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CONTENTS
( pdf dokümanı )
CE-MARKING
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PREFACE
Why a CE-marking dossier?
How to use this dossier
1. The structure of the dossier
2. Tips when using this dossier
PART I: CE-MARKING GENERAL
1. TECHNICAL HARMONISATION
1.1 The internal market and technical harmonisation
1.2 The Old Approach
1.3 To a new approach
2. THE NEW APPROACH
2.1 The directives
2.2 Methodology
2.3 Characteristics
2.4 Structure of New Approach directives
2.5 European standards
2.5.1 Harmonised European Standards
2.5.2 European standardisation institutes
2.5.3 Development of the European Standards
2.6 Testing and certification: the global approach
2.6.1 Principles
2.6.2 Notified Body
2.6.3 European Organisation for Testing and Certification
2.7 Testing modules of the New Approach directives
2.7.1 Module A: Internal production control
2.7.2 Module B: EC type-examination
2.7.3 Module C: Conformity to type
2.7.4 Module D: Production quality assurance
2.7.5 Module E: Product quality assurance
2.7.6 Module F: Product verification
2.7.7 Module G: Unit verification
2.7.8 Module H: Full quality assurance
2.7.9 Conformity assessment procedures in community legislation
3. NEW APPROACH IN PRACTICE
3.1 Plan of action for the implementation of the CE-marking
directives
3.2 Product Liability
3.3 Health and safety at work
3.4 Quality Assurance
3.5 Sanctions
PART II: NEW APPROACH DIRECTIVES
1. MACHINERY
1.1 Introduction
1.2 Scope
1.2.1 Used machines
1.2.2 Renovation and service of machines
1.2.3 Health and safety at work
1.3 Other applicable directives
1.4 Conformity assessment
2. TOYS
2.1 Introduction
2.2 Scope
2.3 Other applicable directives
2.4 Conformity assessment
3. SIMPLE PRESSURE VESSELS
3.1 Introduction
3.2 Scope
3.3 Other applicable directives
3.4 Conformity assessment
4. ACTIVE IMPLANTABLE MEDICAL DEVICES
4.1 Introduction
4.2 Scope
4.3 Other applicable directives
4.4 Conformity assessment
5. PERSONAL PROTECTIVE EQUIPMENT
5.1 Introduction
5.2 Scope
5.3 Other applicable directives
5.4 Conformity assessment
6. ELECTROMAGNETIC COMPATIBILITY (EMC)
6.1 Introduction
6.2 Scope
6.3 Other applicable directives
6.4 Conformity assessment
7. GAS APPLIANCES
7.1 Introduction
7.2 Scope
7.3 Other applicable directives
7.4 Conformity assessment
8. ELECTRICAL EQUIPMENT
8.1 Introduction
8.2 Scope
8.3 Other applicable directives
8.4 Conformity assessment
9. EFFICIENCY REQUIREMENTS HOT-WATER BOILERS
9.1 Introduction
9.2 Scope
9.3 Other applicable directives
9.4 Conformity assessment
10. RECREATIONAL CRAFT
10.1 Introduction
10.2 Scope
10.3 Other applicable directives
10.4 Conformity assessment
11. MEDICAL DEVICES
11.1 Introduction
11.2 Scope
11.3 Other applicable directives
11.4 Conformity assessment
12. NON-AUTOMATIC WEIGHING INSTRUMENTS
12.1 Introduction
12.2 Scope
12.3 Other applicable directives
12.4 Conformity assessment
13. EXPLOSIVES FOR CIVIL USES
13.1 Introduction
13.2 Scope
13.3 Other applicable directives
13.4 Conformity assessment
14. EQUIPMENT FOR EXPLOSIVE ATMOSPHERES
14.1 Introduction
14.2 Scope
14.3 Other applicable directives
14.4 Conformity assessment
15. RADIO EQUIPMENT AND TELECOMMUNICATIONS
TERMINAL EQUIPMENT
15.1 Introduction
15.2 Scope
15.3 Other applicable directives
15.4 Conformity assessment
ANNEX I: Common Technical Requirements
16. CONSTRUCTION PRODUCTS
16.1 Introduction
16.2 Scope
16.3 Other applicable directives
16.4 Interpretative documents
16.5 European Technical Approvals
16.6 Conformity assessment
ANNEX I: Organisations that execute ETA's
ANNEX II: Decisions conformity assessment
17. LIFTS
17.1 Introduction
17.2 Scope
17.3 Other applicable directives
17.4 Conformity assessment
18. ENERGY EFFICIENCY HOUSEHOLD REFRIGERATORS
AND FREEZERS
18.1 Introduction
18.2 Scope
18.3 Other applicable directives
18.4 Conformity assessment
19. PRESSURE EQUIPMENT
19.1 Introduction
19.2 Scope
19.3 Other applicable directives
19.4 Conformity assessment
20. HIGH-SPEED RAIL SYSTEM
20.1 Introduction
20.2 Scope
20.3 Other applicable directives
20.4 Conformity assessment
21. MARINE EQUIPMENT
21.1 Introduction
21.2 Scope
21.3 Other applicable directives
21.4 Conformity assessment
22 IN VITRO DIAGNOSTIC MEDICAL DEVICES
22.1 Introduction
22.2 Scope
22.3 Other applicable directives
22.4 Conformity assessment
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