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Directive 2010/53/EU of the European Parliament and of the CouncilShow full title

Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation

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  1. Introductory Text

  2. CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS

    1. Article 1.Subject Matter

    2. Article 2.Scope

    3. Article 3.Definitions

  3. CHAPTER II THE QUALITY AND SAFETY OF ORGANS

    1. Article 4.Framework for quality and safety

    2. Article 5.Procurement organisations

    3. Article 6.Organ procurement

    4. Article 7.Organ and donor characterisation

    5. Article 8.Transport of organs

    6. Article 9.Transplantation centres

    7. Article 10.Traceability

    8. Article 11.Reporting system and management concerning serious adverse events and reactions

    9. Article 12.Healthcare personnel

  4. CHAPTER III DONOR AND RECIPIENT PROTECTION AND DONOR SELECTION AND EVALUATION

    1. Article 13.Principles governing organ donation

    2. Article 14.Consent requirements

    3. Article 15.Quality and safety aspects of living donation

    4. Article 16.Protection of personal data, confidentiality and security of processing

  5. CHAPTER IV OBLIGATIONS OF COMPETENT AUTHORITIES AND EXCHANGE OF INFORMATION

    1. Article 17.Designation and tasks of competent authorities

    2. Article 18.Records and reports concerning procurement organisations and transplantation centres

    3. Article 19.Exchange of information

  6. CHAPTER V ORGAN EXCHANGE WITH THIRD COUNTRIES AND EUROPEAN ORGAN EXCHANGE ORGANISATIONS

    1. Article 20.Organ exchange with third countries

    2. Article 21.European organ exchange organisations

  7. CHAPTER VI GENERAL PROVISIONS

    1. Article 22.Reports concerning this Directive

    2. Article 23.Penalties

    3. Article 24.Adaptation of the Annex

    4. Article 25.Exercise of the delegation

    5. Article 26.Revocation of the delegation

    6. Article 27.Objection to delegated acts

    7. Article 28.Urgency procedure

    8. Article 29.Implementing measures

    9. Article 30.Committee

    10. Article 31.Transposition

  8. CHAPTER VII FINAL PROVISIONS

    1. Article 32.Entry into force

    2. Article 33.Addressees

    1. ANNEX

      ORGAN AND DONOR CHARACTERISATION

      1. PART A Minimum data set

        1. Minimum data set

      2. PART B Complementary data set

        1. Complementary data set

          1. General data

          2. Donor data

          3. Donor medical history

          4. Physical and clinical data

          5. Laboratory parameters

          6. Image tests

          7. Therapy

  10. ATTACHMENTS

    1. Statement of the European Parliament, the Council and the Commission on Article 290 TFEU

    2. Statement of the European Commission (Urgency)

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