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cem4 | certifico machinery directive

Organizza al meglio il Tuo lavoro sulla Direttiva macchine

Prova il nuovo Metodo di Valutazione dei Rischi EN ISO 12100 Versione 2019

Download CEM4 full gratuita 30 giorni

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Organizza al meglio il Tuo lavoro sulla Direttiva macchine

Prova il nuovo Metodo di Valutazione dei Rischi EN ISO 12100 Versione 2018

Download CEM4 full gratuita 30 giorni

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cem4

certifico machinery directive

Organizza al meglio il Tuo lavoro sulla Direttiva macchine

Download CEM4 full gratuito 30 giorni

Slide background


Organizza al meglio il Tuo lavoro sulla Direttiva macchine

Prova il nuovo Metodo di Valutazione dei Rischi EN ISO 12100 della Versione 2017

Download CEM4 full gratuita 30 giorni

Slide background


Organizza al meglio il Tuo lavoro sulla Direttiva macchine

Prova il nuovo Metodo di Valutazione dei Rischi EN ISO 12100 della Versione 2017

Download CEM4 full gratuita 30 giorni

Slide background
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Organizza al meglio il Tuo lavoro sulla Direttiva macchine

Prova il nuovo Metodo di Valutazione dei Rischi EN ISO 12100 della Versione 2017

Download CEM4 full gratuita 30 giorni

Slide background


Organizza al meglio il Tuo lavoro sulla Direttiva macchine

Prova il nuovo Metodo di Valutazione dei Rischi EN ISO 12100 della Versione 2017

Download CEM4 full gratuita 30 giorni

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The best software solution for Machinery Directive

CEM4 Edition 2017: view the New Standard Risk Assessment EN ISO 12100

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cem4
certifico machinery directive

The best software solution for Machinery Directive

CEM4 Edition 2017: view the New Standard Risk Assessment EN ISO 12100

Download CEM4 free trial 30 days

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cem4

certifico machinery directive

Organizza al meglio il Tuo lavoro sulla Direttiva macchine

Vedi il percorso

 

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cem4

certifico machinery directive

Organizza al meglio il Tuo lavoro sulla Direttiva macchine

Vedi il percorso

 

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www.cem4.eu

è il nuovo sito supporto a CEM4 per gli Utenti nazionali e internazionali.

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CEM4

CEM4

certifico machinery directive

Il Software per la Direttiva macchine 2006/42/CE

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Ultimo

CEM4 Novembre 2019

27 Novembre 2019

Nome Versione: "Power 2020/1"

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Video

CEM4: Valutazione dei Rischi Direttiva 2006/42/CE

1. "Presunzione di Conformità" RESS & Norme armonizzate.
2. "Interazione" Valutazione dei Rischi EN ISO 12100 & Scheda di Valutazione RESS.

Vedi i tutorial

CEM4 4.8.12: Nuova funzione Immagini cover/separatori

CEM4 4 8 12

Descrizione nuova funzione immagini allegate ai separatori in CEM4

CEM4 - Rel. 4.8.12 (Build 0) | March 2018

14 March 2018

La nuova versione 4.8.12 di CEM4 consente di personalizzare con un'immagine i separatori di sezione, la copertina del Fascicolo Tecnico oppure la cover della nuova valutazione (per pericoli o per requisiti). L'immagine viene inserita all'interno del report e visualizzata nell'interfaccia del software.

Per inserire un'immagine, seguire questa procedura:

  • Dall'albero dell'Archivio, espandere il nodo di una macchina e selezionare il nodo del Fascicolo Tecnico;
  • Dalla finestra di documento, selezionare una qualsiasi sezione presente nell'albero oppure una nuova valutazione del rischio;
  • Sul lato destro della finestra selezionare Fai click per allegare una risorsa e scegliere un'immagine;
  • Specificare una eventuale testo da mostrare come didascalia sotto l'immagine stampata sul report.

In fase di anteprima di stampa, le immagini vengono visualizzate come negli esempi seguenti.

