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12/30254927 DC : 0

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

BS EN 16372 - AESTHETIC SURGERY SERVICES

Available format(s)

Hardcopy , PDF

Superseded date

31-01-2015

Superseded by

BS EN 16372:2014

Language(s)

English

£20.00
Excluding VAT

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

BS EN 16372

Committee
CH/403
DocumentType
Draft
Pages
38
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
PREN 16372 : DRAFT 2013 Identical

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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