· Guidance For Industry And FDA Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
· ISO10993 series, Biological evaluation of medical devices www.iso.org
· ISO14971:2007, Medical devices — Application of risk management to medical devices.
· European Parliament And Council Of The European Union, REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 2017: Official Journal of the European Union.
· US CFR-Code of Federal Regulations Title 21 - Chapter 1, subchapter A - Part 73 and 74.
· FDA Recognized Consensus Standards - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.c…
· United States Pharmacopoeia: USP40-NF35 . The United States Pharmacopeial Convention.
· Crump, K. (1984). A new method for determining allowable daily intakes. Fund. Appl. Toxicol. 4, pp. 854-871
· A. Woolley "A guide to practical toxicology - 2 edition" Informa 2008
· International Conference On Harmonization Of Technical Requirements For Registration Of Pharmaceuticals For Human Use Draft Consensus Guideline For Elemental Impurities Q3D - Current Step 4 version dated 16 December 2014
· Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - EMA/CHMP/ CVMP/ SWP/169430/2012 - 20/11/2014
· ICH HARMONISED GUIDELINE ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK - M7(R1) - Current Step 4 version dated 31 March 2017
· Scientific Opinion on Exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC) EFSA Journal: 2012;10(7):2750 [103 pp.].
· Munro IC, Ford RA, Kennepohl E and Sprenger JG, 1996. Correlation of a structural class with No-Observed-effects-Level: a proposal for establishing a threshold of concern. Food Chem. Toxicol. 34, 829-867
· OECD guidance ENV/JM/MONO(2009)5 ("Guidance document for using the OECD (Q)SAR application toolbox to develop chemical categories according to the OECD guidance on grouping of chemicals")
· Scientific Committee on Health and Environmental Risks SCHER - Scientific Committee on Consumer Products SCCP - Scientific Committee on Emerging and Newly Identified Health Risks SCENIHR "Risk assessment methodologies and approaches for genotoxic and carcinogenic substances" 2009
· OECD Guidelines for the Testing of Chemicals, Section 4 https://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testi…
· OECD eChemPortal http://www.webnet3.oecd.org/echemportal
· ECHA website http://echa.europa.eu
· ICH Safety Guidelines http://www.ich.org/products/guidelines/safety/article/safety-guidelines…