Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-89: ISO 80601-2-12 Technical Corrigendum 1, Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators. (Anesthesias)
Date of Standard: 2011. |
| 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) | | |
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| Devices Affected: |
| Lung ventilators incorporating electrical devices designed for medical use excluding lung ventilators specified for use with inhalation anesthetic agents. |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5895 |
Ventilator, Continuous, Facility Use |
Class 2 |
CBK |
| §868.5895 |
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use |
Class 2 |
MNT |
| §868.5895 |
Ventilator, Continuous, Non-Life-Supporting |
Class 2 |
MNS |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Bahram Parvinian |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2534 |
| Silver Spring MD 20993 |
| 301/796-6445 |
| Email: bahram.parvinian@fda.hhs.gov |
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