AAMI TIR27 : 1ED 2001
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE - METHOD VD MAX
Available format(s)
PDF
Language(s)
English
Published date
12-01-2013
Superseded date
04-04-2006
Superseded by
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Summarise this standard
AI-generated summary
Defines a method of substantiation of 25 kGy as the sterilization dose for radiation sterilization of health care products with an average bioburden for the entire product unit (SIP=1) < 1000 colony-forming units (cfu). Application of the method of substantiation of 25 kGy described in this technical report may be used to meet the requirements specified under subclause 6.2.2 relating to product qualification in ISO 11137.
| Committee |
WG 02
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 11137:1995 | Identical |