Relevant bibliographies by topics / THE CE MARKING

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers

Academic literature on the topic 'THE CE MARKING'

Author: Grafiati
Published: 4 June 2021
Last updated: 1 February 2022

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the lists of relevant articles, books, theses, conference reports, and other scholarly sources on the topic 'THE CE MARKING.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Journal articles on the topic "THE CE MARKING"

1

Brändlein, Peter, and Joachim Deppisch. "CE marking of natural stone." Zeitschrift der Deutschen Gesellschaft für Geowissenschaften 158, no. 4 (December 1, 2007): 709–17. http://dx.doi.org/10.1127/1860-1804/2007/0158-0709.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Matsumae, Takashi. "Current situation of the CE marking." Proceedings of the Industrial, Chemical Machinery & Safety Division Conference 2016.winter (2016): OS—3. http://dx.doi.org/10.1299/jsmeicm.2016.winter.os-3.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Schoenmakers, Coen. "CE marking of medical devices." Technology and Health Care 6, no. 4 (October 1, 1998): 271–74. http://dx.doi.org/10.3233/thc-1998-6406.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

Day, Caroline, and David J. Bailey. "CE Marking and diabetes devices." British Journal of Diabetes & Vascular Disease 12, no. 5 (September 2012): 213–15. http://dx.doi.org/10.1177/1474651412466922.

Full text
APA, Harvard, Vancouver, ISO, and other styles
5

Andjelic, Slavica, Vesna Mladenovic, and Marko Trisic. "Serbian producers and CE marking." Trendovi u poslovanju 5, no. 2 (2017): 47–53. http://dx.doi.org/10.5937/trendpos1702047a.

Full text
APA, Harvard, Vancouver, ISO, and other styles
6

Bentley, Dave. "CE marking - what does it really mean?" Journal of Tissue Viability 9, no. 1 (January 1999): 11–15. http://dx.doi.org/10.1016/s0965-206x(99)80004-7.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

Schoenmakers, C. "An outline of the CE marking procedure." RBM-News 20, no. 4 (June 1998): 58–60. http://dx.doi.org/10.1016/s0222-0776(98)80005-9.

Full text
APA, Harvard, Vancouver, ISO, and other styles
8

Muedra, Arsenio Navarro. "Plastic products for construction: The importance of CE marking." Reinforced Plastics 62, no. 5 (September 2018): 275–78. http://dx.doi.org/10.1016/j.repl.2017.07.081.

Full text
APA, Harvard, Vancouver, ISO, and other styles
9

Nübling, Micha. "CE-Kennzeichnung von Point-of-Care-Testsystemen / CE marking of point-of-care test devices." LaboratoriumsMedizin 30, no. 4 (January 1, 2006): 226–29. http://dx.doi.org/10.1515/jlm.2006.029.

Full text
APA, Harvard, Vancouver, ISO, and other styles
10

Walsh, Ian D. "The impact of European standards and CE marking on asphalts." Proceedings of the Institution of Civil Engineers - Construction Materials 167, no. 4 (August 2014): 227–34. http://dx.doi.org/10.1680/coma.13.00030.

Full text
APA, Harvard, Vancouver, ISO, and other styles
More sources

Dissertations / Theses on the topic "THE CE MARKING"

1

Huld, Peter Mattias Pawel. "CE marking of a lifting beam." Thesis, Högskolan Dalarna, Maskinteknik, 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:du-37054.

Full text
Abstract:
Rotork is a company stationed in Falun municipality, Sweden and manufactures electric valve actuators. This thesis will investigate one of their lifting beams used in daily production. Although already being used for more than 10 years, it is still not yet CE market which is necessary for it to be used legally. The purpose of this thesis is to investigate how the lifting beam complies with the existing directives, laws, and standards and provide a basis for CE marking. A six-step method for CE marking was decided as useful to fulfil the aims of this thesis. This method includes everything from identifying applicable directives and standards, relevant tests, documentation and a procedure to CE mark the product.The results show that the lifting beam shall indeed be regarded as a machine by the definition provided in the Machine directive 2006/42/EG and should therefore follow its requirements as well as the Swedish version of the Machine directive, AFS 2008:3. To verify which paragraphs of AFS 2008:3 the lifting beam complies with, does not comply with or are not relevant a risk analysis was performed. In order to interpret the meaning of the paragraphs in AFS 2008:3 and its appliance, a relevant standard for lifting beam was chosen which in this case was SS-EN 13155+A2:2009. The results of the risk analysis show that the lifting beam lacks in two areas, the technical documentation which needs to be completed and further tests of the mechanical constriction are needed for the lifting beam to finally be CE marked.
APA, Harvard, Vancouver, ISO, and other styles
2

