• Rita ConigliaroEmail author
  • Claudio Conti
  • Giuseppe Grande
  • Helga Bertani


Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) are two challenging and increasingly complementary methods in digestive endoscopy.

They are two endoscopic procedures that require a multitude of devices, high-end equipment and image integration. Moreover, an experienced interventional team is required. Taking these prerequisites together, with the fusion of EUS and ERCP, a modern endoscopy unit offers a lot to treat many different bilio-pancreatic disesases by minimally invasive approach.

At the same time, both techniques involve risks, e.g. the risk of transmission of infections. Therefore, all premises must have specific requirements that allow the two methods to be carried out effectively and safely for patients and operators.

In this chapter, the current European standards and the advice given in the few international guidelines that deal with the subject are explained.


ERCP EUS Room Technology standard Requirements 


  1. 1.
    Byron Burlingame, MS, RN, CNOR. Operating room requirements for 2014 and beyond.
  2. 2.
    Calderwood AH, Chapman FJ, Cohen J, et al. Guidelines for safety in the gastrointestinal endoscopy unit. Gastrointest Endosc. 2014;79:363–72.CrossRefGoogle Scholar
  3. 3.
    Blenkharn J. Sharps management and the disposal of clinical waste. Br J Nurs. 2009;18(860):862–4.Google Scholar
  4. 4.
    Decreto Legislativo 26 maggio 2000, n. 187 Attuazione della direttiva 97/43/EURATOM in materia di protezione sanitaria delle persone contro i pericoli delle radiazioni ionizzanti connesse ad esposizioni mediche. Modificato dall’art. 39, Legge 1 marzo 2002, n. 39.Google Scholar
  5. 5.
    Ordinanza concernente la radioprotezione relativa agli impianti a raggi X per uso medico (Ordinanza sui raggi X) 20 gennaio 1998 (Stato 14 aprile 1998).Google Scholar
  6. 6.
    Mulder CJJ, Jacobs MAJ, Leicester RJ, et al. Guidelines for designing a digestive disease endoscopy unit: report of the World Endoscopy Organization. Dig Endosc. 2013;25:365–75.CrossRefGoogle Scholar
  7. 7.
    CEI 62-5, III edizione (UNI EN ISO 60601-1). Electromedical devices. Part 1: general rules for safety.Google Scholar
  8. 8.
    CEI 64-8, Sez.710 Section regulations for premises for medical use.Google Scholar
  9. 9.
    UNI EN ISO 11197 art.3.5 basic safety and essential requirements of power supply units for medical use.Google Scholar
  10. 10.
    European Council Directive 2007/47/CE on Medical Devices.

Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  • Rita Conigliaro
    • 1
    Email author
  • Claudio Conti
    • 2
  • Giuseppe Grande
    • 1
  • Helga Bertani
    • 1
  1. 1.Gastroenterology and Digestive Endoscopy UnitCivil and University HospitalModenaItaly
  2. 2.Clinical Engineering Institute, Civil and University HospitalModenaItaly

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