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peek medical device

peek medical device, Total:500 items.

In the international standard classification, peek medical device involves: Medical equipment, Laboratory medicine, Pharmaceutics, Vocabularies, Applications of information technology, Sterilization and disinfection, Rubber and plastics products, Software development and system documentation, Quality, Medical sciences and health care facilities in general, Graphical symbols, Dentistry, Information sciences. Publishing, Birth control. Mechanical contraceptives, First aid.


International Organization for Standardization (ISO), peek medical device

  • ISO 15309:2013 Implants for surgery.Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
  • ISO 14971:2000 Medical devices - Application of risk management to medical devices
  • IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
  • IEC TR 62366-2-2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
  • IEC/TR 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
  • IEC 62366:2007/AMD 1:2014 Medical devices — Application of usability engineering to medical devices — Amendment 1
  • ISO 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
  • ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
  • ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
  • IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
  • IEC TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
  • IEC/TR 80002-1:2009 Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
  • IEC 62366-1:2015/AMD1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
  • ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
  • IEC 62366-1:2015/AMD 1:2020 Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
  • ISO 14971:2019 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements

Association Francaise de Normalisation, peek medical device

  • NF S94-179*NF ISO 15309:2014 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
  • NF S99-211:2013 Medical devices - Application of risk management to medical devices
  • NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
  • NF EN ISO 14971/A11:2021 Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
  • NF EN ISO 14971:2019 Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux
  • NF S98-116-2*NF ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2 : non-critical medical devices
  • NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
  • NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
  • NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
  • NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
  • NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
  • NF S90-300:1981 MEDICAL AND SURGICAL EQUIPMENT. OXYGENATORS.
  • NF EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique
  • NF S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
  • NF S98-107-1*NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices
  • NF S98-116-1*NF EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1 : critical and semi-critical medical devices
  • NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
  • NF S90-031:1985 Medico-surgical equipment. Intra-uterine devices.
  • NF S91-170:1996 Dentistry. Medical devices for denstistry. Instruments.
  • NF S99-004:2008 Symbols for use in the labelling of medical devices.
  • FD S99-124*FD CEN ISO/TR 24971:2020 Medical devices - Guidance on the application of ISO 14971
  • XP S99-223:2020 Medical Device - Benefit risk management

British Standards Institution (BSI), peek medical device

  • BS ISO 15309:2013 Implants for surgery. Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
  • BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
  • BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
  • BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
  • BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
  • BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
  • BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
  • BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
  • BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
  • BS EN 556-2:2015 Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
  • 23/30457240 DC BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed medical devices
  • 23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices
  • BIP 2071-2005 Medical devices: ISO 13485 and ISO 9001
  • 19/30378069 DC BS ISO 17664-2. Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Part 2. Non-critical medical devices
  • BS EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices

German Institute for Standardization, peek medical device

RU-GOST R, peek medical device

  • GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
  • GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
  • GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
  • GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
  • GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
  • GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
  • GOST R 55544-2013 Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software
  • GOST R 56429-2015 Medical devices. Clinical evaluation
  • GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
  • GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
  • GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
  • GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
  • GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
  • GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
  • GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
  • GOST R ISO 17664-2012 Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
  • GOST R 57449-2017 Medical devices. Guidance on the application of ISO 14971
  • GOST R 57502-2017 Medical equipment. Industrial production regulation

CEN - European Committee for Standardization, peek medical device

  • EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
  • EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
  • EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
  • EN 1441:1997 Medical Devices - Risk Analysis
  • EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"

European Committee for Standardization (CEN), peek medical device

  • EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
  • CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
  • EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
  • EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
  • EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
  • prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements

ZA-SANS, peek medical device

  • SANS 14971:2008 Medical devices - Application of risk management to medical devices
  • SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

Korean Agency for Technology and Standards (KATS), peek medical device

  • KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
  • KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
  • KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
  • KS P ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
  • KS P IEC 62366-1:2018 Medical devices — Part 1:Application of usability engineering to medical devices
  • KS P IEC 62366-1:2021 Medical devices — Part 1: Application of usability engineering to medical devices
  • KS P ISO 15223-2007(2012) Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
  • KS P ISO TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
  • KS P IEC TR 62366-2:2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
  • KS P ISO 11607:2002 Packaging for terminally sterilized medical devices
  • KS P ISO 11607:2007 Packaging for terminally sterilized medical devices

Japanese Industrial Standards Committee (JISC), peek medical device

  • JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
  • JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
  • JIS T 62366-1:2022 Medical devices -- Part 1: Application of usability engineering to medical devices
  • JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied

KR-KS, peek medical device

  • KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
  • KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
  • KS P ISO 17664-2-2022 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
  • KS P ISO 17664-1-2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
  • KS P IEC 62366-1-2018 Medical devices — Part 1:Application of usability engineering to medical devices
  • KS P IEC 62366-1-2021 Medical devices — Part 1: Application of usability engineering to medical devices
  • KS P ISO TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems
  • KS P IEC TR 62366-2-2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
  • KS P ISO 11607-2002 Packaging for terminally sterilized medical devices