Sarbay, Zeynep Saygin. "The Ce Marking And The Implementation In Turkey: The Challenges And The Complexities." Master's thesis, METU, 2012. http://etd.lib.metu.edu.tr/upload/12614082/index.pdf.

Full text
Abstract:
The CE mark confirms that all applicable provisions are fulfilled with regard to conformity assessment within the scope of &ldquo
New Approach&rdquo
directives. The CE mark is a mandatory conformity mark for products placed on the market in the European Union. As a candidate country Turkey is obliged to achieve constitutional modifications in the quality infrastructure institutions to succeed European Union harmonization. The aim of this thesis is to research the harmonization problems in Turkish quality infrastructure system and analyze the challenges and complexities in legal approximation and implementation. Turkey has harmonization problems in standardization, conformity assessment and accreditation
proceed from inability of implementing operating methods and lack of specialized knowledge. These problems disorganize the quality infrastructure system and create disadvantage against Turkish manufacturer and consumer.
APA, Harvard, Vancouver, ISO, and other styles
3

Jenkins, David William. "Risk assessment applied to consumer products with reference to CE marking machines for use at work." Thesis, Aston University, 2004. http://publications.aston.ac.uk/12230/.

Full text
Abstract:
New Approach Directives now govern the health and safety of most products whether destined for workplace or domestic use. These Directives have been enacted into UK law by various specific legislation principally relating to work equipment, machinery and consumer products. This research investigates whether the risk assessment approach used to ensure the safety of machinery may be applied to consumer products. Crucially, consumer products are subject to the Consumer Protection Act (CPA) 1987, where there is no direct reference to 'assessing risk'. This contrasts with the law governing the safety of products used in the workplace, where risk assessment underpins the approach. New Approach Directives are supported by European harmonised standards, and in the case of machinery, further supported by the risk assessment standard, EN 1050. The system regulating consumer product safety is discussed, its key elements identified and a graphical model produced. This model incorporates such matters as conformity assessment, the system of regulation, near miss and accident reporting. A key finding of the research is that New Approach Directives have a common feature of specifying essential performance requirements that provide a hazard prompt-list that can form the basis for a risk assessment (the hazard identification stage). Drawing upon 272 prosecution cases, and with thirty examples examined in detail, this research provides evidence that despite the high degree of regulation, unsafe consumer products still find their way onto the market. The research presents a number of risk assessment tools to help Trading Standards Officers (TSOs) prioritise their work at the initial inspection stage when dealing with subsequent enforcement action.
APA, Harvard, Vancouver, ISO, and other styles
4

Jidegren, Martin, and David Sannéus. "CE-märkning av produkter under byggproduktförordningen." Thesis, Linnéuniversitetet, Institutionen för maskinteknik (MT), 2013. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-26139.

Full text
Abstract:
The purpose of this study is to achieve an understanding of how a CE- marking process is conducted and to identify the relevant factors that must be considered in such a process. We have conducted our study at Lövhults Svets & Smide AB (Lövhults) in Skruv, Småland Sweden, which are manufacturing brackets for small covering constructions. To understand how a CE-marking process is conducted several documents and provisions have been reviewed to achieve a basic understanding and insight of the subject. It thus led to that guideline ETAG 015 were studied and the factors to be considered in the CE-marking of brackets were identified. Together with Jan-Åke Johansson at Lövhults we agreed on four different brackets to investigate for a potential CE-marking. When these brackets had been selected a thorough investigation of these products was conducted, which then were compared with the provisions contained within ETAG 015. It states factors regarding the mechanical resistance, fire safety, environment, health, safety and usefulness that are to be considered. These factors should be specified and given a value / explanation which can be determined by European standards, calculation, calculation and testing, or only through testing. These calculations and tests shall be performed by the company or by a notified body. For a CE-marking to be possible to conduct it is mandatory to examine the manufacturing process of the products. Lövhults products are made of steel (Ymagine D1), which is processed in a punching machine, a bending machine, and finally a welding machine. After this processing, the products are sent for galvanizing and after which they are delivered back to Lövhults for dispatch to the customer. A production control procedure must be established and documented to ensure the quality of the manufactured products. The production control that we propose is simple in nature and is based on visual inspection of incoming materials, visual inspection of the work performed at each processing station and finally a visual check of incoming galvanized products. The manufacturing control needs to be approved by a notified body before it can be considered valid. The result of this study is that several correcting actions must be performed and that contact must be taken with a notified body to ensure that Lövhults products meet all the requirements that are demanded and thereby enable the products to receive a CE-marking. We have a discussion at the end of the report, resulting in the final conclusions and recommendations on whether the CE marking of Lövhults products is something that is worth investing in or not.
Denna studies syfte är att uppnå förståelse kring hur en CE-märkningsprocess går till och att kartlägga de faktorer som måste beaktas i en sådan process. Vi har utfört vår studie på Lövhults Svets & Smide AB (Lövhults) i Skruv, Småland, som producerar vinkelbeslag för täckande konstruktioner av mindre storlek. För att ta reda på hur en CE-märkningsprocess går till har ett flertal dokument och bestämmelser studerats för att skapa en grundläggande förståelse och insikt kring ämnet. Det ledde således till att riktlinje ETAG 015 studerades och att de faktorer som skall beaktas vid en CE-märkning av vinkelbeslag identifierades. Vi kom tillsammans med Jan-Åke Johansson på Lövhults överens om att undersöka fyra olika vinkelbeslag för en potentiell CE- märkning. När vinkelbeslagen valts ut genomfördes en noggrann produktgranskning som sedan ställdes mot de bestämmelser som återfinns i ETAG 015. Där utpekas faktorer gällande mekanisk motståndskraft, brandsäkerhet, miljö, hygien, säkerhet och användbarhet som skall beaktas. Dessa faktorer skall specificeras och ges ett värde/förklaring vilket kan fastställas via europeiska standarder, beräkning, beräkning och provning eller enbart via provning. Dessa beräkningar och provningar utförs av företaget eller av ett anmält organ. För att en CE-märkning ska vara möjlig måste även den tillverkningsprocess som produkterna i fråga genomgår granskas. Lövhults produkter tillverkas av stål (Ymagine D1) vilket bearbetas i en stansmaskin, bockningsmaskin och slutligen en svetsmaskin. Efter denna bearbetning skickas produkterna iväg för galvanisering och återkommer sedan till Lövhults för utleverans till kund. En plan för tillverkningskontroll ska upprättas och dokumenteras för att säkerställa kvalitén på de tillverkade produkterna. Den tillverkningskontroll som vi föreslår är av enkel natur och grundar sig på visuell kontroll av inkommande material, visuell kontroll av utfört arbete vid varje bearbetningsstation och slutligen en visuell kontroll inkomna av galvaniserade produkter. En tillverkningskontrollplan ska godkännas av ett anmält organ innan den kan anses giltig. Resultatet av denna undersökning är att ett flertal åtgärder måste vidtas och att kontakt med ett anmält organ måste tas för att Lövhults produkter ska uppfylla kraven som efterfrågas och därmed gå att CE-märka. Vi för en diskussion i slutet av rapporten vilket resulterar i slutsatser och rekommendationer gällande huruvida en CE-märkning av Lövhults produkter är något som är värt att satsa på eller inte.
Detta arbete är utfört som en fallstudie på Lövhults Svets & Smide AB (Lövhults) med intentionen att försöka skapa ett underlag för CE-märkning av de vinkelbeslag som företaget tillverkar. Tillsammans med företaget pekades fyra vinkelbeslag ut som lämpliga kandidater för en potentiell CE-märkning. För att erhålla kunskap och förståelse kring hur en CE-märkning av vinkelbeslag går till studerades dokument, standarder och bestämmelser från Europeiska Unionen vilket slutligen ledde oss till riktlinje ETAG 015. Denna riktlinje innefattar de bestämmelser som man skall förhålla sig till vid en CE- märkning av vinkelbeslag och den fungerar därmed som en teoretisk grundplattform. Utifrån detta dokument identifierades de faktorer som är relevanta att beakta för de fyra utvalda vinkelbeslagen hos Lövhults. En noggrann undersökning och granskning av produkterna genomfördes för att erhålla önskade specifikationer som sedan ställdes sedan mot de utpekade krav som återfinns i ETAG 015 för att kontrolla produkternas överensstämmelse. Analysen av denna jämförelse resulterar i slutsatsen att ett flertal åtgärder måste vidtas på produkterna och att en tillverkningskontroll behöver implementeras. Vidare förs en diskussion kring de för- och nackdelar en CE- märkning innebär av Lövhults vinkelbeslag. Rapporten avslutas med våra rekommendationer som baseras på de presenterade slutsatser som genererats.
APA, Harvard, Vancouver, ISO, and other styles
5

