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  • UNE-EN 16372:2015

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    Aesthetic surgery services

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  24-06-2015

    Publisher:  Asociacion Espanola de Normalizacion

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    Committee CTN 179
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current

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

    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 (IEC 60601-2-26:2012)
    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 (IEC 60601-2-34:2011)
    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 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 (IEC 60601-2-47:2012)
    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
    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
    EN ISO 1942 : 2010 DENTISTRY - VOCABULARY
    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 (IEC 60601-2-25:2011)
    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 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 (IEC 60601-2-27:2011 + CORRIGENDUM MAY 2012)
    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
    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
    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/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 LABORATORY INFORMATION SYSTEMS - USE PROFILES
    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/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
    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
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