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Medical Devices

With the more than 40 medical device standard collections from AAAMI, ISO, and IEC you can ensure that your devices are meeting the industry requirements for safety. From checking your temperature to using robotics for surgical procedures medical devices to be safe and free of hazards. View our medical devices collections.

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ISO 18562 - Evaluation of Breathing Gas Pathways Package

ISO 18562 - Evaluation of Breathing Gas Pathways Package

Access guidelines and general principles to evaluate and test the biocampatibility of breathing gas pathways in healthcare applications. The ISO 18562 package is applicable to breathing gas medical devices such as ventilators, anesthesia workstations, breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. ISO 18562 - Evaluation of Breathing Gas Pathways Package includes:
ISO 18562-1:2017
ISO 18562-2:2017
ISO 18562-3:2017
ISO 18562-4:2017


ISO 11138 - Sterilization of Health care Products Package

ISO 11138-1, ISO 11138-2, ISO 11138-3, ISO 11138-4 and ISO 11138-5

ISO 11138 - Sterilization of Health care Products Package provides methods for testing systems containing viable microorganisms providing a defined resistance to a specified sterilization process. The biological indicators sterilization processes supported in the ISO 11138 - Sterilization of Health care Products Package includes ethylene oxide, moist heat, dry heat, low-temperature steam and formaldehyde. This package includes the following standards:
ISO 11138-1:2017
ISO 11138-2:2017
ISO 11138-3:2017
ISO 11138-4:2017
ISO 11138-5:2017


ISO 13485 / ISO 9001 - Medical Devices Quality Management Set

ISO 13485 and ISO 9001

The ISO 13485 / ISO 9001 - Medical Devices Quality Management Set specifies regulatory requirements for a medical device quality management system that can be used by organizations, suppliers and others involved in the various stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing, final decommissioning, and disposal of medical devices. ISO 13485 / ISO 9001 - Medical Devices Quality Management Set includes:
ISO 13485:2016
ISO 9001:2015
ISO 13485:2016 - Medical devices - A practical guide


IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package

IEC 62366-1 and IEC/TR 62366-2

IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package provides assistance with the proper use of medical devices as it pertains to human risk factors. It specifies safety related processes to analyze, develop, and evaluate the usability of medical devices. The IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package is applicable to "normal" medical devices usage and is supported with guidance information. IEC 62366-1 / IEC/TR 62366-2 - Medical Devices Package includes:
IEC 62366-1 Ed. 1.0 b:2015
IEC 62366-1 Ed. 1.0 b cor:1:2016
IEC/TR 62366-2 Ed. 1.0 en:2016


ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package

ISO 15223-1, ISO 15223-2, ISO 10993-1, ISO 11607-1 and ISO 11607-2

ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices Package provides the requirements necessary to protect terminally sterilized medical devices until the point of use. ISO 15223 / ISO 10993-1 / ISO 11607 - Medical Devices also provides the requirements to be used for the development, selection and validation of medical devices symbols. In addition the package suggest the risk management process for terminally sterilized medical devices and the package includes:
ISO 15223-1:2016
ISO 15223-2:2010
ISO 11607-1:2006
ISO 11607-2:2006
ISO 10993-1:2009
ISO 11607-1:2006/Amd1:2014
ISO 11607-2:2006/Amd1:2014


ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set

ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set

ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set provides the latest medical devices quality management system requirements for regulatory purposes. The Medical Devices Transition Set has been designed to be applicable medical device QMS at various stages of the life cycle including design/development, production, storage, distribution, installation, and servicing. ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set also enables for organizations to demonstrate their ability to comply with regulatory requirements regardless of their size and type. ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set supports an organization in need of transitioning their Medical Devices QMS program from ISO 13485:2003 to ISO 13485:2016 by providing both versions of the medical devices quality management systems documents for comparison. The ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set includes:
ISO 13485:2016
ISO 13485:2016 - Medical devices - A practical guide
ISO 13485:2003 (Historical Document)


ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set

ISO 9001 and ISO 13485 Medical and Quality Management Set

ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set provides the regulatory reguirements for your medical devices quality management system. ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set enables an organization to consistently meet customer and regulatory expectations as it pertains to the quality management of medical devices. The ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set is applicable to all medical devices organizations and it includes:

ISO 9001:2015
ISO 13485:2016
ISO 9001:2015 for Small Enterprises - What to do - (Value Added Content)


ANSI/ISEA Z358.1 / ANSI/ISEA Z87.1 - Eyewash and Eye Protection Package

ANSI/ISEA Z358.1 and ANSI/ISEA Z87.1

ANSI/ISEA Z358.1 / ANSI/ISEA Z87.1 - Eyewash and Eye Protection Package provides safety methods for occupational emergency eyewashes, shower equipment, eye protection, and face protection devices. ANSI/ISEA Z358.1 / ANSI/ISEA Z87.1 - Eyewash and Eye Protection Package addresses applications for the selection, performance, testing, and maintenance of the equipment. ANSI/ISEA Z358.1 / ANSI/ISEA Z87.1 - Eyewash and Eye Protection Package includes:
ANSI/ISEA Z358.1-2014
ANSI/ISEA Z87.1-2015


ANSI/ISEA Z358.1 / ANSI/ISEA Z308.1 - Workplace First Aid Kits and Eyewash Package

ANSI/ISEA Z358.1 and ANSI/ISEA Z308.1

ANSI/ISEA Z358.1 / ANSI/ISEA Z308.1 - Workplace First Aid Kits and Eyewash Package provides performance requirements for various types and classes of first aid kits that are applicable to workplace injuries. ANSI/ISEA Z358.1 / ANSI/ISEA Z308.1 - Workplace First Aid Kits and Eyewash Package addresses major wounds, minor wounds (cuts and abrasions), minor burns, eye injuries, and is supported with emergency eyewash methods as well. ANSI/ISEA Z358.1 / ANSI/ISEA Z308.1 - Workplace First Aid Kits and Eyewash Package includes:
ANSI/ISEA Z358.1-2014
ANSI/ISEA Z308.1-2015


ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package

ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package

ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package establishes the risk management process associated with the biological evaluation of medical devices. It also provides test methods for in vitro cytotoxicity, irritation and skin sensitization involving medical devices. ISO 10993-1 / ISO 10993-5 / ISO 10993-10 - Biological Evaluation of Medical Devices Package includes:
ISO 10993-1:2009
ISO 10993-5:2009
ISO 10993-10:2010


BS EN 62366 / BS EN ISO 14971 / BS EN 1041 / ISO 10993-1 - Medical Devices Package

BS EN 62366, BS EN ISO 14971, BS EN 1041 and ISO 10993-1 (British Standard)

BS EN 62366 / BS EN ISO 14971 / BS EN 1041 / ISO 10993-1 - Medical Devices Package specifies the process for a manufacturer to analyze, specify, design, verify and validate usability, as it relates to safety of a medical device. It also provides risk management application, evaluation and testing associated with medical devices. BS EN 62366 / BS EN ISO 14971 / BS EN 1041 / ISO 10993-1 - Medical Devices Package includes:
 BS EN 1041:2008+A1:2013
 ISO 10993-1:2009
 ISO 10993-1/Cor1:2010
 BS EN 62366:2008+A1:2015
 BS EN ISO 14971:2012
 


BS EN ISO 18113 - In Vitro Diagnostic Medical Devices Package

BS EN ISO 18113-1, BS EN ISO 18113-2 and BS EN ISO 18113-3 (British Standard)

BS EN ISO 18113 - In Vitro Diagnostic Medical Devices Package defines concepts, establishes general principles and specifies essential requirements for information supplied by manufacturers of IVD medical devices. BS EN ISO 18113 - In Vitro Diagnostic Medical Devices Package includes:
 BS EN ISO 18113-1:2011
 BS EN ISO 18113-2:2011
 BS EN ISO 18113-3:2011
 


ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package

ISO 13485, IEC 62304 and ISO 14971 - Software, Quality and Risk Management of Medical Devices.

The ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package provides the support to develop, implement, and maintain a medical devices quality and risk management system. It also includes the requirements for the software life cycle process for medical device software. The ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package consolidates the IT, quality, and risk management medical devices necessities. It includes:
IEC 62304 Ed. 1.0 b:2006
IEC 62304 Amd.1 Ed. 1.0 b:2015
ISO 13485:2016
ISO 13485:2016 - Medical devices - A practical guide
ISO 14971:2007
 


BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package

BS EN ISO 13485 and BS EN ISO 14971 (British Standard)

The BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package provides regulatory requirements for quality management medical device systems and incorporating and maintaining a risk management system accociated with the use of medical devices. The BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package includes:

 
  • BS EN ISO 13485:2016
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  • BS EN ISO 14971:2012


ANSI/AAMI/ISO 13485 / ANSI/AAMI/IEC 62304 / ANSI/AAMI/ISO 14971 - Medical Devices Package

ANSI/AAMI/ISO 13485, ANSI/AAMI/IEC 62304 and ANSI/AAMI/ISO 14971 - Software, Quality and Risk Management of Medical Devices

The ANSI/AAMI/ISO 13485 / ANSI/AAMI/IEC 62304 / ANSI/AAMI/ISO 14971 - Medical Devices Package provides the support to develop, implement, and maintain a medical devices quality and risk management system. It also includes the requirements for the software life cycle process for medical device software. The ANSI/AAMI/ISO 13485 / ANSI/AAMI/IEC 62304 / ANSI/AAMI/ISO 14971 - Medical Devices Package consolidates the IT, quality, and risk management medical devices necessities. It includes:

 
     
  • ANSI/AAMI/IEC 62304:2006
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  • ANSI/AAMI/IEC 62304:2006/A1:2016
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  • ANSI/AAMI/ISO 14971:2007 (R2010)
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  • ANSI/AAMI/ISO 13485:2016
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ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package

ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11137-2 and ANSI/AAMI/ISO 11137-3

The ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the sterilization process of medical devices. In addition to providing the requirements for the sterilization process of medical devices, this package also considers the products' environment, personnel and their hygiene, packaging / storage, sterilization doses and more to inactivate microbiological contaminants on medical devices. The ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package includes:


BS EN ISO 14971 / BS EN ISO 11607 - Medical Devices Package

Risk and Package of Medical Devices: BS EN ISO 14971, BS EN ISO 11607-1 and BS EN ISO 11607-2 (British Standard)

BS EN ISO 14971 / BS EN ISO 11607 - Medical Devices Package provides the requirements and test methods for packaging intended to maintain the sterility of terminally sterilized medical devices until the point of use. It also provides the requirements for the development and validation of processes including forming, sealing, and assembly of packaging used for sterilized medical devices. The BS EN ISO 14971 / BS EN ISO 11607 - Medical Devices Package also allows for a process that enables manufacturers to identify hazards associated with medical devices. It includes:

  • BS EN ISO 14971:2012
  • BS EN ISO 11607-1:2017
  • BS EN ISO 11607-2:2017


BS EN ISO 14971 / BS EN 62366 - Medical Devices Package

Application of Engineering and Risk Management to Medical Devices: BS EN ISO 14971 and BS EN 62366 (British Standard)

The BS EN ISO 14971 / BS EN 62366 - Medical Devices Package specifies usability engineering and risk management processes intended to minimize use-associated errors and risks. It also provides the means to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls for medical devices. BS EN ISO 14971 / BS EN 62366 - Medical Devices Package includes:

  • BS EN ISO 14971:2012
  • BS EN 62366:2008+A1:2015


BS EN ISO 14971 / BS EN 980 - Symbols and Risk Management of Medical Devices Package

BS EN ISO 14971 and BS EN 980 - Historical Package (British Standard)

The BS EN ISO 14971 / BS EN 980 - Symbols and Risk Management of Medical Devices Package provides the specifications to identify the risk associated with the use of medical devices, while also specifying the labeling of symbols supplied by the manufacturer of medical devices. This package is the perfect manufacturers' guide to identify the risk of medical devices to the consumer and relay those risk using uniform symbols. BS EN ISO 14971 / BS EN 980 - Symbols and Risk Management of Medical Devices Package includes:

  • BS EN ISO 14971:2012
  • BS EN 980:2008


BS EN ISO 14971 / IEC 60601-1-2 - Risk Management of Medical Electrical Equipment Package

BS EN ISO 14971 and IEC 60601-1-2 (British Standard)