Allegati:
Scarica questo file (Valutazione dei Rischi - Cover.pdf)Valutazione dei Rischi | Cover[CEM4 Rel. 4.8.12 2018][IT/EN]79 kB257 Downloads
Scarica questo file (Fascicolo Tecnico - Separatori FT.pdf)Fascicolo Tecnico | Separatori[CEM4 Rel. 4.8.12 2018][IT/EN]151 kB277 Downloads
Scarica questo file (Fascicolo Tecnico - Cover.pdf)Fascicolo Tecnico | Cover[CEM4 Rel. 4.8.12 2018][IT/EN]112 kB263 Downloads

Direttiva macchine: Stato dell’arte

Direttiva macchine: Stato dell’arte

Applicazione del concetto di "Stato dell'Arte" alla Direttiva macchine con riferimenti.

Con la Guida alla Direttiva macchine 2006/42/CE Ed. 2.1 Luglio 2017, si precisa il concetto di "Stato dell’arte”, introdotto già con la Guida 2010, al momento della fabbricazione di una macchina, come requisito non assoluto, ma contestualizzato temporalmente e in modo realistico anche in base alle possibilità tecniche ed economiche del produttore.

....
STATO DELL’ARTE - CONSIDERANDO 14

Al momento della fabbricazione, il produttore è obbligato a dotare la macchina delle misure di sicurezza più adeguate in base anche allo stato dell’arte della tecnologia. La nuova direttiva specifica che lo “stato dell’arte” non può essere inteso come requisito assoluto, ma contestualizzato temporalmente e in modo realistico, anche in base alle possibilità tecniche ed economiche del produttore.

L’approfondimento illustra quanto riportato in merito:

- dalla Guida alla Direttiva macchine 2010;
- dalla Guida alla Direttiva macchine 2017;
- dal Report EU - Methods of referencing standards in legislation with an emphasis on European legislation;
- dalla legislazione nazionale.

Guide machinery Directive 2006/42/CE Ed. 2.1 July 2017

14) The essential health and safety requirements should be satisfied in order to ensure that machinery is safe; these requirements should be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements. 

Re

§16 The state of the art 

Recital (14) introduces the concept of ‘the state of the art’ which shall be taken into account when applying the essential health and safety requirements (EHSRs) set out in Annex I. 

This concept is very important as it means that the EHSRs are not absolute requirements irrespective of economic cost and technical possibilities available on the market for manufacturers – see §161 and §162: comments on General Principle 3, Annex I

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Certifico Srl - IT | Rev. 00 2018 

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EN ISO 3691-1:2015 Carrelli Industriali | Sicurezza e verifiche | CEM

EN ISO 3691-1:2015 Carrelli Industriali | Sicurezza e verifiche

File CEM importabile in CEM4 della norma per la sicurezza dei carrelli industriali; disponibile il file PDF al Documento "Vademecum Sicurezza carrelli elevatori".

La EN ISO 3691-1 è la norma di riferimento per la sicurezza carrelli Industriali. La norma, di tipo C, è armonizzata per la Direttiva macchine 2006/42/CE (vedi le norme armonizzate online)

Oltre a poter essere utilizzata in "Presunzione di Conformità" per la marcatura CE di carrelli industriali nuovi, dovrebbe essere utilizzata per adeguamenti, manutenzioni di carrelli già immessi sul mercato secondo il concetto di "Buona Tecnica / Regola dell'arte", infatti il D.Lgs. 81/2008, conferisce alle norme tecniche, il ruolo primario di  "strumenti sicurezza in progress" (Vedi Art. 18. comma z).

