Introduction : Standards and Regulations
  
Standards and Regulations
The Centricity Perintal product meeds the following requirements.
CE Marking Information
The Centricity Perinatal product bears the CE Mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive.
List of Standards
The following is a list of standards with which the device complies.
Full Standard Number
Standard Title
Standard Revision or Issue Date
EN 62304
Medical device software – Software life cycle processes
2006 A1 (2015)
EN 62366
Medical Devices – Application of usability to medical devices
2008
The country of origin can be found on the product label.
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