CSA ISO 11607-2 : 2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
Hardcopy , PDF
31-07-2021
English, French
01-01-2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Validation of packaging processes
6 Packaging system assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging
Annex A (informative) - Process development
Bibliography
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