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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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
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.
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.
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.
)
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.
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.
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.
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.
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.
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 specific aesthetic concerns;
c) assessment of patient's mental health/psychological state, including past psychological/mental
health history where possible;
d) assessment of patient’s expectations;
e) request relevant blood tests, if necessary;
f) request other relevant investigations;
g) request to communicate with relevant medical colleagues;
If in doubt, the practitioner should consult with or refer medical specialists.
h) if the patient is diagnosed with dysmorphobia no aesthetic medical treatments shall be performed;
i) pre-treatment tests and investigations shall be performed where appropriate. The practitioner shall
inform the patient of the financial implications.
NOTE 1 The consultation is the start of the consent process, see 4.3.
NOTE 2 For consultation documentation, see 4.4.
4.2.12 If the practitioner deems that the environment in which the aesthetic medical treatment shall be
performed, the devices or personnel are not fit for purpose the practitioner shall cancel the treatment.
4.3 Consent
4.3.1 Consent is an ongoing process extending from the time of first contact until the day of the
aesthetic medical treatment; the majority of this process should be completed prior to booking.
4.3.2 The process shall include the following:
a) A clear explanation of the limitations of the aesthetic medical treatment and alternative treatments
that may be available (including those not offered by the practitioner).
b) A clear explanation of the implications of the aesthetic medical treatment, including a clear
explanation of the recovery time, duration of recommended absence from work and follow up
plans.
c) The practitioner shall ensure that the patient clearly understands the risks involved with the
planned treatment. The frequently occurring and the rare, but serious, complications should be fully
explained and understood. A personal low rate of complication shall not be used to entice patient to
undertake aesthetic medical treatment.
If data are available, personal risks should be stated in natural numbers and in relation to a number
of treated patients, for example 1 out of 200 patients suffer from this side effect rather than 0,5 % of
all patients.
d) The discussion shall include an explanation, in clear and understandable terms, of the practitioner’s
expectations of outcome and the relation between the outcome of the treatment with those of
alternative treatments.
e) Written information shall be given as additional material and shall not take the place of an informed
discussion. Practitioners should keep a record of both the discussions and of the information given
to the patient. Both parties shall sign the informed consent form.
f) The practitioner shall ensure that the patient is informed of the limitation, implications and
potential complications of the aesthetic medical treatment before booking it.
g) Until the initial consent process is complete (the time at which the patient fully understands the
limitation, implications and potential complications of the aesthetic medical treatment) all monies,
except for any previously declared non-refundable deposit, shall remain refundable.
h) No patient shall undergo an aesthetic medical treatment without completion of the consent process.
i) Aesthetic medical treatments for patients under the age of 18 years should be exceptional and
linked to a documented medical assessment of the risks and benefits (health, social consequences).
In those cases where it is clinically or psychologically necessary, the consent form shall be available
in a legal form of words appropriate to the patient and/or their parents or guardians prior to the
aesthetic medical treatment. Parental or guardian written agreement is mandatory.
j) The consent forms should be legible, understandable and signed by both parties.
k) The patient's consent shall be performed in a language both parties can understand and agree on.
4.4 Documentation
4.4.1 Medical records and notes shall be legible and understandable.
4.4.2 Medical records shall include patient identification (at least patient's full name, date of birth)
and practitioner’s signature as well as details of the serial numbers, batch, lot numbers for any devices
or healthcare products that are used on a patient (e.g. dermal fillers and other injectables).
4.4.3 Digital records, where possible, shall include the practitioner’s signature.
4.4.4 Medical records and notes shall be stored in appropriate secure facilities which are restricted to
authorized persons.
4.4.5 Data protection in storage and handling of patient medical records and notes and details shall be
ensured.
4.4.6 Medical records and notes shall be stored and handled for a period as legally required. If there is
no legally required period it shall be at least 10 years.
4.4.7 Medical records, notes and photographs shall be available to the patients at their request, they
should be available within a reasonable time, and any charge made for copying notes should be
appropriate and reasonable.
4.4.8 Photographs should be taken for all patients undergoing aesthetic medical treatments.
Photographs should be standardized where possible. Use of patient's pictures shall be strictly limited to
the use authorized and signed by the patient in the consent form.
4.4.9 Patient’s photographs shall be stored appropriately and confidentiality respected.
4.4.10 Where clinical photographs are used as clinical material and shown to other patients the
appropriate consent shall be obtained.
4.4.11 Medical records shall only be released to third parties with the patients or legal representatives
signed consent. Medical records shall only be released to third parties in case of patient’s death.
4.5 Post-treatment follow up and patient satisfaction
4.5.1 Patients should receive a discharge summary when leaving the office or the facility, if applicable.
This should include information about any aesthetic medical treatment performed, if applicable
information about injected medicine/medical device used, post-treatment medication prescribed,
clinical warning signs to watch for, contact details in the case of an emergency and details for first follow
up consultation.
4.5.2 The practitioner shall inform the patients whom they will see at follow up and whom they can
contact if there is a problem after treatment. It is best practice for the practitioner to see the patients
personally. Some aesthetic medical treatments do not need dressings; the practitioner shall inform the
patient accordingly.
4.5.3 Follow up shall be ensured, if necessary.
4.5.4 The practitioner shall keep a documented record of treatments, used devices and products and
follow-up treatments.
4.5.5 In the case of late aesthetic/functional concerns the patient shall have the right to consult
his/her practitioner. The patient shall be informed, that he/she remains responsible to make
appropriate arrangements.
4.5.6 The patient survey should aim to be carried out upon discharge and long-term follow up.
4.5.7 Post-treatment information related to the treatment should be made available to the patient.
4.6 Advertising
Advertising should be avoided.
