AAMI TIR30:2011(R2016)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
Hardcopy , PDF
02-13-2024
English
12-15-2016
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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Superseded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 |
| 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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