Obelis European Authorized Representative Center
"CE Marking Consultants with a Reputation for Excellence"- Home »
- Eu Directive »
- Structure Of The Ped 97 23 Ec »
Structure of the PED 97/23/EC
The directive has 21 Articles and 7 Annexes. The Articles cover general items such as scope and definitions, placing devices on the market and putting them into service, free movement of CE-marked goods in Europe, reference to harmonized standards, vigilance and incident reporting, conformity assessment procedures, appointment of an authorized representative, consequences of wrongly affixed CE marking, confidentiality, etc.
Annex I - The obligations arising from the essential requirements
Annex II – Conformity Assessment Tables
Annex III - Conformity Assessment Procedures
Annex IV – Minimum criteria to be met when designating the notified bodies referred to in article 12 and the recognized third-party organizations referred to in article 13
Annex V – Criteria to be met when authorizing user inspectorates referred to in article 14
Annex VI – Appearance of the CE marking
Annex VII – Content requirements for Declaration of Conformity
Pressure equipment classification is based on the hazard presented by its application. Hazard is determined by the stored energy and the nature of the contained fluid. A manufacturer is obliged to classify the pressure equipment into one of four conformity assessment categories: Categories I to IV.
Assessment and conformity measures differ according to a category, starting from self-certification for the lowest hazard -category I, ending with the full quality management and notified body testing for category IV equipment.
The harmonized standards specify the aspects of the design, production and testing of the equipment. The standards provide information about all aspects of equipment design and production, including dimensions, materials, welding and test methods.
Search
Need an EAR?
Take the Fast Lane
One Link One Solution
Obelis' World Network of Regulatory Advisors and International Representation
Obelis Global Team
Obelis' Worldwide Representatives
GiDoS - Green Regulatory Center
Our sister company GiDoS s.p.r.l. provides REACH, WEEE, RoHS and P&PW compliance services
Newsletter
