Under Review
v1.0.4-LATEST
Class I Device
Architectural Definition
Low-risk medical devices subject only to general controls (e.g., bandages, handheld surgical instruments).
Schema Preview
● application/json
{
"entity": "class-i-device",
"domain": "pharmacy",
"metadata": {
"displayName": "Class I Device",
"status": "DRAFT",
"version": "1.0.4",
"isStandardized": false
}
}Standard
ISO-8601
Data Type
String/Obj
Steward
Arch Council
Verified
Feb 2026