Detection Target
Analysis and Identification of Protective Mask Components
Overview
This solution conforms to the ISO 10993 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process. This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:
(1)The identification of its materials of construction (medical device configuration).
(2)The characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition).
(3)The characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues).
(4)The estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables).
The measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
Operating Conditions
Instrument and Accessories
2) Single-reflection ATR accessory (ZnSe crystal)
Test Parameters
1) Resolution: 4 cm-1
2) Scan times: 32
3) Detector: Pyroelectric Infrared Detector
4) Spectral range: 4000–600 cm-1
Tested Samples
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Medical protective mask | Medical surgical mask | Medical ordinary mask |
Sample Spectra
1. Medical Protective Mask – Infrared Spectrum
1) Outer Layer
2) Middle Layer
3) Inner Layer
2.Medical surgical mask– Infrared Spectrum
1) Outer Layer
2) Middle Layer
3) Inner Layer
3.Medical ordinary mask —— Infrared Spectrum
1) Outer Layer
2) Middle Layer
3) Inner Layer
Conclusion
The spectroscopic analysis of the tested samples revealed quantitative/qualitative data regarding their chemical composition and molecular structure:
(1) The three layers of the medical protective mask are composed of polypropylene (outer layer), polypropylene (middle layer), and polyester (inner layer).
(2) The three layers of the medical surgical mask are all polypropylene (outer, middle, and inner layers).
(3) The three layers of the medical ordinary mask are all polypropylene (outer, middle, and inner layers).