Lundqvist, Oskar. "Metod för konstruktion av lyftredskap." Thesis, Högskolan Dalarna, Maskinteknik, 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:du-28678.

Full text
Abstract:
Examensarbetet har utförts på ELE Engineering AB i Borlänge. Rapportens syfte är att utreda och sammanfatta de krav som ställs för att kunna CE-märka lyftredskap inom EU. Rapporten förklarar kraven som ställs enligt maskindirektivet på lyftredskap. Dessa har sedan arbetats ihop till en metod som kan användas av ELE för att säkerställa att ett lyftredskap uppfyller alla grundläggande krav. Genom att ta upp kraven för dokumentation, dimensionering, funktion, säkerhet och testning så skapades en struktur med 8st punkter i. Dessa punkter gicks igenom med hjälp av PDSA-cykeln för att kunna utnyttja ELE:s nuvarande arbetssätt. För att ELE ska kunna arbeta på ett standardiserat sätt med lyftredskap skapades mallar för kravspecifikationen, lyftprotokoll och bruksanvisning. Genom att metoden som skapades säkerställer att alla krav som ställs på lyftredskap är tillgodosedda kan ELE CE-märka alla lyftredskap som följer metoden.
This thesis has been performed on ELE Engineering AB in Borlänge. The purpose of this report is to investigate and sum the requirements that is necessary for CE-marking of lifting accessories in EU. The report clarifies the requirements that is specified in the machinery directive. The requirements have been combined into a method of construction that ELE can use to ensure that a lifting accessory fulfills all essential requirements. Through the requirements of documentation, design, function and safety was a structure with 8 fragments made. The fragments were worked over by the PDSA-cycle to make use of ELE´s current design method. For ELE to work in a standardized manner with lifting accessories, templates were created for the requirement specification, lifting protocol and operating instructions. By following the method that was formed, ensuring that all requirements for lifting accessories are met, ELE can CE-mark every lifting accessory that is designed.
APA, Harvard, Vancouver, ISO, and other styles
6

Junevičius, Valdas. "Elektrotechninių gaminių ženklinimo procedūros." Bachelor's thesis, Lithuanian Academic Libraries Network (LABT), 2013. http://vddb.laba.lt/obj/LT-eLABa-0001:E.02~2013~D_20130822_161348-13133.

