Recognition List Number: 019 Publication Date: 12/19/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-61: IEC 60601-2-13(2003-05):, Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems. (Anesthesias)
Date of Standard: 2003. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| 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: |
| Anesthesia machines incorporating electrical devices designed for medical use including those which incorporate lung ventilators and lung ventilators intended for use with inhalation anesthetic agents. |
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| Processes Affected: |
| 510(k), Design Control Input |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
Complete standard with the following exceptions or modifications:
Clause 3.4
Clause 5.4, the following modification applies: Any materials or constructions that required demonstration that an equivalent degree of safety is obtained under Clause 3.4 and Clause 5.4 shall include the demonstrative information in the submission.
Clause 6.1q is recognized in part. However, symbol 14 should be accompanied by English text warning on the panel to identify the nature of the hazard.
Clause 6.1.101 is recognized in part. However, symbol 14 should be accompanied by English text warning on the panel to identify the nature of the hazard.
Clause 6.3a is recognized in part. However, the English terms "AC Power", "on", and "off" are preferable markings for on/off switches in the U.S.
Clause 6.4b.
Clause 6.6a. Gas colors must correspond to common U.S. usage. ASTM F1161-88, Table 1. applies.
Clause 6.8.2ff is not recognized. Testing for electromagnetic compatibility should be performed per the Draft Reviewer Guidance for Premarket Notifications. Information submitted to demonstrate conformance with the guidance should include a description of test methods and results.
Clause 6.8.2hh is recognized in part. However, symbol 14 should be accompanied by English text warning on the panel to identify the nature of the hazard.
Clause 10.2.2a third dash. Rather the device should operate within its specification, without changing a voltage selection switch, when powered from line voltages between 95 and 132 volts rms. Refer to Reviewer Guidance for Premarket Notifications.
Clause 17aa is recognized in part. Test methods and results regarding material deterioration due to anesthetic agents should be included for review.
Clause 26. Refer to Reviewer Guidance for Premarket Notifications.
Clause 36 is recognized in part. In addition, testing should be performed per the Draft Reviewer Guidance for Premarket Notifications. Information submitted to demonstrate conformance with the guidance should include a description of test methods and results.
Clause 41.5 is not recognized at this time.
Clause 42.3 is recognized, however, please note that ambient temperature is defined as 35 degrees C.
Clause 43 is recognized, however please note that ambient air is defined as 21% oxygen.
Clause 43.103, second paragraph is recognized, however, please note that an oxygen concentration of 100% is required.
Clause 44.7 is recognized, however please note that the Reviewer Guidance for Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities also applies.
Clause 47. Refer to Reviewer Guidance for Premarket Notifications.
Clause 56.3.a third dash. Connectors should comply with CGA standards.
Clause 56.10.c.aa. Rather, the knob directions referenced in ASTM F 1161-88 should be used.
Clause 57.2.aa third paragraph is recognized in part. Symbol 14 must be accompanied by explanatory text on the device panel. |
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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 |
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| Relevant Guidance: |
Draft Reviewer Guidance for Ventilators, July 1995
Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, April 1996 |
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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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| * 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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