SIST EN 16844:2017+A2:2019
(Main)Aesthetic medicine services - Non-surgical medical treatments
Aesthetic medicine services - Non-surgical medical treatments
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.
Dienstleistungen in der ästhetischen Medizin - Nicht-chirurgische, medizinische Behandlungen
Diese Europäische Norm legt Anforderungen an bestimmte ästhetische nicht-chirurgische, medizinische Behandlungen fest:
- Behandlungen mit resorbierbaren Injektionsmitteln, Botulinumtoxin und Micro-Needling;
- Behandlungen mit nicht-ablativer fraktionierter Hauterneuerungsbehandlung (Resurfacing) und Oberflächenpeelings, Behandlungen mit Laser und vergleichbaren energiebasierten Geräten;
- Behandlungen mit fraktionierter ablativer Behandlung mit Laser und vergleichbaren energiebasierten Geräten und mitteltiefe Peelings; und
- andere Behandlungen, wie tiefe chemische Peelings, vollständig ablative Laserbehandlungen und Fadenliftings.
Diese Europäische Norm gibt Empfehlungen in Bezug auf ästhetische nicht-chirurgische, medizinische Behandlungen, einschließlich des ethischen Rahmens und allgemeiner Grundsätze, nach denen ästhetische medizinische Dienstleistungen durch alle Ärzte und Interessengruppen im Bereich der ästhetischen Medizin erbracht werden. Diese Empfehlungen gelten vor, während und nach der Behandlung.
Jede ästhetische medizinische Behandlung, die das Gewebe unterhalb der Hornschicht der Haut (Stratum corneum) betrifft, oder die einen biologischen Effekt auf das Gewebe unterhalb der Hornschicht der Haut besitzt (mit oder ohne Instrumente(n) oder Geräte(n)), fällt in den Anwendungsbereich dieser Europäischen Norm.
Ästhetische chirurgische Eingriffe nach EN 16372 und Verfahren der Zahnheilkunde sind aus dem Anwendungsbereich dieser Europäischen Norm ausgeschlossen.
Ästhetische nicht-medizinische Behandlungen (Tätowieren und sämtliche Behandlungen, die nicht das Gewebe unterhalb der Hornschicht der Haut betreffen), die von nichtärztlichen Fachgruppen (z. B. von Tätowierern, Kosmetikern) auf gesetzlich zulässige Weise durchgeführt werden können, sind aus dem Anwendungsbereich dieser Europäischen Norm ausgeschlossen.
Services en médecine esthétique Traitements médicaux, non chirurgicaux
La présente Norme européenne traite des exigences relatives aux prestations de services en médecine esthétique proposées aux patients (traitements médicaux non chirurgicaux).
La présente Norme européenne donne des recommandations en matière de traitements de médecine esthétique non chirurgicaux, y compris un cadre éthique et des principes généraux d’exécution des prestations de services en médecine esthétique par tous les praticiens et parties prenantes de ce domaine. Ces recommandations sont applicables avant, pendant et après le traitement.
Tous les traitements de médecine esthétique qui vont au-delà de la couche cornée ou qui ont ou prétendent avoir un effet biologique au-delà de la couche cornée (avec ou sans instruments ou appareils) sont inclus dans le domaine d'application de la présente Norme européenne. Les traitements de médecine esthétique suivants sont explicitement inclus dans le domaine d'application de la présente Norme européenne :
- traitements de médecine esthétique avec produits d'injection résorbables, toxine botulique et micro-needling ;
- traitements de médecine esthétique avec resurfaçage fractionnel non ablatif, peelings superficiels, lasers et dispositifs médicaux comparables fondés sur l’énergie ;
- traitements de médecine esthétique avec lasers fractionnés ablatifs et dispositifs médicaux comparables fondés sur l’énergie, ainsi que peelings moyens ; et
- autres traitements de médecine esthétique tels que les peelings chimiques profonds, les lasers ablatifs continus, la greffe de cheveux (greffe d’unité folliculaire et extraction d’unité folliculaire) et les fils tenseurs sous-cutanés.
Les actes de chirurgie esthétique traités dans l'EN 16372 et les actes de médecine bucco-dentaire ) sont exclus du domaine d'application de la présente Norme européenne.
Les traitements esthétiques non médicaux (tatouage et traitements dont l'application ne touche pas les tissus au-delà de la couche cornée) qui peuvent être réalisés en toute légalité par des personnes qui ne sont pas médecins (par exemple, tatoueurs, esthéticiens) ne relèvent pas du domaine d'application de la présente Norme européenne.
