| 1. |
. |
AAMI TIR34 |
|
|
2007-JAN-01 • 现用 •
Water for the reprocessing of medical devices
|
|
| 2. |
. |
DS DS/EN 15424 |
|
|
2007-MAY-10 • 现用 •
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
|
|
| 3. |
. |
DS DS/EN ISO 22442-1 |
|
|
2008-JAN-18 • 现用 •
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
|
|
| 4. |
. |
DS DS/EN ISO 22442-2 |
|
|
2008-JAN-18 • 现用 •
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
|
|
| 5. |
. |
DS DS/EN ISO 22442-3 |
|
|
2008-JAN-21 • 现用 •
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
|
|
| 6. |
. |
DS DSF/prEN ISO 14937 |
|
|
Date NA • INAC-DOBS •
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process (ISO/DIS 14937:2007)
|
|
| 7. |
. |
ISO 14937 |
|
|
2009-OCT-15 • 现用 •
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices-Second Edition
|
|
| 8. |
. |
ISO 25424 |
|
|
2009-SEP-01 • 现用 •
Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices-First Edition
|
|
| 9. |
. |
ASTM E 1766 |
|
|
1995-NOV-10 • 现用 •
Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
|
|
| 10. |
. |
ASTM E 1837 |
|
|
1996-OCT-10 • 现用 •
Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)
|
|
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