I.S. EN 16844:2017+A2:2019
Current
Current
The latest, up-to-date edition.
Aesthetic medicine services - Non-surgical medical treatments
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
08-25-2019
Publisher
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
European foreword
Introduction
1 Scope
2 Terms and definitions
3 Competencies
4 Management and communication with patients
5 Facilities
6 Treatments
Annex A (normative) - Code of Ethics for marketing
and advertising
Annex B (informative) - A-deviations
Bibliography
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.
| Committee |
TC 403
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| DocumentType |
Standard
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| Pages |
0
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
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| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 16844:2017+A2:2019 | Identical |
| EN 16844:2017 | Identical |
| ISO 10001:2007 | Quality management Customer satisfaction Guidelines for codes of conduct for organizations |
| EN ISO 19011:2011 COR 2011 | GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS (ISO 19011:2011) |
| IEC 60601-2-46:2016 | Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
| IEC 60601-2-57:2011 | Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
| ISO 12609-2:2013 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Part 2: Guidance for use |
| EN 60601-2-26:2015 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| EN 60601-2-34:2014 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| EN 455-1:2000 | Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
| ISO 18308:2011 | Health informatics — Requirements for an electronic health record architecture |
| ISO 8362-7:2006 | Injection containers and accessories Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part |
| EN 12464-1:2011 | Light and lighting - Lighting of work places - Part 1: Indoor work places |
| EN ISO 80601-2-61:2011 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) |
| ISO 19011:2011 | Guidelines for auditing management systems |
| EN 60601-2-47:2015 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| ISO/IEC 27001:2013 | Information technology — Security techniques — Information security management systems — Requirements |
| 2006/95/EC : 2006 | DIRECTIVE 2006/1995/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 12 DECEMBER 2006 ON THE HARMONISATION OF THE LAWS OF MEMBER STATES RELATING TO ELECTRICAL EQUIPMENT DESIGNED FOR USE WITHIN CERTAIN VOLTAGE LIMITS (CODIFIED VERSION) (TEXT WITH EEA RELEVANCE) |
| ISO 80601-2-13:2011 | Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
| EN 60825-1:2014/AC:2017-06 | SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014) |
| EN 1644-1:1997 | Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture of compresses |
| EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| ISO 16054:2000 | Implants for surgery Minimum data sets for surgical implants |
| EN 1500:2013 | Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2) |
| EN ISO 10781:2015 | Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) (ISO 10781:2015) |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| EN ISO 15225:2016 | Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016) |
| IEC 60601-2-47:2012 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
| EN ISO 8362-7:2010 | Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006) |
| EN ISO 1942:2010 | Dentistry - Vocabulary (ISO 1942:2009, Corrected version 2010-03-01) |
| ISO 12609-1:2013 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Part 1: Specification for products |
| IEC 60601-2-26:2012 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
| ISO 31000:2009 | Risk management Principles and guidelines |
| ISO 26000:2010 | Guidance on social responsibility |
| EN 455-4:2009 | Medical gloves for single use - Part 4: Requirements and testing for shelf life determination |
| CEN/TR 15592:2007 | Health services - Quality management systems - Guide for the use of EN ISO 9004:2000 in health services for performance improvement |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 60601-2-25:2015 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| ISO 9170-2:2008 | Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems |
| ISO/TS 21547:2010 | Health informatics Security requirements for archiving of electronic health records Principles |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| EN 794-3:1998+A2:2009 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
| EN ISO 21090:2011 | Health Informatics - Harmonized data types for information interchange (ISO 21090:2011) |
| EN 60601-2-41:2009/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-41: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS (IEC 60601-2-41:2009/A1:2013) |
| EN ISO 8362-6:2011 | Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010) |
| EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| ISO 25424:2009 | Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
| CEN/TR 15133:2005 | Nomenclature - Collective terms and codes for groups of medical devices |
| ISO 11810-2:2007 | Lasers and laser-related equipment Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers Part 2: Secondary ignition |
| IEC 60601-2-30:1999 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| EN 60601-2-57:2011 | Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| ISO/TS 19218-1:2011 | Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes |
