; •(e) seagoing essels and mobile o sho e uni s oge he wi h equipmen on boa d such essels o uni s; •( ) means o anspo , i.e. ehicles and hei aile s in ended solely o anspo ing passenge s by ai o by oad, ail o wa e ne wo ks, as well as means o anspo in so a as such means a e designed o anspo ing goods by ai , by public oad o ail ne wo ks o by wa e . Vehicles in ended o use in a po en ially explosi e a mosphe e shall no be excluded om he scope o his Di ec i e; •(g) he equipmen used o na ional secu i y by a med o ces, police e c. 50 How o Comply wi h he ATEX Di ec i e (2014/34/EU): •The ATEX Di ec i e o e s wo ways o pe o m con o mi y assessmen : 1.In e nal P oduc ion Con ol o CE ma king sel -ce i ica ion: he manu ac u e pe o ms he con o mi y assessmen and documen s he assessmen in his own igh . The in e nal p oduc ion con ol applies o equipmen and de ices unde G oup II, Ca ego y 3. 2.In ol emen o a No i ied Body: in he case o equipmen ; au onomous p o ec i e sys ems; o sa e y de ices o such equipmen o sys ems; and o componen s o such equipmen , sys ems o de ices, unde G oups I and II, Ca ego ies M1, M2, 1 and 2. 51 Classi ica ion o equipmen and sa e y de ices G oup I •ANNEX I - CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS INTO CATEGORIES •Equipmen -g oup I: equipmen is in ended o use in unde g ound pa o mine (gases, dus ) •ca ego y M1 Equipmen in his ca ego y is equi ed o emain unc ional, e en in he e en o a e inciden s ela ing o equipmen , wi h an explosi e a mosphe e p esen . Fo example •employee li e suppo sys ems – en ila ion. •ca ego y M2 - This equipmen is in ended o be de-ene gised in he e en o an explosi e a mosphe e. 52 Classi ica ion o equipmen and sa e y de ices G oup II •Equipmen ca ego y 1 - Equipmen in his ca ego y is in ended o use in a eas in which explosi e a mosphe es caused by mix u es o ai and gases, apou s o mis s o by ai /dus mix u es a e p esen con inuously, o long pe iods o equen ly. •Equipmen ca ego y 2 - Equipmen in his ca ego y is in ended o use in a eas in which explosi e a mosphe es caused by gases, apou s, mis s o ai /dus mix u es a e likely o occu occasionally. •Equipmen ca ego y 3 - Equipmen in his ca ego y is in ended o use in a eas in which explosi e a mosphe es caused by gases, apou s, mis s, o ai /dus mix u es a e unlikely o occu o , i hey do occu , a e likely o do so only in equen ly and o a sho pe iod only. 53 No i ied body •Each di ec i e co e ing you p oduc speci ies whe he an au ho ised hi d pa y (No i ied Body) mus be in ol ed in he con o mi y assessmen p ocedu e necessa y o CE ma king. •This is no obliga o y o all p oduc s, so i is impo an o check whe he he in ol emen o a No i ied Body is indeed equi ed. •These Bodies a e au ho ised by na ional au ho i ies and o icially “no i ied” o he Commission and lis ed in he NANDO (New App oach No i ied and Designa ed O ganisa ions) da abase. 54 Type o assesmen •Assesmen o i s pa y – p oduce : •con o mi y assessmen is pe o med by he en i y ha is he supplie o he subjec o con o mi y assessmen , ie. he inspec ion is pe o med by an in-house en i y ha is also he au ho o he ce i ica e o con o mi y (me allu gical ce i ica e) • he second pa y - cus ome ep esen a i e - Con o mi y assessmen is pe o med by a pe son o o ganiza ion ha ep esen s he in e es s o he use , ie he cus ome : cus ome audi inpu con ol 55 Cus ome audi •Cus ome audi se es o s eng hen supplie -cus ome ela ionships, which a e clea e and mo e anspa en , inc eases he supplie 's c edibili y and e i ies i s abili y o deli e unde he con ac , espond o special cus ome equi emen s and, las bu no leas , inc eases cus ome con idence. In many companies, cus ome audi is pa o he selec ion o supplie app o al. •The hi d pa y - independen body, wi hou obliga ion, any ela ionship o he manu ac u e o p oduc •Au ho ized body 56 P oduc es ing by acc edi ed labo a o y •Labo a o y