0 item(s) ($0.00)
Product Categories
Search Results
Showing 1 - 20 of 75 Results
Sort by

AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
AAMI Member:
$155.00
List Price:
$274.00
Your Price:
$274.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
AAMI Member:
$133.00
List Price:
$236.00
Your Price:
$236.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
AAMI Member:
$72.00
List Price:
$127.00
Your Price:
$127.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR29:2012/(R)2017 (PDF)

Guide for process characterization and control in radiation sterilization of medical devices
AAMI Member:
$126.00
List Price:
$221.00
Your Price:
$221.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR30:2011/(R)2016 (PDF)


A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
AAMI Member:
$132.00
List Price:
$221.00
Your Price:
$221.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR42:2010

Evaluation of particulates associated with vascular medical devices
AAMI Member:
$126.00
List Price:
$221.00
Your Price:
$221.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR44:2012

Non-invasive blood pressure motion artifact - Testing and evaluation of NIBP device performance in the presence of motion artifact
AAMI Member:
$90.00
List Price:
$157.00
Your Price:
$157.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
AAMI Member:
$155.00
List Price:
$274.00
Your Price:
$274.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR97:2019

Principles for medical device security—Postmarket risk management for device manufacturers
AAMI Member:
$133.00
List Price:
$236.00
Your Price:
$236.00
Available for Immediate Download
↑/↓ Full Details


AAMI/IEC TIR62296:2009

Considerations of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements
AAMI Member:
$129.00
List Price:
$216.00
Your Price:
$216.00
↑/↓ Full Details


AAMI/ISO TIR10974:2018 (PDF)

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.
AAMI Member:
$166.00
List Price:
$293.00
Your Price:
$293.00
Available for Immediate Download
↑/↓ Full Details


AAMI/ISO TIR17137:2014 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
AAMI Member:
$90.00
List Price:
$157.00
Your Price:
$157.00
Available for Immediate Download
↑/↓ Full Details


Acquisition Guide for Clinical Technology Equipment

AAMI Member:
$62.00
List Price:
$96.00
Your Price:
$96.00
↑/↓ Full Details


Acquisition Guide for Clinical Technology Equipment

AAMI Member:
$62.00
List Price:
$96.00
Your Price:
$96.00
Available for Immediate Download
↑/↓ Full Details


ANSI/AAMI 26722:2014

Water treatment equipment for hemodialysis and related therapies.
AAMI Member:
$111.00
List Price:
$194.00
Your Price:
$194.00
Available for Immediate Download
↑/↓ Full Details


ANSI/AAMI 2700-1:2019

Medical Devices and Medical Systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model
AAMI Member:
$111.00
List Price:
$194.00
Your Price:
$194.00
Available for Immediate Download
↑/↓ Full Details


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
Your Price:
$274.00
Available for Immediate Download
↑/↓ Full Details


ANSI/AAMI EQ56:2013

Recommended practice for a medical equipment management program
AAMI Member:
$111.00
List Price:
$194.00
Your Price:
$194.00
Available for Immediate Download
↑/↓ Full Details


ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)

MEDICAL ELECTRICAL EQUIPMENT - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
AAMI Member:
$186.00
List Price:
$329.00
Your Price:
$329.00
Available for Immediate Download
↑/↓ Full Details


ANSI/AAMI NS4:2013/(R)2017 (PDF)

Transcutaneous electrical nerve stimulators
AAMI Member:
$72.00
List Price:
$127.00
Your Price:
$127.00
Available for Immediate Download
↑/↓ Full Details