| EN ISO 6009:2016 | Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016) |
| ISO 21090:2011 | Health informatics — Harmonized data types for information interchange |
| IEC 60601-2-22:2007+AMD1:2012 CSV | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| ISO 10003:2007 | Quality management Customer satisfaction Guidelines for dispute resolution external to organizations |
| EN 60601-2-22:2013 | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60601-2-34:2011 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| EN 60601-2-27:2014 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| EN 207:2017 | Personal eye-protection equipment - Filters and eye-protectors against laser radiation (laser eye-protectors) |
| IEC 60601-2-4:2010 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| ISO 80601-2-12:2011 | Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| EN ISO 16054:2002 | Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000) |
| EN ISO 25424:2011 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) |
| EN ISO 23907:2012 | Sharps injury protection - Requirements and test methods - Sharps containers (ISO 23907:2012) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| IEC TR 60825-8:2006 | Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans |
| EN 15224:2016 | Quality management systems - EN ISO 9001:2015 for healthcare |
| ISO 18812:2003 | Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| EN 60601-2-30:2000 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
| ISO 10002:2014 | Quality management Customer satisfaction Guidelines for complaints handling in organizations |
| 2006/25/EC : 2006 AMD 3 2013 | DIRECTIVE 2006/25/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 APRIL 2006 ON THE MINIMUM HEALTH AND SAFETY REQUIREMENTS REGARDING THE EXPOSURE OF WORKERS TO RISKS ARISING FROM PHYSICAL AGENTS (ARTIFICIAL OPTICAL RADIATION) (19TH INDIVIDUAL DIRECTIVE WITHIN THE MEANING OF ARTICLE 16(1) OF DIRECTIVE 89/391/EEC) |
| ISO 1942:2009 | Dentistry Vocabulary |
| IEC 60601-2-52:2009+AMD1:2015 CSV | Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds |
| EN ISO/IEC 27001:2017 | Information technology - Security techniques - Information security management systems - Requirements (ISO/IEC 27001:2013 including Cor 1:2014 and Cor 2:2015) |
| ISO 11810-1:2005 | Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Part 1: Primary ignition and penetration |
| EN ISO 11135-1:2007 | Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
| ISO 8362-6:2010 | Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials |
| EN 13795:2011+A1:2013 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels |
| IEC 60601-2-41:2009+AMD1:2013 CSV | Medical electrical equipment - Part 2-41: Particular requirementsfor the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
| IEC 60601-2-27:2011 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| CEN/TS 15277:2006 | Non-active surgical implants - Injectable implants |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| IEC 60601-2-25:2011 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| EN 455-2:2015 | Medical gloves for single use - Part 2: Requirements and testing for physical properties |
| ISO 80601-2-61:2011 | Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
| ISO 80601-2-55:2011 | Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| ISO 15225:2016 | Medical devices Quality management Medical device nomenclature data structure |
| EN 60601-2-52:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS |
| EN 1644-2:2000 | Test methods for nonwoven compresses for medical use - Part 2: Finished compresses |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| EN ISO 9170-2:2008 | Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) |
| EN 60601-2-52:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS |
| EN ISO 18812:2003 | Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003) |
| EN ISO 11810-1:2009 | Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005) |
| ISO/TR 21548:2010 | Health informatics Security requirements for archiving of electronic health records Guidelines |
| EN 60601-2-46:2011 | Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 1040:2005 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1) |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| EN 62471:2008 | Photobiological safety of lamps and lamp systems |
| ISO 23907:2012 | Sharps injury protection Requirements and test methods Sharps containers |
| ISO 6009:2016 | Hypodermic needles for single use Colour coding for identification |
| EN ISO 80601-2-13:2012 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
| EN ISO 27799:2016 | Health informatics - Information security management in health using ISO/IEC 27002 (ISO 27799:2016) |
| ISO 14607:2007 | Non-active surgical implants Mammary implants Particular requirements |
| EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| EN ISO 11810-2:2009 | Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007) |
| EN 13060:2014 | Small steam sterilizers |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
| EN 60601-2-4:2011 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| ISO 27799:2016 | Health informatics Information security management in health using ISO/IEC 27002 |
| EN 16372:2014 | Aesthetic surgery services |
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