Bsi bs en 16844 2017

2.1 a sthetic medicine ser vic es ser vic s r lated to non-surgical medical tr atment whe e the pr imary aim is the aes hetic change, r stor ation or impr ovement of the a pear anc , the

Aesthetic medicine servic es —

National foreword

This British Stan ard is the UK implementation of EN 1 844:2 1

The UK p rticip tion in it pr p ration was entrust ed t o Te hnical

Committ ee CH/40 , A es hetic Surg ery an A es hetic Non-Surgical

Medical S rvic s

A l s of org nizations r pr sent ed on this committ ee can be o tained on

r q es t o it se r tary

This publ cation does not purp rt t o inclu e al the ne es ary pro isions

of a contract Use s ar r sponsible for it cor e t a plcation

© The British Stan ards Ins itution 2 1

Publshed b BSI Stan ards Limit ed 2 1

ISBN 9 8 05 0 89 2 9

ICS 0 0 0 99; 1 0 0.1

Compl ance with a British Standard cannot co fer immunity from

le al o lg tio s

This British Stan ard was publ shed u de the a uthority of the

Stan ards Polcy an Strat eg C mmitt ee on 3 July 2 1

Amendments /cor ig en a is ued since publ catio

NORME EUROPÉENNE

S rvic s en méde ine eshétiq e - Traitement

médic ux , non chirurg ic u

Diensleis u g en in der ästhetischen Medizin -

Nicht-chirurg ische, medizinische Behan lu g en

This E rope n Stan ard was ap rov ed b C N on 27 February 2017

C N member are bou d to c mply with the C N/C NE E Internal R eg ulations which sip late the c n itions for g ivin this

E rope n Stan ard the satus of a national san ar d without an alteration Up-to-date lss an biblog rap ic al referenc es

c nc rnin such national san ards may be obtained on ap lc ation to the C N-C NE E Manag ement Cente or to an C N

member

This E rope n Stan ard ex iss in thre oficial ver ions (E g lish, French, German) A v er ion in an other lang uage made b

translation u der the responsibi ty of a C N member into it ow n lang uag e an notified to the C N-C NE E Manag ement

Cente has the same satus as the oficial ver ions

C N member are the national san ards bodies of Ausria, Belg ium, B lg aria, Cro tia, Cy prus, Cz ch R ep blc, Denmark, Esonia,

Finlan , Former Y ug oslav R ep blc of Mac edonia, Franc e, Germany, Gre c , Hu g ary, Ic lan , Irelan , Italy, Latv ia, Lith ania,

L x embourg, Malta, Netherlan s, Norway, Polan , Porug al, R omania, S rbia, Slovakia, Slovenia, Spain, Sweden, Switz rlan ,

Turkey an United K in dom

EUR OP A N COMMIT E FOR STAND R DIZA TION

COMITÉ EU OP EN DE NO MALISA ION

EU OPÄISCHES KOMITE FÜ NO MUNG

C N-C NE E Manag ement C ntre: Av n e Marnix 1 , B-1 0 Brus els

© 2 1 CEN A ll r ig hts of ex ploitation in an form an b any me ns reser ved

w or ldw ide for CEN national Memb r

Ref No EN 1 84 :2 1 E

Contents Page

Eur ope n for ewor d 4

Intr oduc tio 5

1 Sc ope 6

2 Ter ms and definitio s 6

3 Competencies 8

3.1 Gener al 8

3.2 Tr aining 8

3.3 Co tinuo s pr ofes io a l develo ment (CPD) and continuo s medical educatio (CME) 9

4 Management and communica tio with patients 9

4.1 Ofice staf/Bo king ar r ang ements 9

4.2 Patient consultation and as es ment 10

4.3 Co sent 11

4.4 Documentatio 12

4.5 Post-tr eatment folow up and patient satis actio 13

4.6 A dver tising 13

4.7 Medic al tour ism and tr avel ing lo g distanc e for tr eatment 14

4.8 Medic al indemnity a nd insur anc e 14

4.9 Fe s 15

4.1 A r r ang ements for o t of ho r s and emer genc y c over 15

4.1 Complaints 15

4.12 Co fidentialty 15

4.13 S fe timing oftreatments 16

4.1 Reg istr atio 16

5 Faciities 1

5.1 Evaluation ofc ompla nc e and r isk management 1

5.2 Per sonnel 1

5.3 Documentatio ofmedical r ecor ds 17

5.4 Faciity 17

5.5 A dministr ative and waiting ar ea 17

5.6 Gener al r equir ements and r ecommen ations for tr eatment r ooms and pr ocedur e r ooms 17

5.7 Patient safety and security 18

5.8 Hyg iene standar ds for tr eatment r ooms and pr oced r e r ooms 19

5.9 Medicines Management 20 5.1 Tr eatment r oom (TR) 21 5.1 Pr ocedur e r oom (PR) 21 6 Tr eatments 22 6.1 Gener al 22 6.2 A esthetic medic al tr eatment categ or ies 22 6.3 Identifying factor s 23 6.3.1 Gener al 23 6.3.2 Pr ac titio e 23 6.3.3 Faciity 2

6.3.4 A na sthesia level 24

6.3.5 Risk lev el oftr eatment 24

6.3.6 Patient physical status a nd ag e 24

6.3.7 Mental status and pa tient ex pectations 25

6.4 Tr eatment identific ation 25

6.5 Co l ng of per iod 25

6.6 A esthetic medical tr eatments 25

A nnex A (nor mative) Co e ofEthic s for mar keting and advertising 28

A nnex B (informative) A–dev iatio s 30

Biblog r ap y 4

Eur opean for ewor d

surgery an aes hetic non-sur g ical medical se vic s”, the se r tar iat of which is held b A SI

This E r opean Stan ar d shal be given the s atus of a national s andard, eithe b publcation of an

identical tex t or b en orsement, at the lates b De embe 2 1 , an confl cting national s an ar ds

A ttention is dr awn to the p s ibi ity that some of the element of this document ma be the subje t of

p tent rig ht CEN [an / r CENELEC] shal not be held r sp nsible for identifying any or al such p tent

rig ht

A ccor ding to the CEN-CENELEC Internal R eg ulations, the national s an ar ds organizations of the

folowing cou tries ar b u d to implement this Eur opean Stan ard: A us ria, Belgium, Bulg ar ia, Cr oatia,

Ge many, Gr ee e, Hu gar y, Ic lan , Ir lan , Italy, L tvia, Lithuania, Lux emb urg , Malta, Nether lan s,

Norway, Polan , Portug al, Romania, S rbia, Slovakia, Slovenia, Sp in, Sweden, Switz r lan , T rkey an

the United Kingdom

Intr oduction

This E r opean Stan ard provides a set of r q ir ment , which ar de med to be es ential for the

provision of aes hetic medicine se vic s (non-surg ical medical tr eatment )

However, attention is drawn to the fact that in c rtain cou tr ies spe ific national r g ulations a ply an

take pr c denc over this Euro ean Standar d Use s of this Eur opean Stan ard ar advised to infor m

themselves of the a plca i ty or non-a plca i ty for this Eur opean Stan ard b their national

r sp nsibleauthorities

aes hetic medicine se vic s This ls is not inten ed to be ex haus ive

Emphasis is plac d on defining r q ir ment for the q alty of the aes hetic medicinese vic sofe ed in

orde to ensur patient afety

competencies, s af beha iour , faci ty design an choic of product an sup ler s

This E ro ean Stan ard is desig ned to bring the folowing advantages to those that ado t it:

— impr ovement in aes hetic medicine se vic s which can enhanc p tient safety an r d c the risk of

complcations;

— to promote consis ently hig h stan ards for aesthetic medicine se vic pr ovide s ac os E ro e;

provided in EN 1 2 4

Req ir ement conc rning the oc up tional health an safety ofse vic provide s an their s af at wor k

ar provided in r levant EU-Dir ctives an national oc up tional health and safety leg islation

1 Scope

tr eatment :

— tr atment with r esor ba leinje ta les, b tuln m tox in an micr o ne dlng;

— tr atment with non-a lative fr actional r esurfacing an super ficial pe ls, laser s an comp r able

ene gy b sed devic s;

pe ls;and

— othe tr atment such as de p chemical pe ls, ful a lative laser s an thr ead lfs

This E ro ean Stan ar d provides r commen ations for aes hetic non-sur g ical medical tr atment ,

inclu ing the ethical fr amework an g ener al pr inciples ac ording to which aes hetic medicine se vic s

r commen ations a ply befor , d ring an afe the tr atment

A ny aes hetic medical tr atment that goes de pe than the s ratum corneum or which has, or claims to

have, a biological efe t beyond the str atum corneum (with or without ins r ument or devic s) is

inclu ed in the sco e of this E ro ean Stan ard

A es hetic surg ical proc d r s cover d b EN 1 3 2 an dentistr y

1)

pr oc d r s ar e ex clu ed from the

sco e of this E r opean Stan ard

A es hetic non-medical tr eatment ( ato ing and any tr atment not afe ting tis ue de pe than the

s ratum corneum) which can be legaly pe for med b non-physicians (e.g tato is , beauty the a is s)

ar ex clu ed fr om the sco e of thisEuro ean Standard

F r the purp ses of this document, the folowing te ms an definitionsa ply

2.1

a sthetic medicine ser vic es

ser vic s r lated to non-surgical medical tr atment whe e the pr imary aim is the aes hetic change,

r stor ation or impr ovement of the a pear anc , the function an / r wel-being at the r q es of an

in ividual with medical tr atments, including the pr vention an tr atment of al kin of aes hetic

conc rn, ag ing proc s , as wel as the pr omotion of health

2.2

adver se event

u favour able, u ex pe ted or u intended temp rary or pe manent medical outcome to the p tient

Note 1 to entry: “Adver se event ” is defined in ISO/TS 1 2 8-1:2 1 , 2.1 as an ev ent as ociated with a medical

device that led to de th or serious injury of a patient, user or other per on, or that mig ht le d to de th or serious

injury of a patient, user or other per son if the ev ent recur T is definition is consistent w ith the g uidance in

G T / G2 N54/R 8:2 06 an definition inclu es malfu ction or deterioration of a device which has not yet

caused de th or serious injury, but which could le d to de th or erious injur y

1) As defined in EN ISO 1 42

Note 2 to entry: “Adv er e ev ent ” is defined in 2 0 / 0 E , A rticle 2 (m)as an u towar d medical oc ur rence in

a patient or clinical trial subject administ ered a medicinal prod ct an which do s not neces ar ily hav e a causal

relationship with this t r eatment

2.3

competenc e

demons rated an q alfied a i ty to a ply es a lshed scientific k owledg e an ski s ac ording with

the law an r g ulations of the cou try whe e is practic d

2.4

complaint

ex pr s ion of dis atis action made to an org anization or a pr actitione , r lated to it se vic s an / r

r sult , or the complaint -han lng pr oc s it elf, whe e a r sp nse or r solution is ex plcitly or

implcitly ex pe ted

2.5

“co lng of” per io

time between the en of the consultation whe e the tr atment is pr oposed, it r isks ar e ex plained an

the detai ed fe es imation isg iven, an the de ision to proc ed with this tr atment

Note 1 to entry: T is definition is from the pre mble to the Constitution of the Wor ld He lth Org anization as

adopted by the International He lth Conference, New York, 1 – 2 Ju e 1 4 ; sig ned on 2 July 1 4 by the

representatives of 61 States (Oficial R ecor ds of the W orld He lth Org anization, no 2, p 1 0) an ent ered into

for e on 7 April 1 48

2.8

patient satis actio

p tient'sper ception of the deg re to which the p tien s r eq ir ment have be n fulfi ed

Note 1 to entry: Patient complaints are a common in icator of low patient satisfaction but their a sence do s

not neces arily imply hig h patient satisfaction

Note 2 to entry: Even when patient r eq irements have b en ag re d wit h the patient an fulfiled, t his do s not

neces arily ensure hig h patient satisfaction

Note 3 to entry: T is definition was adapted from EN ISO 9 0 :2 1 , 3.9.2

notification of an adverse event, defe tive health car pr od ct or negligent se vic delvery to the

r levant competent authorities

3 Competencies

3.1 Gener al

3.1.1 During car activity, the pr actitione shal control the competencies and ca acities of per son( s)

he/she is the employer shal:

— deter mine the ne es ary competenc of per son( ) doing wor k u de it contr ol,

— ensur these per sons ar competent on the b sis of training, ski sand ex pe ienc ,

— whe e a plca le, take actions to acq ir the ne es ary competenc , and evaluate the efe tivenes

of theactions taken,

— r tain documented infor mation as evidenc of competenc ,

— che k the profes ional cr edentials and c rtified tr aining of any profes ional a plying to provide

3.1.2 If the aes hetic medicine se vic s ar delver ed in a faci ty plac d un e supe vision of a

manag ing dir ector, tasks desc ibed in 3.1.1 ar e u de r sp nsibi ty of b th practitione and managing

dir ctor

national, c rtified, updated r eg ularly an fr ely ac es ible to publc in p rticular via the inte net