Storitve estetske medicine - Nekirurški medicinski posegi
Ta evropski standard obravnava zahteve za določene estetske nekirurške medicinske posege:
– posegi z resorpcijskimi snovmi za injiciranje, botulinotoksini in mikrobrizgami;
– posegi z neablativnimi frakcijskimi in površinskimi pilingi ter laserskimi in primerljivimi energijskimi napravami;
– posegi s frakcijskimi ablativnimi laserji in primerljivimi energijskimi napravami ter srednje globokimi pilingi;
– drugi posegi, kot so globoki kemični pilingi, ablativni laserski posegi za celoten obraz in liftingi obraza.
Ta evropski standard določa priporočila za estetske nekirurške medicinske posege, vključno z etičnim okvirjem in splošnimi načeli, v skladu s katerimi vsi izvajalci in zainteresirane strani na področju storitev estetske medicine zagotavljajo te storitve. Ta priporočila se uporabljajo pred in med posegom ter po njem.
Kateri koli estetski medicinski poseg, ki seže globlje od poroženele plasti ali ki (domnevno) ima biološki učinek zunaj poroženele plasti (z instrumenti/pripomočki ali brez njih), spada na področje uporabe tega standarda.
Postopki estetskih medicinskih posegov, ki so opredeljeni v standardu EN 16372, in zobozdravstveni posegi ne spadajo na področje uporabe tega standarda.
Estetski nemedicinski postopki (tetoviranje in kateri koli postopki, ki ne vplivajo na tkivo globlje od rožene plasti), ki jih lahko zakonito izvajajo osebe, ki niso zdravniki (npr. osebe, ki tetovirajo, lepotni terapevti), so zunaj področja uporabe tega evropskega standarda.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 16844:2017+A2:2019
01-oktober-2019
Nadomešča:
SIST EN 16844:2017+A1:2018
Storitve estetske medicine - Nekirurški medicinski posegi
Aesthetic medicine services - Non-surgical medical treatments
Dienstleistungen in der ästhetischen Medizin - Nicht-chirurgische, medizinische
Behandlungen
Services en médecine esthétique Traitements médicaux, non chirurgicaux
Ta slovenski standard je istoveten z: EN 16844:2017+A2:2019
ICS:
11.020.10 Zdravstvene storitve na Health care services in
splošno general
SIST EN 16844:2017+A2:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 16844:2017+A2:2019
---------------------- Page: 2 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2019
EUROPÄISCHE NORM
ICS 11.020.10; 03.080.99 Supersedes EN 16844:2017+A1:2018
English Version
Aesthetic medicine services - Non-surgical medical
treatments
Services en médecine esthétique - Traitements Dienstleistungen in der ästhetischen Medizin - Nicht-
médicaux, non chirurgicaux chirurgische, medizinische Behandlungen
This European Standard was approved by CEN on 20 December 2017 and includes Amendment 2 approved by CEN on 16 April
2019.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 16844:2017+A2:2019 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2:2019 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Terms and definitions . 6
3 Competencies . 8
3.1 General . 8
3.2 Training . 9
3.3 Continuous professional development (CPD) and continuous medical education
(CME) . 9
4 Management and communication with patients . 9
4.1 Office staff/Booking arrangements . 9
4.2 Patient consultation and assessment . 10
4.3 Consent . 11
4.4 Documentation . 12
4.5 Post-treatment follow up and patient satisfaction . 13
4.6 Advertising . 13
4.7 Medical tourism and travelling long distance for treatment . 14
4.8 Medical indemnity and insurance . 15
4.9 Fees . 15
4.10 Arrangements for out of hours and emergency cover . 15
4.11 Complaints . 16
4.12 Confidentiality . 16
4.13 Safe timing of treatments . 16
4.14 Registration . 16
5 Facilities . 16
5.1 Evaluation of compliance and risk management . 16
5.2 Personnel . 16
5.3 Documentation of medical records . 17
5.4 Facility . 17
5.5 Administrative and waiting area . 17
5.6 General requirements and recommendations for treatment rooms and procedure
rooms . 17
5.7 Patient safety and security . 18
5.8 Hygiene standards for treatment rooms and procedure rooms . 19
5.9 Medicines Management . 20
5.10 Treatment room (TR) . 21
5.11 Procedure room (PR) . 21
6 Treatments . 23
6.1 General . 23
6.2 Aesthetic medical treatment categories . 23
6.3 Identifying factors . 23
6.3.1 General . 23
Figure 1 — Relations . 23
2
---------------------- Page: 4 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2:2019 (E)
6.3.2 Practitioner . 24
6.3.3 Facility . 24
6.3.4 Anaesthesia level . 24
6.3.5 Risk level of treatment . 24
6.3.6 Patient physical status and age . 25
6.3.7 Mental status and patient expectations . 26
6.4 Treatment identification . 26
6.5 Cooling off period . 26
6.6 Aesthetic medical treatments . 26
Annex A (normative) Code of Ethics for marketing and advertising . 29
Annex B (informative) A–deviations . 31
Bibliography . 47
3
---------------------- Page: 5 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2:2019 (E)
European foreword
This document (EN 16844:2017+A2:2019) has been prepared by Technical Committee CEN/TC 403
“Aesthetic surgery and aesthetic non-surgical medical services”, the secretariat of which is held by
AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2020, and conflicting national standards shall
be withdrawn at the latest by February 2020.
