ENGLISH

Radiation Sterilization: Validation and Routine Operations Handbook

By Anne F. Booth

Book information

Publisher
PDA/DHI
Year
2008
ISBN
1933722177
Language
english
Format
PDF
Filesize
5 MB (5750139 bytes)
Pages
170\170
Topic
Medicine
Library
Kingdwarf
Time added
2010-01-07 06:59:20
каталогиМедицинские дисциплины;Медицинские словарисправочникитаблицыэнциклопедии;Справочники

Description

This comprehensive handbook is intended to provide a framework for the validation and routine operation of irradiation sterilization processes. It defines methods to assist you in the interpretation and understanding of ancillary standards and guidelines. It offers practical procedures for the validation and routine monitoring of your specific radiation sterilization process. Although the scope of the standards refers to medical devices, the requirements and guidance may be applicable to other health care products.The guidance presented complies with:ANSI/AAMI/ISO 11137-1: 2006: Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices;ANSI/AAMI/ISO 11137-2: 2006: Sterilization of health care products Radiation Part 2: Establishing the sterilization dose;ANSI/AAMI/ISO 11137-3: 2006 Sterilization of health care products Radiation Part 3: Guidance on Dosimetric aspects.

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