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Standards in the ASU Library: AA-AFPA: AAMI

List of available industry standards from organizations whose acronyms are between "AA" and "AFPA".

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standards labeled as: 

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    AA-AFPA

    AGA-ANS

    ANSI

    ANSLG-ARMA

    AS-AWWA

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Please note ...

The ASU Library's standards collection is intended for the use of ASU faculty, staff and currently enrolled students. 

Individuals not affliated with ASU who live in the Phoenix metropolitan area are welcome to come to the Noble Library on the Tempe campus to view the standards.  Items in the collection are not available for checkout or loan to other libraries; because of copyright restrictions, we do not provide photocopies or scanned copies to those unaffiliated with ASU.  

AAMI (Association for the Advancement of Medical Instrumentation)

The following AAMI standards are available in paper copy in the Noble Library on the Tempe Campus, unless noted otherwise. Standards housed in Noble are "Library use only" and are not available for checkout.

  • AAMI 10993-1 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing)
    ASU has: 1994
 
  • AAMI 10993-2 (Biological Evaluation of Medical Devices - Part2: Animal Protection Requirements )
    ASU has: 1993 - See AAMI 10993-1 1994
 
  • AAMI 10993-11 (Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity)
    ASU has:  1993 - See AAMI 10993-1 1994
 
  • AAMI 11140-3 (Sterilization of Health Care Products - Chemical Indicators - Part 3: Class 2 Indicator Systems for Use in the Bowie and Dick-type Steam Penetration Test)
  • ASU has:  2007
 
  • AAMI 11140-4 (Sterilization of Health Care Products - Chemical Indicators - Part 4: Class 2 Indicators an an Alternative to the Bowie and Dick-type for Detection of Steam Penetration)
    ASU has:  2007
 
  • AAMI 11140-5 (Sterilization of Health Care Products - Chemical Indictors - Part 5: Class 2 Indicator for Bowie and Dick-type Air Removal Tests)
    ASU has: 2007
 
  • AAMI 13408-1 
    ASU has: 2008 See AAMI ISO 13408-1
 
  • AAMI 13408-2:2003
    See AAMI ISO 13408-2:2003 
  • AAMI 13408-3:2006 
    See AAMI ISO 13408-3:2006
  • AMMI 13408-4:2005 
    See AAMI ISO 13408-4:2005
  • AMMI 13408-5:2006 
    See AAMI ISO 13408-5:2006
  • AAMI 13408-6:2005 
    See AAMI ISO 13408-6:2005
  • AAMI  15223-1 (Medical Devices - Symobls to be Used with Medical Device Labels, Labeling, and Information to be Supplied - Part 1: General Requirements)
  • AAMI 80601-2-58:2008  
    ASU has 2008; See AAMI IEC 80601-2-58:2008 
 
  • AAMI AT6 (Autologous transfusion devices)
    ASU has: 1981, 1991 
 
  • AAMI BE 83 (Biological evaluation of medical devices - Part 18: Chemical characterization of materials)
    ASU has: 2006
 
  • AAMI BF 7 (Blood transfusion micro-filters)
    ASU has: 1982
 
  • AAMI BP 22 (Blood pressure transducers)
    ASU has: 1986, 1994 
 
  • AAMI BP 23 (Interchangeability and Performance of Resistive Bridge Type Blood Pressure Transducers)
    ASU has: 1986
 
  • AAMI CVP 3 
    ASU has: 1981
 
  • AAMI DF 2 (Cardiac Defibrillator Devices )
    ASU has: 1981, 1989
 
  • AAMI DF 39 (Automatic External Defibrillators and Remote-Control Defibrillators)
    ASU has: 1993
 
  • AAMI EC 11 (Diagnostic electrocardiographic devices)
    ASU has: 1982, 1991 
 
  • AAMI EC 12 (Disposable ECG electrodes)
    ASU has: 1983,1991, 2000
 
  • AAMI EC 13 (Cardiac Monitors, Heart Rate Meters and Alarms)
    ASU has: 1983, 1992 
 
  • AAMI EC 38 (Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, or ambulatory electrocardiographic systems)
    ASU has: 1994, 1998
 
  • AAMI EC 53 (ECG cables and leadwires )
    ASU has: 1995 (Includes Amendment of 2008 and Errata from 2001 and 1998)

 

  • AAMI EC 57:2012 (Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms)
 
  • AAMI ES 1 (Safe Current Limits for Electromedical Apparatus)
    ASU has: 1985, 1993
 
  • AAMI HE 48 (Human factors engineering guidelines and preferred practices for the design of medical devices)
    ASU has: 1993
 
  • AAMI HF18 (Electrosurgical Devices)
    ASU has: 1986, 1993, 2001 
 
  • AAMI ID 26 (Medical electrical equipment- Part 2: Particular requirements for the safety of infusion pumps and controllers)
    ASU has: 1992 
 