The BS EN ISO 14971 / IEC 60601-1-2 - Risk Management of Medical Electrical Equipment Package specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems, while identifying the hazards and risks associated with them. It also provides the means to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls of the risk associated with medical electrical devices. BS EN ISO 14971 / IEC 60601-1-2 - Risk Management of Medical Electrical Equipment Package includes:

  • BS EN ISO 14971:2012
  • IEC 60601-1-2 Ed. 4.0 b:2014


ANSI/AAMI/ISO 81060-1 / ANSI/AAMI/ISO 81060-2 / ANSI/AAMI/IEC 80601-2-30 Sphygmomanometer Set

ANSI/AAMI/ISO 81060-1 / ANSI/AAMI/ISO 81060-2 / ANSI/AAMI/IEC 80601-2-30 Sphygmomanometer Set

The Sphygmomanometer Set specifies requirements for mechanical sphygmomanometers and their accessories that, by means of inflatable cuffs, are used for the non-invasive measurement of blood pressure. It also specifies the requirements and methods for the clinical validation of me equipment used for the intermittent non-invasive automatic estimation of the arterial blood pressure by utilizing a cuff.

 
     
  • The Sphygmomanometer Set includes:
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  • ANSI/AAMI/ISO 81060-1
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  • ANSI/AAMI/ISO 81060-2
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  • ANSI/AAMI/IEC 80601-2-30:2009 and A1:2013/(R2016)
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ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set

ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set

The ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set addresses a broad range of human factors engineering (HFE) topics in a structured format. The material emphasizes adoption of a user-centered focus throughout the product design and development process, with the goal of making medical devices easier to use and less prone to use error. By providing a structured approach to user interface design, this set documents can help manufacturers develop safe and usable medical devices.

 
     
  • The ANSI/AAMI HE75 and ANSI/AAMI/IEC 62366 Human Factor Set includes
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  • ANSI/AAMI HE75:2009 (R2013) (ANSI/AAMI HE 75:2009 (R2013))
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  • ANSI/AAMI/IEC 62366-1:2015
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AAMI TIR11 / ANSI/AAMI ST65 / ANSI/AAMI PB70 Protective Barriers Resource Bundle

AAMI TIR11 / ANSI/AAMI ST65 / ANSI/AAMI PB70 Protective Barriers Resource Bundle

The AAMI TIR11 / ANSI/AAMI ST65 / ANSI/AAMI PB70 Protective Barriers Resource Bundle provides guidance on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. It also provides provides guidelines for the proper handling, processing, and preparation of reusable surgical textiles either on-site or off-site for use in health care facilities.

 
     
  • AAMI TIR11 / ANSI/AAMI ST65 / ANSI/AAMI PB70 Protective Barriers Resource Bundle includes:
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  • AAMI TIR11:2005 (R2015)
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  • ANSI/AAMI ST65:2008 (R2013) (ANSI/AAMI ST 65:2008 (R2013))
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  • ANSI/AAMI PB70:2012 (ANSI/AAMI PB 70:2012)
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IEC 60601-1 / 60601-1-2 / 60601-1-4 / 60601-1-6 Medical Electrical Equipment Package

IEC 60601-1 / 60601-1-2 / 60601-1-4 / 60601-1-6 Medical Electrical Equipment Package

IEC 60601-1 / 60601-1-2 / 60601-1-4 / 60601-1-6 Medical Electrical Equipment Package provide the general requirements for basic safety and essential performance of medical electrical equipment and medical electrical systems. The general requirements of medical electrical equipment includes testing, classification, identification / marking and protection against electrical hazards. The IEC 60601-1 / 60601-1-2 / 60601-1-4 / 60601-1-6 Medical Electrical Equipment Package specifically address electromagnetic compatibility, programmable electrical medical systems and usability of medical electrical equipment. This package includes:
IEC 60601-1 Ed. 3.1 en:2012
IEC 60601-1-2 Ed. 4.0 b:2014
IEC 60601-1-4 Ed. 1.1 b:2000 - HISTORICAL DOCUMENT
IEC 60601-1-6 Ed. 3.1 b:2013