3.1.4 Dir ctive 2 0 / 6/EC deman s for mal b sic medical training or spe ials medical training to

be r cogniz d b a national competent author ity

practic medicine autonomously Medical doctor s author iz d b the national competent authority ar

entitled to pe for m aes hetic medical tr eatment pr ovided they ar e trained to these tr atment

author iz d healthcar pr ofes ionals who shal be working u de the pr actitione ’s dir ect supe vision

(dir ct supe vision means to be physicaly pr sent in the faci ty an a le to r esp n an act ac ording

to the level of r isk of the proc d r )

3.1.6 A uthor iz d healthcar pr ofes ionals who ar alowed to work u de the pr actitioner 's dir ct

supe vision shal have a profes ional tr aining of at leas 3 year s

3.1.7 Tr atment with the use of lase s ( clas 2 an highe ), lght- (IPL an LED) an othe ene gy

b sed devic s shal only be a pled b q alfied medical practitioner s or b author iz d healthcar

profes ionals u de pr actitione 'sdir ct supe vision

3.1.8 Deleg ation of aes hetic medical tr atment to practitioner s who do not me t the national

r q ir ed competency shal not be alowed

3.2 Tr aining

3.2.1 A practitione un e taking aes hetic medical tr atment shal be trained in the r spe tive

tr eatment an this training shal be in complanc with the national competent author ity's rule with a

minimum of 3 year s

3.2.2 This training shal inclu e outcomes which r q ir e a fir m u der standing of the b sic scienc

principles an evidenc p s which u de pin tr eatment This includes but is not ex clusive to anatomy,

physiology, pharmacolo y, immunolog y, p tholo y an me hanis ic u der stan ing in the r espe tive

tr atment A deq ate k owledge is r q ir d to minimiz ina pro r iate tr atment or mis ed diag nosis

K nowledg e of a pr opriate medical tr eatment o tions is r q ir d to o timiz car Re og nition,

diag nosis an the a i ty to manag e complcationsr elating to ther levant tr atment is r q ir d

3.2.3 Training should also inclu e is ues r lating to ethics, psycholog y, consent an in emnity

3.2.4 Training shal have a theor tical par t an a practical p rt The pr actical p rt of the tr aining shal

inclu e a per iod of mentorship

(CME)

3.3.1 The pr actitione shal:

a) maintain a v ld r g is r ation b the national competent authorities of the cou tr y of pr actic an

shal beinvolved in aes hetic pr actic on a r gular b sis; an

b) aten at leas two CME ac r edited scientific event pe year r levant to the sphe e of aes hetic

practic he/sheper for msor ac r ditation b the r cogniz d national profes ion society

3.3.2 Practitioner s should pr fer ably be membe of a scientific society of their profes ion

practic an shal comply with the national ed cational r q ir ement , r elc nsing an / r maintenanc

of practic ag re ment

4.1.1 Hospitals, private es a lshment an private pr actic s as wel as al their medical or othe wise

involved p r tne s that ar e in a position to o tain p tient's information shal have a confidentialty p lcy

on prote ting p tien s privacy that is clear, u de s o d an wel k own b al s af

profes ionals to entic p tient to consult or to ha e primary or combined aes hetic medical tr atment

Economic consider ations shal not over ide p tient safety

4.1.3 The consultation pr oc s is an o por tunity to ex plor the conc pt of aes hetic medical tr atment

d ring which the patients shal have the implcations, lmitations an complcations of tr atment

ex plained in language they u de s an , an with written infor mation, inclu ing infor mation pr sented

on inte net websites, for them to r ead late – it shal not involve any entic ment to pr oc ed T e

consultation shal bedone in a lang uag e b th p rties can u de s and and agre on

4.1.4 The practitione shal g ive impartial o je tive advic d r ing the consultation for which a fe

should be charged

4.1.5 C nc lation polcies shal be clear to the p tient befor any p yment is made A ful r fu d of

tr atment fe s shal be g iven if any pr -p yment is made when the canc lation is within the “ co lng

of” per iod Furthe ar angement ar e at thepractitione /clnics discr etion but shal be clear ly ex plained

an set out in wr iting to p tient

4.1.6 The identification of any practitione who pe for ms the tr atment an his/he spe ialty(ies)

oficialy r cog niz d b the national competent authority shal a pear ac ur ately an without ambig uity

on lete heads an in al commu ications with thep tient

4.2.1 The initial consultation shal be with the practitione plan ing to u der take the aesthetic

medical tr atment

4.2.2 A ny othe pr ofes ional involved in the consultation proc s shal de lar their name, ex pe tise

an q alfications an ex plain their r ole in the consultation, i.e ju ior doctor in training, medical

se r tary or nur se Practitioner s should ex plain their role in scr eening or gene al health as es ment

Nur ses and non-medical profes ionals shal not be used as a shortcut for the practitione who r mains

r sp nsible for car efuly as es ing the p tient an thoroug hly u de taking the consent proc s

( e 4.3) Pr actitione s should make themselves awar of r eg ulator s' guidanc on r mote pr scr ibing

Pr actitioner s should s a infor med of g uidelnes an r ecommen ations is ued b competent authorities

on telemedicine It is g ood pr actic to wear an identification b dge

tr atment that he/she pe forms, the devic s that he/she uses an the r lated safety is ues

4.2.4 The practitione shal inform the p tient on outcome in icators ofthe tr atment that he/she

pe for ms, the devic s he/she uses an be a le to r late these outcome in icators with alte native

4.2.5 The pr actitione shal pr ovide infor mation that is u de s an a le, timely, verifia le, ac urate,

complete, truthful an not misleading

4.2.6 The pr actitione shal provide infor mation on the aim of the aes hetic medical tr atment,

benefit and harms, p tential adver se conseq enc s, inclu ing their fr q ency, alte native o tions an

cos s

alte natives The rationale should inclu e q alty as uranc and evidenc The practitione shal pro ide

b ckgrou d lte atur on the devic or pr od ct and it use up n r q es

4.2.8 A t the en of the fir st consultation al p tient shal be made awar e of the risks and benefit of

the pro osed aes hetic medical tr atment an shal be given the o portu ity to dig es the information

an r fle t on discus ions befor de iding to proc ed

for mor e r isky/ser ious tr atment Patient should be infor med that al consultations ne es ary to

his/he consent ar avaia le to him/he but also d ly infor med of financial ar ang ement r eg arding this

ad itional consultations

4.2.10 Proc s es designed to r fle t intention of outcome shal be used hones ly They shal not be used

as a marketing to l The lmitations of the proc s shal be ex plained to the p tient Practitioner s ar e

modified to manipulate the outcome of the tr atment

4.2.11 The initial consultation( ) shal inclu e

a) verification of the p tient’scondition to che k medical feasibi ty of the planned tr atment;

b) ex plor the spe ific aes hetic conc rns;

c) as es ment of patient's mental health/ sychological s ate, inclu ing pas psycholog ical/mental

health his ory whe e p s ible;

d) as es ment of p tient’sexpe tations;

e) r q es r elevant blo d tes s, if ne es ary;

f) r q es othe r elevant inves igations;

g ) r q es to communicate with r levant medical coleag ues;