This document includes Amendment 1 approved by CEN on 12 December 2017.
This document includes Amendment 2 approved by CEN on 16 April 2019.
This document supersedes EN 16844:2017+A1:2018.
The start and finish of text introduced or altered by amendment 1 is indicated in the text by tags
! ".
The start and finish of text introduced or altered by amendment 2 is indicated in the text by tags
# $.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
4
---------------------- Page: 6 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2:2019 (E)
Introduction
This European Standard provides a set of requirements, which are deemed to be essential for the
provision of aesthetic medicine services (non-surgical medical treatments).
However, attention is drawn to the fact that in certain countries specific national regulations apply and
take precedence over this European Standard. Users of this European Standard are advised to inform
themselves of the applicability or non-applicability for this European Standard by their national
responsible authorities.
Furthermore, recommendations for other aspects of good practice are provided. The Bibliography
provides a list of European and International Standards and other documents of general interest for
aesthetic medicine services. This list is not intended to be exhaustive.
Emphasis is placed on defining requirements for the quality of the aesthetic medicine services offered in
order to ensure patient safety.
Other factors which influence the overall quality of service include: qualifications and professional
competencies, staff behaviour, facility design and choice of products and suppliers.
This European Standard is designed to bring the following advantages to those that adopt it:
— improvement in aesthetic medicine services which can enhance patient safety and reduce the risk of
complications;
— to promote consistently high standards for aesthetic medicine service providers across Europe;
— enhance patient satisfaction.
Requirements for a quality management system based on EN ISO 9001 for health care services are
provided in EN 15224.
Requirements concerning the occupational health and safety of service providers and their staff at work
are provided in relevant EU-Directives and national occupational health and safety legislation.
5
---------------------- Page: 7 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2:2019 (E)
1 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.
)
1
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.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
aesthetic medicine services
services related to non-surgical medical treatments where the primary aim is the aesthetic change,
restoration or improvement of the appearance, the function and/or well-being at the request of an
individual with medical treatments, including the prevention and treatment of all kind of aesthetic
concern, aging process, as well as the promotion of health
1) As defined in EN ISO 1942.
6
---------------------- Page: 8 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2:2019 (E)
2.2
adverse event
unfavourable, unexpected or unintended temporary or permanent medical outcome to the patient
Note 1 to entry: “Adverse event” is defined in ISO/TS 19218-1:2011, 2.1 as an event associated with a medical
device that led to death or serious injury of a patient, user or other person, or that might lead to death or serious
injury of a patient, user or other person if the event recurs. This definition is consistent with the guidance in
GHTF/SG2/N54/R8:2006 and definition includes malfunction or deterioration of a device which has not yet
caused death or serious injury, but which could lead to death or serious injury.
Note 2 to entry: “Adverse event” is defined in 2001/20/EC, Article 2 (m) as any untoward medical occurrence in
a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal
relationship with this treatment.