IEC 60601-1 and IEC 60601-1-2 Medical Electrical Equipment Package

IEC 60601-1 and IEC 60601-1-2 Medical Electrical Equipment Package

IEC 60601-1 and IEC 60601-1-2 Medical Electrical Equipment Package provide the general requirements for basic safety and essential performance of medical electrical equipment and medical electrical systems. The general requirements of medical electrical equipment includes testing, classification, identification / marking and protection against electrical hazards. The IEC 60601-1 and IEC 60601-1-2 Medical Electrical Equipment Package specifically address the electromagnetic compatibility of medcial electrical equipment. This package includes:
IEC 60601-1 Ed. 3.1 en:2012
IEC 60601-1-2 Ed. 4.0 b:2014


ISO 15223 - Symbols for Medical Devices Package

ISO 15223-1 and ISO 15223-2

The ISO 15223 - Symbols for Medical Devices Package provides the requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also specifies a process for developing, selecting and validating symbols which may be used on the device, its package or in associated documentation. The ISO 15223 - Symbols for Medical Devices Package includes ISO 15223-1:2016 and ISO 15223-2:2010.


BS EN 980 / BS EN 1041 / BS EN ISO 14971 / BS EN ISO 13485 Medical Devices Package

BS EN 980, BS EN 1041, BS EN ISO 14971 and BS EN ISO 13485 - Historical Package (British Standard)

BS EN 980 / BS EN 1041 / BS EN ISO 14971/ BS EN ISO 13485 Medical Devices Package specifies the requirements for medical devices information supplied by a manufacturer along with symbols and labeling used in conjunction with that information. This package also provides the application of risk management and quality management systems in association with medical devices. The BS EN 980 / BS EN 1041 / BS EN ISO 14971/ BS EN ISO 13485 Medical Devices Package includes:
 BS EN 980:2008 - Historical Document
 BS EN ISO 13485:2016
 BS EN ISO 14971:2012
 BS EN 1041:2008+A1:2013
 


BS EN 980 and BS EN 1041 Manufacturers Information and Symbols for Medical Devices Package

BS EN 980 and BS EN 1041 - Historical Package (British Standard)

BS EN 980 and BS EN 1041 Manufacturer Information and Symbols for Medical Devices Package specifies the requirements for medical device information supplied by a manufacturer along with symbols used in conjunction with that information. The BS EN 980 and BS EN 1041 Manufacturer Information and Symbols for Medical Devices Package includes: BS EN 1041:2008+A1:2013 and BS EN 980:2008.


IEC/TR 80002-1 and ISO 14971 Medical Devices Software Package

IEC/TR 80002-1 and ISO 14971 Medical Devices Software Package

The IEC/TR 80002-1 and ISO 14971 Medical Devices Software Package specifies the process of identifying, controling and monitoring risk and hazards associated with medical device software. This package can be to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device. IEC/TR 80002-1 and ISO 14971 Medical Devices Software Package is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system and those who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. It includes ISO 14971:2007 and IEC/TR 80002-1 Ed. 1.0 en:2009.


IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package

IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package

The IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package specifies the process of identifying, controling and monitoring risk and hazards associated with medical device software. It also defines the life cycle requirements for medical device software, set of processes, activities, and tasks establishing a common framework for medical device software life cycle processes. IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package is applicable to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. It includes:
ISO 14971:2007
IEC 62304 Ed. 1.0 b:2006
IEC 62304 Amd.1 Ed. 1.0 b:2015
IEC/TR 80002-1 Ed. 1.0 en:2009


ANSI/AAMI/ISO 13408 - Aseptic Processing of Health Care Products Package

ANSI/AAMI/ISO 13408 - Aseptic Processing of Health Care Products Package

The ANSI/AAMI/ISO 13408 - Aseptic Processing of Health Care Products Package provides guidance and the requirements on processes, programs and procedures to develop, validate and control the manufacturing process of a aseptically-processed health care products. An alternative to terminal sterilization, asseptic processing enables the sterility of pre-sterilized components and products during assembly allowing the final product to be sterile in its final container (resulting in an terminally sterilized product). In addition to the general requirement, the ANSI/AAMI/ISO 13408 - Aseptic Processing of Health Care Products Package provides the various processes to attain a terminally sterilized product. The process include the filtration, lyophilization (drying process), clean-in-place technology (CIP), sterilization in place (SIP) and isolator system used to maintain aseptic conditions. The package includes:
ANSI/AAMI/ISO 13408-1:2008 (R2017)/A1:2013
ANSI/AAMI/ISO 13408-2:2003 (R2013)
ANSI/AAMI/ISO 13408-3:2006 (R2015)
ANSI/AAMI/ISO 13408-4-2005 (R2014)
ANSI/AAMI/ISO 13408-5-2006 (R2015)
ANSI/AAMI/ISO 13408-6:2005 (R2013)/A1:2013
ANSI/AAMI/ISO 13408-7:2012


