| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
047
|
Date of Entry 08/21/2017
|
|
FR Recognition Number
|
1-124
|
| Standard | |
ISO 8835-7 First edition 2011-11-01
Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases |
|
Scope/AbstractISO 8835-7:2011 specifies safety and performance requirements for anaesthetic systems and components that:
- can function in the absence of a supply of compressed medical gases or mains electricity;
- can withstand a challenging environment, including high temperatures, humidity, shocks and vibration, and dust;
- allow local servicing and maintenance;
- may be suitable for use with flammable anaesthetic agents. |
|
| 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. |
|
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*
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Guidance for Industry and Food and Drug Administration Staff, 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 Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
