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AAMI TIR30:2011(R2016)

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

13-02-2024

Language(s)

English

Published date

15-12-2016

Glossary of equivalent standards
Committee representation
Acknowledgments
Foreword
Introduction
1 Scope
2 Definitions, abbreviations, and symbols
3 Device materials
4 Device design
5 Cleaning processes available in health
  care facilities
6 Test soils
7 Test methods, equipment, and acceptance
  criteria
8 Regulatory considerations
Annexes
A - Cleaning validation protocol
B - Determining surface area and volume of
    a channel
C - Bibliography

Provides information regarding test protocols, materials, test soils, and acceptance criteria that can be used by medical device manufacturers to validate cleaning processes for reusable medical devices.

DocumentType
Standard
ISBN
978-1-57020-419-7
Pages
60
ProductNote
Reconfirmed 2016
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
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

ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
EN ISO 14729:2001/A1:2010 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses - Amendment 1 (ISO 14729:2001/Amd 1:2010)
ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations
AAMI TIR34 : 2014 WATER FOR THE REPROCESSING OF MEDICAL DEVICES
ISO 15883-3:2006 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
AS 2945-1998 Batch-type washer/disinfectors for health care facilities
ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
AAMI RD47 : 2008 REPROCESSING OF HEMODIALYZERS
BS 2745-2:1993 Washer-disinfectors for medical purposes Specification for human waste container washer-disinfectors
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
AS 3836-1998 Rack conveyor washers for health care facilities
ISO 14729:2001 Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AS 2773-1985 Ultrasonic cleaners for hospital use
ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
AAMI ST15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS

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