Full text
Abstract:
Kiekvieną dieną naudojame įvairius prietaisus ir įrankius skirtus palengvinti mūsų gyvenimą. Pramonės gamyklos įdiegia naujus įrenginius, kurie pagreitina ir atpigina gamybos kaštus. Kiekvienas netinkamai suprojektuotas įrenginys gali kelti pavojų vartotojui ar aplinkai. Elektrotechniniai įrenginiai išsiskiria specifiniais elektros saugos reikalavimais. Kadangi rinkoje gausybė prekių, kurias gali įsigyti visi rinkos dalyviai yra būtina įdiegti bendrus saugos reikalavimus. Gamintojai privalo laikytis šių reikalavimų ir prisiimti visą atsakomybę už savo gaminių padarytą žalą vartotojui. Tam, kad apsaugoti vartotojus, Europos Sąjunga įteisino specialią bendrosios rinkos sistemą. Ši sistema palaiko rinkoje saugius gaminius ir neatitinkančius saugos reikalavimų – šalina. Taip rinkoje dalyvauja tik tokie gaminiai, kurie pagaminti taip, jog nepažeidžia jokių iki šiol nustatytų saugos, sveikatos bei aplinkos apsaugos reikalavimų. Tačiau vartotojas neturėtų aklai pasitikėti šia sistema, kadangi atsiranda gamintojų, piktnaudžiaujančių šiais saugos reikalavimais. Tokie gamintojai rizikuodami pardavinėja nesaugius gaminius manydami, jog nieko blogo neatsitiks. Iš kitos pusės, kai kurie gamintojai nepakankamai išmanydami šiuos reikalavimus netyčiomis pardavinėja nesaugius produktus. Rinką prižiūrinčios institucijos gali nespėti laiku aptikti ir uždrausti gaminius.
We are using devices and tools to facilitate our lives every single day. An improperly designed device can pose a risk to consumers or the environment. There are many items in the market that can be purchased by any user, so it is necessary to implement common safety requirements. In order to protect consumers, the European Union enacted a special single market framework. This system holds safe products on the market and eliminates the ones that do not conform safety requirements.
APA, Harvard, Vancouver, ISO, and other styles
7

Cervanová, Iva. "Právní aspekty a praktické dopady posuzování shody výrobků - označení shody CE." Master's thesis, Vysoká škola ekonomická v Praze, 2012. http://www.nusl.cz/ntk/nusl-164018.

Full text
Abstract:
The topic of my diploma thesis is removing the technical barriers of the trade of goods via harmonization of the essential requirements on the products -- mainly the legal aspects and practical consequences of the conformity assessment and the CE conformity marking. The goal of my thesis is firstly to find out what the main objective of the CE marking is and whether it really fulfills its role. Secondly, I want to find out how the process of conformity assessment looks like in practice. Thirdly I want to find out how the market surveillance is organized and how effective it is. My thesis is divided into six chapters. The first chapter depicts the situation as it had been before the marking was introducted. The second describes the statutory regulation of the CE marking system. The fourth chapter is dedicated to the process of the conformity assessment. The fifth chapter is about the market surveillance. The final sixth chapter explores problems that are related to the CE marking system.
APA, Harvard, Vancouver, ISO, and other styles
8

Pita, Joana Fonseca. "Acompanhamento técnico e controlo de qualidade de produção na Pedreira e na Serração da Empresa Plácido José Simões S.A." Master's thesis, Universidade de Évora, 2014. http://hdl.handle.net/10174/15007.

Full text
Abstract:
No presente documento é feita a descrição dos trabalhos de extração e transformação de mármore, bem como de todos os equipamentos e normas utilizadas neste processo, tendo sido feito todo o acompanhamento técnico dos trabalhos executados. Apresenta-se ainda o estudo de uma nova área de exploração com vista ao alargamento da cavidade extrativa tendo como base as caraterísticas geológicas da região. Este estudo foi complementado com a realização e análise de uma sondagem como meio de prospeção. Finalmente são expostas as tarefas de controlo de produção associadas à aplicação da Marcação CE; ABSTRACT: Technical Monitoring and Production Quality Control in the Quarry and Sawmilling of Plácido José Simões S.A. Company. Marble extraction and transformation activities are described in this work. Equipment, procedures and norms used in this dimension stone chain processing are also detailed. The technical monitoring of the work performed in the Plácido Simões company quarry and processing plant having also been done. It is also presented the study of a new area of exploration aiming at extending the mining cavity having as a basis the geological characteristics of the region. This study was complemented with the making and analysis of a mining survey drilling as means of prospection. Finally the production control tasks associated with the implementation of CE marking are explained and described in detail.
APA, Harvard, Vancouver, ISO, and other styles
9

Prins, Pontus. "Utredning av säker och användarvänlig lyftanordning för dataskåp." Thesis, KTH, Tillämpad maskinteknik (KTH Södertälje), 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-232690.