If in doub the practitione should consult with or r fe medical spe ials s

h) if thep tient isdiag nosed with dysmorpho ia no aes hetic medical tr atment shal be pe formed;

i) pr -tr atment tes s an inves ig ations shal be per formed whe ea pr opriate The practitione shal

infor m the p tient of the financial implcations

NOT 1 T e consultation is the start of the consent proces , se 4.3

NOT 2 For consultation documentation, se 4.4

4.2.12 If the practitione de msthat the environment in which the aes hetic medical tr atment shal be

pe for med, the devic s or pe son el ar e not fit for purp se the practitione shal canc l the tr eatment

4.3.1 C nsent is an ongoing proc s ex ten ing from the time of firs contact unti the da of the

aes hetic medical tr atmen the majority of this pr oc s should be completed prior to b oking

4.3.2 The pr oc s shal inclu e the folowing:

a) A clear ex planation of the lmitations of the aes hetic medical tr atment and alte native tr atment

that ma be avaia le ( including those not ofe ed b the practitione )

b) A clear ex planation of the implcations of the aes hetic medical tr atment, including a clear

plans

c) The pr actitione shal ensur that the p tient clearly u der stan s the r isks involved with the

plan ed tr atment The fr q ently oc urr ing an therar , but ser ious, complcationsshould be fuly

ex plained an un e s o d A per sonal low r ate of complcation shal not be used to entic patient to

un e take aes hetic medical tr atment

If data ar avaia le, per sonal risks should be s ated in natural n mber s an in r lation to a n mbe

of tr ated p tient , for ex ample 1 out of 2 0 patient sufe from this side efe t r athe than 0,5 % of

al p tient

d) Thediscus ion shal inclu e an ex planation, in clear an un er stan a le ter ms, of the pr actitioner ’s

ex pe tations of outcome an the r elation between the outcome of the tr atment with those of

alternative tr eatment

e) W r iten information shal be given as ad itional mate ial and shal not take the plac of an informed

discus ion Practitioner s should ke p a r cord of b th the discus ions an of the information g iven

to the p tient Both p rties shal sig n the informed consent for m

p tential complcations of the aes hetic medical tr atment befor b oking it

g) Unti the initial consent proc s is complete ( he time at which the p tient fuly u de s an s the

l mitation, implcations and potential complcations of the aes hetic medical tr atment) al monies,

ex cept for any pr viously de lar ed non-r efu da le dep sit, shal r emain r fu da le

h) No p tient shal u der go an aes hetic medical tr atment without completion of the consent pr oc s

i) A es hetic medical tr atment for p tient u de the ag e of 1 year s should be exceptional and

l n ed to a documented medical as es ment of the risks and benefit ( health, social conseq enc s)

In those cases whe e it is cl nicaly or psycholog icaly ne es ary, the consent form shal be avaia le

in a leg al form of words a pro riate to the patient an / r their p r nt or guardians pr ior to the

aes hetic medical tr atment Par ental or g uardian written agre ment is man atory

j) Theconsent for ms should be legible, u der stan a le and signed b b th parties

k) The p tient's consent shal bepe for med in a lang uageb th p r ties can un er stan an ag re on

4.4.1 Medical r cords an notes shal be leg ible an u de stan a le

4.4.2 Medical r cor ds shal inclu e patient identification (at leas p tient's ful name, date of bir th)

an practitione ’s signatur e as wel as detais of the se ial n mber s, b tch, lot n mber s for any devic s

or healthcar prod ct that ar used on a p tient (e.g de mal fi e s an othe inje ta les)

4.4.3 Digital r ecords, whe e p s ible, shal inclu e the pr actitione ’ssig natur

4.4.4 Medical r ecords an notes shal be s or ed in a pr opriate se ur e faci ities which ar e r s r icted to

author iz d per sons

4.4.5 Data prote tion in s or age an han lng of p tient medical r cords an notes an detais shal be

ensur ed

4.4.6 Medical r cords an notes shal be s or ed an han led for a pe iod as legaly r eq ir ed If the e is

no legaly r q ir ed per iod it shal be at leas 1 year s

4.4.7 Medical r cords, notes an photogra hs shal be avaia le to the p tients at their r eq es , they

should be avaia le within a r asona le time, an any char g e made for co ying notes should be

a pro riate an r easona le

P otog r aphs should be s an ardiz d wher e p s ible Use of p tient's pictur es shal be s r ictly lmited to

the use author iz d an sig ned b the p tient in the consent for m

4.4.9 Patient’s photogra hs shal be s or ed a pro r iately an confidentialty r spe ted

a pro riate consent shal be o tained

4.4.11 Medical r cords shal only be r eleased to third p r ties with the p tient or leg al r epr sentatives

sig ned consent Medical r cords shal only be r leased to third p rties in caseof p tient’sdeath

4.5.1 Patients should r c ive a discharge summary when leaving the ofic or the faci ty, if a plca le

This should inclu e information a out any aes hetic medical tr atment pe for med, if a plca le

cl nical warning sig nsto watch for, contact detai s in the case of an eme gency an detais for fir st folow

up consultation

contact if the e is a pro lem afe tr eatment It is bes practic for the practitione to se the patient

per sonaly Some aes hetic medical tr atment do not ne d dr s ing s; the pr actitione shal infor m the

p tient ac or ding ly

4.5.3 F low up shal be ensur d, if ne es ary

4.5.4 The practitione shal ke p a documented r ecord of tr atment , used devic s and product and

folow-up tr atment

4.5.5 In the case of late aes hetic/fu ctional conc rns the p tient shal have the rig ht to consult

a pro riatear ang ement

4.5.6 The p tient sur vey should aim to be car r ied out upon discharg e and long -ter m folow up

4.5.7 Pos -tr eatment information r lated to the tr eatment should bemade avaia le to the p tient

4.6 A dver tising

A dvertising should be avoided

In cou tr ies, wher e adver tising is alowed, the folowing a ples:

a) National advertising rules and prohibition shal be folowed b any in ivid al, group or busines

wishing to commu icate with, or advertiseto, p tient in the countr y conc r ned

b) A dvertising an marketing in any for m shal be leg al, de ent, hones , tr uthful an socialy

r sponsible

NOT Gener al g uidance on social responsibility is provided in ISO 260 0

c) A dvertorial tr ansp r ency shal be as ur d an p tient shal be awar fr om the tex t when an article

is an advertorial

d) Fr e consultation shal not be used as a marketing to l

e) No models shal be used eithe in advertising or marketing an a de lar ation of conflct of inter es

shal bepr ominent

emplo e s, ar e involved in blog/web commu icationsthey shal de lar their true identity

g ) Theoficial profes ional s atus/q alfication of the practitione shal be clear ly stated

h) Practitione ’s q alfications shal not be misr pr esented and only the spe ialty ls ed in

