Module 14: Design Development and Certification of Medical Devices

17/11/2023

Biological Evaluation Report - 2

 Quantitative Formulation

Ingredient /Chemical

% w/w

Quality Standard

CAS No

Function

Petrolatum

15%

Ph Eur

Emollient 8012-95-1

The Organisation for Professionals in Regulatory Affairs

21

Biological Evaluation Report - 3

• Exposure Assessment and Calculation of Margin of Safety • Describes exposure conditions: frequency, duration, quantities • Describes method of calculation of MoS

• Toxicological Assessment of Components • Toxicity profiles of individual ingredients/components, inc MoS • Toxicity assessment of leachables/degradants

The Organisation for Professionals in Regulatory Affairs

22

11