1. Introductory Text

  2. Article 1.Purpose

  3. Article 2.Scope

  4. Article 3.Definitions

  5. Article 4.Significant changes

  6. Article 5.Risk management process

  7. Article 6.Independent assessment

  8. Article 7.Safety assessment reports

  9. Article 8.Risk control management/internal and external audits

  10. Article 9.Feedback and technical progress

  11. Article 10.Entry into force

  12. Signature

    1. ANNEX I

      1. 1. GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS

        1. 1.1. General principles and obligations

          1. 1.1.1. The risk management process covered by this Regulation shall start...

          2. 1.1.2. This iterative risk management process:

          3. 1.1.3. . . . . . . . . . ....

          4. 1.1.4. The actors who already have in place methods or tools...

          5. 1.1.5. . . . . . . . . . ....

          6. 1.1.6. . . . . . . . . . ....

          7. 1.1.7. . . . . . . . . . ....

        2. 1.2. Interfaces management

          1. 1.2.1. . . . . . . . . . ....

          2. 1.2.2. . . . . . . . . . ....

          3. 1.2.3. . . . . . . . . . ....

          4. 1.2.4. . . . . . . . . . ....

          5. 1.2.5. . . . . . . . . . ....

          6. 1.2.6. . . . . . . . . . ....

          7. 1.2.7. . . . . . . . . . ....

      2. 2. DESCRIPTION OF THE RISK ASSESSMENT PROCESS

        1. 2.1. General description

          1. 2.1.1. The risk assessment process is the overall iterative process that...

          2. 2.1.2. The system definition should address at least the following issues:...

          3. 2.1.3. . . . . . . . . . ....

          4. 2.1.4. The risk acceptability of the system under assessment shall be...

          5. 2.1.5. . . . . . . . . . ....

          6. 2.1.6. . . . . . . . . . ....

          7. 2.1.7. . . . . . . . . . ....

        2. 2.2. Hazard identification

          1. 2.2.1. The proposer shall systematically identify, using wide-ranging expertise from a...

          2. 2.2.2. . . . . . . . . . ....

          3. 2.2.3. . . . . . . . . . ....

          4. 2.2.4. . . . . . . . . . ....

          5. 2.2.5. . . . . . . . . . ....

          6. 2.2.6. Whenever a code of practices or a reference system is...

        3. 2.3. Use of codes of practice and risk evaluation

          1. 2.3.1. . . . . . . . . . ....

          2. 2.3.2. The codes of practice shall satisfy at least the following...

          3. 2.3.3. . . . . . . . . . ....

          4. 2.3.4. . . . . . . . . . ....

          5. 2.3.5. If one or more hazards are controlled by codes of...

          6. 2.3.6. . . . . . . . . . ....

          7. 2.3.7. . . . . . . . . . ....

          8. 2.3.8. When all hazards are controlled by codes of practice, the...

        4. 2.4. Use of reference system and risk evaluation

          1. 2.4.1. . . . . . . . . . ....

          2. 2.4.2. A reference system shall satisfy at least the following requirements:...

          3. 2.4.3. If a reference system fulfils the requirements listed in point...

          4. 2.4.4. . . . . . . . . . ....

          5. 2.4.5. . . . . . . . . . ....

        5. 2.5. Explicit risk estimation and evaluation

          1. 2.5.1. . . . . . . . . . ....

          2. 2.5.2. The acceptability of the estimated risks shall be evaluated using...

          3. 2.5.3. . . . . . . . . . ....

          4. 2.5.4. Where hazards arise from failures of technical systems not covered...

          5. 2.5.5. . . . . . . . . . ....

          6. 2.5.6. If a technical system is developed by applying the 10-9...

          7. 2.5.7. The explicit risk estimation and evaluation shall satisfy at least...

      3. 3. DEMONSTRATION OF COMPLIANCE WITH SAFETY REQUIREMENTS

        1. 3.1. . . . . . . . . . ....

        2. 3.2. . . . . . . . . . ....

        3. 3.3. . . . . . . . . . ....

        4. 3.4. . . . . . . . . . ....

      4. 4. HAZARD MANAGEMENT

        1. 4.1. Hazard management process

          1. 4.1.1. . . . . . . . . . ....

          2. 4.1.2. . . . . . . . . . ....

        2. 4.2. Exchange of information

      5. 5. EVIDENCE FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS

        1. 5.1. . . . . . . . . . ....

        2. 5.2. . . . . . . . . . ....

      6. Appendix

        Risk management process and independent assessment

    2. ANNEX II

      CRITERIA WHICH MUST BE FULFILLED BY THE ASSESSMENT BODIES

      1. 1. . . . . . . . . . ....

      2. 2. . . . . . . . . . ....

      3. 3. . . . . . . . . . ....

      4. 4. The staff responsible for the assessments must possess:

      5. 5. . . . . . . . . . ....

      6. 6. . . . . . . . . . ....

      7. 7. . . . . . . . . . ....