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 Information:	Order Code	Member Price	List Price	Buy Now
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
  

RETURN TO TOP > RETURN TO STANDARDS PUBLICATIONS