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$485.00 $242.50

Sterilization, Part 3: Industrial Process Control, 2013 Edition
standard by Association for the Advancement of Medical Instrumentation, 2013

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Description

This collection of 38 documents has been updated to include nine new/ revised standards. It features new guidance for sterilization of single-use medical devices incorporating materials of animal origins (14160), requirements for products labeled “sterile” (ST67), dry heat sterilization of health care products (20857), radiation (11137-2), and more.

Whether using in-house or contract facilities, manufacturers that ship their products sterile should not be without this book.

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
  • 14160 Sterilization of single-use medical devices incorporating materials of animal origin – Validation and routine control of sterilization by liquid chemical sterilants
  • 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 the population of microorganisms on products
  • 11737-2 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation, and maintenance 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
  • 20857 Sterilization of health care products-Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices
  • 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 Physical aspects of ethylene oxide sterilization
  • TIR16 Microbiological aspects of ethylene oxide sterilization
  • TIR28 Product adoption and process equivalence for ethylene oxide sterilization
  • 10993-7 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
  • 11137-1 Sterilization of health care products – Radiation – Part 1: Requirements for 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
  • TIR37 Sterilization of health care products — Radiation — Guidance on sterilization of human tissue-based products
  • TIR40 Sterilization of health care products — Radiation — Guidance on dose setting utilizing a Modified Method 2
  • TIR29 Guide for process control in radiation sterilization
  • TIR17 Compatibility of materials subject to sterilization
  • 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 Aseptic processing of health care products – Part 2: Filtration
  • 13408-3 Aseptic processing of health care products – Part 3: Lyophilization
  • 13408-4 Aseptic processing of health care products – Part 4: Clean-in-place technologies
  • 13408-5 Aseptic processing of health care products – Part 5: Sterilization in place
  • 13408-6 Aseptic processing of health care products – Part 6: Isolator systems
  • 13408-7 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products

Product Details

Published:
2013
Sale!

$485.00 $242.50

Sterilization, Part 3: Industrial Process Control, 2013 Edition
standard by Association for the Advancement of Medical Instrumentation, 01/01/2013

NOTE: Our website provide PDF immediately download(In Your Account),
If you purchased items can't online download, please contact us.We will send the document to you with email.
Category:

Description

The 2013 collection of 38 documents is intended primarily for manufacturers who ship their products sterile. It features new guidance for sterilization of single-use medical devices incorporating materials of animal origins (14160), requirements for products labeled “sterile” (ST67), dry heat sterilization of health care products (20857), radiation (11137-2), and more.

Product Details

Published:
01/01/2013
Part of:
AAMI STBK13-S