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ANSI/AAMI ES60601-1:2005/(R)2012, (IEC 60601-1:2005, MOD)

This standard incorporates Amendment 1 with changes highlighted in the text.
AAMI Member:
$604.00
List Price:
$1,029.00
Your Price:
$1,029.00
Available for Immediate Download
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ANSI/AAMI/ISO 14971:2007/(R)2016

Medical devices - Application of risk management to medical devices.
AAMI Member:
$155.00
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$274.00
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$274.00
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AAMI News Individual, Non-US Subscribers

AAMI's official monthly newsletter keeps more than 6,000 members on top of AAMI standards activities and publications; key regulatory and legislative proposals and actions; and association programs, policies, and educational offerings. AAMI News is a benefit of AAMI membership. Non-members may subscribe.
AAMI Member:
$220.00
List Price:
$220.00
Your Price:
$220.00
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AAMI News Individual, US Subscribers

AAMI's official monthly newsletter keeps more than 6,000 members on top of AAMI standards activities and publications; key regulatory and legislative proposals and actions; and association programs, policies, and educational offerings. AAMI News is a benefit of AAMI membership. Non-members may subscribe.
AAMI Member:
$185.00
List Price:
$185.00
Your Price:
$185.00
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AAMI 40th Anniversary Book

This commemorative coffee-table style book, published in recognition of AAMI’s 40th anniversary in 2007, examines the evolution of AAMI and the medical device industry over the last four decades. Using pictures and narrative from pioneers in the field, this keepsake explores the role of device regulation, the engineering community, the standards program, and quality systems initiatives.
AAMI Member:
$22.00
List Price:
$36.00
Your Price:
$36.00
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AAMI RT2:2017 (PDF)

Radiation therapy readiness check
AAMI Member:
$0.00
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$0.00
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$0.00
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TIR19 & A1 Combined

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
AAMI Member:
$63.00
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$111.00
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$111.00
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AAMI TIR45:2012/(R)2018

Guidance on the use of AGILE practices in the development of medical device software
AAMI Member:
$129.00 - $133.00
List Price:
$229.00 - $236.00
Your Price:
$229.00 - $236.00
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AAMI TIR58:2014

Water testing methodologies
AAMI Member:
$133.00
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$221.00
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$221.00
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AAMI TIR60:2014

Common mode rejection in ECG monitoring
AAMI Member:
$72.00
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$127.00
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$127.00
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AAMI TIR77:2018 (PDF)

Sorbent-based regenerative hemodialysis systems
AAMI Member:
$90.00
List Price:
$157.00
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$157.00
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AAMI/BSI/FDA International Standards Conference - April 2019

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The AAMI/BSI/FDA International Conference on Medical Device Standards and Regulation will be held on 24-25 April 2019 at the Hyatt Regency Reston, 1800 Presidents St, Reston, VA 20190.  The conference will provide updates and analysis of new FDA initiatives and European Medical Device regulation and will review changes to key international standards.

The programme includes two keynote presentations; one comparing safety perspectives in healthcare with the airline industry and the other providing a insight on future trends in regulations of medical devices from the UK MHRA. Other sessions include:

  • FDA updates on
    • The new safety and performance pathway
    • The Accreditation Scheme for Conformity Assessment (ASCA) of medical devices
    • The programme for the adoption of standards
    • The digital health initiatives
  • Machine learning and artificial intelligence in medical technology
  • Implementation of the European Medical Devices Regulations with a focus on:
    • Clinical evidence
    • Technical documentation
  • Implications of Brexit
  • Updates and practical experiences of 
    • The International Medical Device Regulatory Forum (IMDRF)
    • The Medical Devices Single Audit Programme (MDSAP)
  • Updates on standards and regulations for
    • Quality management systems for medical devices
    • Cybersecurity
    • Risk management
    • Medical device software
    • Post-market servicing, repair and refurbishment
    • Interoperability
    • Sterilization and packaging for sterile devices
    • Unique Device Identification (UDI)
    • Medical electrical equipment
    • Good clinical practice
    • Device labelling and instructions for use


$765 (AAMI Member)
$995 (Non-member)
$400 (Government Employee)

Book your hotel room today at the Hyatt Regency Reston: click here!

Alternative Hotels Nearby:
The Westin Reston Heights - 1.6 miles
Sheraton Reston - 1.4 miles
Hyatt House - 1.7 miles
SpringHill Suites Herndon Reston - 1.4 miles
Hampton-Inn & Suites Herndon-Reston - 1.5 miles
Residence Inn Herndon Reston - 1.7 miles


Start Date:
Wednesday, April 24, 2019
End Date:
Thursday, April 25, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
Hyatt Regency Reston
1800 Presidents St
Reston, VA 20190
UNITED STATES
AAMI Member
$400.00 - $765.00
List Price
$400.00 - $995.00


AAMI/IEC TIR80001-2-8:2016 (PDF)

AAMI Member:
$133.00
List Price:
$236.00
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$236.00
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ANSI/AAMI AT6:2013

Autologous transfusion devices.
AAMI Member:
$72.00
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$127.00
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$127.00
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ANSI/AAMI BF64:2012

Leukocyte reduction filters.
AAMI Member:
$72.00
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$127.00
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$127.00
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ANSI/AAMI BF7:2012

Blood transfusion micro-filters.
AAMI Member:
$72.00
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$127.00
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$127.00
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ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers
AAMI Member:
$72.00
List Price:
$127.00
Your Price:
$127.00
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ANSI/AAMI CI86:2017 (PDF)

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
AAMI Member:
$155.00
List Price:
$274.00
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$274.00
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ANSI/AAMI EC12:2000/(R)2015

Disposable ECG electrodes
AAMI Member:
$72.00
List Price:
$127.00
Your Price:
$127.00
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