EU-Dir ctive 2 05 3 /EC in which the practitione is q al fied shal be used No te ms shal be used

that g ive patient or the publc the wrong impr es ion of a q alfication in a spe ialty ls ed in

EU-Dir ctive 2 05 3 /EC or spe ialties r cog niz d at national level, in ther espe tive cou try

i) Commis ion b sed p tient advisor s shal not be used Refe ring profes ionals or othe pe sons,

inclu ing p tient , shal not r ec ive pa ment/r mu er ation or fe discou t for making p tient

r fe rals Patient shal ex pe t that any r fe ral is made in their bes medical inte es an does not

involve any financial transaction

j) Patient's tes imonial used b practitione s for publc infor mation shal be ver ifia le, trac a le and

u p id

k) F r furthe detais, se A nnex A

4.7 Medical tour ism and tr avel ing long distance for tr eatment

Medical tourism an tr avel ng long dis anc for tr eatment ar rar ly in the p tient's bes inte es In

ad ition to the othe subclausesin Clause 4 the medical es a lshment an the practitione :

tr atment an that folow up, an the manag ement of even minor complcations/ dis atis action

be omes a complcated pr oc s ;

practitioner s ar eq ivalent to se ing the pr actitione pe forming the tr atment at any time that

ma be ne es ar y in the futur ;

ex plaining the dificulties in the case of complcations/ dis atis action with the r sult It is advised

this is pr esented as a risk disclosur e document and that it is sig ned b the p tient;

d) shal infor m the p tient in the case of category 3 an 4 aes hetic medical tr atment ( e 6.2) a out

the risk of long dis anc tr avel ng in the pr - an p s -tr atment pe iod;

complcations to third p rties They act as an ind c ment b making a dangerous pr oc s slg htly

mor atractive but no les dang erous;

ar angement of the pr actitione and, if a plca le, the medical es a lshment wher e tr atment ar e

pe for med;

g ) should infor m p tient oftier s of r esp nsibi ty should pr oblems ar ise Patient shal not be misled

into beleving that the comp ny making the ar angement for their trip car ies medical la i ty

insur anc ;

Req ir ment in this E r opean Stan ard also a ply to travel ng practitione s

4.8.1 Practitioner s shal hold a medical in emnity insuranc for each kin of tr eatment they per for m

This insuranc should also cover damages or pro lems that ar e u ex pe ted or u for ese a le at the time

of tr atment

4.8.2 Patients shal be infor med that the pr actitione u de taking their aes hetic medical tr atment

p s es es profes ional in emnity insur anc that it is r cogniz d as being a pro riate an adeq ate for

practic in the cou try involved If the in emnity insuranc is held out ide the country of practic the

practitione should infor m the p tient of this an of any p tential financial/ r eg ulatory implcations

a pro riate in emnity for the tr atment being u de taken, r gis er ed in the cou try whe e the

tr atment is pe for med

aes hetic medical tr eatment he/she pe forms to the insur er, th s ensuring that he/she r mains

4.9.2 L ng te m financial implcations should be clear

4.9.3 Financial ar rangement for complcations should be ex plcit

tr eatment or fur the tr atment

deposit

4.10 A r rang ements for out of hour and emerg ency cover

4.1 1 Patient shal be provided with contact detais for their practitione / medical es a lshment in

the case of eme g ency

4.1 2 Out of hour s car would normaly be ex pe ted to be provided b the practitione involved in the

ex plained to the p tient

4.1 3 If a practitione is not a ai a le for any r ason they shal pr ovide p tient with a pr opriate an

adequate cover, of a simiar level of profes ional ex pe tise F r tr atment with hig he risk a thor ough

handover of p tient is expe ted

4.1 1 A ll practic s/ medical establshment ofe ing aes hetic medicine se vic s shal have a clear

complaint proc d r an proc s , including timefr ame for r sp n ing

4.1 2 Patient should be madeawar of the practic / medical es a lshment ' complaint pr oc d r e

NOT General g uidance for complaints han ling is provided in ISO 1 0 1, ISO 1 0 2an ISO 1 0 3

Patient confidentialty shal be r spe ted at al times

4.13 S fe timing of tr eatments

4.13.1 The pr actitione shal inform the p tient if the timing, complexity, or d ration of their aes hetic

medical tr atment could introd c ad itional risks/complcations ( e.g pe lng befor e su ex posur e)

4.13.2 The practitione shal inform the patient of ad itional risks as ociated with the aes hetic

medical tr atment if p tient behaviour ma modify these, e.g smoking c s ation an weig ht los

4.13.3 The pr actitione shal inform the p tient if s o ping or taking any medication would modify r isk

of the aes hetic medical tr eatment

psychological s ate when consider ing whethe aes hetic medical tr eatment is a pro riate

A ll practitioner s an medical establshment shal ber gis er ed an / r authoriz d with the a pro r iate

r gulatory b diesin the cou try of practic , an these detais shal be avaia le to the publc

5.1.1 C nsis ent with it commitment to complanc , a pr oc d r ( s) for per iodicaly evaluating

implemented an maintained Records of the r sult of the pe iodic evaluations shal be kept

5.1.2 The practitione shal not u de take any aes hetic medical tr atment r eq es ed b a patient if it

is consider ed that the r isk-benefit b lanc is u favoura le (primum non noc r )

r p rted to the vig ilanc contact point in the national competent authorities Whe e a pr opriate,

provisions shal be in plac if such adver se event oc ur in te ms of product r ecal, contact to the

man factur of the pr od ct, etc Pr oc d r s to cal b ck p tient shal be pr e-es a lshed if such adver se

event oc ur The data ase alowing to r cal p tient shal be r gular ly updated

5.2.1 The Medical Dir ector shal be a Medical Doctor who is actively involved in the manag ement and

dai y routineof the faci ty

activities, inclu ing devic s an pr oc d r s uti z d in the tr atment of eme g encies Their ski s shal

be updated per iodicaly, pr fe a ly an ualy and whenever ne es ary, i.e d e to chang e( ) in national

r eg ulations or medical r commen ations for g iven tr atment

5.2.3 A ll medical pe son el dir ectly involved in p tient car should be trained in cardiovascular

r esuscitation an in spe ific eme g encies r levant to aes hetic medical tr eatment

descr iptions

5.3 Documentation ofmedical r ecor ds

5.3.1 Ther e shal be faci ties an wor king sp c s for documenting p tient ’ his ory A ll p tient ’

his ory shal be se ur ly kept an only ac es ible to author iz d per sonal

5.3.2 Medical r cor ds shal be leg ible, documented an completed ac ur ately an in a timely man e

Medical r cords shal bekept b the numbe of year s legaly r q ir d and at leas 1 years

