Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-95: IEC 60601-2-27 Edition 3.0 2011-03, Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment, edition 3.0. (Cardiovascular)
Date of Standard: 2011. |
| Address of Standards 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: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
|
|
| Devices Affected: |
| Electrocardiographic monitors |
|
| Processes Affected: |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
The complete standard is recognized except for any reference to IEC 60601-1-2005 (i.e. the 3rd edition of 60601-1). FDA recognizes the ANSI/AAMI ES60601-1:2005 standard instead.
Transition period: FDA recognition of IEC 60601-2-27: (2005-08)is hereby superseded by recognition of IEC 60601-2-27 Edition 3.0 2011-03, Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment, edition 3.0. FDA will accept declaration of conformity, in support of premarket submissions, to IEC 60601-2-27: (2005-08)until June 30, 2013. After this transitional period, declaration of conformity to IEC 60601-2-27: (2005-08) will not be accepted. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.2340 |
Electrocardiograph |
Class 2 |
DPS |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Charles Ho, Ph.D. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1318 |
| Silver Spring MD 20993 |
| 301/796-6320 |
| Email: charles.ho@fda.hhs.gov |
|
|
