Medical Device Cybersecurity

A Guide for HTM Professionals
Edited by Stephen L. Grimes 
and Axel Wirth

A must-have resource for professionals in healthcare technology management, this comprehensive guide includes chapters on cybersecurity fundamentals, the regulatory and standards environment, and inventory and configuration management. It provides examples of purchase agreements and vendor contracts, risk assessment and management practices, and cybersecurity guidance from leading healthcare systems.

Complete Dialysis Collection

This collection of 15 AAMI dialysis standards and technical information reports includes the latest versions of all dialysis documents. AAMI adopted the 2019 ISO 23500 series of dialysis fluid standards as replacements for the ANSI/AAMI 2014 versions, which have been technically revised. AAMI also adopted the ISO 8637 series standards, which supersede the previous versions that had been published under separate designations.

ANSI/AAMI ES60601-1

Medical electrical equipment— Part 1: General requirements for basic safety and essential performance

This is the American adoption of the IEC 60601-1 standard, which includes U.S. deviations, such as the U.S. national electrical codes. This version contains the 2005 3rd edition of 60601-1 as well as Amendment 1, which was approved in 2012. This international standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems.

HTM Levels Application

AAMI’s HTM Levels Guide is an assessment tool to be used for identifying performance improvement opportunities for your department and the services it provides.

AAMI developed this guide to support healthcare technology management (HTM) departments in optimizing the services they provide to healthcare delivery organizations (HDOs). This guide is a product of AAMI’s strategic initiative to standardize, elevate, and support the evolution of the HTM field.

PDF version available

Basic Concepts in Validation and Qualification of Cleaning and Sterilization Processes for Reusable Medical Devices

Basic Concepts in Validation and Qualification of Cleaning and Sterilization Processes for Reusable Medical Devices is a timely update to Donna Swenson’s bestselling resource for sterile processing personnel and medical device manufacturers.The book covers basic information about the science behind sterilization, quality management, and the principles of validation. The text then applies those principles to cleaning processes, the validation of various sterilization processes, and product quality assurance testing of cleaning and sterilization processes. The intent of the book is to help sterile processing and medical device manufacturing personnel be on the “same page” and able to use the same language and concepts in discussing and understanding cleaning and sterilization processes. 

AAMI TIR49:2013/(R)2020 

Design of training and instructional materials for medical devices used in non-clinical environments

It is widely recognized that medical devices are increasingly being used outside of a traditional healthcare setting and by individuals with little, or no, prior training on the use of these devices. The purpose of this TIR is to support safe, accurate, and efficient user performance by providing guidance on the design of user instructions and training.

AAMI/ISO TIR20416:2020

Medical devices–Post-market surveillance for manufacturers

This technical information report (TIR) provides a common understanding of post-market surveillance, or PMS facilitating international cooperation in this area. The Technical Report is intended for use by manufacturers of medical devices. With PMS, the manufacturers can collect, evaluate, and analyze experience gained with their devices after placing on the market. The resulting information can be used for, among others, improvement of the devices.

AAMI/ISO TIR24971:2020

Medical devices—Guidance on the application of ISO 14971

This Technical Report provides guidance that addresses specific areas that experience has shown are problematic for those implementing a risk management system. This guidance does not require any change to existing implementations of ISO 14971. The document is not a general guidance on implementation of risk management. Such documents already exist from various sources. Rather the document focuses on expectations in certain critical areas such as guidance on formulation of a risk management policy; the role of product and process standards in the risk management process; guidance on how the feedback loop can work; guidance on the differentiation of information for safety as a risk control measure and disclosure of residual risk; and an expansion of the discussion of overall residual risk.

ANSI/AAMI/ISO 11607-1:2019

Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

This standard specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

AAMI TIR76:2021

Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S

This report describes a method for substantiating a selected sterilization dose that achieves maximally a selected sterility assurance level (SAL) for radiation sterilization of healthcare products. AAMI TIR76 comes with an online Calculation Tool that calculates the appropriate VDmax SD-S verification does and dose augmentation values.