CE Conformity Marking and New Approach Directives

Ray Tricker (MSc IEng FIET FCIM FIQA FIRSE)9780750648134, 0-7506-4813-9

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.

---

Table of contents :
Preface……Page 11
1 BACKGROUND TO NEW APPROACH DIRECTIVES……Page 15
European Directives……Page 19
EU Member States……Page 21
EFTA Countries……Page 22
Eastern European affiliates……Page 23
Others……Page 24
Mutual Recognition Agreements……Page 25
Types of Directives and Standards……Page 27
Product-Specific Directives (type C)……Page 28
Aim of Standardisation……Page 29
International Standardisation……Page 32
European Harmonised Standards……Page 33
Revision of Harmonised Directives……Page 35
CEN……Page 36
CENELEC……Page 37
Technical Structure of CENELEC……Page 38
ETSI……Page 40
How a Standard is made……Page 41
Recognition of European Standards……Page 45
The CE Conformity Marking Directive……Page 47
CE Marking……Page 49
Directives Affected by the CE Conformity Marking Directive……Page 50
Quality Marking……Page 51
At Design Level……Page 53
At Production Level……Page 54
CE User Manual……Page 55
Products……Page 56
Industrial Product Withdrawal……Page 57
CE Marking and ISO 9000……Page 58
2 STRUCTURE OF NEW APPROACH DIRECTIVES……Page 60
Definitions……Page 61
Harmonised Standards……Page 62
Placing on the Market……Page 63
Conformity……Page 64
Adoption of New Approach Directives……Page 65
Transitional Provisions……Page 67
Annexes……Page 68
Main Part……Page 69
General Guidelines……Page 70
Conformity Assessment Modules……Page 71
Conformity Assessment Modules – short description……Page 73
Explanatory notes and other considerations……Page 74
Module A……Page 76
Module B……Page 77
Module C……Page 80
Module D……Page 81
Module E……Page 83
Module F……Page 85
Module G……Page 87
Module H……Page 88
CE Marking……Page 90
General points regarding CE Marking……Page 92
Affixing CE Marking……Page 94
Withdrawal of Product……Page 100
General responsibilities……Page 101
Specific tasks……Page 102
Notified Bodies……Page 103
Relevant Standards of the EN 45000 Series for each module……Page 104
Manufacturer’s cleaning and sterilisation instructions……Page 0
Role of the Notified Body……Page 106
Tasks of a Notified Body……Page 108
Specific requirements associated with CE Marking……Page 109
Subcontracting part of the Notified Bodies work……Page 110
Essential Requirements……Page 111
Conformance……Page 112
CE Marking and Inscriptions……Page 113
Low Voltage Equipment (73/23/EEC)……Page 114
ElectroMagnetic Compatibility (89/336/EEC)……Page 119
Safety of Machinery (98/37/EC)……Page 125
Equipment and Protective Systems in Potentially Explosive Atmospheres ( 94/ 9/ EC)……Page 133
Radio and Telecommunications Terminal Equipment ( 99/ 5/ EC)……Page 140
Personal Protective Equipment (89/686/EEC)……Page 146
Explosives for Civil Use (93/15/EEC)……Page 152
Simple Pressure Vessels (87/404/EEC)……Page 158
Pressure Equipment (97/23/EC)……Page 163
Active Implantable Medical Devices (90/385/EEC)……Page 169
Medical Devices (93/42/EEC)……Page 173
Non Automatic Weighing Instruments (90/384/EEC)……Page 182
Gas Appliances (90/396/EEC)……Page 187
Energy Efficiency Requirements for Household Electric Refrigerators, Freezers and Combinations Thereof ( 96/ 57/ EC)……Page 192
Safety of Toys (89/376/EEC)……Page 194
Recreational Craft (94/25/EEC)……Page 198
New Hot-Water Boilers Fired with Liquid or Gaseous Fluids ( Efficiency Requirements) ( 92/ 42/ EEC)……Page 203
Construction Products (89/106/EEC)……Page 206
Lifts (95/16/EEC)……Page 209
Product Liability Directive (85/374/EEC)……Page 213
General Product Safety Directive (92/59/EEC)……Page 214
Model EC Declaration of Conformity……Page 215
Mandatory Certification……Page 216
EC Declaration of Conformity……Page 218
Quality Management System……Page 219
Technical Documentation……Page 220
ISO 9000……Page 221
Continued Surveillance by the Notified Body……Page 222
Conformance Requirements for New Approach Directives……Page 223
Manufacturer’s tasks under each module……Page 225
Basic requirements of manufacturers of industrial products……Page 237
EC Verification……Page 239
Chemical, physical and biological properties……Page 241
Construction and environmental properties……Page 242
Protection against radiation……Page 243
Requirements for industrial products connected to or equipped with an energy source……Page 244
Distributor……Page 246
User……Page 247
Annex A: Glossary……Page 248
Standards……Page 268
Other publications……Page 272
‘New Approach’ Website……Page 273
Annex C: Abbreviations and Acronyms……Page 274
Government and Non-Government Organisations……Page 278
Commercial Sales Agents……Page 279
Availability of national standards……Page 281
Information sources……Page 283
About the Author……Page 285
Index……Page 287