MADCAD.com - The Cloud-Based Reference Library

- Free Trial - Webinar - Feedback

Cart (0)

No items in cart.

Total

There is a technical issue about last added item. You can click "Report to us" button to let us know and we resolve the issue and return back to you or you can continue without last item via click to continue button.

Home

Content

eLibrary

Not a subscriber? Register for a trial account.

Username:
Password:

Incorrect username/password.

Already a subscriber?

MADCAD.com Free Trial

Sign up for a 3 day free trial to explore the MADCAD.com interface, PLUS access the
2009 International Building Code to see how it all works.

If you like to setup a quick demo, let us know at support@madcad.com
or +1 800.798.9296 and we will be happy to schedule a webinar for you.

Email *
Password *
Confirm *
First Name *
Last Name *
Title
Company Name *
Company Size *
Industry *
Address *
Address 2
City *
State *	Zip *
Country *
Phone *
How did you hear about MADCAD.com? *

Print page(s), starting from page (current page)

Continue to Print

Reset password

Enter your personal account email address to request
a password reset:

Reset password

Enter your account email address to request
a password reset:

Save As:

Are you sure you want to delete this group?

Security check

Please check the following box:

Please login to your personal account to use this feature.

Email:

Password:

Forgot your password?

Remember me for one month

Need a login? Register now.

Please login to your authorized staff account to use this feature.

Username:

Password:

Are you sure you want to empty the cart?

There were no books found for the applied search filters.

CLICK TO START OVER

Report To Us

Please fill the form below so that we can contact you.

Full name*
Email*
Phone

Contact us for a custom quote

Please fill the form below and a member of our staff will contact you shortly. The contents of your cart will automatically be sent to us so we can provide an accurate custom quote.

Company*
Full name*
Email*
Phone

To continue with accurate pricing,
please select your company type below:

Large goverment organizations

Large multi-national corporation (more than $5B annual revenue)

None of the above

Your company has a special pricing case for IEEE.
For pricing, please contact us by filling out the form.

Full name*
Email*
Phone
Your selection

We need your input!

Are you a code official in a jurisdiction with less than 300,000 population?

Yes No

This item is only available for the code officials of jurisdictions less then 300K population.

If you do not meet the criteria item will be removed and you will be able to continue shopping other items.

Cart Warning

eLibrary > AAMI/ISO TIR22456:2022, Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products >

AAMI/ISO TIR22456:2022, Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products, 2022

AAMI/ISO TIR22456:2022, Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products, 2022

AAMI/ISO TIR22456:2022; Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Title page
Copyright information
AAMI Technical Information Report
Contents Page
Committee representation
Background of AAMI adoption of ISO/TS 22456:2021
Foreword
Introduction
1 Scope [Go to Page]
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Definition and maintenance of product families
5 Selection and testing of product for bioburden and tests of sterility [Go to Page]
5.1 General
5.2 Nature of product
5.3 Sample Item Portion (SIP)
5.4 Sampling conditions [Go to Page]
5.4.1 General
5.4.2 Considerations for human tissue donor batches in sterilization
5.4.3 Use of multiple batches
5.4.4 Considerations for packaging
5.5 Microbiological testing [Go to Page]
5.5.1 Bioburden test considerations for biologics/tissues [Go to Page]
5.5.1.1 General
5.5.1.2 Extraction fluid
5.5.1.3 Extraction methods
5.5.1.4 Membrane filter selection
5.5.1.5 Filtration considerations
5.5.1.6 Most Probable Number (MPN)
5.5.1.7 Media for incubation
5.5.1.8 Culture conditions
5.5.1.9 Enumeration and characterization
5.5.1.10 Interpretation of data
5.5.2 Test of sterility considerations for biologics/tissues [Go to Page]
5.5.2.1 General
5.5.2.2 Performance of test of sterility
5.5.2.3 Culture conditions
5.5.2.4 Membrane filtration of eluate
5.5.2.5 Examination of growth medium
5.5.3 Verification of microbiological methods [Go to Page]
5.5.3.1 Method suitability
5.5.3.2 Bioburden test verification (recovery efficiency test)
5.5.3.3 Method suitability for test of sterility (bacteriostasis/fungistasis test)
5.5.4 Rapid microbiology tests
Bibliography [Go to Page]

About Us / Careers / support@madcad.com / 1.800.798.9296

MADCAD.com Free Trial

Report To Us

Contact us for a custom quote

To continue with accurate pricing, please select your company type below:

We need your input!

Cart Warning

AAMI/ISO TIR22456:2022, Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products, 2022

To continue with accurate pricing,
please select your company type below: