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Sterilization,
Part 3: Industrial Process Control,
2006-2007 edition

Whether using
in-house or contract facilities, manufacturers that ship their products
sterile should not be without this book. Updated for 2007 to include 32 important documents, including new guidance for radiation sterilization and packaging. To see the scope and ordering information for individual
standards, click on the underlined titles below.
| Order
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Order
Code |
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Price |
List Price |
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Sterilization,
Part 3 |
STBK06-3 |
$299 |
$425 |
|
Contents
- 14937 Sterilization
of health care products - General requirements for characterization
of a sterilizing agent and the development, validation, and routine
control of a sterilization process for medical devices

- 14161 Sterilization
of health care products — Biological indicators — Guidance for
the selection, use, and interpretation of results, 2nd edition
-
15882 Sterilization
of healthcare products - Chemical indicators - Guidance on the selection,
use, and interpretation of results, 3rd edition
- 11737-1 Sterilization
of medical devices - Microbiological methods - Part 1: Determination
of the population of microorganisms on products, 2nd edition
-
11737-2 Sterilization
of medical devices - Microbiological methods - Part 2: Tests of
sterility performed in the validation of a sterilization process
- ST72 Bacterial
endotoxins - Test methodologies, routine monitoring, and alternatives
to batch testing
-
17665-1 Sterilization of health care products—Moist heat—Part 1: Requirements for development validation, and routine control of a sterilization process for medical devices
- TIR13 Principles
of industrial moist heat sterilization
- 11135 Medical
devices - Validation and routine control of ethylene oxide sterilization,
3rd edition
- TIR14 Contract
sterilization for ethylene oxide, 1ed and amendment
- TIR15 Ethylene oxide
sterilization equipment, process considerations, and pertinent calculations
- TIR16 Process
development and performance qualification for ethylene oxide sterilization
- Microbiological aspects
-
TIR20 Parametric
release for ethylene oxide sterilization
- TIR28 Product
adoption and process equivalency for ethylene oxide sterilization
-
10993-7 Biological evaluation of medical devices—Part 7: Ethylene oxide........ sterilization residuals, 2nd edition
- TIR19 Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological
evaluation of medical devices, Part 7: Ethylene oxide sterilization
residuals
- 11137-1 Sterilization of health care products—Radiation—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
-
11137-2 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
-
11137-3 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects
- TIR33 Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose—Method VDmax
- TIR15843 Sterilization of health care products — Radiation
Sterilization — Product families, sampling plans for verification
dose experiments and sterilization dose audits, and frequency
of sterilization dose audits
-
TIR17 Radiation sterilization—Material qualification
- TIR29 Guide
for process control in radiation sterilization
-
14160 Sterilization
of single-use medical devices incorporating materials of animal
origin - Validation and routine control of sterilization by liquid
chemical sterilants
- ST63 Sterilization
of healthcare products - Requirements for the development, validation,
and routine control of an industrial sterilization process for
medical devices - Dry heat
- 11139 Sterilization
of health care products - Vocabulary, 2nd edition
-
ST67 Sterilization
of health care products - Requirements for products labeled "STERILE"
-
11607-1 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging, 3rd edition
-
11607-2 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing, and assembly processes
-
TIR22 Guidance
for ANSI/AAMI/ISO 11607:2000, Packaging for terminally sterilized medical
devices
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