Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-107: IEC 80601-2-30 Edition 1.0 2009-1, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. (Cardiovascular)
Date of Standard: 2009. |
| Address of Standards Organization: |
| 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, except for the following changes:
- CDRH does not recognize IEC 60601-1:2005, 3rd edition, CDRH does recognize ANSI/AAMI/IES 60601-1:2005
- Clause 201.7.9.2.13 Maintenance is not recognized
- Clauses 201.104, 201.105.3.1 and 201.105.3.2 are not recognized since FDA believes that the duration in which the cuff is deflated between consecutive determinations should be longer than 5 seconds, except for the short-term automatic mode.
Note that this standard is recognized when used together with ISO 81060-2 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type, as recommended by Clause 201.106. |
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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 |
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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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