  • AAMI II 36 (Medical electrical equipment - Part 2: Particular requirements for safety of baby incubators)
    ASU has: 1991 
 
  • AAMI IEC 62304:2006 (Medical Device Software- Software Life Cycle Processes)
    ASU has: 2006 
 
  • AAMI IEC 80601 - 2-58:2008 (Medical Electrical Equipment - Part 2-58: Particular requirement for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery.)
    ASU has 2008 
 
  • AAMI ISO 5840 (Cardiovascular Implants- Cardiac Valve Prostheses)
    ASU has: 1991
 
  • AAMI ISO 10993-2
    ASU has: 1993 (See AAMI 10993-1 1994)
 
  • AAMI ISO 10993-3
    ASU has: 1993 (See AAMI 10993-1 1994)
 
  • AAMI ISO 10993-4
    ASU has: 1993 (See AAMI 10993-1 1994)
 
  • AAMI ISO 10993-5 
    ASU has: 1993 (See AAMI 10993-1 1994)
 
  • AAMI ISO 10993 7 (Biological Evaluation of Medical Devices:Ethylene Oxide Sterilization Residuals)
    ASU has: 1995
 
  • AAMI ISO 10993 14 (Biological Evaluation of Medical Devices: Degradation Products from Ceramics)
    ASU has: 2001
 
  • AAMI ISO 11134 (Sterilization of Health Products: Industrial Moist Heat Sterilization)
    ASU has: 1993
 
  • AAMI ISO 11135   (Medical Devices- Routine Control of Ethylene)
    ASU has: 1994
 
  • AAMI ISO 11137  (Sterilization of Health Products: Validation and Routine Control- Radiation Sterilization)
    ASU has: 1994
 
  • AAMI ISO 11137-1
    ASU has: 1995
 
  • AAMI ISO 11138-1 (Sterilization of Health Products: Biological Indicators)
    ASU has: 2006
 
  • AAMI ISO 11138-2  (Sterilization of Health Products: Biological Indicators)
    ASU has: 2006
 
  • AAMI ISO 11138-3   (Sterilization of Health Products: Biological Indicators for Moist Heat Sterilization)
    ASU has: 2006
 
  • AAMI ISO 11138-4  (Sterilization of Health Products: Biological Indicators for Dry Heat Sterilization)
    ASU has: 2006
 
  • AAMI ISO 11138-5  (Sterilization of Health Products: Biological Indicators for Low Temp Sterilization)
    ASU has: 2006
 
  • AAMI ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging)
    ASU has: 2006
 
  • AAMI ISO 11607-2 (Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes)
    ASU has: 2006
 
  • AAMI ISO 13408-1 (Aseptic processing of health care products - Pt 1: General Requirements)
    ASU has: 2008
 
  • AAMI ISO 13408-2 (Aseptic processing of health care products - Pt 2: Filtration)
    ASU has: 2003
 
  • AAMI ISO 13408-3 (Aseptic processing of health care products - Pt 3: Lyophilization)
    ASU has: 2006 
 
  • AAMI ISO 13408-4 (Aseptic processing of health care products - Pt 3: Clean in place techologies)
    ASU has: 2005 
 
  • AAMI ISO 13408-5 (Aseptic processing of health care products - Pt 5: Sterilization in place)
    ASU has: 2006 
 
  • AAMI ISO 13408-6 (Aseptic processing of health care products - Pt 6: Isolator Systems)
    ASU has: 2005
 
  • AAMI ISO 13485    (Quality Systems-Medical Devices)
    ASU has: 1996
 
  • AAMI ISO 14971   (Medical Devices- Application of Risk Management)
    ASU has: 2000, 2007 (See also: CSA PLUS 14971 2007 (The ISO 14971:2007 Essentials -- A Practical Handbook for Implementing the ISO 14971 Standard for Medical Devices
 
  • AAMI ISO 15223  
    ASU has: 2000
 
  • AAMI ISO 15223-1  (Medical Devices - Syymbols to be Used With Medical Device Labels, Labelling, and Information to be Supplied - Part 1: General Requirements)
    ASU has: 2007
 
  • AAMI ISO 15225   (Nomenclature Systems for Medical Devices-Data Exchange)
    ASU has: 2000
 
  • AAMI ISO TIR 14969 (Medical devices - Quality management systems -- Guidance for the application of ISO 13485:2003)
    ASU has: 2004
 
  • AAMI NS 4   (Transcutaneous Electrical Nerve Stimulators)
    ASU has: 1985
 
  • AAMI NS 14   (Implantable Spinal Cord Stimulators )
    ASU has: 1984, 1995 
 
  • AAMI NS 15   (Implantable Peripheral Nerve Stimulators)
    ASU has: 1995
 
  • AAMI NS 28   (Intracranial Pressure Monitoring Devices)
    ASU has: 1988
 
  • AAMI PAC 49  (Pacemaker Emergency Intervention System)
    ASU has: 1993
 
  • AAMI PAC 69  
    ASU has: 2000
 
  • AAMI PC 69 (Active Implantable Medical Devices - Electromagnetic Compatibility - EMC Test Protocols for Implantable Cardiac Pacemakers and Implantable Cardioverter Defibrillators )
    ASU has: 2007
 
