1.GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS 1.1.General principles and obligations 1.1.1.The risk management process covered by this Regulation shall start...1.1.2.This iterative risk management process: 1.1.3.. . . . . . . . . ....1.1.4.The actors who already have in place methods or tools...1.1.5.. . . . . . . . . ....1.1.6.. . . . . . . . . ....1.1.7.. . . . . . . . . ....1.2.Interfaces management 1.2.1.. . . . . . . . . ....1.2.2.. . . . . . . . . ....1.2.3.. . . . . . . . . ....1.2.4.. . . . . . . . . ....1.2.5.. . . . . . . . . ....1.2.6.. . . . . . . . . ....1.2.7.. . . . . . . . . ....2.DESCRIPTION OF THE RISK ASSESSMENT PROCESS 2.1.General description 2.1.1.The risk assessment process is the overall iterative process that...2.1.2.The system definition should address at least the following issues:...2.1.3.. . . . . . . . . ....2.1.4.The risk acceptability of the system under assessment shall be...2.1.5.. . . . . . . . . ....2.1.6.. . . . . . . . . ....2.1.7.. . . . . . . . . ....2.2.Hazard identification 2.2.1.The proposer shall systematically identify, using wide-ranging expertise from a...2.2.2.. . . . . . . . . ....2.2.3.. . . . . . . . . ....2.2.4.. . . . . . . . . ....2.2.5.. . . . . . . . . ....2.2.6.Whenever a code of practices or a reference system is...2.3.Use of codes of practice and risk evaluation 2.3.1.. . . . . . . . . ....2.3.2.The codes of practice shall satisfy at least the following...2.3.3.. . . . . . . . . ....2.3.4.. . . . . . . . . ....2.3.5.If one or more hazards are controlled by codes of...2.3.6.. . . . . . . . . ....2.3.7.. . . . . . . . . ....2.3.8.When all hazards are controlled by codes of practice, the...2.4.Use of reference system and risk evaluation 2.4.1.. . . . . . . . . ....2.4.2.A reference system shall satisfy at least the following requirements:...2.4.3.If a reference system fulfils the requirements listed in point...2.4.4.. . . . . . . . . ....2.4.5.. . . . . . . . . ....2.5.Explicit risk estimation and evaluation 2.5.1.. . . . . . . . . ....2.5.2.The acceptability of the estimated risks shall be evaluated using...2.5.3.. . . . . . . . . ....2.5.4.Where hazards arise from failures of technical systems not covered...2.5.5.. . . . . . . . . ....2.5.6.If a technical system is developed by applying the 10-9...2.5.7.The explicit risk estimation and evaluation shall satisfy at least...3.DEMONSTRATION OF COMPLIANCE WITH SAFETY REQUIREMENTS 3.1.. . . . . . . . . ....3.2.. . . . . . . . . ....3.3.. . . . . . . . . ....3.4.. . . . . . . . . ....4.HAZARD MANAGEMENT 4.1.Hazard management process 4.1.1.. . . . . . . . . ....4.1.2.. . . . . . . . . ....4.2.Exchange of information 5.EVIDENCE FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS 5.1.. . . . . . . . . ....5.2.. . . . . . . . . ....1.. . . . . . . . . ....2.. . . . . . . . . ....3.. . . . . . . . . ....4.The staff responsible for the assessments must possess: 5.. . . . . . . . . ....6.. . . . . . . . . ....7.. . . . . . . . . ....
Commission Regulation (EC) No 352/2009
of 24 April 2009
on the adoption of a common safety method on risk evaluation and assessment as referred to in Article 6(3)(a) of Directive 2004/49/EC of the European Parliament and of the Council
(Text with EEA relevance) (repealed)
F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annotations:
Amendments (Textual)
Repealed by Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 Text with EEA relevance.