| ISO 26825 First edition 2008-08-15 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 1-79 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
| FDA Tech | Neel Patel FDA/OMPT/CDRH/ODE/DAGID/ANDB/ 301-796-6274 Neel.Patel@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 26825:2008 gives requirements for labels which the user attaches to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, , design and general properties of the label and the typographical characteristics of the wording for the drug name.
ISO 26825:2008 does not give requirements for labels applied to a syringe or cartridge by the drug manufacturer.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5860 | Syringe, Piston | Class 2 | FMF |
| §880.5725 | Pump, Infusion | Class 2 | FRN |
| §868.5140 | Anesthesia Conduction Kit | Class 2 | CAZ |
| There is no relevant guidance developed at this time. |