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E-raamat: CE Conformity Marking: and New Approach Directives

(Principal Consultant and Managing Director of Herne European Consultancy Ltd, UK)
  • Formaat: PDF+DRM
  • Ilmumisaeg: 01-May-2000
  • Kirjastus: Butterworth-Heinemann Ltd
  • Keel: eng
  • ISBN-13: 9780080500812
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CE Conformity Marking: and New Approach DirectivesSuurem pilt
  • Formaat: PDF+DRM
  • Ilmumisaeg: 01-May-2000
  • Kirjastus: Butterworth-Heinemann Ltd
  • Keel: eng
  • ISBN-13: 9780080500812
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Translating European standards into terms accessible to an American reader, Tricker (author and consultant for a private firm) explains the meaning of CE Marking and outlines its history and current status. He also describes how the European Directive affects the manufacturers of industrial products, and offers guidance on meeting the requirements for CE Conformance. Annotation c. Book News, Inc., Portland, OR (booknews.com)

CE Marking can be regarded as a product's trade passport for Europe. It is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in the European Directive.


The prime aim of the CE Directive is to ensure that "all industrial products that are placed on the market do not compromise the safety and health of users when properly installed, maintained and used in accordance with their intended purpose. Users and third parties should be provided with a high level of protection and the devices should attain the performance levels claimed by the manufacturer."

This book explains the meaning of CE Marking, its history, how the Directive can affect all manufacturers of industrial products, its current status, its associated quality management requirements, and how manufacturers can easily and cost-effectively meet the requirements for CE Conformance.

Essential information for any manufacturer or distributor wishing to trade in the European Union.

Practical and easy to understand.

