ISO 8871-3:2003/Amd.1:2018
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count AMENDMENT 1

Standard No.

ISO 8871-3:2003/Amd.1:2018

Release Date

2003

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 8871-3:2003/Amd 1:2018

Latest

ISO 8871-3:2003/Amd 1:2018

Introduction

This amendment to Part 3 of a series addressing elastic components used in injectables and medical devices provides specifications for determining the release particle count. It updates and supplements the original standard issued in 2003, offering enhanced methodologies and criteria for assessing the quality and safety of these components.

*** Please note: This description may not be accurate, please refer to the official documentation.

ISO 8871-3:2003/Amd.1:2018 history

• 2018 ISO 8871-3:2003/Amd 1:2018 Elastomeric parts for parenterals and for devices for pharmaceutical usePart 3:Determination of released-particle count
• 2003 ISO 8871-3:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count

Standard and Specification