AAMI TIR52 : 2014(R2017)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
Hardcopy , PDF
27-04-2023
English
10-10-2017
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Glossary of equivalent standards
Committee representation
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General principles
5 Factors to consider when establishing
an EM program
6 Sampling plans
7 EM methods
8 Microbial characterization
9 Setting alert and action levels
10 Trending results
11 Investigation of EM excursions
12 Planned and unplanned interruptions
13 Water monitoring
14 Compressed gasses
Bibliography
Defines routine monitoring for viable (i.e. microorganisms) and non-viable particulates in controlled environments used to produce healthcare products that are intended to be terminally sterilized.
| DocumentType |
Technical Report
|
| ISBN |
978-1-57020-515-6
|
| Pages |
23
|
| ProductNote |
Reconfirmed 2017
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| ISO 14644-6:2007 | Cleanrooms and associated controlled environments Part 6: Vocabulary |
| ISO 14698-2:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data |
| ISO 14644-2:2015 | Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| IEST RP CC006.3 : 2004 | TESTING CLEANROOMS |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| IEST RP CC023.2 : 2006 | MICROORGANISMS IN CLEANROOMS |
| ISO 8573-1:2010 | Compressed air Part 1: Contaminants and purity classes |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
| ISO 14644-3:2005 | Cleanrooms and associated controlled environments Part 3: Test methods |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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