• There are no items in your cart

I.S. EN 16372:2014

Current
Current

The latest, up-to-date edition.

AESTHETIC SURGERY SERVICES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Preview

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.

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Competencies
4 Management and communication with patients
5 Facilities
6 Procedures
Annex A (normative) - Code of Ethics for marketing
        and advertising
Annex B (informative) - Classification of practitioners
Annex C (informative) - A-deviations
Bibliography

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.

DocumentType
Standard
Pages
52
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN 16372:2014 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 60601-2-57:2011 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 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 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 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
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)
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
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)
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
ISO 27789:2013 Health informatics Audit trails for electronic health records
EN ISO 80601-2-12:2011/AC:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011)
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
EN ISO 27789:2013 Health informatics - Audit trails for electronic health records (ISO 27789:2013)
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
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
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
ISO 10003:2007 Quality management Customer satisfaction Guidelines for dispute resolution external to organizations
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 ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
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 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 60601-2-46 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES
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 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
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
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
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 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)
ISO/HL7 10781:2015 Health Informatics — HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM)
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
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

View more information
US$83.31
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.