ISO-11607-1 › Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
To find similar documents by classification:
11.080.30 (Sterilized packaging)
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:ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems
Standard Test Method for Seal Strength of Flexible Barrier Materials
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Feb. 1, 2019