Recognition List Number: 027 Publication Date: 08/02/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-78: AAMI / ANSI / IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers. (Cardiovascular)
Date of Standard: 2009. |
| Addresses of Standards Organizations: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
| |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| Devices Affected: |
| Non-invasive Blood pressure Monitors |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete Standard - Instead of using IEC 60601-1:2005, 3 rd edition, use CDRH recognized ANSI/AAMI ES 60601-1:2005
Note that this standard is recognized when used together with ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.1130 |
System, Measurement, Blood-Pressure, Non-Invasive |
Class 2 |
DXN |
| |
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| Relevant Guidance: |
| Non-invasive Blood Pressure (NIBP) Monitor Guidance (version 1.0 issued March 10, 1997) |
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| FDA Technical Contacts: |
| 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 |
|
| 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 |
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