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Vol 21 No 11 Nov/Dec 2016

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CE Conformity Marking and New Approach Directives

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ISBN13: 9780750648134
ISBN: 0750648139
Published: October 2000
Publisher: Butterworth-Heinemann
Country of Publication: UK
Format: Paperback
Price: £48.99



This is a Print On Demand Title.
The publisher will print a copy to fulfill your order. Books can take between 1 to 3 weeks. Looseleaf titles between 1 to 2 weeks.

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.

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Contents:
1. BACKGROUND TO THE NEW APPROACH DIRECTIVES: European Directives
Transition Period and Overlapping of Directives
Application
Mutual Recognition Agreements/European Conformity Assessment Protocols
Types of Directives and Standards
Concurrent Application of Directives
Aim of Standardisation
International Standardisation
Harmonised European Standards
Revision of Harmonised Directives
Management of the List of Standards
Recognition of European Standards.
2. STRUCTURE OF NEW APPROACH DIRECTIVES: Articles
Adoption of New Approach Directives
Transposition of New Approach Directives
Advisory Committee
Review and Reporting
Transitional Provisions
Repeal
Entry into Force.
3. STRUCTURE OF THE CE CONFORMITY MARKING DIRECTIVE (93/465/EEC): Main Part
General Guidelines
Conformity Assessment Modules - Short Description
Choice of Module
CE Marking
Industrial Product Type conformity
Competent Authority
Notified Bodies
Essential Standards for Notified Bodies
Relevant Standards of the EN45000 Series for Each Module
Notified Bodies Tasks Under Each Module
Requirements of the Various Directives affected by CE Marking
Content of the Directives
Conformance
Principle Directives
Other Directives
Medical Devices - in vitro diagnostics (COM (95) 130) 180
Other Directives Associated with the CE Marking Directive.
4. GAINING OF CONFORMITY: Self Declaration
Voluntary Certification
Mandatory Certification
The 5 Steps to Conformity
Quality Management System
Conformity Assessment Procedures
Conformity requirements of each Module
Conformance Requirements of New Approach Directives
Manufacturers
Manufactuer's Tasks Under Each Module
Basic Requirements of manufacturers of Industrial Products
Registration of manufacturers
EC Verification
Design and Construction Requirements
Index.