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AAMI TIR52 : 2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
Available format(s)

Hardcopy , PDF

Superseded date

01-23-2020

Language(s)

English

Published date

01-01-2017

Publisher

Association for the Advancement of Medical Instrumentation

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
Standard
Pages
23
ProductNote
Reconfirmed 2014
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

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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Hardcopy - English
PDF - English - DRM

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