Hello. Sign In
Standards Store
Look Inside

ISO DIS 11608-4

2016 Edition, February 11, 2016

Complete Document

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics

Includes all amendments and changes through Draft , February 11, 2016


View Abstract
Product Details
Document History

Detail Summary

Active, Most Current

EN
Additional Comments:
SEE ALSO ISO 11608-4
Format
Details
Price (USD)
PDF
Single User
$232.00
Print
In Stock
$232.00
Add to Cart

People Also Bought These:

IEC 60601-1
IEC 60068-2-6
ISO 2859-1
BS EN ISO 11608-5

Product Details:


Description / Abstract:

This part of ISO 11608 specifies reference requirements and test methods for needle-based injection systems (NIS) containing electronics (with or without software) intended to be used with needles and with replaceable or non-replaceable containers. The electronic needle based injection system (ENIS) can be single use, reusable, and/or rechargeable. It is intended to deliver medication to an end-user by self-administration or with assistance.

This part of ISO 11608 is not applicable for devices that are capable of delivering drug while connected to an external power supply.

This part of ISO 11608 is not applicable for ancillary electrical equipment such as chargers for the device.

This part of ISO 11608 is not applicable for needle-free injectors (as covered in ISO 21649).
The 9000 Store