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Recognized Consensus Standards

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Recognition List Number: 037 FR Publication Date: 10/17/2014 

Part B: Supplementary Information

Recognition Number 19-8: IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests. (General II (ES/EMC))

Date of Standard: 2014. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
ALL OFFICES AND DIVISIONS IN CDRH
Devices Affected:
All Electrical Medical Devices, Except for Active Implanted Devices
Processes Affected:
510(k), PMA, PDP, HDE, GMP, Design Controls
Type of Standard:
 Horizontal, International
Extent of Recognition:
Complete standard with the following exceptions:

* In Subclause 8.9, Table 8 on Page 39: The citation of Note b) under "Conducted disturbances induced by RF fields" (4th Row) is not recognized.
* Please note the following corresponding titles, subtitles or provisions:
** Subclause 8.9: IMMUNITY TEST LEVELS
** Table 8: Signal input/output parts PORT
** Note b): SIP/SOPS whose maximum cable length is less than 3 m in length are excluded
** 4th Row: Conducted disturbances induced by RF fields

Transition:
FDA recognition of IEC 60601-1-2 Edition 3:2007-03 [Rec#19-1] and ANSI/AAMI/IEC 60601-1-2:2007/(R)2012 [Rec#19-2] will be superseded by recognition of IEC 60601-1-2 Edition 4.0 2014-02 [Rec#19-8]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec#19-1] and/or [Rec#19-2] until April 1, 2017. After this transition period, declarations of conformity to [Rec#19-1] and/or [Rec#19-2] will not be accepted.
Relevant Guidance:
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Document Issued on: August 13, 2013
FDA Technical Contacts:
 Jeff Silberberg
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue WO62 RM1216
  Silver Spring MD 20993
  301/796-2584
  email: jeffrey.silberberg@fda.hhs.gov
 Donald Witters
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 1130
  Silver Spring MD 20993
  301/796-2483
  email: donald.witters@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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