  • AAMI RD 16 (Cardiovascular Implants and Artifical Organs - Hemodialyzers, Hemodiafilters, Hemofilters, and Hemoconcentrators)
    ASU has: 1984, 2007
 
  • AAMI RD 17 (Cardiovascular Implants and Artifical Organs - Extracorporeal Blood Circuit for Hemodialyzers, Hemodiafilters, and Hemofilters )
    ASU has: 1984, 1994, 2005, 2007
 
  • AAMI RD 47 (Reprocessing of Hemodialyzers)
    ASU has: 1993
 
  • AAMI RD 62    (Water Treatment Equipment for Hemodialysis Applications)
    ASU has: 2006
 
  • AAMI SCL 12   (Safe Current Limits for Electromedical Apparatus)
    ASU has: 1978
 
  • AAMI SP 9   (Non-Automated Sphygmomanometers)
    ASU has: 1985, 1994
 
  • AAMI SP 10  (Manual, Electronic, or Automated Sphygmomanometers)
    ASU has: 1987, 1992, 2002
 
  • AAMI ST 8  (Hospital Steam Sterilizers)
    ASU has: 1982, 1988, 1994, 2001
 
  • AAMI ST 19   (Hospital Steam Sterilizers)
    ASU has: 1985, 1999
 
  • AAMI ST 21 (Indicators for Ethylene Oxide)
    ASU  has: 1986, 1999 
 
  • AAMI ST 24 (Ethylene Oxide Sterilizers)
    ASU has: 1987, 1992, 1999
 
  • AAMI ST 25 (Moist Heat Sterilization)
    ASU has: 1987
 
  • AAMI ST 27 (Ethylene Oxide Sterilization of Medical Devices)
    ASU has: 1988
 
  • AAMI ST 29 (Residual Ethylene Oxide in Medical Devices)
    ASU has: 1988
 
  • AAMI ST 30 (Residual Ethylene Chlorohydrin and Ethylene Glycol in Medical Devices)
    ASU has: 1989
 
  • AAMI ST 31 (Electron Beam Radiation Sterilization of Medical Devices)
    ASU has: 1990
 
  • AAMI ST 32  (Guideline for Gamma Radiation Sterilization)
    ASU has: 1991
 
  • AAMI ST 33 (Guidelines for Rigid Sterilization Container Systems)
    ASU has: 1990, 1996
 
  • AAMI ST 34 (Sterilization Container Systems Processes)
    ASU has: 1991
 
  • AAMI ST 35 (Safe Handling Biological Decontamination of Medical Devices)
    ASU has: 1991, 1996
 
  • AAMI ST 37 (Flash Sterilization)
    ASU has: 1992, 1996
 
  • AAMI ST 40 
    ASU has: 1992, 2004 
 
  • AAMI ST 41 (Ethylene Oxide Sterilization and Sterility Assurance)
    ASU has: 1992, 2008
 
  • AAMI ST 42  (Steam Sterilization and Assurance)
    ASU has: 1992
 
  • AAMI ST 43 (Ethylene Oxide Gas- Ventilation)
    ASU has: 1993
 
  • AAMI ST 44 (BIER/EO Gas Vessels)
    ASU has: 1992
 
  • AAMI ST 45 (BIER/EO Steam Vessels)
    ASU has: 1992
 
  • AAMI ST 46 (Steam Sterilization and Sterility Assurance in Health Care Facilities)
    ASU has: 1993, 2002
 
  • AAMI ST 50 (Dry Heat Sterilizers)
    ASU has: 1995
 
  • AAMI ST 55 (Table-Top Steam Sterilizers)
    ASU has: 2003
 
  • AAMI ST 65 (Processing of Reusable Surgical Textiles)
    ASU has: 2000
 
  • AAMI ST 66 (Sterilization of Health Care Products-Chemical Indicators)
    ASU has: 1999
 
  • AAMI ST 67 (Sterilization of Medical Devices)
    ASU has: 2003
 
  • AAMI ST 77 (Containment Devices for Reusable Medical Device Sterilization)
    ASU has: 2006
 
  • AAMI ST 79 
    ASU has: 2006
 
  • AAMI SW68 (Medical Device Software-Software Life Cycle Processes)
    ASU has: 2001
 
  • AAMI TIR 24 (Acquisition and Use of Physiologic Waveform Databases for Testing of Medical Devices) Ordered 2/14/13
  • AAMI TIR 33  (Medical Devices- Quality Management Systems)
    ASU has: 2005
  • AAMI TIR 60: 2014 (Common mode rejection in ECG monitoring) 
 
  • AAMI VP 20 (Vascular Graft Prostheses)
    ASU has: 1986, 1994 
 

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