Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-97: ISO 81060-2 First edition 2009-05-01, Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. (Cardiovascular)
Date of Standard: 2009. |
| 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: |
| 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: |
The complete standard is recognized except for the following.
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.
The sentence in Clause 5.1.6 Special patient populations: "If the sphygmomanometer has been evaluated according to the requirements of 5.1.1, it shall then be validated in at least an additional 35 special population subjects."
- Examples 3 and 6 in Clause 5.2.4.2.2 Data analysis
- Clause 5.2.4.2.2 Data analysis, on its disallowing use of averaging the reference blood pressure determinations taken before and after each test monitor determination.
- Clause 5.2.5 Additional requirements for a sphygmomanometer intended for use in exercise stress testing environments
- Clause 5.2.6 Additional requirements for a sphygmomanometer intended for use in ambulatory monitoring
- The sentences in Clause 6.1.3.1 Age distribution: "For a sphygmomanometer additionally intended for use in children, an additional 5 children aged between 3 y and 12 y shall be included in the validation study.
NOTE 2 Minimum total of 20 subjects."
- The sentence in Clause 6.1.6 Special patient populations: "If the sphygmomanometer has been evaluated according to the requirements of 6.1.1, then only seven additional special population patients shall be included in the validation study."
FDA Notes:
The standard is recognized when used together with ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
FDA believes that a special patient population should be validated on its own - typically via an 85-subject study if a non-invasive reference is used, or a 15-subject study if an invasive reference is used.
FDA is currently unaware of any validated protocol to validate a blood pressure monitor during motion or transport conditions.
Because Clause 5.2.4.1.1 Procedure removes from the clinical study any patient whose reference systolic blood pressure determinations differ by more than 12 mmHg or whose reference diastolic blood pressure determinations differ by more than 8 mmHg, device labeling should indicate that the device is not intended to record blood pressure from subjects whose blood pressure values change significantly during the data recording session.
For Clause 6.2.4 Determining the reference blood pressure, please calculate the variation of the reference systolic blood pressure and that of the reference diastolic blood pressure separately. If the number of reference blood pressure determinations is very small, the mathematically calculated standard deviation can be artificially large, resulting in a variation (i.e., the limits of mean +/- one standard deviation) that is larger than the range of the reference blood pressure. In that case, please simply average all reference systolic (or separately for diastolic) blood pressures to use as the comparator for the test monitor systolic (or diastolic) determination. |
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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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| * 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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