Recognition List Number: 021 Publication Date: 03/18/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-74: ISO 5360 Second edition 2006-10-01, Anaesthetic vaporizers - Agent specific filling systems. (Anesthesias)
Date of Standard: 2006. |
| 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: |
| Agent-Specific Anesthesia Vaporizers |
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| Processes Affected: |
| 510(K), IDE, Design Control Input |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
The entire standard, with the following exceptions:
Clauses 4, 5, 6, 7 and 11 (and associated tables and figures) are not recognized as the agent bottle, bottle collar, and bottle adapters are regulated by Center of Drug Evaluation and Research (CDER).
Clause 8 is not recognized.
Clause 10 is not recognized, refer to ASTM F 1161 clause 12.1.11. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5160 |
Gas-Machine, Anesthesia |
Class 2 |
BSZ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5880 |
Vaporizer, Anesthesia, Non-Heated |
Class 2 |
CAD |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Neel Patel |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2532 |
| Silver Spring MD 20993 |
| 301/796-6274 |
| Email: neel.patel@fda.hhs.gov |
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