| 1. |
. |
AAMI 11137 |
|
|
1994-JAN-01 • 已撤销 •
Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization-Includes Amendment 1: 2002
|
|
| 2. |
. |
AAMI TIR27 |
|
|
2001-JAN-01 • 已撤销 •
Sterilization of Health Care Products - Radiation Sterilization Substantiation of 25kGy as a Sterilization Dose Method VD Max
|
|
| 3. |
. |
AAMI TIR29 |
|
|
2002-OCT-21 • 现用 •
GUIDE FOR PROCESS CONTROL IN RADIATION STERILIZATION-Cited by FDA as "relevant guidance" for ANSI/AAMI/ISO 11137: 1994
|
|
| 4. |
. |
AAMI TIR35 |
|
|
2006-JAN-01 • 现用 •
Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits-Former designation: AAMI ST31, AAMI ST32, and AAMI TIR5
|
|
| 5. |
. |
AAMI TIR13409 |
|
|
1996-JAN-01 • 已撤销 •
Sterilization of health care products?Radiation Sterilization?Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches-Includes Amendment 1: 2000
|
|
| 6. |
. |
AAMI TIR15843 |
|
|
2000-JAN-01 • 已撤销 •
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT FAMILIES AND SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS, AND FREQUENCY OF STERILIZATION DOSE AUDITS-Cited by FDA as "relevant guidance" for ANSI/AAMI/ISO 11134: 1994
|
|
| 7. |
. |
BSI BS EN ISO 11137-3 |
|
|
2007-MAR-30 • 现用 •
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
|
|
| 8. |
. |
CNIS GB 16352-96 |
|
|
1996-MAY-23 • 现用 •
Standards for -rays radiation sterilization of disposable medical appliances
|
|
| 9. |
. |
CNIS GB 16383-96 |
|
|
1996-MAY-23 • 现用 •
Quality control standards for radiation sterilization of medical and hygienical products
|
|
| 10. |
. |
CSA ISO 11137-98-CAN/CSA |
|
|
1998-MAR-01 • 现用 •
Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization-ISO 11137: 1995
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|
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