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EN ISO 12100: la Riduzione del rischio in CEM4 Report

EN ISO 12100: la Riduzione del rischio in CEM4 Report

Dalla versione di CEM4 Rel. 4.8.9, è stata introdotta sui report, la visualizzazione grafica/numerica del fattore di riduzione della stima del rischio da iniziale a finale/residuo in accordo con il metodo ibrido del Rapporto Tecnico ISO/TR 14121-2 p.6.5

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CEM4 | Rel. 4.8.9 "Risk reduction"

CEM4 - Rel. 4.8.9 (Build 0) | October 2017

12 October 2017

"Risk reduction"

Nella presente Versione, sono aggiunte, in particolare, funzioni di:

- Calcolo della riduzione all'interno del report AR1/AR2/CR2/VX1/VX2
- Elenco ultime finestre di documento e di gestione chiuse nella sessione corrente
- Debugger documenti

Evaluation of Directive 2006/42/EC on Machinery

Evaluation of Directive 2006/42/EC on Machinery

30.09.2017 Technopolis group - Final report

This report presents the Evaluation of Directive 2006/42/EC on Machinery. It was commissioned by EC Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW), and undertaken by a consortium led by Technopolis Group over an 18-month period during 2016-2017.

The findings and conclusions are based on a programme of research and analyses, which included a public consultation, a series of targeted consultation surveys, a programme of interviews, a review of relevant documentation and an analysis of statistical databases and reports.

Scope of the evaluation

The focus of the evaluation is the 2006 Machinery Directive (MD), which is concerned with the free movement of machinery within the EU internal market, and with ensuring health safety of users of machinery. It is in fact the latest revision to a much earlier Directive (89/392/EEC) adopted in 1989.

The purpose of the evaluation is to review the performance of the Directive and to determine the extent to which it is fit for purpose, providing evidence and conclusions that might form the basis for possible future legislative initiatives. In particular, the study is asked to assess the extent to which the Directive has met its twin objectives of (i) guaranteeing the free movement of relevant machinery within the Single Market, and (ii) ensuring a high level of safety and protection for machinery users (workers and consumers). To this end, the aims were to assess the relevance, effectiveness, coherence, efficiency and EU added value of the Directive, by addressing 18 specific evaluation questions. The evaluation covers the functioning of the Directive, including the processes involved in transposing, implementing and enforcing it. It covers all relevant product categories and 33 countries (EU28, EFTA and Turkey) and focuses on the period from 2010 (after the deadline for application of the MD).

Relevance of the Directive

The two objectives of the Directive – facilitating free movement of machinery and ensuring health and safety – remain entirely relevant to market needs (manufacturers and users). The machinery sector continues to be an important part of the EU economy 30 years after the adoption of the original Directive, accounting for 4% of all manufacturing businesses, 9% of all manufacturing production (value) and 10% of employment in the manufacturing sector. Its importance in terms of trade is also significant, with machinery accounting for nearly one-quarter of the value of all EU exports in 2015, and 60% of this trade occurring between Member States.

Facilitating the free movement of machinery is therefore a significant EU-wide concern. The great majority of stakeholders consulted for the study also agree that ensuring free movement of machinery is a very important objective, providing a strong indication that this is of high relevance to the needs and concerns of EU stakeholders, with widespread relevance both to the machinery market and amongst users. The vast majority also agreed that the Directive (at least in its concept and intentions) is an entirely appropriate response to the aim of ensuring free movement of machinery.

In relation to ensuring health and safety, despite a downward trend in the number of accidents at work (both in terms of absolute numbers and per 100,000 employees), there were still over 3 million nonfatal accidents and nearly 3,700 fatal accidents in EU workplaces in 2013 (all sectors). This implies that on average most people will have an accident at work during their lifetime causing more than three days of absence, or death, making this a significant and widespread issue. There are sizeable financial and other (social) costs of these accidents (e.g. productivity loss, healthcare, reduced quality of life, administration), which have been calculated in different countries as equating to 1-5% of GDP annually. Importantly, those sectors and occupations that are most relevant to machinery (and the Directive) tend to have some of the highest rates of injuries (e.g. the Manufacturing, Construction and Agriculture sectors combined accounted for 51% and 38% of all fatal and non-fatal accidents respectively in 2013), making this an even more pressing issue for this sector. Nearly all stakeholders consulted through the study placed great importance on ensuring a high level of health and safety for users of machinery, providing a strong indication that this objective is of high relevance to the needs and concerns of EU stakeholders. The majority also felt that the Directive (its scope and provisions) was an ‘entirely appropriate’ response to addressing this aim.

