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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

21-12-2022

Publisher

Association for the Advancement of Medical Instrumentation

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.

DocumentType	Standard
ISBN	978-1-57020-863-8
Pages	38
PublisherName	Association for the Advancement of Medical Instrumentation
Status	Current

Standards	Relationship
ISO 17664-1:2021	Identical

AAMI TIR30:2011(R2016)	A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
ISO 11139:2018	Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards
AAMI TIR12:2020(R2023)	Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices