EN 16844-2017 en Aesthetic medicine services - Non-surgical medical treatments (Incorporates Amendment A1 2018).pdf

1、Aesthetic medicine services Nonsurgical medical treatmentsBS EN 16844:2017Incorporating corrigendum July 2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16844 June 2017 ICS 03.080.99; 11.020.10 English Version

2、Aesthetic medicine services - Non-surgical medical treatments Services en mdecine esthtique - Traitements mdicaux, non chirurgicaux Dienstleistungen in der sthetischen Medizin - Nicht-chirurgische, medizinische Behandlungen This European Standard was approved by CEN on 27 February 2017. CEN members

3、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 t

4、o 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

5、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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lith

6、uania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marn

7、ix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16844:2017 ENational forewordThis British Standard is the UK implementation of EN 16844:2017.The UK committee draws readers attention to hair transplantati

8、on, as a treatment modality, not being covered in this standard or the corresponding surgical standard, BS EN 16372, Aesthetic Surgery Services. The UK committee are of the opinion that hair transplantation should be standardized at CEN level and will put a proposal forward to CEN. The UK participat

9、ion in its preparation was entrusted to Technical Committee CH/403, Aesthetic Surgery and Aesthetic Non-Surgical Medical Services.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provision

10、s of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 51146 2ICS 03.080.99; 11.020.10Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was

11、published under the authority of the Standards Policy and Strategy Committee on 31 July 2017.Amendments/corrigenda issued since publicationDate Text affected 31 July 2017 Missing National Foreword text addedBRITISH STANDARDBS EN 16844:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16844 Ju

12、ne 2017 ICS 03.080.99; 11.020.10 English Version Aesthetic medicine services - Non-surgical medical treatments Services en mdecine esthtique - Traitements mdicaux, non chirurgicaux Dienstleistungen in der sthetischen Medizin - Nicht-chirurgische, medizinische Behandlungen This European Standard was

13、approved by CEN on 27 February 2017. 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 na

14、tional 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 lan

15、guage 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, Former Yugoslav Republic of Macedonia, France, Germany, Greec

16、e, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR N

17、ORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16844:2017 EBS EN 16844:2017EN 16844:2017 (E) 2 Contents Page European foreword 4 Introduction 5 1 Scope .

18、 6 2 Terms and definitions . 6 3 Competencies . 8 3.1 General . 8 3.2 Training 8 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 .

19、 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 . 14 4.9 Fees . 15 4.10 Arrangements for out of hours and emergency cover .

20、15 4.11 Complaints . 15 4.12 Confidentiality 15 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 Gen

21、eral 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 . 22 6.1 Gen

22、eral 22 6.2 Aesthetic medical treatment categories 22 6.3 Identifying factors . 23 6.3.1 General 23 6.3.2 Practitioner 23 6.3.3 Facility . 23 6.3.4 Anaesthesia level . 24 BS EN 16844:2017EN 16844:2017 (E) 3 6.3.5 Risk level of treatment . 24 6.3.6 Patient physical status and age 24 6.3.7 Mental stat

23、us and patient expectations . 25 6.4 Treatment identification . 25 6.5 Cooling off period 25 6.6 Aesthetic medical treatments . 25 Annex A (normative) Code of Ethics for marketing and advertising . 28 Annex B (informative) Adeviations 30 Bibliography 45 BS EN 16844:2017EN 16844:2017 (E) 4 European f

24、oreword This document (EN 16844:2017) has been prepared by Technical Committee CEN/TC 403 “Aesthetic surgery and aesthetic non-surgical medical services”, the secretariat of which is held by ASI. This European Standard shall be given the status of a national standard, either by publication of an ide

25、ntical text or by endorsement, at the latest by December 2017, and conflicting national standards shall be withdrawn at the latest by December 2017. 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 h

26、eld 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, Eston

27、ia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16844:2017

28、EN 16844:2017 (E) 5 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

29、 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

30、 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 offe

31、red 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 th

32、ose 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 syst

33、em 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. BS EN 16844:2017EN 16844:

34、2017 (E) 6 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 ene

35、rgy 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 treatm

36、ents, 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

37、 deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard. Aesthetic surgical procedures covered by EN 16372 and dentistry1)procedures are excluded from t

38、he 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

39、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-bein

40、g 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 2.2 adverse event unfavourable, unexpected or unintended temporary or permanent medical outcome to the patient Note 1

41、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

42、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. 1) As defined in EN ISO 1942. BS EN 16844:2017EN 16844:2017 (E) 7 Note 2 to entr

43、y: “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 ap

44、ply 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 r

45、esponse 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 establi

46、shment 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

47、adopted by the International Health Conference, New York, 1922 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 patients perception of the degree t

48、o which the patients 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 f

49、ulfilled, 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 BS EN 16844:2017EN 16844:2017 (E) 8 3 Competencies 3.1 General 3.1.1 During care activity, the practitioner shall control the competencies and capac