Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-96: ISO 81060-1 First edition 2007-12-01, Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type. (Cardiovascular)
Date of Standard: 2007. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
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| Devices Affected: |
| Manual (non-automated) Non-invasive Blood Pressure Monitors, and Blood Pressure Cuffs |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete standard, except that instead of using IEC 60601-1:2005, 3rd edition, please use the FDA/CDRH recognized ANSI/AAMI ES 60601-1:2005 standard. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.1120 |
Blood Pressure Cuff |
Class 2 |
DXQ |
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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 |
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| 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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