• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 032 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 13-46: ASTM F2761-09, medical devices and medical systems - essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ice) - part 1: general requirements and conceptual model. (Software/Informatics)

Date of Standard: 2009. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
(3)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Electromedical devices that have an electronic data interchange port
Processes Affected:
510(k), PMA, PDP,IDE, HDE, Design Control Input
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.2300 System,Network And Communication,Physiological Monitors Class 2 MSX
Relevant Guidance:
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
FDA Technical Contact:
 Sandy Weininger
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 4212
  Silver Spring MD 20993
  301/796-2582
  email: sandy.weininger@fda.hhs.gov
-
-