CE Conformity Marking (eBook)

Cover 1
Contents 6
Chapter 1. Background to New Approach Directives 16
1.1 European Directives 20
1.2 Transitional Period and Overlapping of Directives 22
1.3 Application 22
1.4 Mutual Recognition Agreements/European Conformity Assessment Protocols 26
1.5 Types of Directives and Standards 28
1.6 Concurrent Application of Directives 30
1.7 Aim of Standardisation 30
1.8 International Standardisation 33
1.9 European Harmonised Standards 34
1.10 Revision of Harmonised Directives 36
1.11 Management of the Lists of Standards 37
1.12 Recognition of European Standards 46
1.13 The CE Conformity Marking Directive 48
1.14 CE Marking 50
1.15 Directives Affected by the CE Conformity Marking Directive 51
1.16 Quality Marking 52
1.17 Conformity Assessment 54
1.18 Products 57
1.19 Industrial Products 58
Chapter 2. Structure of New Approach Directives 61
2.1 Articles 62
2.2 Harmonised Standards 63
2.3 Conformity 65
2.4 Adoption of New Approach Directives 66
2.5 Transposition of New Approach Directives 68
2.6 Standing Committee 68
2.7 Review and Reporting 68
2.8 Transitional Provisions 68
2.9 Repeal 69
2.10 Entry into Force 69
2.11 Annexes 69
Chapter 3. Structure of the CE Conformity Marking Directive (93/465/EEC) 70
3.1 Main Part 70
3.2 General Guidelines 71
3.3 Conformity Assessment Modules – short description 74
3.4 Choice of Module 91
3.5 CE Marking 91
3.6 Industrial Product Type Conformity 102
3.7 Competent Authority 102
3.8 Notified Bodies 104
3.9 Essential Standards for Notified Bodies 105
3.10 Relevant Standards of the EN 45000 series for each module 105
3.11 Notified Bodies’ tasks under each module 107
Chapter 4. Requirements of the various Directives affected by CE Marking 112
4.1 Content of the Directives 112
4.2 Conformance 113
4.3 Principal Directives 115
4.4 Other Directives 159
4.5 Other Directives associated with the CE Marking Directive 214
4.6 Model EC Declaration of Conformity 216
Chapter 5. Gaining CE Conformity 217
5.1 Self-declaration 217
5.2 Voluntary Certification 217
5.3 Mandatory Certification 217
5.4 The Five Steps to Conformity 219
5.5 EC Declaration of Conformity 219
5.6 Quality Management System 220
5.7 Conformity Assessment Procedures 224
5.8 Conformance Requirements for Each Module 224
5.9 Conformance Requirements for New Approach Directives 224
5.10 Manufacturers 226
5.11 Manufacturer’s tasks under Each module 226
5.12 Basic requirements of manufacturers of industrial products 238
5.13 Registration of Manufacturers 240
5.1 4 EC Verification 240
5.1 5 Design and Construction Requirements 242
5.16 Importer/person responsible for placing the product on the market 247
5.17 Distributor 247
5.1 8 Assembler and installer 248
5.19 User 248
Annex A: Glossary 249
Annex B: References 269
Annex C: Abbreviations and Acronyms 275
Annex D: Addresses 279
Index 288