Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

Name: Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: accreditation,accreditation-scheme,assessment,conformity-assessment,guidances,industry,laboratories,performance,pilot,safety,standards,testing

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Topics

Premarket

Published

September 25, 2020

Last updated

September 19, 2023

Description

This document provides guidance on safety and performance standards for medical electrical equipment, systems, and laboratory equipment.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

Feedback

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1 Main file

Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

Updated on September 19, 2023

pdf (607.8KB)

URL: https://www.fda.gov/media/142385/download
Permalink: https://data.openrid.co/en/datasets/r/234f66a5-d7e2-41f5-942b-d353ecd87d3e
MIME Type: application/pdf

Created on: September 25, 2020
Modified on: September 19, 2023

Size: 607.8KB