AAMI ISO 11607 : 2ED 2000
Superseded
Superseded
View Superseded by
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES
Available format(s)
PDF
Language(s)
English
Published date
01-12-2013
Superseded date
05-01-2006
Superseded by
Excluding Tax where applicable
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
|
| Pages |
0
|
| 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Superseded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 |
| 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 |
| ANSI Z80.7 : 2013 | OPHTHALMIC OPTICS - INTRAOCULAR LENSES |
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