Full text
Abstract:
Ericsson AB har byggt en anläggning för test av 3G, 4G och 5G i Rosersberg utanför Stockholm i Sverige. Testutrustningen är monterad i standardiserade dataskåp byggda för att klara tuffare miljöer som exempelvis jordbävningar. Detta tillsammans med faktumet att dataskåpen är placerade tätt gör det svårt att flytta när de är placerade, vilket Ericsson ibland har behov av att göra. En lyftanordning som spänns fast inuti skåpet utvecklades därför, den lösta de problem Ericsson upplevde. Syftet med examensarbetet var att utreda eventuell föreskrift som måste följas för att CE-märka lyftanordningen, och om några förbättringar eller andra lösningar kunde genomföras för att öka säkerheten och användarvänligheten. Förutom att vara konstruerad utifrån tillämpbara krav i AFS 2008:3 Maskiner resulterade examensarbetet i förbättringsförlag på några av de viktigaste upplevda problemen vid användningen av lyftanordningen. Med hjälp av en lösning som synkroniserade fyra av de gängstänger som använts för att lyfta med en rullkedja så lyfter lyftanordningen alltid skåpet i en jämn nivå. Skåpet är även lättare att transportera och styra med den föreslagna lyftanordningen. Detta är tack vare ett par kulrullar som är föreslaget istället för hjul som används på den befintliga lyftanordningen. Förutom att möjliggöra förflyttning i alla riktningar så är friktionen även mindre i kulrullarna, vilket kommer minska den kraft som krävs för att flytta skåpet och öka stabiliteten något. Då den befintliga lyftanordningen upplevdes som för tung har ett materialbyte från stål till aluminium nästan halverat vikten, trots att nya komponenter lagts till.
Ericsson AB has constructed a test facility for 3g, 4g and 5g in Rosersberg outside of Stockholm in Sweden. The equipment is mounted in standardized cabinets built for use at rougher environmental conditions such as earthquakes. This and the fact that the cabinets are placed in tight formations results in the cabinets being difficult to move them when placed, which is sometimes needed. A lift device that is mounted inside of the cabinets was therefore developed; this solved some major problems Ericsson was experiencing. The purpose of this thesis project was therefore to investigate possible regulations to follow to gain CE marking, and if any improvements or other solutions could be made to increase safety and usability. Aside from being constructed with regards to applicable requirements in AFS 2008:3 Maskiner the thesis project resulted in suggestions for improving some of the important problems experienced when using the lift device. By using a solution which synchronizes four of the threaded rods used for lifting with a roller chain, the lifting is always leveled. The cabinet is also easier to transport and steer with the proposed lift device. This is because of the use of ball transfer units instead of castors previously used. Besides providing movement in any direction, the ball transfer units friction is lower decreasing the force needed to push the cabinet and increasing some stability. Since there was a need for a weight reduction, it’s proposed to switch from use of steel for the majority of the lift to aluminum which almost halved the weight despite adding more components.
APA, Harvard, Vancouver, ISO, and other styles
10

Moberg, Casper, and Niklas Kant. "CE-märkning av medicintekniska produkter ur ett nystartat företags perspektiv." Thesis, KTH, Skolan för teknik och hälsa (STH), 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-192322.

