Sterilization, Part 3: Industrial Process Control, 2009 edition
Whether using in-house or contract facilities, manufacturers that ship their products
sterile should not be without this book. Updated for 2009 to include 37 important documents, it features new guidance for ethylene oxide, moist heat, chemical indicators, biological indicators, and aseptic processing. To see the scope and ordering information for individual
standards, click on the titles below.
ORDER INFORMATION |
ORDER CODE |
MEMBER PRICE |
LIST PRICE |
BUY ONLINE |
| Sterilization, Part 3 | STBK09-3 |
$310 |
$450 |
 |
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
- 15882 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
- 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
- ST72 Bacterial endotoxin-Test methodologies, routine monitoring and alternatives to batch testing
- 17665-1 Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices
- 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1
- 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- TIR11135-2 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
- TIR14 Contract sterilization using ethylene oxide
- TIR15 Ethylene oxide sterilization equipment, process considerations and pertinent calculations
- TIR16 Process development and performance qualification for ethylene oxide sterilization -- Microbiological aspects
- TIR28 Product adoption and process equivalence for ethylene oxide sterilization
- 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- TIR19 Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- TIR20 Parametric release for ethylene oxide sterilization
- 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 sterilization - Substantiation of a selected sterilization dose - Method VDmax
- TIR35 Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
- TIR17 Compatibility of materials subject to sterilization
- 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 health care products -- Requirements for the development, validation and routine control of an industrial sterilization process for medical devices--Dry heat
- TIR11139 Sterilization of health care products - Vocabulary
- ST67 Sterilization of medical devices—Requirements for products labeled 'STERILE”
- 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
- 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, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006
- 13408-1 Aseptic processing of health care products - Part 1: General requirements
- 13408-2 ANSI/AAMI/ISO 13408-2:2003, Aseptic processing of health care products - Part 2: Filtration
- 13408-3 ANSI/AAMI/ISO 13408-3:2006, Aseptic processing of health care products - Part 3: Lyophilization
- 13408-4 ANSI/AAMI/ISO 13408-4:2005, Aseptic processing of health care products - Part 4: Clean-in-place technologies
- 13408-5 ANSI/AAMI/ISO 13408-5:2006, Aseptic processing of health care products - Part 5: Sterilization in place
- 13408-6 ANSI/AAMI/ISO 13408-6:2005, Aseptic processing of health care products - Part 6: Isolator systems