TH-TISI, peek medical device

  • TIS 14971-2013 Medical devices.application of risk management to medical devices
  • TIS 2278-2006 Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices

Professional Standard - Medicine, peek medical device

  • YY/T 0316-2016 Medical devices.Application of risk management to medical devices
  • YY/T 0316-2008 Medical devices.Application of risk management to medical devices
  • YY/T 0316-2003 Medical devices-Application of risk management to medical devices
  • YY/T 0468-2015 Medical devices.Quality management.Medical device nomenclature data structure
  • YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
  • YY/T 0297-1997 Clinical investigation of medical devices
  • YY/T 1406.1-2016 Medical device software.Part 1:Guidance on the application of ISO 14971 to medical device software
  • YY/T 1406.1-2016/IEC/TR 80002-1 Medical Device Software Part 1: Guidelines for YY/T 0316 Applied to Medical Device Software
  • YY/T 0615.1-2007 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
  • YY/T 0615.2-2007 Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices

International Electrotechnical Commission (IEC), peek medical device

  • IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
  • IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices
  • IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
  • IEC 62366-1:2015/COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 62366-1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
  • IEC 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: Application of usability engineering to medical devices
  • ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
  • ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
  • ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
  • ISO/TR 24971:2020 Medical devices -- Guidance on the application of ISO 14971

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, peek medical device

  • GB/T 42062-2022 Medical devices—Application of risk management to medical devices
  • GB/Z 42217-2022 Medical device —Validation of software for medical device quality system

未注明发布机构, peek medical device

  • DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
  • BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
  • DIN EN ISO 10993-18:2009 Biological assessment of medical devices

Danish Standards Foundation, peek medical device

  • DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
  • DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
  • DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
  • DS/CEN/CR 14060:2001 Medical device traceability
  • DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
  • DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
  • DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
  • DS/EN ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
  • DS/ISO 17664-2:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
  • DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
  • DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
  • DS/EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
  • DS/IEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
  • DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
  • DS/EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
  • DS/EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
  • DS/ISO/TR 24971:2013 Medical devices - Guidance on the application of ISO 14971

ES-UNE, peek medical device

  • UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
  • UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
  • UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
  • UNE-EN ISO 17664-1:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

Standard Association of Australia （SAA）, peek medical device

  • AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
  • AS/NZS 4815 Set:2008 Sterilising Medical instruments Set
  • ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

国家食品药品监督管理局, peek medical device

  • YY/T 1474-2016 Application of medical device usability engineering to medical devices

American National Standards Institute （ANSI), peek medical device

  • ANSI/AAMI/ISO 17664-2:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
  • ANSI/AAMI/ISO 17664-1:2022 Processing of health care products -Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
  • ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1
  • ANSI/AAMI ST108:2023 Water for the processing of medical devices

Canadian Standards Association (CSA), peek medical device

CENELEC - European Committee for Electrotechnical Standardization, peek medical device

  • EN 62366:2008 Medical devices - Application of usability engineering to medical devices

国家药监局, peek medical device

  • YY/T 0802-2020 Disposal of medical devices Information provided by medical device manufacturers

Lithuanian Standards Office , peek medical device

  • LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
  • LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
  • LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
  • LST EN 1639-2010 Dentistry - Medical devices for dentistry - Instruments
  • LST EN 1641-2010 Dentistry - Medical devices for dentistry - Materials
  • LST EN 1640-2010 Dentistry - Medical devices for dentistry - Equipment

AENOR, peek medical device

  • UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • UNE-EN 1639:2010 Dentistry - Medical devices for dentistry - Instruments
  • UNE-EN 1641:2010 Dentistry - Medical devices for dentistry - Materials
  • UNE-EN 1640:2010 Dentistry - Medical devices for dentistry - Equipment

Group Standards of the People's Republic of China, peek medical device

PL-PKN, peek medical device

US-FCR, peek medical device

AT-ON, peek medical device

  • OENORM EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO/FDIS 17664-1:2021)

CH-SNV, peek medical device

  • SN EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

卫生健康委员会, peek medical device

VN-TCVN, peek medical device

  • TCVN 6916-2001 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied

RO-ASRO, peek medical device

Jiangsu Provincial Standard of the People's Republic of China, peek medical device

  • DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions
  • DB32/T 4553-2023 Guidelines for Monitoring Adverse Events of Medical Devices in Medical Institutions

US-AAMI, peek medical device

EU/EC - European Union/Commission Legislative Documents, peek medical device

  • MEDDEV 2.15-2008 GUIDELINES ON MEDICAL DEVICES Committees/Working Groups contributing to the implementation of the Medical Device Directives (REV 3)

IX-EU/EC, peek medical device

IT-UNI, peek medical device

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