Performance Standards for Ionizing Radiation Emitting Products

United States · Last verified: 2026-09-08

Number

21 CFR 1020

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

电离辐射发射产品性能标准：含电视接收机、冷阴极气体放电管，以及医疗器械最关键的诊断 X 射线系统及其主要部件、摄影设备、透视设备、CT 设备和机柜式 X 射线系统。

Source: U.S. Food and Drug Administration (public domain)