Full text
Abstract:
Regelverket för medicintekniska produkter är omfattande och medicintekniska företag lägger idag stora resurser på att säkerställa att deras produkter uppfyller de lagar och krav som finns. Detta arbete beskriver författarnas bidrag till CE-märkningsprocessen på det nystartade företaget LARA Diagnostics första produkt, en handhållen enhet för utvärdering av perifer neuropati samt hur processen att CE-märka en medicinteknisk produkt generellt går till för ett mindre eller nystartat företag. Arbetet syftar till att visa vilka utmaningar mindre bolag har i synnerhet vid processen att CE-märka sin första produkt samt vad företag kan göra för att effektivisera sin process. I arbetet visas att mindre företag kan effektivisera sin process genom att: Tidigt lägga grunden till CE-märkningen. Se till att rätt kompetens finns eller införskaffas utifrån Redan i produktutvecklingen säkerställa att väsentliga krav uppfylls, gärna genom att följa harmoniserade standarder. Arbetet visar även att kraven inom det regulatoriska området för medicintekniska produkter blir hårdare med tiden och att den utvecklingen förväntas fortsätta.
The regulatory framework for medical devices is extensive and the medical device industry spends considerable resources on ensuring that their products comply with existing laws and requirements. This paper describes the authors’ contribution to the CE marking process of the very first product from the startup company LARA Diagnostics, a handheld device for the evaluation of peripheral neuropathy, as well as how the process of CE marking a medical device is carried out in general for a small or startup business. The work aims to point out the challenges for smaller companies in particular to get their first product certified, but also what can be done to streamline that process. The paper shows that small companies can improve the process by: Laying the foundation for CE marking early in the process. Ensure that the right skills exist internally or are acquired externally. Making sure that essential requirements are met early in the product development life cycle, preferably by adhering to harmonized standards. The paper also shows that the requirements within the regulatory framework for medical devices are becoming stricter over time and that this trend is expected to continue.
APA, Harvard, Vancouver, ISO, and other styles
More sources

Books on the topic "THE CE MARKING"

1

Braster, Patrick. CE marking for telecommunications: A handbook to the telecommunications directives. Piscataway, NJ: Inst. of Electrical and Electronics Engineers, 1997.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
2

Lohbeck, David. CE marking handbook: A practical approach to global safety certification. Boston: Newnes, 1998.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
3

Institution, British Standards. CE Marking for machinery: A guide to the European directive -. London: BSI Standards, 1999.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
4

Centre, SATRA Footwear Technology. A users guide to safety footwear: CE marking and the directives. Kettering: SATRA, 1993.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
5

Zuozhou, Du, ed. Maikeer jiao yu ce liang fa cuo yao. [Beijing: Beijing zhong xian tuo fang ke ji fa zhan you xian gong si, 2012.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
6

Industry, Great Britain Department of Trade and. CE marking: Proposed council directive and proposed council decision : an information document. London: Department of Trade and Industry, 1993.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
7

CE conformity marking: EMC directive and German EMC legislation : impact on manufactures and products. 2nd ed. Erlangen: Publicis MCD Verlag, 1996.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
8

Junjie, Wang, and Peng Leiqing, eds. Ying xiao qu dao jue ce yu guan li: Marking channels : decision and management. 3rd ed. Beijing: Zhongguo ren min da xue chu ban she, 2015.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
9

VanRenterghem, Cynthia. Electrical product acceptance in Europe: NEMA guide to Europe's new approach directives and CE marking. Washington, DC (2101 L St., NW, Washington, DC 20037-1526): National Electrical Manufacturers Association, 1995.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
10

Schoenmakers, C. C. W. CE marking for medical devices: A handbook to the medical devices directives : Medical Device Directive 93/42/EEC : the Active Implantable Medical Device Directive 90/396/EEC. New York, NY: Standards Information Network/IEEE Press, 1997.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
More sources

Book chapters on the topic "THE CE MARKING"

1

Nahler, Gerhard. "CE marking." In Dictionary of Pharmaceutical Medicine, 24. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_175.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Playle, Mervyn. "CE Marking – the Essential Requirements." In Advances in Systems Safety, 251–71. London: Springer London, 2010. http://dx.doi.org/10.1007/978-0-85729-133-2_15.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Dori, Fabrizio, Ernesto Iadanza, Roberto Miniati, and Samuele Mattei. "Risk Management Process and CE Marking of Software as MD." In XII Mediterranean Conference on Medical and Biological Engineering and Computing 2010, 1017–20. Berlin, Heidelberg: Springer Berlin Heidelberg, 2010. http://dx.doi.org/10.1007/978-3-642-13039-7_257.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

Brander, Linus, and Björn Schouenborg. "CE-Marking of Natural Stone—Practical Application and Solutions in Sweden." In Engineering Geology for Society and Territory - Volume 5, 309–12. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-09048-1_59.

