SS-EN-ISO-8871-3 › Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

SS-EN-ISO-8871-3 - 2005 EDITION - CURRENT


Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:

Included in this current edition are the following subparts:

 2005 EDITION - April 1, 2005
 FOR 2005 EDITION AMENDMENT 1 SEE - April 5, 2019

Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations. This part of ISO 8871 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing. It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

ORDER

Price:

$100.05        


Want this as a site license?



Designation Name

SS-EN ISO 8871-3:2005

Revision Level

2005 EDITION

Status

Current

Publication Date

April 1, 2005

Language(s)

English

Page Count

11

International Equivalent

ISO 8871-3:2003(IDT); EN ISO 8871-3:2004(IDT)