EN 16372-2014 en Aesthetic surgery services《美容外科服务》.pdf

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1、BSI Standards PublicationBS EN 16372:2014Aesthetic surgery servicesBS EN 16372:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 16372:2014.The UK committee agrees that this standard provides a frameworkto work by for those working in Aesthetic Services and a

2、lso aguideline for those seeking treatment. It will act as a benchmark forAesthetic Services in the United Kingdom and across Europe.Please note that Annex C, which lists A-deviations for the UK, is notrelevant to the Aesthetic Surgical Services Standard. It only appliesto prEN 16844 Aesthetic medic

3、ine services - Non-surgical medicalprocedures, which was developed at the same time as this standard.Therefore, this text is not relevant to this Aesthetic Surgical ServicesStandard in the United Kingdom.The UK participation in its preparation was entrusted to TechnicalCommittee CH/403, Aesthetic Su

4、rgery and Aesthetic Non-SurgicalMedical Services.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Stan

5、dards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 77027 2ICS 03.080.99; 11.020Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 January

6、 2015.Amendments issued since publicationDate Text affectedBS EN 16372:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16372 December 2014 ICS 03.080.99; 11.020 English Version Aesthetic surgery services Services en chirurgie esthtique Dienstleistungen in der sthetischen Chirurgie This Euro

7、pean Standard was approved by CEN on 28 October 2014. 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 c

8、oncerning 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

9、 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, Former Yugoslav Republic of Macedonia, Franc

10、e, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOM

11、ITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16372:2014 EBS EN 16372:2014EN 16372:2014 (E) 2 Contents Page Foreword 4 Introduction .5 1 Scope

12、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 .9 4.3 Co

13、nsent 11 4.4 Documentation 12 4.5 Investigations 12 4.6 Cooling off period . 13 4.7 Post-operative follow up and dressings 13 4.8 Publicity and advertising . 14 4.9 Travelling long distance for treatment . 14 4.10 Medical indemnity and insurance . 15 4.11 Fees 15 4.12 Arrangements for out of hours a

14、nd emergency cover . 15 4.13 Allied health professionals 16 4.14 Complaints 16 4.15 Confidentiality . 16 4.16 Multiple aesthetic surgical procedures 16 4.17 Safe timing of procedures . 16 4.18 Registration . 17 5 Facilities . 17 5.1 Evaluation of compliance and risk management 17 5.2 Personnel . 17

15、5.3 Documentation of medical records. 17 5.4 Facility 18 5.5 Administrative and waiting area 18 5.6 General requirements and recommendations for procedure rooms and operating theatres 18 5.7 Safety and security . 19 5.8 Anaesthesia Device 20 5.9 Hygiene standards for procedure rooms and operating th

16、eatres . 21 5.10 Medications . 21 5.11 Procedure room (PR) 22 5.12 Operating theatre (OP) . 23 6 Procedures 25 6.1 General . 25 6.2 Aesthetic surgical procedure categories . 25 6.3 Identifying factors . 25 6.3.1 General . 25 6.3.2 Practitioner 26 6.3.3 Facility 26 BS EN 16372:2014EN 16372:2014 (E) 3

17、 6.3.4 Anaesthesia level 26 6.3.5 Risk level of procedure . 26 6.3.6 Patient physical status and age . 26 6.3.7 Duration of the procedure 27 6.4 Procedure identification . 27 6.5 Procedure list . 27 Annex A (normative) Code of Ethics for marketing and advertising. 30 Annex B (informative) Classifica

18、tion of practitioners . 32 Annex C (informative) Adeviations . 33 Bibliography 43 BS EN 16372:2014EN 16372:2014 (E) 4 Foreword This document (EN 16372:2014) has been prepared by Technical Committee CEN/TC 403 “Project Committee - Aesthetic surgery and aesthetic non-surgical medical services”, the se

19、cretariat of which is held by ASI. 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 June 2015 and conflicting national standards shall be withdrawn at the latest by June 2015. Attention is drawn to

20、 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 co

21、untries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

22、Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16372:2014EN 16372:2014 (E) 5 Introduction This European Standard provides a set of requirements, which are deemed to be essential for the provision of aesthetic surgery services. However,

23、 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 respo

24、nsible 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 surgery services. This list is not intended to be exhaustive. Emphasis is p

25、laced on defining requirements for the quality of the aesthetic surgery 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

26、suppliers. This European Standard is designed to bring the following advantages to those that adopt it: improvement in aesthetic surgery services which can enhance patient safety and reduce the risk of complications; to promote consistently high standards for aesthetic surgery service providers acro