a e acc edi ed by CAI – independen hi d pa y •Czech Acc edi a ion Ins i u e •In he Czech Republic, CAI has de eloped an acc edi a ion sys em, in compliance wi h in e na ional equi emen s and ules (es ablished by EC and EA), which seeks an achie emen o a sys em compa able wi h he sys ems used in EU and EFTA coun ies. The ac i i y was he e o e, om he ou se , ocused on in e na ional co-ope a ion wi h an objec i e o become membe in he epu able in e na ional o ganisa ions dealing wi h acc edi a ion and a signa o y o mul ila e al ag eemen s. 63 CAI – membe o in e na ional o ganiza ion 64 Eu opean Acc edi a ion In e na ional Labo a o y Acc edi a ion Coope a ion Technical documen a ion •The manu ac u e has o es ablish he echnical documen a ion equi ed by he di ec i e(s) o he assessmen o he p oduc ’s con o mi y o he ele an equi emen s, and o he isk assessmen . •Toge he wi h he EC decla a ion o con o mi y, he echnical documen a ion mus be p esen ed on eques o he app op ia e na ional au ho i ies (e.g. d awings, diag ams, p o ocol, es esul s) 65 Ins uc ion o use – essen ial equi emen s – annex 2 •All equipmen and p o ec i e sys ems mus be accompanied by ins uc ions, including a leas he ollowing pa icula s: •a ecapi ula ion o he in o ma ion wi h which he equipmen o p o ec i e sys em is ma ked, oge he wi h any app op ia e addi ional in o ma ion o acili a e main enance (e.g. add ess o he epai e , e c.); •ins uc ions o sa e: pu ing in o se ice, use, assembling and disman ling, main enance (se icing and eme gency epai ), ins alla ion and adjus men ; •whe e necessa y, an indica ion o he dange a eas in on o p essu e- elie de ices and aining ins uc ions; •de ails which allow a decision o be aken beyond any doub as o whe he an i em o equipmen in a speci ic ca ego y o a p o ec i e sys em can be used sa ely in he in ended a ea unde he expec ed ope a ing condi ions; •elec ical and p essu e pa ame e s, maximum su ace empe a u es and o he limi alues; whe e necessa y, special condi ions o use, including pa icula s o possible misuse which expe ience has shown migh occu and he essen ial cha ac e is ics o ools which may be i ed o he equipmen o p o ec i e •The ins uc ions mus con ain he d awings and diag ams necessa y o he pu ing in o se ice, main enance, inspec ion, checking o co ec ope a ion and, whe e app op ia e, epai o he equipmen o p o ec i e sys em, oge he wi h all use ul ins uc ions, in pa icula wi h ega d o sa e y. 66 ANNEX X - Con en o EU DECLARATION OF CONFORMITY •1.P oduc model/p oduc (p oduc , ype, ba ch o se ial numbe ): •2. Name and add ess o he manu ac u e and, whe e applicable, his au ho ised ep esen a i e: •3. This decla a ion o con o mi y is issued unde he sole esponsibili y o he manu ac u e . •4. Objec o he decla a ion (iden i ica ion o p oduc allowing aceabili y; i may, whe e necessa y o he iden i ica ion o he p oduc , include an image): •5. The objec o he decla a ion desc ibed abo e is in con o mi y wi h he ele an Union ha monisa ion legisla ion - i.e. e e ences o he ele an ha monised s anda ds used o e e ences o he o he echnical speci ica ions in ela ion o which con o mi y is decla ed •7. Whe e applicable, he no i ied body … (name, numbe ) pe o med … (desc ip ion o in e en ion) and issued he ce i ica e: •8. Addi ional in o ma ion – signa u e, name … 67 CE ma king •The CE ma king mus be a ixed by he manu ac u e , o by his au ho ised ep esen a i e. •I mus be a ixed acco ding o i s legal o ma isibly, legibly and indelibly o he p oduc o i s da a pla e. •I a No i ied Body was in ol ed in he p oduc ion con ol phase, i s iden i ica ion numbe mus also be displayed. •I is he manu ac u e ’s esponsibili y o d aw up and sign an “EC decla a ion o con o mi y” p o ing ha he p oduc mee s he equi emen s. 68 Thank you o you a en ion hana. ezniko [email p o ec ed] This wo k is licensed unde CC BY 4.0 NPO_VŠB-TUO_MSMT-16605/2022 69