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ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017 [HISTORICAL]
Aseptic processing of health care products—Part 1: General requirements (includes Amendment 1)
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Summary
Specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process for aseptically processed health care products. The included amendment corrects spelling errors; clarifies a definition note; and replaces terms used in Table 1 and Table 2. Annex 3
Technical characteristics
| Publisher | Association for the Advancement of Medical Instrumentation (AAMI) |
| Publication Date | 01/01/2008 |
| Confirmation Date | 01/01/2017 |
| Page Count | 0 |
| Themes | Sterilization—Industrial |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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01/01/2023
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01/01/2008
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