ANSI/AAMI/ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects Package

Historical Package

The ANSI/AAMI/ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects Package defines procedures and requirements for the conduct and performance of clinical investigations of medical devices under normal clinical use. This package aims to protect human subjects, ensure the scientific conduct of the clinical investigation and assist monitors, investigators, ethic committees and all bodies involved in the conformity assessment of medical devices. This package includes ANSI/AAMI/ISO 14155-1:2003 and ANSI/AAMI/ISO 14155-2:2003.


DIN EN 980 and DIN EN 1041 Medical Devices Package

DIN EN 980 and DIN EN 1041 Medical Devices Package: HISTORICAL PACKAGE (Foreign Standard)

The DIN EN 980 and DIN EN 1041 Medical Devices Package specifies the guidelines and requirements for information that is to be supplied by a manufacturer of medical devices regulated by Council Directive 90/385/EEC and Council Directive 93/42/EEC. It also provides symbols for use in the information supplied by the manufacturer of medical devices. The DIN EN 980 and DIN EN 1041 Medical Devices Package enable a conformity of a manufacturers' informational requirements and symbols for medical devices. DIN EN 980 and DIN EN 1041 Medical Devices Package includes: DIN EN 980:2008 and DIN EN 1041:2008.


ISO 13485 / 14971 / 14969 - Medical Devices Package

ISO 13485 / 14971 / 14969 - Medical Devices Package

The ISO 13485 / 14971 / 14969 - Medical Devices Package provides regulatory requirements for quality management medical device systems and incorporating and maintaining a risk management system accociated with the use of medical devices. This package includes:
ISO 13485:2016
ISO 13485:2016 - Medical devices - A practical guide
ISO 14971:2007
ISO/TR 14969:2004 Historical Document


ISO 11135 - Sterilization of Health Care Products Package

ISO 11135-1 and ISO/TS 11135-2 - HISTORICAL PACKAGE

ISO 11135 - Sterilization of Health Care Products Package specifies the requirements for the development, validation and routine control of ethylene oxide sterilization process for medical devices and other healthcare products. ISO 11135 - Sterilization of Health Care Products Package includes ISO 11135-1:2007, ISO/TS 11135-2:2008 and ISO/TS 11135-2/Cor1:2009.


ANSI/AIHA/ASSE Z88. Respirator Package

ANSI/AIHA/ASSE Z88.6, ANSI/AIHA/ASSE Z88.7, and ANSI/AIHA/ASSE Z88.10

ANSI/AIHA/ASSE Z88. Respirator Package provides guidance for medical professional to determine the qualifications to administer the use of respirators on patients under the respiratory protection program. The ANSI/AIHA/ASSE Z88. Respirator Package also provides guidance for training individuals on conducting respirator fit testing and air purifying respirator components. This package includes all parts of ANSI/AIHA/ASSE Z88 nationally adopted standards:

 
     
  • ANSI/AIHA/ASSE Z88.6-2006
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  • ANSI/AIHA/ASSE Z88.7-2010
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  • and ANSI/AIHA/ASSE Z88.10-2010
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ISO 13485 and ISO 14971 - Medical Devices Package

ISO 13485 and ISO 14971 - Medical Devices Package.

