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ible Barrier Materials. 2009: West Conshohocken, PA 19428-2959, United States.
[61] European Committee for Standardization, EN 868 - Packaging for Terminally Ster-
ilized Medical Devices—Part 5: Sealable Pouches and Reels of Porous Materials and
Plastic Film Construction—Requirements and Test Methods, 2009 (CEN: Brussels).
[62] European Commission, EudraLex—Volume 4—EU Guidelines for Good Manufac-
turing Practice for Medicinal Products for Human and Veterinary Use—Annex 15:
Qualification and Validation, Directorate-General for Health and Food Safety, Editor,
2015. Brussels.
[63] International Council for Harmonisation (ICH), Validation of Analytical Procedures:
Text and Methodology Q2(R1), 2005.
[64] ASTM International, ASTM E691–15 Standard Practice for Conducting an Interlaboratory
Study to Determine the Precision of a Test Method. 2015, ASTM International.
[65] International Organization for Standardization, ISO 5725-1:1994 Accuracy (Trueness
and Precision) of Measurement Methods and Results—Part, Vol. 1, General principles
and definitions, Geneva, 1994.
[66] International Organization for Standardization, ISO 5725-2:1994 Accuracy (true-
ness and precision) of measurement methods and results—Part 2: Basic method for
the determination of repeatability and reproducibility of a standard measurement
method. 1994.
[67] Council and European Parliament, Proposal for a REGULATION OF THE EU-
ROPEAN PARLIAMENT AND OF THE COUNCIL on Medical Devices, and
Amending Directive 2001/83/EC, Regulation (EC) no 178/2002 and Regulation
(EC) no 1223/2009. 2016.
[68] International Organization for Standardization, ISO 10993-1:2009—Biological Eval-
uation of Medical Devices—Part Vol. 1: Evaluation and testing within a risk manage-
ment process. 2009: Geneva.
[69] ASTM International, ASTM F2475-11 Standard Guide for Biocompatibility Evalua-
tion of Medical Device Packaging Materials, 2011.
[70] S.C. Gad, M.G. McCord, S.C. Gad, Safety Evaluation in the Development of Medical De-
vices and Combination Products, third ed., Informa Healthcare, New York, 2008, p. 300. viii.
[71] European Medicine Agency (EMA), EMA Guideline on Plastic Immediate Packaging
Materials, in CPMP/QWP/4359/03 and EMEA/CVMP/205/04, C.F.M.P.F.H.U.
(CHMP) and C.F.M.P.F.V.U. (CVMP), Editors. 2005: London.
[72] International Organization for Standardization, ISO 11607-1:2009/Amd 1:2014
Packaging for Terminally Sterilized Medical Devices—Part, Vol. 1, Requirements for
materials, sterile barrier systems and packaging systems, Geneva, 2014.
[73] D4169-09 standard practice for performance testing of shipping containers and sys-
tems, in: ASTM International, 2009. West Conshohocken, PA 19428-2959, United
States.
[74] ISTA, Guidelines for selecting and using ISTA® test procedures & projects. 2012.
[75] international Organization for Standardization, ISO 11139 Sterilization of Health
Care Products—Vocabulary of Terms Used in Sterilization and Related Equipment
and Process Standards, 2018. Geneva.
[76] T. Trier, et al., The role of packaging size on contamination rates during simulated
presentation to a sterile field, PLoS One 9 (7) (2014).
[77] SBA, Usability of sterile barrier systems for medical devices, Sterile Barrier Associa-
tion (SBA), 2015.
[78] European Commission, Commission Communication in the Framework of the Im-
plementation of the Council Directive 93/42/EEC Concerning Medical Devices
(Text with EEA Relevance) (Publication of Titles and References of Harmonised
Standards under the Directive). OJ, 2009. C 41/06.
[79] Council, COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the