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PD CEN ISO/TS 13004:2014 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD >
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PD CEN ISO/TS 13004:2014 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD, 2014
- Section sec_1
- Section sec_1.1
- Section sec_1.2
- Section sec_1.3
- Section sec_2
- Section sec_3
- Section sec_4
- Section sec_4.1
- Section sec_4.2
- Section sec_4.2.1
- Section sec_4.2.2
- Section sec_4.2.3
- Section sec_4.2.4
- Section sec_4.3
- Section sec_4.3.1
- Section sec_4.3.1.1
- Section sec_4.3.1.2
- Section sec_4.3.1.3
- Section sec_4.3.2
- Section sec_4.3.3
- Section sec_4.3.4
- Section sec_4.4
- Section sec_4.4.1
- Section sec_4.4.2
- Section sec_4.4.3
- Section sec_4.5
- Section sec_5
- Section sec_5.1
- Section sec_5.1.1
- Table tab_1
- Section sec_5.1.2
- Section sec_5.2
- Section sec_5.2.1
- Section sec_5.2.2
- Section sec_5.2.3
- Table tab_2
- Section sec_5.2.4
- Section sec_5.2.5
- Section sec_5.2.6
- Section sec_5.3
- Section sec_5.3.1
- Section sec_5.3.2
- Section sec_5.3.3
- Section sec_5.3.4
- Section sec_5.3.5
- Section sec_5.4
- Section sec_5.4.1
- Section sec_5.4.2
- Section sec_5.5
- Section sec_5.5.1
- Section sec_5.5.2
- Section sec_5.5.3
- Section sec_5.5.4
- Section sec_5.5.5
- Section sec_6
- Section sec_6.1
- Section sec_6.2
- Section sec_6.2.1
- Section sec_6.2.1.1
- Section sec_6.2.1.2
- Section sec_6.2.2
- Section sec_6.2.3
- Section sec_6.2.3.1
- Section sec_6.2.3.2
- Section sec_6.2.4
- Section sec_6.2.4.1
- Section sec_6.2.4.2
- Section sec_6.2.4.3
- Table tab_3
- Section sec_6.2.5
- Section sec_6.2.5.1
- Table tab_4
- Section sec_6.2.5.2
- Section sec_6.2.5.3
- Section sec_6.2.6
- Section sec_6.2.6.1
- Section sec_6.2.6.2
- Section sec_6.2.6.3
- Section sec_6.2.7
- Section sec_6.2.7.1
- Section sec_6.2.7.2
- Section sec_6.2.7.3
- Section sec_6.2.8
- Section sec_6.2.8.1
- Section sec_6.2.8.2
- Section sec_6.2.8.3
- Section sec_6.2.8.3.1
- Section sec_6.2.8.3.2
- Section sec_6.2.8.4
- Section sec_6.2.8.4.1
- Section sec_6.2.8.4.2
- Section sec_6.3
- Section sec_6.3.2
- Section sec_6.3.2.1
- Section sec_6.3.2.2
- Section sec_6.3.2.3
- Section sec_6.3.4
- Section sec_6.3.4.1
- Section sec_6.3.4.2
- Section sec_6.3.5
- Section sec_6.3.5.1
- Section sec_6.3.5.2
- Section sec_6.3.5.3
- Section sec_6.3.6
- Section sec_6.3.6.1
- Section sec_6.3.6.2
- Section sec_6.3.7
- Section sec_6.3.7.1
- Section sec_6.3.7.2
- Section sec_6.3.7.3
- Section sec_6.3.8
- Section sec_6.3.8.1
- Section sec_6.3.8.2
- Section sec_6.3.8.3
- Section sec_6.3.9
- Section sec_6.3.9.1
- Section sec_6.3.9.2
- Section sec_6.3.9.3
- Section sec_6.3.9.3.1
- Section sec_6.3.9.3.2
- Section sec_6.3.9.4
- Section sec_6.3.9.4.1
- Section sec_6.3.9.4.2
- Section sec_7
- Section sec_7.1
- Section sec_7.2
- Section sec_7.2.1
- Section sec_7.2.2
- Section sec_7.2.2.1
- Section sec_7.2.2.2
- Section sec_7.3
- Section sec_7.3.1
- Section sec_7.3.2
- Section sec_7.3.3
- Section sec_7.3.3.1
- Section sec_7.3.3.1.1
- Section sec_7.3.3.1.2
- Section sec_7.3.3.2
- Section sec_7.3.3.3
- Section sec_7.3.3.3.1
- Section sec_7.3.3.3.2
- Section sec_7.3.3.4
- Section sec_7.3.3.4.1
- Section sec_7.3.3.4.2
- Section sec_7.3.3.5
- Section sec_7.3.3.5.1
- Section sec_7.3.3.5.2
- Section sec_7.3.3.5.3
- Section sec_7.3.3.6.1
- Section sec_7.3.3.6.1.1
- Section sec_7.3.3.6.1.2
- Section sec_7.3.3.6.2
- Section sec_7.3.3.6.3
- Section sec_7.3.3.6.3.1
- Section sec_7.3.3.6.3.2
- Section sec_7.3.3.6.4
- Section sec_7.3.3.7
- Section sec_7.3.4
- Section sec_8
- Table tab_5
- Table tab_6
- Table tab_7
- Table tab_8
- Table tab_9
- Table tab_10
- Table tab_11
- Section sec_9
- Section sec_9.1
- Table tab_12
- Section sec_9.2
- Table tab_13
- Section sec_9.3
- Table tab_14
- Reference ref_1
- Reference ref_2
- Reference ref_3
- Reference ref_4
- Reference ref_5
- Reference ref_6
- Reference ref_7
- Reference ref_8
- Reference ref_9
- Reference ref_10
- Reference ref_11
- Reference ref_12
- Foreword
- Introduction
- 1 Scope
- 1.1 Inclusions
- 1.2 Exclusions
- 1.3 Application
- 2 Normative references
- 3 Terms and definitions
- 4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing
- 4.1 General
- 4.2 Defining product families
- 4.3 Designation of product to represent a product family
- 4.4 Maintaining product families
- 4.5 Consequence of failure of sterilization dose substantiation or sterilization dose audit
- 5 Selection and testing of product for substantiating and auditing a selected sterilization dose
- 5.1 Nature of product
- 5.2 Sample item portion (SIP)
- 5.3 Manner of sampling
- 5.4 Microbiological testing
- 5.5 Irradiation
- 6 Method  — Substantiation of a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5, or 35 kGy
- 6.1 Rationale
- 6.2 Procedure for Method  for multiple production batches
- 6.3 Procedure for Method  for a single production batch
- 7 Maintaining process effectiveness
- 7.1 General
- 7.2 Determination of bioburden
- 7.3 Sterilization dose audit
- 8 Tables of values for SIP equal to 1,0 VDmaxSD, SIP dose reduction factor and augmentation dose corresponding to applicable values of average bioburden for selected sterilization doses of 17,5, 20, 22,5, 27,5, 30, 32,5 and 35 kGy
- 9 Worked examples
- 9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0)
- 9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0)
- 9.3 Sterilization dose audit for a sterilization dose substantiated using Method VDmax22,5, the findings from which necessitated augmentation of the sterilization dose
- Bibliography [Go to Page]
