jQuery Mobile Framework
Search Home >> Standards Wordwide >> Other Standards >> AAMI ISO TIR 13004-2013 Sterilization Of Health Care Products - Radiation - Substantiation Of A Selected Sterilization Dose: Method Vd[Max][Sd]

AAMI ISO TIR 13004-2013 Sterilization Of Health Care Products - Radiation - Substantiation Of A Selected Sterilization Dose: Method Vd[Max][Sd]

Standard Number:  AAMI ISO TIR 13004-2013
Title:  Sterilization Of Health Care Products - Radiation - Substantiation Of A Selected Sterilization Dose: Method Vd[Max][Sd]
Language:  English
Adopted International Standard:  ISO TS 13004 Identical

Status:  Unknown
Publisher:  Other Standards
Price:  
Number of Pages:85  

Description:Specifies a method for substantiating a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 10[-6] or less for radiation sterilization of health care products.  
Catalog:Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO TS 13004:2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Definition and maintenance of product families for
sterilization dose substantiation and sterilization
dose auditing
5 Selection and testing of product for substantiating
and auditing a selected sterilization dose
6 Method VD[max][SD] - Substantiation of a selected
sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5,
or 35 kGy
7 Maintaining process effectiveness
8 Tables of values for SIP equal to 1.0 VD[max][SD], SIP
dose reduction factor and augmentation dose
corresponding to applicable values of average bioburden
for selected sterilization doses of 17.5, 20, 22.5, 27.5,
30, 32.5 and 35 kGy
9 Worked examples
Bibliography  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  200KB
Tile in English:  Sterilization Of Health Care Products - Radiation - Substantiation Of A Selected Sterilization Dose: Method Vd[Max][Sd]

Full Text Information

Related

Top 10

New 10

PC Version