TS EN 16844

TS EN 16844 is a standard for aesthetic medicine services focused on non-surgical medical treatments. It brings together treatments such as injectable fillers, botulinum toxin, microneedling, lasers and similar energy-based devices, covering interventions that go beyond the stratum corneum or are claimed to produce a biological effect beyond that layer.

Beyond the individual techniques, the standard also addresses the ethical framework and general principles for delivering aesthetic medical services. It applies before, during and after treatment, which reflects the fact that aesthetic procedures are not only about the device or product used, but also about patient assessment, procedural planning and follow-up. In general technical terms, these treatments are grouped because they act at different tissue depths and use different mechanisms, so their practical considerations are not identical.

What the scope brings together

• Resorbable injectables, botulinum toxin and microneedling
• Non-ablative fractional resurfacing, superficial peels, lasers and comparable energy-based devices
• Fractional ablative lasers, comparable energy-based devices and medium-depth peels
• Deep chemical peels, full ablative lasers and thread lifts

The scope includes any aesthetic medical treatment that penetrates deeper than the stratum corneum, or that claims a biological effect beyond it, whether performed with instruments/devices or not. Aesthetic surgical procedures covered by EN 16372 are excluded, as are dentistry procedures. It also excludes non-aesthetic, non-medical treatments that do not affect tissue deeper than the stratum corneum and may legally be performed by non-physicians, such as tattooing.