🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
AAMI 13004 2022

AAMI 13004 2022

$148.96

ANSI/AAMI/ISO 13004:2022 Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD

Published By Publication Date Number of Pages
AAMI 2022 75
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Category:

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

This document describes a method for substantiating a select sterilization dose that achieves a sterility assurance level of 10-6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 13004:2022; Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
3 Title page
4 AAMI Standard
5 Copyright information
6 Committee representation
11 Background of ANSI/AAMI adoption of ISO 13004:2022
12 Foreword
13 Introduction
15 1 Scope
2 Normative references
3 Terms and definitions
20 4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing
4.1 General
4.2 Defining product families
21 4.3 Designation of product to represent a product family
4.3.1 Product to represent a product family
4.3.2 Master product
22 4.3.3 Equivalent product
4.3.4 Simulated product
4.4 Maintaining product families
4.4.1 Periodic review
4.4.2 Modification to either product or manufacturing process, or both
4.4.3 Records
4.5 Consequence of failure of sterilization dose substantiation or sterilization dose audit
23 5 Selection and testing of product for substantiating and auditing a selected sterilization dose
5.1 Nature of product
Table 1 — Nature of product items for sterilization dose substantiation and for sterilization dose auditing
5.2 Sample item portion (SIP)
24 Table 2 — Examples for calculation of SIP
25 5.3 Manner of sampling
5.4 Microbiological testing
5.5 Irradiation
26 6 Method VDmaxSD—Substantiation of a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy
6.1 Rationale
27 6.2 Procedure for Method VDmaxSD for multiple production batches
6.2.1 General
6.2.2 Stage 1: Obtain samples of product
6.2.3 Stage 2: Determine average bioburden
6.2.4 Stage 3: Obtain the selected sterilization dose
28 Table 3 — Upper limit of average bioburden for selection of a given sterilization dose
6.2.5 Stage 4: Obtain VDmaxSD
Table 4 — Table in Clause 8 corresponding to the selected sterilization dose
29 6.2.6 Stage 5: Perform verification dose experiment
6.2.7 Stage 6: Interpretation of results
30 6.2.8 Confirmatory verification dose experiment
6.2.8.1 General
6.2.8.2 Stage 1: Obtain samples of product
6.2.8.3 Stage 2: Perform confirmatory verification dose experiment
31 6.2.8.4 Stage 3: Interpretation of results
6.3 Procedure for Method VDmaxSD for a single production batch
6.3.1 Rationale
6.3.2 General
32 6.3.3 Stage 1: Obtain samples of product
6.3.4 Stage 2: Determine average bioburden
6.3.5 Stage 3: Obtain the selected sterilization dose
33 6.3.6 Stage 4: Obtain VDmaxSD
6.3.7 Stage 5: Perform verification dose experiment
6.3.8 Stage 6: Interpretation of results
34 6.3.9 Confirmatory verification dose experiment
6.3.9.1 General
6.3.9.2 Stage 1: Obtain samples of product
6.3.9.3 Stage 2: Perform confirmatory verification dose experiment
35 6.3.9.4 Stage 3: Interpretation of results
7 Maintaining process effectiveness
7.1 General
7.2 Frequency of determination of bioburden
7.3 Sterilization dose audit
7.3.1 Frequency
7.3.2 Outcome
36 7.3.3 Procedure for auditing a sterilization dose substantiated using Method VDmaxSD
7.3.3.1 General
7.3.3.2 Stage 1: Obtain samples of product
7.3.3.3 Stage 2: Determine average bioburden
7.3.3.4 Stage 3: Perform verification dose experiment
37 7.3.3.5 Stage 4: Interpretation of results
38 7.3.3.6 Confirmatory sterilization dose audit
7.3.3.6.1 General
7.3.3.6.2 Stage 1: Obtain samples of product
7.3.3.6.3 Stage 2: Perform confirmatory verification dose experiment
7.3.3.6.4 Stage 3: Interpretation of results
39 7.3.3.7 Augmentation of a sterilization dose substantiated using Method VDmaxSD
7.3.4 Failure of a sterilization dose audit
40 8 Tables of values for SIP
Table 5 — 17,5 kGy selected sterilization dose for which the upper limit of average bioburden is 9,0
41 Table 6 — 20 kGy selected sterilization dose for which the upper limit of average bioburden is 45
43 Table 7 — 22,5 kGy selected sterilization dose for which the upper limit of average bioburden is 220
46 Table 8 — 27,5 kGy selected sterilization dose for which the upper limit of average bioburden is 5 000
51 Table 9 — 30 kGy selected sterilization dose for which the upper limit of average bioburden is 23 000
57 Table 10 — 32,5 kGy selected sterilization dose for which the upper limit of average bioburden is 100 000
63 Table 11 — 35 kGy selected sterilization dose for which the upper limit of average bioburden is 440 000
71 9 Worked examples
9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0)
Table 12 — Method VDmax17,5 substantiation (SIP less than 1,0)
72 9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0)
Table 13 — Method VDmax30 substantiation (SIP equal to 1,0)
73 9.3 Sterilization dose audit for a sterilization dose substantiated using
9.4 Method VDmax22,5
Table 14 — Sterilization dose audit following which augmentation of the sterilization dose was required (selected sterilization dose substantiated using Method VDmax22,5)
75 Bibliography

Related products

AAMI 13004 2022
$148.96