|Recognition List Number: 031 FR Publication Date: 08/05/2013
Part B: Supplementary Information
Recognition Number 1-91: ISO 5360 Third edition 2012-01-15, anaesthetic vaporizers - agent specific filling systems. (Anesthesias)
Date of Standard: 2012.
|Address of Standards Development Organization:|
| International Organization for Standardization (ISO)*|
| 1, Rue de Varembe|
| Case Postale 56|
| CH 1211 Geneva 20, 0 |
|CDRH Office and Division associated with recognized standards:|
|OFFICE OF DEVICE EVALUATION (ODE) |
|Agent-Specific Anesthesia Vaporizers|
|Processes Affected: |
|510(K), IDE, Design Control Input|
|Type of Standard:|
| International, Vertical|
|Extent of Recognition:|
|Complete 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.
|Related CFR Citations and Product Codes:|
||Vaporizer, Anesthesia, Non-Heated
|FDA Technical Contact:|
| Neel Patel |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue WO66 RM2532 |
| Silver Spring MD 20993 |
| 301/796-6274 |
| email: firstname.lastname@example.org|