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AAMI TIR30:2011/(R)2016 [HISTORICAL]

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

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AAMI TIR30:2011/(R)2016 [HISTORICAL]

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

PUBLISH DATE 2011

Document Information

This report is intended as a resource for manufacturers of medical devices who must validate the instructions for reprocessing that they include with their devices. In addition to describing available processes, materials, test methods, and acceptance criteria for cleaning medical devices that are labeled by the manufacturer for reuse and reprocessing, the report also discusses some of the underlying problems and challenges associated with validating a cleaning method. Extensive references and a sample cleaning validation outline and also are included. This document has been superseded by ANSI/ST98:2022; Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices. This document is no longer being maintained by and should not be used for new designs. Every standard is subjected to review at least every five (5) years. When a standard is more than five years old, has not undergone revision or review, and/or no longer carries the ANSI designation, it is reasonable to conclude that the contents, while still of some historic value, do not reflect the present state of the art. All copyrights remain in full effect.


SDO	AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number	TIR30
Publication Date	Jan. 1, 2011
Language	en - English
Page Count	60
Revision Level
Supercedes
Committee

Publish Date	Document Id	Type	View
Jan. 1, 2011		Revision

SDO	Document	Title
ASTM	E2314	Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test) (Withdrawn 2021)
ASTM	E1837	Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test) (Withdrawn 2023)
ASTM	F3321	Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
ASTM	F3208	Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
ASTM	F3293	Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
BSI	BSI BS EN ISO 17664-2	Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices -- Non-critical medical devices
BSI	BSI BS EN IEC 61189-5-504	Test methods for electrical materials, printed board and other interconnection structures and assemblies -- General test methods for materials and assemblies. Process ionic contamination testing (PICT)
IEC	IEC 61189-5-504	Test methods for electrical materials, printed boards and other interconnection structures and assemblies - Part 5-504: General test methods for materials and assemblies - Process ionic contamination testing (PICT)
CSA	CSA ISO 17664-2	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 (Adopted ISO 17664-2:2021, first edition, 2021-02)
ISO	ISO 17664-2	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
AAMI	ANSI/AAMI/ISO 17664-2	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
BSI	BSI BS EN ISO 17664-1	Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices -- Critical and semi-critical medical devices
ASTM	F3438	Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices
BSI	BSI DD ISO/TS 10993-20	Biological evaluation of medical devices -- Principles and methods for immunotoxicology testing of medical devices
BSI	BSI BS EN IEC 63215-2	Endurance test methods for die attach materials -- Temperature cycling test method for die attach materials applied to discrete type power electronic devices
BSI	BSI BS EN ISO 10993-18	Biological evaluation of medical devices -- Chemical characterization of medical device materials within a risk management process
AAMI	ANSI/AAMI/ISO 17664-1	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
CSA	CSA ISO 17664-1	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 (Adopted ISO 17664-1:2021, first edition, 2021-07)
ISO	ISO 17664-1	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
ASTM	E1766	Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices (Withdrawn 2023)
BSI	BSI BS EN 60749-38	Semiconductor devices. Mechanical and climatic test methods -- Soft error test method for semiconductor devices with memory
ISO	ISO/TS 10993-20	Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
BSI	BSI BS 6469-1-1.3	Insulating and sheathing materials of electric cables. Methods of test for general application -- Insulating and sheathing materials of electric cables. Methods of test for general application. Methods for determining the density. Water absorption tests. Shrinkage test
BSI	BSI PD IEC/TR 80002-3	Medical device software -- Process reference model of medical device software life cycle processes (IEC 62304)
IEC	IEC 63215-2	Endurance test methods for die attach materials - Part 2: Temperature cycling test method for die attach materials applied to discrete type power electronic devices