EN 16844:2017+A2:2019

Aesthetic medicine services - Non-surgical medical treatments EN 16844:2017+A2:2019

Publication date:   Nov 14, 2019

Scope

This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments:
- treatments with resorbable injectables, botulinum toxin and micro needling;
- treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices;
- treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and
- other treatments such as deep chemical peels, full ablative lasers and thread lifts.
This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment.
Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard.
Aesthetic surgical procedures covered by EN 16372 and dentistry ) procedures are excluded from the scope of this European Standard.
Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.