AAMI TIR12:2020(R2023)
Current
The latest, up-to-date edition.
Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
Hardcopy , PDF
English
07-09-2023
Important note : Users cannot be edited or removed once added to your Multi user PDF.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 |
| 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 |
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