ISO/TS 13004-2013 pdf free download.Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VD maxSD.
This Technical Specification describes a method for substantiating a selected sterilization dose of 17,5,20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10- 6 or less for radiation
sterilization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137-1.
1.2 Exclusions
This method is for the substantiation of a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5,or 35 kGy only and is not used to substantiate other sterilization doses. The method is not used for the substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3).
NOTE The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this Technical Specification; they are described in ISo 11137-2.
1.3 Application
If the decision is made to use this method of sterilization dose establishment, the method is to be followed according to the requirements (shall) and guidance (should) stipulated herein.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11137-1:2006, Sterilization ofhealth care products一Radiation 一Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
ISO 11737-1, Sterilization of medical devices一Microbiological methods一Part 1: Determination of a population of microorganisms on products
ISO 11737-2, terilization of medical devices 一Microbiological methods一Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
3 Terms and definitions
For the purposes of this document, the following abbreviations, terms and definitions apply.
3.1 batch
defined quantity of product, intended or purported to be uniform in character and quality, that has been
produced during a defined cycle of manufacture
[SOURCE: ISO/TS 11139:2006, 2.1]
3.2 bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO/TS 11139:2006, 2.2]
3.3 correction
action to eliminate a detected nonconformity
Note 1 to entry: A correction can be made in conjunction with corrective action (3.4).
[SOURCE: ISO 9000:2005, 3.6.6, modified]
3.4 corrective action
action to eliminate the cause of a detected nonconformity or other undesirable situation
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.
Note 3 to entry: There is a distinction between correction and corrective action.[SOURCE: ISO 9000:2005, 3.6.5].ISO/TS 13004 pdf download.
Tags: Sterilization of health care products
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