5.4 Faci ity

5.4.1 The entir faci ty (inclu ing corr idors) shal be maintained and cleaned

5.4.2 Smoking shal be prohibited in the whole healthcar e faci ty

5.4.3 Ther e shal be a lavatory and changing ro ms (if ne ded) for p tient The lavatory faci ties

or ar a for the p tient shal ensur e the privacy of the patient

5.4.4 Medical sup les, devic s and eq ipment shal be s or d in a safe man e to b th maintain their

cleanlnes , s er ilty, fu ctionalty an to pr vent injury to p tient

5.4.5 Storag e sp c shal be cleaned, maintained and fr e of ltter an clutter

5.4.6 The faci ty shal be pr ovided with a pr opriate lghting

5.5 A dministrative and w aiting ar ea

5.5.1 Ther e shal be a clean waiting ro m, maintained an fr e of clute an lte an lg hted

5.5.2 If ne ded, the e should be an ar a for adminis r ative activities This ar a shal be ventiated,

temper atur controled for pe sonnel comfort, cleaned, maintained an lt

r ooms

faci ities ne ded to ensur e the safety of the p tient d ring provision of aes hetic medicine se vic s

con itioner , if pr sent, should be individ aly r gulated, r gularly cleaned and s o ped up n patient

r q es In ad ition, the air tr atment system( s)shal be r g ularly contr oled, cleaned an verified

5.6.3 Flo r ties shal be sealed, if in ivid al flo r tiesar e used

5.6.4 The c i ng shal be dus -tig ht

5.6.5 A ll o ena le windows to the out ide shal be prote ted ag ains the entranc of inse t , e.g b

inse t win ow sc e ns, an shal be view prote ted

5.6.6 Each ro m shal be of a siz to alow for the pr senc of al devic s an per son el ne es ary for

the pe formanc of the aesthetic medical tr atment

5.6.7 Each ro m shal have wiring that me t the man factur r’s spe ifications The e shal be no

overlo ded wal plug s or ex tensions, no alte ed grou ding plug s an no wir s that ar broken, wor n or

u shielded

5.6.8 Ther e shal bean o er ating ta le or tr atment chair with al ne es ary aux ilar y devic s

NOT Particular req irements for the b sic safety an es ential per formance of oper ating t ables are provided

in EN6060 – –4

5.6.9 F ci ties for hand washing, waste disp sal and wor k surfac s shal be avaia le

5.7 Patient safety and sec urity

5.7.1 Unauthoriz d in ivid als shal be pr vented fr om entering b means of e.g locks, alar ms, faci ty

pe son el or se ur ity per son el

5.7.2 A ll o ening s to ex te nal sp c shal be pr otected a ains theentranc of la individuals

5.7.3 A pr oc s shal be implemented to as es the medical faci ty’s a i ty to me t p tient, s atutory,

faci ity In addition, the pe son r sp nsible ofthe medical es a lshment (inclu ing the practitione

r q ir ement , the practitione shal take a pr opriate action on the eq ipment or any devic afe ted

s ated inten ed use sup led b the man factur er Of la el use is the spe ific r esponsibi ty of the

practitione and the p tient shal beinfor med of any of la el use

5.7.5 A ll medical hazardous was es an their p ckaging shal be s or d in suita le container s, an

separated fr om g ene al waste/r efuse for spe ial cole tion an handlng

5.7.6 A ll medical hazar dous was es an their packa ing shal be disposed of in sealed, la eled

containe s

5.7.7 Ther e shal be a F ci ty Safety Man al The F ci ty Safety Man al shal provide employees with

infor mation r lating to al hazar dous chemicals used an methods to minimiz ex posur e to per son el

5.7.8 Hazardous chemicals shal be la eled an s or d in ac ordanc with r ecog niz d s an ar ds

5.7.9 If a lase of clas 1 , 3B or 4 or intense pulsed lght (IPL) devic is used, al a plca le lase

safety stan ards shal be implemented an folowed

NOT 1 F rther g uidance for the safe use of laser b ams an IP dev ices on h mans an laser eq ipment is

provided in IE /TR 60 2 – an IE /TR 6247 – respectiv ely E uipment clas ification an req irements for

laser prod cts are pr ovided in EN 60 2 – an EN 6060 – – 2 E uipment clas ification an req irements for

IP devices are provided in EN 6247 an EN 6060 – – 7

5.7.10 A ny ex plosive or combustible mater ials an sup les shal be stor d an han led in a safe

5.7.11 C mpr s ed g as cylin er s, if pr sent, shal be s or d an han led in a safe man e

5.7.12 Ther e shal be a writ en p lcy spe ifying an man ating the use of a pro riate per sonal

protective eq ipment or the prote tion of the p tient for each spe ific task in the faci ty

5.7.13 Fir ex ting uishe s shal be avaia le, r gularly inspe ted an shal confor m to local fir e codes

throug hout thefaci ty

5.7.14 Fir ex it sig ns shal be sig np sted an i uminated In case of p we faiur ther e shal be

emer g ency lg ht for ex it routes an patient car ar eas Pas ag e and halways shal alow evacuation of a

p tient b eme g ency pe son el (inclu ing s r tcher s, etc.) If a s airwa is pr sent, it shal be wide

enoug h to alow evacuation of a p tient b eme g ency per sonnel ( inclu ing their devic ) If an elevator

is pr sent, it shal be large enoug h to alow evacuation of a p tient b emer g ency per son el (inclu ing

their devic ) In caseof fir e elevator s shal not be used for the evacuation of a p tient

5.7.15 Ther e shal be a writen protocol for S curity emer g encies:

— for fir e an fir e dri s,

— for cal ng a pro r iate pe son el for unplan ed or eme g ency r tur n of p tient to his/he the r oom

an ,

— if a plca le, for immediate or timely r turn to the tr atment r oom for p tient eme gencies