2.3
competence
demonstrated and qualified ability to apply established scientific knowledge and skills according with
the law and regulations of the country where is practiced
2.4
complaint
expression of dissatisfaction made to an organization or a practitioner, related to its services and/or
results, or the complaints-handling process itself, where a response or resolution is explicitly or
implicitly expected
2.5
“cooling off” period
time between the end of the consultation where the treatment is proposed, its risks are explained and
the detailed fee estimation is given, and the decision to proceed with this treatment
2.6
facility
medical establishment where aesthetic medical treatments and procedures are performed
2.7
health
state of complete physical, mental and social well-being and not merely the absence of disease or
infirmity
Note 1 to entry: This definition is from the preamble to the Constitution of the World Health Organization as
adopted by the International Health Conference, New York, 19–22 June 1946; signed on 22 July 1946 by the
representatives of 61 States (Official Records of the World Health Organization, no. 2, p. 100) and entered into
force on 7 April 1948.
2.8
patient satisfaction
patient's perception of the degree to which the patient's requirements have been fulfilled
Note 1 to entry: Patient complaints are a common indicator of low patient satisfaction but their absence does
not necessarily imply high patient satisfaction.
Note 2 to entry: Even when patient requirements have been agreed with the patient and fulfilled, this does not
necessarily ensure high patient satisfaction.
Note 3 to entry: This definition was adapted from EN ISO 9000:2015, 3.9.2.
7
---------------------- Page: 9 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2:2019 (E)
2.9
practitioner
medical doctor authorized by national competent authority to practice medicine autonomously
2.10
reporting
notification of an adverse event, defective health care product or negligent service delivery to the
relevant competent authorities
3 Competencies
3.1 General
3.1.1 During care activity, the practitioner shall control the competencies and capacities of person(s)
doing work under his/her control. In addition, the medical establishment or the practitioner when
he/she is the employer shall:
— determine the necessary competence of person(s) doing work under its control,
— ensure these persons are competent on the basis of training, skills and experience,
— where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness
of the actions taken,
— retain documented information as evidence of competence,
— check the professional credentials and certified training of any professional applying to provide
services under its responsibility.
3.1.2 If the aesthetic medicine services are delivered in a facility placed under supervision of a
managing director, tasks described in 3.1.1 are under responsibility of both practitioner and managing
director.
3.1.3 A registration for all practitioners performing aesthetic medical treatments is highly
recommended within two years after publication of this European Standard. This register shall be
national, certified, updated regularly and freely accessible to public in particular via the internet.
3.1.4 Directive 2005/36/EC demands formal basic medical training or specialist medical training to
be recognized by a national competent authority.
3.1.5 The practitioner shall be a medical doctor authorized by national competent authority to
practice medicine autonomously. Medical doctors authorized by the national competent authority are
entitled to perform aesthetic medical treatments provided they are trained to these treatments.
Assistants shall be medical doctors, who are in a recognized post-graduate training scheme, or
authorized healthcare professionals who shall be working under the practitioner’s direct supervision
(direct supervision means to be physically present in the facility and able to respond and act according
to the level of risk of the procedure).
3.1.6 Authorized healthcare professionals who are allowed to work under the practitioner's direct
supervision shall have a professional training of at least 3 years.
3.1.7 Treatments with the use of lasers (class 2 and higher), light- (IPL and LED) and other energy
based devices shall only be applied by qualified medical practitioners or by authorized healthcare
professionals under practitioner's direct supervision.
8
---------------------- Page: 10 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2:2019 (E)
3.1.8 Delegation of aesthetic medical treatments to practitioners who do not meet the national
required competency shall not be allowed.
3.2 Training
3.2.1 A practitioner undertaking aesthetic medical treatments shall be trained in the respective
treatment and this training shall be in compliance with the national competent authority's rule with a
minimum of 3 years.
3.2.2 This training shall include outcomes which require a firm understanding of the basic science
principles and evidence past which underpin treatments. This includes but is not exclusive to anatomy,
physiology, pharmacology, immunology, pathology and mechanistic understanding in the respective
treatment. Adequate knowledge is required to minimize inappropriate treatment or missed diagnosis.
Knowledge of appropriate medical treatment options is required to optimize care. Recognition,
diagnosis and the ability to manage complications relating to the relevant treatment is required.
3.2.3 Training should also include issues relating to ethics, psychology, consent and indemnity.
3.2.4 Training shall have a theoretical part and a practical part. The practical part of the training shall
include a period of mentorship.
3.3 Continuous professional development (CPD) and continuous medical education
(CME)
3.3.1 The practitioner shall:
a) maintain a valid registration by the national competent authorities of the country of practice and
shall be involved in aesthetic practice on a regular basis; and
b) attend at least two CME accredited scientific events per year relevant to the sphere of aesthetic
practice he/she performs or accreditation by the recognized national profession society.
