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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 019 Publication Date: 12/19/2007 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 1-60: IEC 60601-2-12:(2001-10):, Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators. (Anesthesias)

Date of Standard: 2001. 
Address of Standards Organization:
  International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Lung ventilators incorporating electrical devices designed for medical use excluding lung ventilators specified for use with inhalation anesthetic agents.
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard with the following exceptions:

Clause 3.4, is not recognized.

Clause 5.4, 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.

NOTE: 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 is not recognized.

Clause 6.6a. Gas colors must correspond to common U.S. usage. ASTM F1161-88, Table 1 applies.

Clause 6.8.2dd. is not recognized. Testing for electromagnetic compatibility should be performed per the Draft Reviewer Guidance for Premarket Notifications and Draft Reviewer Guidance for Ventilators. Information submitted to demonstrate conformance with the guidances should include descripton of test methods and results.

Clause 10.2.2a third dash is not recognized. 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 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 and Draft Reviewer Guidance for Ventilators. Information submitted to demonstrate conformance with the guidances should include description of test methods and results.

Clause 41.5 is not recognized at this time.

Clause 42.3 is not recognized. Surface temperature testing should be performed per the Reviewer Guidance for Premarket Notification Submissions.

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 49.4 is not recognized. ASTM F 1100-90, clause 5.11.3.1 applies.

Clause 56.3a third dash. Connectors should comply with CGA standards.

Clause 56.10.c.aa.

Clause 57.2.aa third paragraph is recognized in part. Symbol 14 must be accompanied by explanatory text on the device panel.
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
 
Relevant Guidance:
Draft Reviewer Guidance for Ventilators, July 1995

Labelling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance, April 1999
FDA Technical Contact:
  Melanie Choe
  FDA/CDRH/ODE
  9200 Corporate Blvd., HFZ-480
  Rockville MD 20850
  240/276-4254
  Email: melanie.choe@fda.hhs.gov
* 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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