Standard: AAMI 11607-1

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES – PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING

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Scope:

This part of ISO 11607 specifies the 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.

This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.

This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 11607-1
Publish Date: 2006-01-01
Page Count: 63
Change Type: A1
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
AAMI 11607-1 Change Type: A1 Revision: 06 Status: ACTV
AAMI 11607-1 Change Type: REAF Update Date: 2006-01-01 Revision: 06 Status: ACTV

Standards That Reference This Standard

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