In countries, where advertising is allowed, the following applies:
a) National advertising rules and prohibition shall be followed by any individual, group or business
wishing to communicate with, or advertise to, patients in the country concerned.
b) Advertising and marketing in any form shall be legal, decent, honest, truthful and socially
responsible.
NOTE General guidance on social responsibility is provided in ISO 26000.
c) Advertorial transparency shall be assured and patients shall be aware from the text when an article
is an advertorial.
d) Free consultation shall not be used as a marketing tool.
e) No models shall be used either in advertising or marketing and a declaration of conflict of interest
shall be prominent.
f) Web, blog and any social media transparency shall be assured and if practitioners, or their
employees, are involved in blog/web communications they shall declare their true identity.
g) The official professional status/qualification of the practitioner shall be clearly stated.
h) Practitioner’s qualifications shall not be misrepresented and only the speciality listed in EU-
Directive 2005/36/EC in which the practitioner is qualified shall be used. No terms shall be used
that give patients or the public the wrong impression of a qualification in a speciality listed in EU-
Directive 2005/36/EC or specialities recognized at national level, in the respective country.
i) Commission based patient advisors shall not be used. Referring professionals or other persons,
including patients, shall not receive payment/remuneration or fee discount for making patient
referrals. Patients shall expect that any referral is made in their best medical interest and does not
involve any financial transaction.
j) Patient's testimonial used by practitioners for public information shall be verifiable, traceable and
unpaid.
k) For further details, see Annex A.
4.7 Medical tourism and travelling long distance for treatment
Medical tourism and travelling long distance for treatment are rarely in the patient's best interest. In
addition to the other subclauses in Clause 4 the medical establishment and the practitioner:
a) shall make patients fully aware of the implications and risks of long distance travelling for
treatment and that follow up, and the management of even minor complications/ dissatisfaction
becomes a complicated process;
b) should not reassure patients that pre- and post-treatment appointments made with other, local,
practitioners are equivalent to seeing the practitioner performing the treatment at any time that
may be necessary in the future;
c) should emphasize the importance of follow up. Documentation shall be made of discussions
explaining the difficulties in the case of complications/ dissatisfaction with the result. It is advised
this is presented as a risk disclosure document and that it is signed by the patient;
d) shall inform the patient in the case of category 3 and 4 aesthetic medical treatments (see 6.2) about
the risk of long distance travelling in the pre- and post-treatment period;
e) should not recommend insurance schemes that hand over the responsibility for looking after
complications to third parties. They act as an inducement by making a dangerous process slightly
more attractive but no less dangerous;
f) shall inform patients travelling long distances for treatment of the professional indemnity
arrangements of the practitioner and, if applicable, the medical establishment where treatments are
performed;
g) should inform patients of tiers of responsibility should problems arise. Patients shall not be misled
into believing that the company making the arrangements for their trip carries medical liability
insurance;
h) shall inform patients if the practitioner is travelling long distance to provide treatment.
Requirements in this European Standard also apply to travelling practitioners.
4.8 Medical indemnity and insurance
4.8.1 Practitioners shall hold a medical indemnity insurance for each kind of treatments they perform.
This insurance should also cover damages or problems that are unexpected or unforeseeable at the time
of treatment.
4.8.2 Patients shall be informed that the practitioner undertaking their aesthetic medical treatment
possesses professional indemnity insurance that it is recognized as being appropriate and adequate for
practice in the country involved. If the indemnity insurance is held outside the country of practice the
practitioner should inform the patient of this and of any potential financial/ regulatory implications.
4.8.3 Patients shall be informed that their practitioner/practitioners possesses adequate and
appropriate indemnity for the treatments being undertaken, registered in the country where the
treatment is performed.
4.8.4 The practitioner shall honestly declare all information regarding scope and location of the
aesthetic medical treatments he/she performs to the insurer, thus ensuring that he/she remains
insured.
4.8.5 The practitioner shall not act outside his/her area of expertise and insurance cover.
4.9 Fees
4.9.1 Fees shall be transparent and a detailed and written quote shall be delivered prior consent being
obtained.
4.9.2 Long term financial implications should be clear.
4.9.3 Financial arrangement for complications should be explicit.
4.9.4 Financial discounts shall not be used to encourage patients to consider aesthetic medical
treatment or further treatments.
4.9.5 Patients shall be informed of the terms and conditions of any payment made, particularly
deposits.
4.10 Arrangements for out of hours and emergency cover
4.10.1 Patients shall be provided with contact details for their practitioner/ medical establishment in
the case of emergency.
4.10.2 Out of hours care would normally be expected to be provided by the practitioner involved in the
treatment, unless other arrangements have been clearly defined with healthcare staff/ facilities and
explained to the patient.
4.10.3 If a practitioner is not available for any reason they shall provide patients with appropriate and
adequate cover, of a similar level of professional expertise. For treatments with higher risk a thorough
handover of patients is expected.
4.11 Complaints
4.11.1 All practices/ medical establishments offering aesthetic medicine services shall have a clear
complaints procedure and process, including timeframe for responding.
4.11.2 Patients should be made aware of the practice/ medical establishments' complaints procedure.
NOTE General guidance for complaints handling is provided in ISO 10001, ISO 10002 and ISO 10003.
4.12 Confidentiality
Patient confidentiality shall be respected at all times.
4.13 Safe timing of treatments
4.13.1 The practitioner shall inform the patient if the timing, complexity, or duration of their aesthetic
medical treatment could introduce additional risks/complications (e.g. peeling before sun exposure).
4.13.2 The practitioner shall inform the patient of additional risks associated with the aesthetic
medical treatment if patient behaviour may modify these, e.g. smoking cessation and weight
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