Buy this standard

Abstract Preview

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.

ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.


General information

  • Status :  Published
    Publication date : 2008-06
  • Edition : 2
    Number of pages : 45
  • Technical Committee
    :
    ISO/TC 198
    Sterilization of health care products
  • ICS :
    11.080.01
    Sterilization and disinfection in general

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

3
Good Health and Well-being

Buy this standard

Format Language
PDF
Paper
  • CHF158

Life cycle


Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information.

  2. Store
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.080
  7. 11.080.01
  8. ISO 13408-1:2008