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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
↑/↓ Full Details


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
↑/↓ Full Details


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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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
List Price:
$111.00
Your Price:
$111.00
Available for Immediate Download
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AAMI TIR45:2012, Guidance on the use of AGILE practices Webinar

This webinar archive provides detailed information about AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software and its recommendations for complying with international standards and FDA guidance documents when using AGILE practices to develop medical device software.
AAMI Member:
$119.00
List Price:
$199.00
Your Price:
$199.00
Available for Immediate Download
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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
Available for Immediate Download
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AAMI TIR58:2014

Water testing methodologies
AAMI Member:
$133.00
List Price:
$221.00
Your Price:
$221.00
Available for Immediate Download
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AAMI TIR60:2014

Common mode rejection in ECG monitoring
AAMI Member:
$72.00
List Price:
$127.00
Your Price:
$127.00
Available for Immediate Download
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AAMI TIR77:2018 (PDF)

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

http://my.aami.org/aamiresources/images/events/HyattRegencyWeston.jpg

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.

Planned sessions will review:

  • Key FDA programs and initiatives, such as the standards recognition program, the digital health initiatives, and the single file program
  • Implementation of the European Medical Device Regulations (including the implications of Brexit)
  • The status of the Medical Device Single Audit Program, including a case-study of one manufacturer’s experience with MDSAP
  • Review of new guidance from the International Medical Device Regulators Forum, including guidance on the use of standards to support regulation and the new Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
  • The future of Quality Management Systems, including the proposed FDA switch from 21 CFR 820 to ISO 13485 and prospective eventual alignment of ISO 13485 and ISO 9001
  • New cybersecurity laws or standards affecting medical devices from around the world.
  • Implications of the upcoming new edition of ISO 14155, Clinical investigation of medical devices for human subjects
  • The use of a full Product Life Cycle Approach in medical device regulations and standards
  • A review of progress in standards for health software and health IT (including the new provisional AAMI HIT1000 series for health IT systems, revision of IEC 62304 for health software and revision of the IEC/ISO 80001 series for medial IT systems)
  • Overview of developing standards and regulatory approaches governing artificial intelligence and machine-learning algorithms in medical technology. 
Breakout sessions will address developments in standards or regulations for UDIs, mobile applications and wearable devices, Amendment 2 to IEC 60601-1, the ISO 10993 biocompatibility series, sterile packaging, robotics, and combination products.

Register by February 8, 2019 and receive $25 off the listed registration fees. Discount applied at the time of registration.
$765 (AAMI Member)
$995 (Non-member)
$400 (Government Employee)


Book your hotel room today at the Hyatt Regency Reston: click here!
The deadline to receive the AAMI discounted hotel rate is Tuesday, April 2, 2019


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
Your Price:
$236.00
Available for Immediate Download
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Acute Hemodialysis: Survey Readiness Handbook

AAMI Member:
$145.00
List Price:
$248.00
Your Price:
$248.00
Available for Immediate Download
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Acute Hemodialysis: Survey Readiness Handbook Set

AAMI Member:
$220.00
List Price:
$360.00
Your Price:
$360.00
↑/↓ Full Details




ANSI/AAMI AT6:2013

Autologous transfusion devices.
AAMI Member:
$72.00
List Price:
$127.00
Your Price:
$127.00
Available for Immediate Download
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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 HE75:2009/(R)2018 (PDF)

AAMI Member:
$235.00
List Price:
$415.00
Your Price:
$415.00
Available for Immediate Download
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ANSI/AAMI/IEC 60601-1-2:2014

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
AAMI Member:
$186.00
List Price:
$329.00
Your Price:
$329.00
Available for Immediate Download
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ANSI/AAMI/IEC 80601-2-30:2009/A1:2013

AAMI Member:
$38.00
List Price:
$62.00
Your Price:
$62.00
Available for Immediate Download
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ANSI/AAMI/ISO 10993-3:2014

Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
AAMI Member:
$72.00
List Price:
$127.00
Your Price:
$127.00
Available for Immediate Download
↑/↓ Full Details