| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
051
|
Date of Entry 01/14/2019
|
|
FR Recognition Number
|
1-141
|
| Standard | (Included in ASCA) |
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)] |
|
Scope/AbstractISO/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. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Transition Period
| FDA recognition of ISO 80601-2-13 First edition 2011-08 [Including: Amendment 1 (2015) and Amendment 2 (2018)] [Rec# 1-141] will be superseded by recognition of ISO 80601-2-13 Second edition 2022-04 [Rec# 1-165]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-141] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 1-141] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.5160 |
Gas-Machine, Anesthesia
|
Class 2
|
BSZ
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series
2. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Issued March 2015.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
