AAMI TIR37 2013

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AAMI TIR37:2013 – Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products

Published By	Publication Date	Number of Pages
AAMI	2013	29

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This AAMI Technical Information Report (TIR) provides guidance for development, validation and routine control associated with the radiation sterilization processing of biologics and tissue-based products.

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PDF Pages	PDF Title
1	AAMI TIR37: 2013, Sterilization of health care products—Radiation— Guidance on sterilization of biologics and tissue-based products
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents
6	Glossary of equivalent standards
7	Committee representation
10	Foreword
11	Introduction
13	1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references 3 Terms and definitions
15	4 Definition and maintenance of product families for dose setting, dose substantiation and sterilization dose auditing 4.1 General
16	4.2 Defining product families 4.3 Designation of product to represent a product family for performance of a verification dose experiment or a sterilization dose audit 4.3.1 Product to represent a product family 4.3.2 Master product 4.3.3 Equivalent product
17	4.3.4 Simulated product 4.4 Maintaining product families 4.4.1 Periodic review 4.4.2 Modification to product and/or manufacturing process 4.4.3 Records 4.4.4 Evaluating a new product for adoption into an existing product family 4.5 Effect of failure on establishment of sterilization dose or of a sterilization dose audit on a product family 5 Selection and testing of product for establishing and verifying the sterilization dose 5.1 General
18	5.2 Nature of product 5.3 Sample Item Portion (SIP) 5.4 Sampling conditions 5.4.1 General
19	5.4.2 Special considerations for batches 5.4.3 Use of multiple batches in dose setting 5.5 Microbiological testing 5.5.1 Bioburden test considerations for biologics/tissues 5.5.1.1 General 5.5.1.2 Extraction fluid 5.5.1.3 Extraction methods
20	5.5.1.4 Membrane filter selection 5.5.1.5 Filtration considerations 5.5.1.6 Media for incubation
21	5.5.1.7 Culture conditions 5.5.1.8 Enumeration 5.5.2 Test of sterility considerations for biologics/tissues 5.5.2.1 General 5.5.2.2 Performance of test of sterility 5.5.2.3 Culture conditions
22	5.5.2.4 Membrane filtration 5.5.2.5 Examination of growth medium after test of sterility 5.5.3 Validation of microbiological test methods 5.5.3.1 General 5.5.3.2 Bioburden test validation (recovery efficiency test) 5.5.3.3 Test of sterility validation (Bacteriostasis/Fungistasis or method suitability test)
23	5.6 Irradiation 5.6.1 General 5.6.2 Loading pattern—Special considerations for refrigerated product 5.6.3 Dose mapping—Special considerations for refrigerated product
24	5.6.4 Use of simulated materials 5.6.5 Requirements for repetition of dose mapping 5.6.6 Routine processing 5.6.7 Product consistency 5.6.8 Time constraints 5.6.9 Maintaining process effectiveness
25	6 Methods of dose establishment 6.1 General 6.2 Selecting a method for the establishment of a sterilization dose 6.3 Establishing a maximum acceptable dose
26	Annex A: Selection of a Dose Setting Method
28	Bibliography


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Standard Title	AAMI TIR37:2013 – Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products
Published Code	AAMI
Publication Date	2013
Pages Count	29

AAMI TIR37 2013

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