DIN EN 16844:2018
Aesthetic medicine services - Non-surgical medical treatments; German version EN 16844:2017+A1:2018

Standard No.

DIN EN 16844:2018

Release Date

2018

Published By

German Institute for Standardization

Status

Be replaced 2019-10

Replace By

DIN EN 16844:2019

Latest

DIN EN 16844:2019-10

Replace

DIN EN 16844:2015

Scope

This European Standard addresses the requirements for aesthetic medicine services to patients 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. These recommendations apply before, during and after the procedure. Dentistry procedures and aesthetic surgical procedures covered by EN 16372 are excluded from the scope of this European Standard. Aesthetic non-medical procedures (tattooing and any procedure 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.

DIN EN 16844:2018 Referenced Document

• DIN ISO 10001:2008 Quality management - Customer satisfaction - Guidelines for codes of conduct for organizations (ISO 10001:2007); Text in German, English and French
• DIN ISO 10002:2010 Quality management - Customer satisfaction - Guidelines for complaints handling in organizations (ISO 10002:2004 + Cor. 1:2009)
• DIN ISO 10003:2008 Quality management - Customer satisfaction - Guidelines for dispute resolution external to organizations (ISO 10003:2007); Text in German, English and French
• DIN ISO 26000:2011 Guidance on social responsibility (ISO 26000:2010)
• DIN ISO 31000:2011 Risk management - Guidelines (ISO 31000:2018)*， 2024-04-20 Update
• 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)*， 2024-04-20 Update
• EN 1041:2008 Information supplied by the manufacturer of medical devices
• EN 12464-1:2011 Light and lighting - Lighting of work places - Part 1: Indoor work places
• EN 13060:2014 Small steam sterilizers
• EN 13795:2011 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 (Incorporates A
• EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
• EN 1500:2013 Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2)
• EN 15224:2016 Quality management systems - EN ISO 9001:2015 for healthcare
• EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
• EN 16372:2014 Aesthetic surgery services
• EN 1644-1:1997 Test methods for nonwoven compresses for medical use - Part 1: Nonwovens used in the manufacture of compresses
• EN 1644-2:2000 Test methods for nonwoven compresses for medical use - Part 2: Finished compresses
• EN 207:2017 Personal eye-protection equipment - Filters and eye-protectors against laser radiation (laser eye-protectors)
• EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
• EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes*， 2024-04-20 Update
• EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties
• EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
• EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
• 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
• EN 60601-2-4:2011 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
• EN 794-3:1998 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators (Incorporates Amendment A2: 2009)

DIN EN 16844:2018 history

• 2019 DIN EN 16844:2019-10 Aesthetic medicine services - Non-surgical medical treatments; German version EN 16844:2017+A2:2019
• 2019 DIN EN 16844:2019 Aesthetic medicine services - Non-surgical medical treatments (includes Amendment :2019)
• 2018 DIN EN 16844:2018 Aesthetic medicine services - Non-surgical medical treatments; German version EN 16844:2017+A1:2018
• 1970 DIN EN 16844 E:2015-04 Aesthetic medicine services - Non-surgical medical treatments
• 2015 DIN EN 16844 E:2015 Draft Document - Aesthetic medicine services - Non-surgical medical procedures; German and English version prEN 16844