27、ss Europe; enhance patient satisfaction. Requirements for a quality management system based on EN ISO 9001:2008 for health care services are provided in EN 15224. BS EN 16372:2014EN 16372:2014 (E) 6 1 Scope This European Standard addresses the requirements for clinical aesthetic practice: This cover

28、s surgical services to patients who want to change their physical appearance. This European Standard provides recommendations for procedures for clinical treatment, including the ethical framework and general principles according to which clinical services are provided by all aesthetic practitioners

29、. These recommendations apply before, during and after the procedure. Dentistry1)procedures, reconstructive surgery procedures and aesthetic non-surgical medical procedures are excluded from the scope of this European Standard. Aesthetic non-medical procedures (e.g. tattoos, piercing) which can be l

30、egally performed by non-physicians (e.g. beauty therapists, hairdressers) 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 surgery services services related to operative procedur

31、es where the primary aim is the change, the restoration or improvement of the appearance, the function and well-being at the request of an individual Note 1 to entry: A list of aesthetic surgical procedures is included in Table 1. 2.2 adverse event situation or event that has caused harm to a patien

32、t Note 1 to entry : “Adverse event” is defined in ISO/TS 19218-1:2011, 2.1 as 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 defi

33、nition is consistent with 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 Directive 2001/20/EC, Article

34、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. SOURCE: EN 15224:2012, 3.5.2, modified Note 1 to entry and Note 2 to entry have been added. 2.3 claim expres

35、sion of dissatisfaction with services or results where a personal compensation is explicitly or implicitly expected with a medical or financial compensation Note 1 to entry: Medical or financial compensations are e.g. corrective operation, reimbursement or compensation under the terms of an insuranc

36、e policy. 1) As defined in EN ISO 1942. BS EN 16372:2014EN 16372:2014 (E) 7 2.4 competence demonstrated and qualified ability to apply knowledge and skills according with the law and regulations of the country where is practiced 2.5 complaint expression of dissatisfaction made to an organization, re

37、lated to its services and/or results, or the complaints-handling process itself, where a response or resolution is explicitly or implicitly expected 2.6 “cooling off” period time between the end of the consultation where the procedure is proposed, its risks are explained and the detailed fee estimat

38、ion is given, and the decision to proceed with this procedure 2.7 facility establishment, medical or clinical 2.8 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 Constituti

39、on 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. 2.9 patient satisfac

40、tion patients perception of the degree to 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

41、 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 9000:2005, 3.1.4. 2.10 practitioner medical doctor authorized by national competent authority to practice autonomously 2.11 reporting

42、 notification of an adverse event, defective health care product or negligent service delivery to the relevant competent authorities 2.12 surgeon medical doctor who has successfully completed a nationally recognized surgical speciality training programme and a final professional surgical examination

43、 and holds a certificate of completion of speciality surgical training and holds a license from the national competent authority BS EN 16372:2014EN 16372:2014 (E) 8 3 Competencies 3.1 General 3.1.1 The facility shall: determine the necessary competence of person(s) doing work under its control, ensu

44、re 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. 3.1.2 It shall be the responsibility of th

45、e clinical director or the responsible officer or the chief executive of the facility to check the professional credentials, certified training and criminal record of any professional applying to provide services in the facility. 3.1.3 A registration for all practitioners performing aesthetic surgic

46、al procedures is highly recommended within two years after publication of this European Standard. 3.1.4 Directive 2005/36/EC demands formal training recognized by a national competent authority. Medical training and education for practitioners according to UEMS syllabi is the guarantee that these pr

47、actitioners have the education to perform aesthetic surgical procedures. National competent authorities may recognize additional training and education for the performance of aesthetic surgical procedures for practitioners who are not classified in UEMS monospeciality sections in their respective co

48、untries. NOTE Aesthetic surgical procedures are already included in certain UEMS syllabi. UEMS is the Union Europenne des Mdecins Spcialistes, European Union of Medical Specialists. The information on UEMS syllabi is given in Annex B. 3.1.5 Practitioners shall be monospeciality surgeons with aesthet

49、ic surgery in the field of their competence or otherwise competent, qualified medical doctors authorized by national competent authority to practise aesthetic surgery. The competent, qualified, experienced medical doctor shall have had appropriate basic surgical training of two years followed by at least four years training in aesthetic surgery supervised by a national authorized trainer in aesthetic surgery. 3.1.6 Anaesthesiologists shall be qualified specialists authorized by national competent authority to practice autonomously. Assistants shall be medic