AAMI ISO 11607 : 2ED 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES
01-05-2006
12-01-2013
Defines requirements for single-use materials and reusable containers used for packaging of terminally sterilized medical devices, whether produced industrially or in health care facilities. Also includes the principal requirements for packaging process development and validation for the manufacturer of terminally sterilized medical devices and requirements for essential criteria used to evaluate the performance of the package used to protect device components during handling, distribution, and storage.
| Committee |
ST/WG 07
|
| DocumentType |
Standard
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 11607:2003 | Identical |
| EN 868-1 : 1997 | Similar to |
| AAMI ST63 : 2002 | STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES - DRY HEAT |
| ANSI Z80.7 : 2013 | OPHTHALMIC OPTICS - INTRAOCULAR LENSES |
| ASTM F 2475 : 2011 : REDLINE | Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
| BS EN 13503-6:2002 | Ophthalmic implants. Intraocular lenses Shelf-life and transport stability |
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