Medical Device Toxicological Risk Assessment Form
Systematically assess and document the toxicological risks associated with a medical device.
Device Identification
Provide key information about the medical device being assessed.
Device Name
*
Model/Version Number
*
Manufacturer Name
*
Contact Person (Name and Title)
*
Device Description (including intended use)
*
Materials and Components
List all materials/components that come into direct or indirect contact with the patient.
List of Materials/Components (including chemical composition if available)
*
Patient Contact Assessment
Specify the type and duration of patient contact.
Type of Patient Contact
*
Surface-contacting (skin, mucosal, breached/compromised surface)
External communicating (blood path, tissue/bone/dentin, circulating blood)
Implant device
Other
Duration of Patient Contact
*
Limited (<24 hours)
Prolonged (24 hours to 30 days)
Long-term (>30 days)
Toxicological Endpoints Assessment
*
Rows
Potential Concern
Not Relevant
Relevant – No Risk Identified
Relevant – Risk Identified
Cytotoxicity
1
2
3
4
Sensitization
5
6
7
8
Irritation/Intracutaneous Reactivity
9
10
11
12
Systemic Toxicity
13
14
15
16
Genotoxicity
17
18
19
20
Carcinogenicity
21
22
23
24
Reproductive/Developmental Toxicity
25
26
27
28
Risk Evaluation
Assess the likelihood and severity of identified toxicological risks.
Likelihood of Toxicological Risk
*
Very Unlikely
1
2
3
4
Very Likely
5
1 is Very Unlikely, 5 is Very Likely
Severity of Potential Harm
*
Negligible
1
2
3
4
Critical
5
1 is Negligible, 5 is Critical
Risk Mitigation Measures
*
Overall Toxicological Risk Acceptability
*
Acceptable
Acceptable with Mitigation Measures
Not Acceptable
Additional Comments or Notes
Submit Assessment
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