Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-09-2023

Publisher

Association for the Advancement of Medical Instrumentation

This document provides guidance to medical device manufacturers, who are required to provide instructions that detail the processing steps from pre-treatment at the point of use through the terminal process and storage to accompany reusable and single-use medical devices that are processed by a health care facility prior to clinical use.

DocumentType	Standard
ISBN	978-1-57020-779-2
Pages	73
ProductNote	This standard also refers to ISO 10993, ISO 15883-4
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current
Supersedes	AAMI TIR12:2020

ANSI/AAMI/ISO 17664-1:2022	Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
ANSI/AAMI/ISO 17664-2:2022	Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices