Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-18: ISO 8359:1996, Oxygen concentrators for medical use - Safety requirements. (Anesthesias)
Date of Standard: 1996. |
| 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: |
| Oxygen concentrators excluding those intended to supply gas to several patients via a piped medical gas installation or those intended for use in the presence of flammable anesthetic or cleaning agents or both. |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
Complete standard with the following exceptions:
Clause 26 is not recognized, refer to the Draft Reviewer Guidance for Premarket Notifications, November 1993 for mechanical vibration and shock resistance information.
Clause 36 is not recognized, refer to the Draft Reviewer Guidance for Premarket Notification, November 1993 for electromagnetic compatibility information.
Clause 42.1 is not recognized, refer to the Draft Reviewer Guidance for Premarket Notifications, November 1993 for surface temperature information.
Clause 47 is not recognized, refer to the Draft Reviewer Guidance for Premarket Notifications, November 1993 for electrostatic discharge information.
Clause 48 is not recognized, refer to ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
Clause 53 is not recognized, refer to the Draft Reviewer Guidance for Premarket Notifications, November 1993 for environmental test information. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5440 |
Generator, Oxygen, Portable |
Class 2 |
CAW |
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| Relevant Guidance: |
| Reviewer Guidance for Premarket Notifications (Draft), November 1993 |
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| FDA Technical Contact: |
| Amy Levelle |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2547 |
| Silver Spring MD 20993 |
| 301/796-6963 |
| Email: amy.levelle@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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