5.7.16 Ther e shal be a writen protocol for:

b) situation in which the practitione be omes inca acitated,

c) r sponse to powe fai ur eme g encies,

d) trans e r ing patient in an eme g ency,

e) plan for eme g ency evacuation of faci ty

5.8 Hyg iene standar ds for tr eatment r ooms and pr ocedur e r ooms

r q ir ement

5.8.2 In orde to prote t the p tient, aseptic con itions shal be ensur ed b using s er ile, prote tive

g owns, a rons, masks, eye prote tion an gloves as a pro riate

5.8.3 Disp sa le mater ials an devic s should be used If this is not p s ible r -s e i za le mate ials

an devic s shal be used

5.8.4 Ther e shal be a sched le for cleaning an disinfe tion for al r ooms an al devic s to pr event

5.8.5 In or de to prote t the patient, any risk of contamination in uc d b blo d an b dy fluids shal

be pr vented b efe tive cleaning an disinfe tion using a pro riate g er micides in icated as virucidal,

b cter icidal, tube culocidal, fu g icidal, levur icidal, myco acter icidal, sp ricidal

5.8.6 The wals an cou te to s shal be cover d with smo th, an easy to clean mater ial which is

fr e fr om tears, br aks or c acks The flo r shal be easiy washa le Carpet an curtain shal not be

used W asha le bl n s ar per mitted

5.8.7 Used disp sa le sharp items shal be plac d in se ur pu ctur -r sis ant containe s which ar e

located as close to the tr eatment ar ea as is practical

NOT R eq irements for harps container s ar e inclu ed in EN ISO 2 9 7

5.8.8 If a steri z r prod c s monitoring r ecords, they ar r viewed b a pro riate per son el an

s or d

5.8.9 Each s e i z d p ck shal be marked with the date of s e i zation an when a plca le, with the

ex piration date, so as to deter mine which supples ar to be r -s er ilz d and to identify sup les that

wer s e i z d firs an ar ther efor e to be used first When mor e than one s e i z r is avaia le, each

p ck shal ad itionaly be la eled so as to identify in which s er ilz r it was s er ilz d Ster ilz d

ins rument should be s or d in a man e that pr se ves the integrity of the p ckage T ey should be

s or d in enclosed ca inet , racking or drawers fr ee from mois ur or , an not s or d on the flo r, u de

sin s, on win ow si s, or adjac nt o air vent

5.8.10 Dirty devic san ins rument shal be s r ictly sep r ated fr om those which have be n cleaned

a pro riate r ecords shal be kept

5.8.12 Befor usag e of r e-usa le medical devic s they shal be de ontaminated, cleaned and s er ilz d

ac ording to r elevant s an ards, inclu ing pe sonal pr ote tion, for cleaning , disinfe tion an

s er ilzation

5.8.13 F r ins r uments that can ot be s e i z d b a heating proc s a valdated pr oc s for cleaning

an disinfe tion shal be folowed

member s shal be trained to use them

5.9.2 If nar cotics ar used, the e shal be a dated, seq ential nar otic inventory an control r cor d

which inclu es the use of nar cotics on in ivid al p tients Such r cords shal be kept in a r trievable

for mat

5.9.3 A ll nar otics an contr oled subs anc s, if pr sent, shal be se ur d an locked, not p rta le, and

u de supe vised ac es

Medications shal be s or ed in a tempe atur e controled envir onment Refr igerators shal be eq ip ed

with a temper atur alarm

5.9.5 A ll medications ne es ary for emer g ency cases shal be avaia le an stor d in a spe ific ar ea

5.9.6 A t leas the folowing eme gency medications shal be avai a le in the faci ty at al times:

— epinephr ine,

— amiodar one,

— seizur e ar es ing medication (a benzodiaz pine),

— bronchospasm ar es ing medication ( in aled beta ag onis ),

— intravenous or intramuscular corticos e oids,

In addition to 5.6 r q ir ement spe ific for a tr eatment r oom ar e:

a) Ther e shal be sp c an al ne es ary eq ipment to ensur e safe an aseptic tr atment of the

patient Pe sonal pr ote tive eq ipment, which shal be worn for the pr ote tion of the p tient, shal

be avaia le an r oom to put it on is provided

b) A n automated ex te nal defibr ilator (A ED) should be pr sent in close prox imity and s af member s

trained to use it

c) A s a minimum, the folowing shal be avaia le:

1) lghting for ex amination and tr atment;

In addition to 5.6 r q ir ement spe ific for a proc d r r oom ar e:

a) If the practitione per for ming the aes hetic medical tr atment leaves ther oom d ring the tr eatment

the e shal be at leas a fuly q alfied n r se or doctor ’s as is ant pr esent No patient can be lef

alone without medical supe vision d r ing a tr atment

b) A ppro riate tr ansportation p s ibi ties shal be pr ovided, e.g whe lchair ,troley or l f faci ties

c) The pr oc dur r oom shal be physicaly an dis inctly sep r ate an segreg ated from the g ener al

ofic ar ea (e.g waiting ro m, ex am ro m, adminis rative ar a, physician ofic , s af lou g es)

d) The proc d r r oom shal have an eme gency p we sour ce, ( e.g b ter y p wer d inverte ), with

suficient ca acity to o er ate medical ele tr ical eq ipment, caute y and lg hting u ti the tr atment

can be s o ped in a safe manne This eme g ency p wer sour ce shal be a le to begin g ene ating

ample p wer to o er ate al the es ential ele tr ical devic being used in the tr atment within 3 s in

case of a p wer fai ur e The eme g ency p wer devic shal be che ked r g ularly (e.g monthly) to

g ) F r aes hetic medical tr atment pe formed u de sedation, the e shal be a tr ans e ag re ment with

a local ac r edited or lc nsed acute car hospital which is a proved b the faci ty’s medical s af or

the practitione has privieg es to admit p tient to such a hospital afe having pe for med the

aes hetic medical tr atment in the faci ty

h) The p tient shal be monitor d d r ing and afe the aes hetic medical tr atment

2

an suction shal be pr ovided

j) Eme gency Cart shal be avaia le with defibri ator , ne es ary drugs an othe devic s ne ded for

car dio ulmonary emer g ency A n automated ex ter nal defibr ilator (A ED) shal be pr sent an staf

member s trained to use it

k) Ther e shal be a pro r iate stor age of phar mac uticals, disp sa le items, mater ial for inje tions,

s e ie medical pr oduct

l) The flo r shal be antistatic an sealed

m) W als and flo rs shal be washa le an r sis ant ag ains disinfe tant

n) Me hanical air-venting is ne es ary in gene al

o) The windows shal be closed, and shal be o ened only in case of eme g ency

p) A s a minimum, the folowing eq ipment shal be avaia le:

1) faci ties for infusion an r suscitation;

2) lg hting for ex amination an tr atment;

