BS EN 16844:2017+A2:2019 PDF

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 dentistry¹) 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.

Cross References:
EN ISO 6009
EN ISO 19011
CEN/TS 15277
EN 60601-2-26
EN ISO 13606 (all parts)
EN 207
EN 15224
EN 1644-2
IEC/TR 62471-3
EN 60601-2-4
EN ISO 8362-6
EN 1500
EN 455-3
EN ISO 14644-1
EN 16372
EN 12464-1
EN ISO 25424
EN ISO 27799
EN 60601-2-52
CEN/TR 15133
EN 1644-1
EN 60601-2-47
EN ISO 22600 (all parts)
EN 12470 (all parts)
EN ISO 10079 (all parts)
ISO/TS 21547
ISO 18308
EN 60601-2-41
EN ISO 14971
EN ISO 80601-2-12
EN 62471
ISO/TR 21548
EN ISO 16061
ISO 10002
EN 13795
EN ISO 10781
EN 60601-2-57
EN 60601-2-25
EN 285
EN ISO 7396 (all parts)
ISO 10001
EN 455-2
EN 62304
EN 13060
EN ISO 11073 (all parts)
EN ISO 15225
CEN/TR 15592
ISO 26000
ISO 31000
ISO/TS 19218-1:2011
EN ISO 9000:2015
EN 60601-2-27
EN ISO 1942
ISO 12609-2
EN ISO 16054
EN ISO 8362-7
GHTF/SG2/N54/R8:2006
EN 14180
EN ISO 80601-2-55
ISO/TR 12773 (all parts)
EN 455-1
EN 1422
EN ISO 18812
EN ISO 17665-1
EN ISO 23907
EN 1041
EN ISO 21090
EN 60601-2-22
EN ISO/IEC 27001
EN ISO 9170-2
EN ISO 12967 (all parts)
EN 60601-2-30
EN ISO 80601-2-13
EN ISO 11135-1
EN 15986
ISO 17090 (all parts)
EN ISO 11810-2
EN ISO 11810-1
ISO 12609-1
EN 794-3
IEC/TR 60825-8
EN ISO 80601-2-61
EN 455-4
EN ISO 15223-1
EN ISO 14607
ISO 10003
EN ISO 13485
EN 1040
EN 60601-2-34
EN ISO 14630
EN 60601-2-46
EN 60825-1


Incorporates the following:
Amendment, August 2019; Corrigendum, August 2018

File Size :	1 file , 1.1 MB
ISBN(s) :	9780539061598
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	56
Product Code(s) :	30401483, 30401483, 30401483
Published :	08/30/2019