| ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)] |
| Recognition Number | Anesthesiology |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 1-141 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
| FDA Tech | Bahram Parvinian FDA/OMPT/CDRH/OSEL/DBP/ 301-796-6445 bahram.parvinian@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:
- anaesthetic gas delivery system;
- anaesthetic breathing system;
- anaesthetic gas scavenging system;
- anaesthetic vapour delivery system;
- anaesthetic ventilator;
- monitoring equipment;
- alarm system;
- protection device.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5160 | Gas-Machine, Anesthesia | Class 2 | BSZ |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Issued March 2015. |