Panel Guides/Publications

Guidance document on establishing timeframes for testing associated with the requirements of ISO 11137/11737/13004
The Microbiology Working Group of the Irradiation Panel has issued new guidance on how to establish and justify timeframes for microbiological testing associated with bioburden determination and dose audit testing.
Guidance on timeline of microbial testin[...]
Adobe Acrobat document [299.6 KB]

Introduction and overview of methods for performance qualification (PQ) dose mapping based on ISO 11137-1 (ISO 2006).
Dose_mapping_report_July_2022.pdf
Adobe Acrobat document [1.4 MB]

Document comparing 2019 and 2009 version of ISO 11737-2 Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilisation process
ISO11737-2_2019vs2009 assessment FINAL.p[...]
Adobe Acrobat document [405.7 KB]

Guide on Sterilisation Dose Audit failure risk assessment - ISO11137-2 section 10.4
Guidance SDA risk assessment ISO11137-2 [...]
Adobe Acrobat document [527.9 KB]

Document comparing the 2018 and 2006 version of ISO 11737-1 Microbiological methods - Determination of a population of microorganisms on products
Differences ISO11737-1 2018 and 2006 ver[...]
Adobe Acrobat document [760.2 KB]

Guidance document on what is required under ISO 11137 to change irradiation modality, for example from gamma to X-ray
Change of Irradiation Modalities Final.p[...]
Adobe Acrobat document [567.1 KB]

Updated guide on the use of Statistical Process Control methods in Radiation Sterilisation
Updated to reflect ISO 11137 Part 3 2017 terminology
Panel SPC Method 2018.pdf
Adobe Acrobat document [450.2 KB]

Guide on differences between ISO 11137 part 3 new 2017 version and previous 2006
Panel ISO11137-3 2017vs2006.pdf
Adobe Acrobat document [597.9 KB]

Feedback by the Panel to the EU as part of the consultation on the legal framework for Food Irradiation, October 2017
Panel feedback to EU legal framework con[...]
Adobe Acrobat document [316.0 KB]

Database of D10 values of microbial resistances to gamma irradiation in EXCEL format
Contains the same data as the database (.mdb) file available below but in more convenient format
Micro_D10_referencedata.xls
Microsoft Excel sheet [693.0 KB]

Guide to establishing the maximum acceptable dose under ISO 11137 Part 1
Guide establish Dmaxacc.pdf
Adobe Acrobat document [224.0 KB]

Guide on the use of low energy electron beams for the decontamination of surfaces
Guide low energy e-beam decontamination [...]
Adobe Acrobat document [1.0 MB]

Guide on Establishing the Sterilisation Dose in ISO 11137 Part 2
Guide Establishing Sterilisation Dose 11[...]
Adobe Acrobat document [242.9 KB]

Guide on Dose Tolerances in ISO 11137 Part 2
Guide Dose Tolerances 11137-2 2012.pdf
Adobe Acrobat document [176.2 KB]

Guide on the use of Monte Carlo Modelling in Radiation Processing
Guide Monte Carlo modelling 2010.pdf
Adobe Acrobat document [438.9 KB]

Guide on Bioburden Distribution Metrics
Guide Bioburden Distribution metrics 201[...]
Adobe Acrobat document [171.4 KB]

Guide on Uncertainty in Routine Dosimetry for Gamma and e-beam plants
Guide Uncertainty in Routine Dosimetry 1[...]
Adobe Acrobat document [115.3 KB]

Database of D10 values of microbial resistances to gamma irradiation
Compressed (WinZip) Microsoft Access database file (.mdb)
gamma resist D10 db.zip
Compressed archive in ZIP format [294.5 KB]

Applications of Radiation Processing
Applications of Radiation Processing 199[...]
Adobe Acrobat document [267.7 KB]

Panel history 1963 to 1984
Panel Brief History 1963-84.pdf
Adobe Acrobat document [2.9 MB]