Muu info

Essential information for any manufacturer or distributor wishing to trade in the European Union. Practical and easy to understand.
Background to New Approach Directives
1(45)
European Directives
5(2)
Transitional Period and Overlapping of Directives
7(1)
Application
7(4)
EU Member States
7(1)
EFTA Countries
8(1)
Eastern European affiliates
9(1)
Others
10(1)
Mutual Recognition Agreements/European Conformity Assessment Protocols
11(2)
Mutual Recognition Agreements
11(2)
European Conformity Assessment Protocols
13(1)
Types of Directives and Standards
13(2)
Basic Directives (type A)
14(1)
Generic Directives (type B)
14(1)
Product-Specific Directives (type C)
14(1)
Concurrent Application of Directives
15(1)
Aim of Standardisation
15(3)
International Standardisation
18(1)
European Harmonised Standards
19(2)
Revision of Harmonised Directives
21(1)
Management of the Lists of Standards
22(9)
CEN
22(1)
CENELEC
23(1)
Technical Structure of CENELEC
24(2)
CENELEC Central Secretariat
26(1)
ETSI
26(1)
How a Standard is made
27(4)
European Standards (ENs)
31(1)
European Pre-Standards (ENVs)
31(1)
CEN Reports (CRs)
31(1)
CEN Workshop Agreements (CWAs)
31(1)
Recognition of European Standards
31(2)
The CE Conformity Marking Directive
33(2)
CE Marking
35(1)
Directives Affected by the CE Conformity Marking Directive
36(1)
Quality Marking
37(2)
Conformity Assessment
39(3)
At Design Level
39(1)
At Production Level
40(1)
Notified Bodies
41(1)
Technical File or Technical Documentation
41(1)
CE User Manual
41(1)
Products
42(1)
Industrial Products
43(3)
Industrial Product Withdrawal
43(1)
European Product Liability
44(1)
CE Marking and ISO 9000
44(2)
Structure of New Approach Directives
46(9)
Articles
47(1)
Background
47(1)
Scope and Aims
47(1)
Definitions
47(1)
Essential Requirements
48(1)
Harmonised Standards
48(2)
Placing on the Market
49(1)
Putting into Service
50(1)
Free Movement of Goods
50(1)
Safeguards
50(1)
Conformity
50(1)
Notified Bodies and Surveillance Authorities
51(1)
CE Marking
51(1)
Safeguard Clause
51(1)
Adoption of New Approach Directives
51(2)
Transposition of New Approach Directives
53(1)
Standing Committee
53(1)
Review and Reporting
53(1)
Transitional Provisions
53(1)
Repeal
54(1)
Entry into Force
54(1)
Annexes
54(1)
Structure of the CE Conformity Marking Directive (93/465/EEC)
55(42)
Main Part
55(1)
General Guidelines
56(3)
Guidelines for the Use of Conformity Assessment Procedures
57(1)
Conformity Assessment Modules
57(2)
Variants of the Basic Modules
59(1)
Conformity Assessment Modules - short description
59(17)
Explanatory notes and other considerations
60(2)
Module A
62(1)
Module B
63(3)
Module C
66(1)
Module D
67(2)
Module E
69(2)
Module F
71(2)
Module G
73(1)
Module H
74(2)
Choice of Module
76(1)
CE Marking
76(11)
General points regarding CE Marking
78(2)
Displaying the CE Marking
80(1)
Affixing CE Marking
80(6)
Wrongly Affixed CE Marking
86(1)
Other Considerations
86(1)
Withdrawal of Product
86(1)
Industrial Product Type Conformity
87(1)
Industrial products which do not need to be CE marked
87(1)
Competent Authority
87(2)
General responsibilities
87(1)
Specific tasks
88(1)
Notified Bodies
89(1)
Essential Standards for Notified Bodies
90(1)
Relevant Standards of the EN 45000 series for each module
90(2)
Notified Bodies' tasks under each module
92(5)
Role of the Notified Body
92(2)
Guidelines for Notified Bodies
94(1)
Tasks of a Notified Body
94(1)
Criteria to be met for the designation of Notified Bodies
95(1)
Requirements of a Notified Body
95(1)
Specific requirements associated with CE Marking
95(1)
Subcontracting part of the Notified Bodies work
96(1)
Requirements of the various Directives affected by CE Marking
97(105)
Content of the Directives
97(1)
Scope
97(1)
General Clause for Placing Goods on the Market
97(1)
Essential Requirements
97(1)
Free Movement of Goods
98(1)
Proof of Conformity
98(1)
Management of the Standards
98(1)
Safeguard Clause
98(1)
Standing Committee
98(1)
Means of Attestation of Conformity
98(1)
Conformance
98(2)
CE Marking and Inscriptions
99(1)
Principal Directives
100(44)
Low Voltage Equipment (73/23/EEC)
100(5)
ElectroMagnetic Compatibility (89/336/EEC)
105(6)
Safety of Machinery (98/37/EC)
111(8)
Equipment and Protective Systems in Potentially Explosive Atmospheres (94/9/EC)
119(7)
Radio and Telecommunications Terminal Equipment (99/5/EC)
126(6)
Personal Protective Equipment (89/686/EEC)
132(6)
Explosives for Civil Use (93/15/EEC)
138(6)
Other Directives
144(55)
Simple Pressure Vessels (87/404/EEC)
144(5)
Pressure Equipment (97/23/EC)
149(6)
Active Implantable Medical Devices (90/385/EEC)
155(4)
Medical Devices (93/42/EEC)
159(7)
Medical Devices - In Vitro Diagnostics (COM(95)130)
166(2)
Non Automatic Weighing Instruments (90/384/EEC)
168(5)
Gas Appliances (90/396/EEC)
173(5)
Energy Efficiency Requirements for Household Electric Refrigerators, Freezers and Combinations Thereof (96/57/EC)
178(2)
Safety of Toys (89/376/EEC)
180(4)
Recreational Craft (94/25/EEC)
184(5)
New Hot-Water Boilers Fired with Liquid or Gaseous Fluids (Efficiency Requirements (92/42/EEC)
189(3)
Construction Products (89/106/EEC)
192(3)
Lifts (95/16/EEC)
195(4)
Other Directives associated with the CE Marking Directive
199(2)
Product Liability Directive (85/374/EEC)
199(1)
General Product Safety Directive (92/59/EEC)
200(1)
Model EC Declaration of Conformity
201(1)
Gaining CE Conformity
202(32)
Self-declaration
202(1)
Voluntary Certification
202(1)
Mandatory Certification
202(2)
The Five Steps to Conformity
204(1)
EC Declaration of Conformity
204(1)
Quality Management System
205(4)
Documenting the Manufacturer's QMS
206(1)
Technical Documentation
206(1)
Quality Management System - Application Requirements
207(1)
ISO 9000
207(1)
Audit of the Manufacturer's Quality Management System by a Notified Body
208(1)
Continued Surveillance by the Notified Body
208(1)
Other Considerations
209(1)
Conformity Assessment Procedures
209(1)
Conformance Requirements for Each Module
209(1)
Conformance Requirements for New Approach Directives
209(2)
Manufacturers
211(1)
Manufacturer's tasks under Each module
211(12)
Basic requirements of manufacturers of industrial products
223(2)
Registration of Manufacturers
225(1)
EC Verification
225(2)
Design and Construction Requirements
227(5)
Chemical, physical and biological properties
227(1)
Construction and environmental properties
228(1)
Products with a measuring function
229(1)
Protection against radiation
229(1)
Requirements for industrial products connected to or equipped with an energy source
230(1)
Manufacturer's Instructions
231(1)
Manufacturer's cleaning and sterilisation instructions
232(1)
Authorised representatives
232(1)
Importer/person responsible for placing the product on the market
232(1)
Distributor
232(1)
Assembler and installer
233(1)
User
233(1)
Annex A: Glossary 234(20)
Annex B: References 254(6)
1 Standards
254(4)
2 Other publications
258(1)
3 `New Approach' Website
259(1)
Annex C: Abbreviations and Acronyms 260(4)
Annex D: Addresses 264(9)
1 Availability of published standards
264(3)
2 Availability of national standards
267(2)
3 Information sources
269(4)
Index 273


Ray Tricker is the Principal Consultant of Herne European Consultancy Ltd - a company specialising in ISO 9000 Management Systems - and is also an established author. He served with the Royal Corps of Signals (for a total of 37 years) during which time he held various managerial posts culminating in being appointed as the Chief Engineer of NATO's Communication Security Agency (ACE COMSEC). Most of Ray's work since joining Herne has centred on the European Railways. He has held a number of posts with the Union International des Chemins de fer (UIC) (e.g. Quality Manager of the European Train Control System (ETCS)) and with the European Union (EU) Commission (e.g. T500 Review Team Leader, European Rail Traffic Management System (ERTMS) Users Group Project Co-ordinator, HEROE Project Co-ordinator) and currently (as well as writing books!) he is busy assisting small businesses from around the world produce their own auditable Quality and/or Integrated Management Systems to meet the requirements of ISO 9001:2008, ISO 14001 and OHSAS standards. He is also a UKAS Assessor for the assessment of certification bodies for the harmonisation of the trans-European high speed railway network.
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