Full text
APA, Harvard, Vancouver, ISO, and other styles
5

Iadanza, E., C. Ignesti, and G. Biffi Gentili. "Risk Management Process in a Microwave Thermal Ablation System for CE Marking." In IFMBE Proceedings, 1170–73. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-00846-2_290.

Full text
APA, Harvard, Vancouver, ISO, and other styles
6

Lachaud, Eric. "Could the CE Marking Be Relevant to Enforce Privacy by Design in the Internet of Things?" In Data Protection on the Move, 135–62. Dordrecht: Springer Netherlands, 2016. http://dx.doi.org/10.1007/978-94-017-7376-8_6.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

Critchley, Sarah. "Dynamics 365 for Marketing." In Dynamics 365 CE Essentials, 575–99. Berkeley, CA: Apress, 2018. http://dx.doi.org/10.1007/978-1-4842-3973-5_13.

Full text
APA, Harvard, Vancouver, ISO, and other styles
8

Tricker, Ray. "Gaining CE conformity." In CE Conformity Marking, 202–33. Elsevier, 2000. http://dx.doi.org/10.1016/b978-075064813-4/50017-5.

Full text
APA, Harvard, Vancouver, ISO, and other styles
9

"Preface." In CE Marking Handbook, xi—xiv. Elsevier, 1998. http://dx.doi.org/10.1016/b978-075069819-1/50000-8.

Full text
APA, Harvard, Vancouver, ISO, and other styles
10

Lohbeck, David. "Europe's Approach to Total Harmonization." In CE Marking Handbook, 1–13. Elsevier, 1998. http://dx.doi.org/10.1016/b978-075069819-1/50001-x.

Full text
APA, Harvard, Vancouver, ISO, and other styles

Conference papers on the topic "THE CE MARKING"

1

Sathyendra, M. G. "EMC directive & CE marking." In 8th International Conference on Electromagnetic Interference and Compatibility. IEEE, 2003. http://dx.doi.org/10.1109/icemic.2003.238093.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Barrett, Michael J. "Laser machine guarding and CE marking in Europe." In ILSC® 2005: Proceedings of the International Laser Safety Conference. Laser Institute of America, 2005. http://dx.doi.org/10.2351/1.5056597.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Marshman, Chris. "Summary of Conformity Assessment for apparatus (CE Marking)." In 2008 IEEE International Symposium on Electromagnetic Compatibility - EMC 2008. IEEE, 2008. http://dx.doi.org/10.1109/isemc.2008.4652232.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

MONICA, LUIGI, MARIANNA MADONNA, and SARA ANASTASI. "RISK ASSESSMENT ON MACHINES WITH CE MARKING AND WITH EMBEDDED INDUSTRY 4.0 ENABLING TECHNOLOGIES." In RISK ANALYSIS 2020. Southampton UK: WIT Press, 2020. http://dx.doi.org/10.2495/risk200051.

Full text
APA, Harvard, Vancouver, ISO, and other styles
5

Ting, S. L., P. K. Tan, I. Withana, H. Tan, and C. Q. Chen. "Simple Circuit Edit Passive Voltage Contrast Technique to Identify Leakage Location." In ISTFA 2020. ASM International, 2020. http://dx.doi.org/10.31399/asm.cp.istfa2020p0070.

Full text
Abstract:
Abstract Passive voltage contrast (PVC) is widely used to detect underlying connectivity issues between metals based on the brightness of upper metals using scanning electron microscopy (SEM) or focused ion beam (FIB). [1] However, it cannot be applied in all cases due to the uniqueness of each case where brightness alone is insufficient to tell leakage location. In this study, propose a simple technique using platinum (Pt) marking as a circuit edit (CE) technique to alter metal PVC to identify the actual leakage location. Conventional SEM and PVC contrast imaging are unable to pinpoint exact defects without data confirming the leakage from nano-probing such as Atomic Force Probing (AFP) or SEM base nano-probing (NP) [2]. Using this method, we can improve the analysis cycle time by direct analysts the defective location in SEM, while also saving tool cost.
APA, Harvard, Vancouver, ISO, and other styles
You might also be interested in the extended bibliographies on the topic 'THE CE MARKING' for particular source types:
Journal articles Dissertations / Theses Books
We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!

To the bibliography