The ISO 13485 and ISO 14971 - Medical Devices Package provides regulatory requirements for quality management medical device systems and incorporating and maintaining a risk management system associated with the use of medical devices. This package includes:
ISO 13485:2016
ISO 13485:2016 - Medical devices - A practical guide
ISO 14971:2007


ISO 21549 - Health Informatics Package

ISO 21549-1, ISO 21549-2, ISO 21549-3, ISO 21549-4, ISO 21549-5, ISO 21549-6, ISO 21549-7 and ISO 21549-8

The ISO 21549 - Health Informatics Package provides the platform for developing the structure of the patient healthcard data. The structure consists of device data, identification data, administrative data, clinical data, electronic prescription, security data and limited / extended clinical data. Additional standards are included that establish a common framework for the content / structure, architecture for electronic health records, physical characteristics of the healthcard and good principles and practices for a clinical data warehouse. This package contains the following documents:
ISO 21549-1:2013
ISO 21549-2:2014
ISO 21549-3:2014
ISO 21549-4:2014
ISO 21549-5:2015
ISO 21549-6:2008
ISO 21549-7:2016
ISO 21549-8:2010


ISO 11607 - Terminally Sterilized Medical Devices Package

ISO 11607 - Terminally Sterilized Medical Devices Package.

The ISO 11607 - Terminally Sterilized Medical Devices Package provides the requirements and test methods for packaging intended to maintain the sterility of terminally sterilized medical devices until the point of use. It also provides the requirements for the development and validation of processes including forming, sealing, and assembly of packaging used for sterilized medical devices. This package includes ISO 11607-1:2006, ISO 11607-1:2006/Amd1:2014, ISO 11607-2:2006 and ISO 11607-2:2006/Amd1:2014. It has been reduced 15% off of the individual list price.


ISO 11737 - Sterilization of Medical Devices Package

ISO 11737 - Sterilization of Medical Devices Package.

The ISO 11737 - Sterilization of Medical Devices Package provides the requirements to estimate and determine the population of viable microorganisms on a product and to test the sterility of a product that has been treated with a sterilizing agent. The determination of bioburden can be used to validate the sterilization process, monitor the manufacturing processes and assess the overall environmental monitoring programme. It has been reduced 25% off the list price. This package includes:
ISO 11737-1:2018
ISO 11737-2:2009


ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package

ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package

The ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality management system for an organization that needs to consistently meet regulatory requirements applicable to medical devices and related services. The guidance standard ISO/TR 14969 provides approaches to establish objectives, implement, monitor and measure the processes to improve performance. The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services. This package has a total savings of 30% off the list price and includes:
ISO 13485:2016
ISO 13485:2016 - Medical devices - A practical guide
ISO/TR 14969:2004 Historical Document


ISO 11137 - Sterilization of Health Care Products Package

ISO 11137-1, ISO 11137-2 and ISO 11137-3

The ISO 11137 - Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the sterilization process of medical devices. In addition to providing the requirements for the sterilization process of medical devices, this package also considers the products' environment, personnel and their hygiene, packaging / storage, sterilization doses and more to inactivate microbiological contaminants on medical devices. This package is reduce by 25% off of the standard list price and includes the following ISO Standards: ISO 11137-1:2006, ISO 11137-1:2006/Amd1:2013, ISO 11137-2:2013 and ISO 11137-3:2017.


ISO 10993 - Biological Evaluation of Medical Devices Package

ISO 10993 - Medical Devices Complete Set, Parts 1 thru 20

The ISO 10993 - Biological Evaluation of Medical Devices Package has an array of standards on testing, the identification / quantification of degradation products and other general biological evaluation of medical devices. The general biological evaluation of medical devices standards in this package include basic evaluation and testing, sterilization residuals, limits for leachable substances, and the preparation of samples / reference materials for testing. The referenced products are for the identification / quantification of degradation products are metals / alloys, ceramics and polymeric devices. These particular standards are supported by a toxicokinetic study design standard and framework standard for potential degradation products. The medical devices tests in this package are for system toxicity, hypersensitivity, local effects after implantation, genotoxicity, carcinogenicity, reproductive toxicity and interactions with blood. This package is 45% off the individual list price and includes the following standards:

