Cart Summary
0 item(s) ($0.00)
Product Categories
Search Results
Showing 21 - 40 of 64 Results

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.
$192.00
$339.00
$339.00
Available for Immediate Download

ANSI/AAMI ST24:1999/(R)2018 (PDF)

Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
$93.00
$162.00
$162.00
Available for Immediate Download

ANSI/AAMI ST77:2013/(R)2018 (PDF)

Containment devices for reusable medical device sterilization
$93.00
$162.00
$162.00
Available for Immediate Download


ANSI/AAMI/IEC 60601-1-12:2016 (PDF)

Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
$137.00
$243.00
$243.00
Available for Immediate Download

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.
$192.00
$339.00
$339.00
Available for Immediate Download

ANSI/AAMI/IEC 60601-2-27:2011/(R)2016

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
$137.00
$243.00
$243.00
Available for Immediate Download

ANSI/AAMI/IEC 60601-2-47:2012/(R)2016

Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
$137.00
$243.00
$243.00

ANSI/AAMI/IEC 80001-1 • Successfully Launching an 80001-1-Based Program

ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities introduces a new framework for managing safety and security when medical devices are included on a convergent, heterogeneous IT-network. This approach not only identifies the activities necessary to maintain key properties of the network (safety, effectiveness, and security), it also identifies the roles that are needed and the collaboration necessary between a healthcare delivery organization and its networked technology suppliers.
$0.00
$85.00
$85.00
Available for Immediate Download

ANSI/AAMI/ISO 10993-12:2012

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
$93.00
$162.00
$162.00
Available for Immediate Download

ANSI/AAMI/ISO 11607-1:2019

Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems
$93.00
$162.00
$162.00
Available for Immediate Download

ANSI/AAMI/ISO 11607-2:2019

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
$74.00
$131.00
$131.00
Available for Immediate Download

ANSI/AAMI/ISO 11658:2012

Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems.
$65.00
$114.00
$114.00
Available for Immediate Download

ANSI/AAMI/ISO 13408-6:2005/(R)2013

Aseptic processing of health care products -- Part 6: Isolator systems. (Includes Amendment 1)
$74.00
$131.00
$131.00
Available for Immediate Download

ANSI/AAMI/ISO 13485:2016/(R)2019

Medical devices—Quality management systems—Requirements for regulatory purposes
$137.00
$243.00
$243.00
Available for Immediate Download

ANSI/AAMI/ISO 15674:2016 (PDF)

Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
$65.00
$114.00
$114.00
Available for Immediate Download

ANSI/AAMI/ISO 15675:2016 (PDF)

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
$65.00
$114.00
$114.00
Available for Immediate Download

ANSI/AAMI/ISO 18241:2016 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps
$93.00
$162.00
$162.00
Available for Immediate Download

ANSI/AAMI/ISO 18242:2016 (PDF)

Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps
$74.00
$131.00
$131.00
Available for Immediate Download

ANSI/AAMI/ISO 25539-1:2017 (PDF)

Cardiovascular implants— Endovascular devices—Part 1: Endovascular prostheses
$114.00
$200.00
$200.00
Available for Immediate Download