• 12/30254927 DC : 0

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN 16372 - AESTHETIC SURGERY SERVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-01-2015

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Competencies
    4 Management and communication with patients
    5 Facilities
    6 Procedures
    7 Quality assurance and improvement
    Annex A (normative) - Code of Ethics for marketing
            and advertising
    Annex B (informative) - UEMS
    Bibliography

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee CH/403
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 10001:2007 Quality management Customer satisfaction Guidelines for codes of conduct for organizations
    ISO 18308:2011 Health informatics — Requirements for an electronic health record architecture
    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
    ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    ISO 16054:2000 Implants for surgery Minimum data sets for surgical implants
    EN ISO 10781:2015 Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) (ISO 10781:2015)
    EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
    ISO 31000:2009 Risk management Principles and guidelines
    ISO 26000:2010 Guidance on social responsibility
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN ISO 27789:2013 Health informatics - Audit trails for electronic health records (ISO 27789:2013)
    ISO/TS 21547:2010 Health informatics Security requirements for archiving of electronic health records Principles
    EN ISO 21090:2011 Health Informatics - Harmonized data types for information interchange (ISO 21090:2011)
    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
    ISO/IEC 27002:2013 Information technology Security techniques Code of practice for information security controls
    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
    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
    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 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)
    IEC TR 60825-8:2006 Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans
    ISO 18812:2003 Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles
    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 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 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 80601-2-61:2011 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
    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
    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 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 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 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)
    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
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