ORA.AeMC.200 Management system
Regulation (EU) No 1178/2011
The AeMC shall establish and maintain a management system that includes the items addressed in ORA.GEN.200 and, in addition, processes:
(a) for medical certification in compliance with Part-MED; and
(b) to ensure medical confidentialityat all times.
GM1 ORA.AeMC.200 Management system
ED Decision 2012/007/R
RESEARCH
If aero-medical research is conducted at an AeMC, its management system should include processes to conduct that research and publish the results.
ORA.AeMC.210 Personnel requirements
Regulation (EU) No 1178/2011
(a) The AeMC shall:
(1) have an aero-medical examiner (AME) nominated as head of the AeMC, with privileges to issue class 1 medical certificates andsufficient experience in aviation medicine to exercise his/her duties; and
(2) have on staff an adequate number of fully qualified AMEs and other technical staff and experts.
(b) The head of the AeMC shall be responsible for coordinating the assessment of examination results and signing reports, certificates, and initial class 1 medical certificates.
AMC1 ORA.AeMC.210 Personnel requirements
ED Decision 2012/007/R
GENERAL
(a) The aero-medical examiner (AME) should have held class 1 privileges for at least 5 years and have performed at least 200 aero-medical examinations for a class 1 medical certificate before being nominated as head of an AeMC.
(b) The AeMC may provide practical AME training for persons fully qualified and licensed in medicine.
ORA.AeMC.215 Facility requirements
Regulation (EU) No 1178/2011
The AeMC shall be equipped with medico-technical facilities adequate to perform aero-medical examinations necessary for the exercise of the privileges included in the scope of the approval.
AMC1 ORA.AeMC.215 Facility requirements
ED Decision 2012/007/R
MEDICAL-TECHNICAL FACILITIES
The medical-technical facilities of an AeMC should consist of the equipment of a general medical practice and, in addition, of:
(a) Cardiology
Facilities to perform:
(1) 12-lead resting ECG;
(2) stress ECG;
(3) 24-hour blood pressure monitoring; and
(4) 24-hour heart rhythm monitoring.
(b) Ophthalmology
Facilities for the examination of:
(1) near, intermediate and distant vision;
(2) external eye, anatomy, media and fundoscopy;
(3) ocular motility;
(4) binocular vision;
(5) colour vision (anomaloscopy or equivalent);
(6) visual fields;
(7) refraction; and
(8) heterophoria.
(c) Hearing
(1) pure-tone audiometer
(d) Otorhinolaryngology
Facilities for the clinical examination of mouth and throat and:
(1) otoscopy;
(2) rhinoscopy;
(3) tympanometry or equivalent; and
(4) clinical assessment of vestibular system.
(e) Examination of pulmonary function
(1) spirometry
(f) The following facilities should be available at the AeMC or arranged with a service provider:
(1) clinical laboratory facilities; and
(2) ultrasound of the abdomen.
Regulation (EU) No 1178/2011
In addition to the records required in ORA.GEN.220, the AeMC shall:
(a) maintain records with details of medical examinations and assessments performed for the issue, revalidation or renewal of medical certificates and their results, for a minimum period of 10 years after the last examination date; and
(b) keep all medical records in a way that ensures that medical confidentiality is respected at all times.