The Directive has maintained its relevance, despite changes in technology and the business environment. It has undergone several iterations since 1989, adding or revising elements, including in its scope and requirements. However, these changes have been to improve clarity, adjust coverage of pre-existing machinery (and address associated risks), or reflect changes in the perceived relevance/ importance of certain aspects of health and safety. They have not come about as a reaction to shifts in technology or the market. This is unsurprising, given that New Approach Directives (including the MD) are limited to essential requirements (“principles”), while the state of technology (state of the art) is then determined by stakeholders through technical specifications. As such, the majority view of stakeholders is that the MD copes well with change. Having said this, a significant minority of those consulted have highlighted that specific new innovations may test the suitability of the Directive and reduce its effectiveness going forward. This includes innovations in the areas of digitisation, robotics, software and autonomous control, as well as the increasing prevalence of etrade, fulfilment houses and (un-checked) non-compliance of products from third countries.

Most stakeholders believe the rate and extent of innovation in the machinery sector has increased over the past decade, but the link between this and the Machinery Directive (specifically) is less clear. This is because the Directive has acted as both an enabler and barrier to innovation in the sector: positively influencing innovation through the facilitation of trade, support for technology transfer and encouragement of innovative safety features, tools and techniques; while at the same time reducing the rate of innovation by adding to the cost or complexity of introducing new technology.

...

Table of Contents

Executive Summary 
1 Introduction
2 Background to the Machinery Directive
2.1 Origins, rationale and objectives of the Directive
2.2 Summary of the main provisions of the Directive
2.3 Transposition and implementation of the Directive
2.4 Defining the intervention logic for the Machinery Directive
3 Evaluation requirements and questions 
4 Overview of research approach and methodology 
4.1 Main phases of the evaluation
4.2 Principle research methods and sources of evidence 
4.3 Summary of consultation numbers
4.4 Limitations for the analysis 
5 Answers to the evaluation questions
5.1 Evaluation Question 1: the current size and structure of the market / sector 
5.2 Evaluation Question 2: correspondence between objectives and current needs
5.3 Evaluation Question 3: The extent to which the Directive deals with innovation 
5.4 Evaluation Question 4: discrepancies in interpretation of requirements 
5.5 Evaluation Question 5: the extent to which the Directive has contributed to objectives 
5.6 Evaluation Question 6/7: the effectiveness of conformity assessment options 
5.7 Evaluation Question 8: the effectiveness of European harmonised standards
5.8 Evaluation Question 9: the effectiveness of mechanisms relating to non-compliance
5.9 Evaluation Questions 10/11: enablers and barriers to effectiveness 
5.10 Evaluation Question 12: the costs involved as a result of the Directive 
5.11 Evaluation Question 13: the benefits realised as a result of the Directive
5.12 Evaluation Question 14: the extent to which costs are reasonable and proportionate
5.13 Evaluation Questions 15 & 16: potential for simplification and reduced inefficiency 
5.14 Evaluation Question 17: coherence and complementarity of the Directive 
5.15 Evaluation Question 18: added value of a European directive
6 Conclusions
6.1 Context of the Directive
6.2 Relevance of the Directive
6.3 Effectiveness of the Directive 
6.4 Efficiency of the Directive
6.5 Coherence of the Directive
6.6 European Added Value of the Directive
Appendices 
Appendix A Methodology 
A.1 Evaluation approach 
A.2 Conduct of the evaluation
A.3 Principle evaluation methods and sources 
A.4 Limitations and mitigation measures 
Appendix B Stakeholder consultation
B.1 Consultation strategy and process 
B.2 Consultation responses
B.3 Targeted consultation questionnaires
B.4 Survey consultation results
Appendix C Additional data 
C.1 Distribution of published EN by technical body 
C.2 Suggested gaps in the Harmonised Standards portfolio
C.3 Mapping of actions (and costs) triggered by the Machinery Directive
C.4 Price deflation calculations

Fonte: Commissione Europea

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Scarica questo file (Evaluation Directive 2006 42 EC Machinery - September 2017.pdf)Evaluation Directive 2006 42 EC Machinery - September 2017[Techopolis group 09.2017][IT]4406 kB1 Download