ISO-8871-2 › Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:
The following bibliographic material is provided to assist you with your purchasing decision:
This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.
The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.
To find similar documents by classification:
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.
Customers who bought this document also bought:
ISO-10993-1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO-10993-12
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO-15223-1
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Document Number
ISO 8871-2:2020
Revision Level
2ND EDITION
Status
Current
Publication Date
May 1, 2020
Committee Number
ISO/TC 76