Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests | Guideline Explorer

Description

A sunlamp product is an electronic product designed to use one or more ultraviolet lamp(s) and is intended for irradiation of any part of the living human body by ultraviolet radiation within a specified range of wavelengths to induce skin tanning. The ultraviolet lamps, subject to the performance standard, produce radiation within a prescribed range of wavelengths and are intended for use in sunlamp products.

Scope & Applicability

Product Classes

4

Intravascular Administration Sets

Subject of the guidance document for premarket notification submissions.; Subject of the premarket notification guidance

Blood Administration Set

device used to administer and filter blood components

Class II

The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers

Intravascular Administration Set

The primary device type covered by the guidance; device used to administer fluids from a container to a patient's vascular system

Stakeholders

1

manufacturer

Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.

Regulatory Context

Attributes

3

Intended use

Significant changes to intended use are likely remanufacturing.; The purpose for which the device is used, which must not change.

SAL

Sterility Assurance Level

Sterility assurance level (SAL) of 1 x 10⁻⁶

Required level for a sterile device

Identified Hazards

Hazards

6

Risks to Health

Identified risks that special controls must mitigate.

Unrestricted flow

Warning required for infusion pumps with no restricted flow feature

Device malfunction

Identified risk associated with sharps injury prevention features

Adverse tissue reaction

Risk management information should identify hazardous situations such as adverse tissue reaction.

Infection

Risk to human health from failure to assure sterility

Improper use