ISO 10993-1:2009

ISO 10993-1/Cor1:2010

ISO 10993-2:2006

ISO 10993-3:2014

ISO 10993-4:2017

ISO 10993-5:2009

ISO 10993-6:2016

ISO 10993-7:2008

ISO 10993-7/Cor1:2009

ISO 10993-9:2009

ISO 10993-10:2010

ISO 10993-11:2017

ISO 10993-12:2012

ISO 10993-13:2010

ISO 10993-14:2001

ISO 10993-15:2000

ISO 10993-16:2017

ISO 10993-17:2002

ISO 10993-18:2005

ISO/TS 10993-19:2006

ISO/TS 10993-20:2006


Biological Evaluation of Medical Devices Standards

Biological Evaluation of Medical Devices Standards Package

Biological Evaluation of Medical Devices Series, Edition 2007.1. Includes

  • ANSI/AAMI/ISO 10993-1:2009;Biological evaluation of medical devices - Part 1: Evaluation and testing
  • ANSI/AAMI/ISO 10993-2:2006 (R2010);Biological evaluation of medical devices - Part 2: Animal welfare requirements
  • ANSI/AAMI/ISO 10993-3:2003 (R2009);Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ANSI/AAMI/ISO 10993-4:2002 (R2009) & A1/2006 (R2009); Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
  • ANSI/AAMI/ISO 10993-5:2009;Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • ANSI/AAMI/ISO 10993-6:2007/(R)2010;Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
  • ANSI/AAMI/ISO 10993-7:2008 ;Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • ANSI/AAMI/ISO 10993-9:2009;Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • ANSI/AAMI/ISO 10993-10:2010;Biological evaluation of medical devices - Part 10:
  • ANSI/AAMI 10993-11:2006 (r2010);Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • ANSI/AAMI/ISO 10993-12:2007;Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
  • ANSI/AAMI/ISO 10993-13:2010;Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric devices
  • ANSI/AAMI/ISO 10993-14:2001 (R2006); Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
  • ANSI/AAMI/ISO 10993-15:2000 (R2006);Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
  • ANSI/AAMI/ISO 10993-16: 2010;Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
  • ANSI/AAMI/ISO 10993-17:2002 (R2008);Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
  • ANSI/AAMI BE83:2006;Biological evaluation of medical devices - Part 18: Chemical characterization of materials
  • ANSI/AAMI/ISO TIR10993-19:2006;Biological evaluation of medical devices - Part 19: Physio-chemical, morphological and topographical characterization of materials
  • ANSI/AAMI/ISO TIR10993-20:2006;Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
  • ANSI/AAMI/ISO 14155-2011;Clinical investigation of medical devices for human subjects - Good Clinical Practice
  • ANSI/AAMI/ISO 22442-1:2007: Medical devices utilizing animal tissues and their derivatives-Part 1: Application of risk management
  • ANSI/AAMI/ISO 22442-2:2007: Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and Handling
  • ANSI/AAMI/ISO 22442-3:2007: Medical devices utilizing animal tissues and their derivatives-Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
  • AAMI TIR19:1998:Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals.


CARDIO MEDICAL DEVICE PACKAGE

ANSI/AAMI/ISO 81060-2, ANSI/AAMI/IEC 60601-2-47, ANSI/AAMI EC53, ANSI/AAMI EC12, ANSI/AAMI EC57, ANSI/AAMI EC11, ANSI/AAMI BP22, ANSI/AAMI/IEC 60601-2-4...

This Cardiovascular Medical Device Package includes the safety, monitoring and performance requirements for the more frequently used cardio medical devices. The package consists of standards that envelope cardiac monitors, sphygmomanometers, electrocardiographs, ECG cables / lead wires / electrodes, blood pressure transducers and defibrillator devices. This 10 standard Cardiovascular Medical Device package is essential. This collection contains the following AAMI documents:

 
     
  • ANSI/AAMI/IEC 60601-2-4:2010 (R2015)
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  • ANSI/AAMI/IEC 60601-2-27:2011 (R2016)
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  • ANSI/AAMI/IEC 60601-2-47:2012 (R2016)
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  • ANSI/AAMI/ISO 81060-2:2013
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  • ANSI/AAMI EC53:2013 (ANSI/AAMI EC 53:2013)
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  • ANSI/AAMI EC57:2012 (ANSI/AAMI EC 57:2012)
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  • ANSI/AAMI EC12:2000 (R2015)
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  • ANSI/AAMI EC11:1991/(R)2001 (Historical Standard)
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  • ANSI/AAMI BP22:1994 (R2011) (ANSI/AAMI BP 22:1994 (R2011))
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  • ANSI/AAMI EC71:2001(R2013) (ANSI/AAMI EC 71:2001(R2013)) (Historical Standard)
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