3.3.2 Practitioners should preferably be member of a scientific society of their profession.
3.3.3 The continuous professional development undertaken shall enhance the practitioner’s aesthetic
practice and shall comply with the national educational requirements, relicensing and/or maintenance
of practice agreement.
4 Management and communication with patients
4.1 Office staff/Booking arrangements
4.1.1 Hospitals, private establishments and private practices as well as all their medical or otherwise
involved partners that are in a position to obtain patient's information shall have a confidentiality policy
on protecting patient's privacy that is clear, understood and well known by all staff.
4.1.2 Financial inducements shall not be used towards patient, practitioners, staff, or other
professionals to entice patients to consult or to have primary or combined aesthetic medical treatments.
Economic considerations shall not override patient safety.
4.1.3 The consultation process is an opportunity to explore the concept of aesthetic medical treatment
during which the patients shall have the implications, limitations and complications of treatment
explained in language they understand, and with written information, including information presented
on internet websites, for them to read later – it shall not involve any enticement to proceed. The
consultation shall be done in a language both parties can understand and agree on.
9
---------------------- Page: 11 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2:2019 (E)
4.1.4 The practitioner shall give impartial objective advice during the consultation for which a fee
should be charged.
4.1.5 Cancellation policies shall be clear to the patient before any payment is made. A full refund of
treatment fees shall be given if any pre-payment is made when the cancellation is within the “cooling
off” period. Further arrangements are at the practitioner/clinics discretion but shall be clearly explained
and set out in writing to patients.
4.1.6 The identification of any practitioner who performs the treatment and his/her speciality(ies)
officially recognized by the national competent authority shall appear accurately and without ambiguity
on letterheads and in all communications with the patient.
4.2 Patient consultation and assessment
4.2.1 The initial consultation shall be with the practitioner planning to undertake the aesthetic
medical treatment.
4.2.2 Any other professional involved in the consultation process shall declare their name, expertise
and qualifications and explain their role in the consultation, i.e. junior doctor in training, medical
secretary or nurse. Practitioners should explain their role in screening or general health assessments.
Nurses and non-medical professionals shall not be used as a shortcut for the practitioner who remains
responsible for carefully assessing the patients and thoroughly undertaking the consent process
(see 4.3). Practitioners should make themselves aware of regulators' guidance on remote prescribing.
Practitioners should stay informed of guidelines and recommendations issued by competent authorities
on telemedicine. It is good practice to wear an identification badge.
4.2.3 The practitioner shall be knowledgeable on the legislation and scientific literature on the
treatments that he/she performs, the devices that he/she uses and the related safety issues.
4.2.4 The practitioner shall inform the patient on outcome indicators of the treatment that he/she
performs, the devices he/she uses and be able to relate these outcome indicators with alternative
treatments and devices.
4.2.5 The practitioner shall provide information that is understandable, timely, verifiable, accurate,
complete, truthful and not misleading.
4.2.6 The practitioner shall provide information on the aim of the aesthetic medical treatment,
benefits and harms, potential adverse consequences, including their frequency, alternative options and
costs.
4.2.7 The practitioner shall provide transparency on the device or product used and possible
alternatives. The rationale should include quality assurance and evidence. The practitioner shall provide
background literature on the device or product and its use upon request.
4.2.8 At the end of the first consultation all patients shall be made aware of the risks and benefits of
the proposed aesthetic medical treatment and shall be given the opportunity to digest the information
and reflect on discussions before deciding to proceed.
4.2.9 Patients shall be made aware that further consultations are advisable and shall be encouraged
for more risky/serious treatments. Patients should be informed that all consultations necessary to
his/her consent are available to him/her but also duly informed of financial arrangement regarding this
additional consultations.
10
---------------------- Page: 12 ----------------------
SIST EN 16844:2017+A2:2019
EN 16844:2017+A2:2019 (E)
4.2.10 Processes designed to reflect intention of outcome shall be used honestly. They shall not be used
as a marketing tool. The limitations of the process shall be explained to the patient. Practitioners are
advised that when example photographs are used to demonstrate outcomes, they should be
accompanied by a disclaimer explaining the result cannot be guaranteed. Photographs shall not be
modified to manipulate the outcome of the treatment.
4.2.11 The initial consultation(s) shall include
a) verification of the patient’s condition to check medical feasibility of the planned treatment;
b) explore the spec
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.