A es hetic medical tr atment ar subje t to change This clause set out curr ent practic an the g ene ic

g roups of these tr atment F r ex act definitions of tr atment pe r r viewed journals, Euro ean an

national competent org anizations an authorities should be consulted

The fol owing aes hetic medical tr atment categor ies a ply:

C teg ory 1: A esthetic medical tr eatment with r esorb ble inje ta les, b tulnum tox in an micr o

ne dlng;

C teg ory 2: A es hetic medical tr atment with non-a lative fractional r surfacing an supe ficial

pe ls, lase san comp ra le ene gy b sed devic s;

Category 3: A esthetic medical tr eatments with fr actional a lative laser s an comp ra le ene g y

b sed devic s and medium depth pe ls;

Category 4: A esthetic medical tr atment not categ oriz d in C tegories1, 2 or 3, such as de p

chemical pe ls, ful a lative laser s an thr ad lfs

— anaes hesia level, se 6.3.4;

— risk level of tr atment, se 6.3.5;

— patient physical s atusan ag e, se 6.3.6;

— patient mental status and ex pe tations, se 6.3.7

The r elation between aes hetic medical tr atment an categ or ies is outlned in Fig ur 1

Fig ur e 1 — Rela tio s

The practitione is the mos imp rtant identifying factor A thor ough k owledge of the spe ific aes hetic

medical tr atment a pr actitione wishes to pe form shal be o tained throug h r cog niz d training

b dies ( e Clause 3)

6.3.3 Faciity

To promote p tient safety, minimum s an ards shal be fulfi ed to ensur that the pr actitione wi be

a le to deal with al u for ese n cir cums anc s an p tential complcations of any tr atment they ma

medication, infras ructur e an pe sonal competencies as pr sented in Clause 5

The r ooms, in which aes hetic medical tr atment ar pe for med, ar defined as folows:

TR Tr atment ro m for aes hetic medical tr atment of categ ories 1, 2 an 3 as defined in 6.2

( e Clause 5, espe ialy 5.1 ),

PR Proc d r e r oom for aes hetic medical tr eatment of categ ory 4 as defined in 6.2 ( se Clause5,

espe ialy 5.1 )

6.3.4 A na sthesia level

I To ical or no anaes hesia,

I L cal, loco-r egional anaes hesia (per ipher al ne ve blocks) without sedation

6.3.5 Risk level oftr eatment

Risk levels ar e defined as folows:

A Minimal r isk ( i.e mid transient signs/symptoms);

B imp ir ment (i.e moder ate tr ansient sig ns/symptoms);

C disa i ty (pe manent damag e without fu ctional r es rictions);

D handica (per manent damag e with fu ctional r s rictions);

E death

Ther e ar no risk fr e tr atment A ny aes hetic medical tr atment car ies an element of risk of

pe manent scar ing , per manent disa i ty and even death

Tr atment in Ta le 1 ar e categ oriz d ac ording to the mos sever complcation of the tr atment, but

ex clu ing risk level E (death)

6.3.6 Patient p ysical status and ag e

A ll p tient shal be as es ed as descr ibed in 4.2.1 Patient ' physical s atus isdefined as folows:

1 normal healthy p tient (no organic, physiologic or psychiatric dis urb nc , healthy with g ood

ex er cise toler anc ),

2 p tient with mid sys emic disease (no fu ctional lmitations; p tient has a wel-controled disease of

one b dy system; controled hype tension or dia etes without systemic efe t , cig ar ete smoking

without chr onic o s r uctive pulmonary disease (COPD); mid o esity, pr gnancy),

3 p tient with sever e systemic disease ( ome fu ctional lmitation; p tient has a controled disease of

cong es ive heart faiur e (CHF), s a le angina, old heart atack, p or ly controled hype tension,

morbid o esity, chronic r enal faiur ; br onchosp s ic disease with inter mitent symptoms),

4 p tient with sever systemic disease that is a constant thr at to lfe (p tient has at leas one sever e

disease that is p orly controled or at end s ag e; p s ible r isk of death; u s a le ang ina,

symptomatic COPD, symptomatic CHF, hepator nal faiur ),

5 mor ibu d p tients who ar not ex pe ted to sur vive without surg ery (not ex pe ted to sur vive afe

haemodynamic instabi ty, hypother mia, po rly controled co gulo athy),

6 de lar ed br ain-dead p tients whose org ans ar being r moved for donor purp ses

Patient ' physical s atus4, 5 an 6 ar not used for thepur pose of this Euro ean Standard

F r p tient two ag e-levels ar defined:

Y Below 1 year s of ag e

O 1 years of ag e or a ove

6.3.7 Mental status and patient ex pectations

A ll p tient shal be as es ed as desc ibed in 4.2.1 to ex clu e u r als ic ex pe tations an some mental

disorder s such as dysmor pho ia

Sinc Ta le 1is not inten ed to be ex haus ive, aes hetic medical tr atment not inclu ed in Ta le 1 shal

be alocated b the practitione to an ‘eq ivalent’ tr atment that is inclu ed in Ta le 1 A es hetic

medical tr atment that can ot be alocated shal be ls ed sep rately T ese tr atment an tr atment

that do not yet ex is at this time shal be clas ified as folows:

ex is ing or mentioned tr atment , using an evidenc b sed a pr oach

sufe ing of mid systemic diseases(physical s atus 1 or 2 ac or ding to 6.3.6)

6.5 Cool ng of per iod

The “co lng of” pe iod depen s on the aes hetic medical tr atment category ( e 6.2) and on the r isk

levels ( se 6.3.5) The minimum “ co lng of” pe iod should be:

a) for tr atment categ ories 1 an 2: No “co lng of” per iod;

b) for tr atment categ ories 3 an 4:

1) risk level A to C: 24 h;

2) risk level D: 1 week;

c) for p tient with mental health impair ment: 4 weeks

Some phenol pe ls an a lative non-fractional r surfacing of the fac might r q ir g ener al anaes hesia

or loco-r gional anaesthesia with sedation In such cases, even thoug h gene al anaes hesia an

loco-r gional anaes hesia with sedation ar e not cover d in this Euro ean Stan ar d, these tr eatment shal be

carr ied out in an o e ating theatr envir onment with an anaes hesiolog is

Non-r esorb ble fi er s shal not be used u ti ong oing clnical trials pr ove long te m safety

Based on the factor s identified in 6.3 aes hetic medical tr atment ar clas ified in Ta le1 In Ta le 1,

tr atments ar categ oriz d ac ording to the mos sever complcation of the tr atment, but excluding

risk level E (death); it shal be noted, that al these aes hetic medical tr atment can lead to a r isk of

death

In orde to ensur p tient safety al tr atment shal be carr ied out ac ording to bes clnical practic

with spe ial at ention to s er ilty an safety of the eq ipment used ( e 5.8)