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Standards on CD - Biological Evaluation of Medical Devices Series
MEDICAL
DEVICE PRODUCT DEVELOPMENT AND TESTING JUST GOT EASIER. AND MORE
ECONOMICAL.
AAMI's newest CD brings together all the American National Standards
that manufacturers, researchers, laboratories, and regulators involved
in development, testing, or approval should not be without
— you can't get the ANSI/AAMI/ISO 10993 series
of standards for less anywhere!
AAMI is now offering the entire collection of ANSI/AAMI/ISO standards
for biological evaluation of medical devices, widely accepted in
the U.S., Europe, and other markets that rely on international standards,
in a comprehensive, convenient, easy-to-use CD.
| Order
Information: |
Order
Code |
Member
Price |
List Price |
Buy
Now |
| AAMI Standards on CD-Biological Evaluation of Medical Devices Series |
BIOTCD |
$295 |
$495 |
|
For more info... Call 877-249-8226 or 240-646-7031 for more information.
WHAT'S
INCLUDED
With AAMI Standards on CD-Biological Evaluation of Medical Devices
Series, you'll get every current published AAMI/American National
Standard on this topic for less than $14 per document!
- Part
1: Evaluation and testing, 3ed (ANSI/AAMI/ISO 10993-1:2003)
- Part
2: Animal welfare requirements, (ANSI/AAMI/ISO 10993-2:2006)
- Part
3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity,
2ed (ANSI/AAMI/ISO 10993-3:2003)
- Part
4: Selection of tests for interactions with blood (ANSI/AAMI/ISO
10993-4:2002 & A1:2006)
- Part
5: Tests for in vitro cytotoxicity, 2ed (ANSI/AAMI/ISO 10993-5:1999)
- Part
6: Tests for local effects after implantation, 2ed (ANSI/AAMI/ISO
10993-6:2007)
- Part
7: Ethylene oxide sterilization residuals, 2ed (ANSI/AAMI/ISO
10993-7:1995/(R)2001)
- Part
9: Framework for identification and quantification of potential
degradation products, 2ed (ANSI/AAMI/ISO 10993-9:1999/(R)2005)
- Part
10: Tests for irritation and delayed type hypersensitivity, 2ed
(ANSI/AAMI BE78:2002; adoption of ISO 10993-10:2002 with national
deviation)
- Part
11: Tests for systemic toxicity (ANSI/AAMI 10993-11:2006)
- Part
12: Sample preparation and reference materials, 3ed (ANSI/AAMI/ISO
10993-12:2007)
- Part
13: Identification and quantification of degradation products
from polymeric medical devices, 1ed (ANSI/AAMI/ISO 10993-13:1999/(R)2004)
- Part
14: Identification and quantification of degradation products
from ceramics, 1ed (ANSI/AAMI/ISO 10993-14:2001/(R)2006)
- Part
15: Identification and quantification of degradation products
from metals and alloys, 1ed (ANSI/AAMI/ISO 10993-15:2000/(R)2006)
- Part
16: Toxicokinetic study design for degradation products and leachables
from medical devices, 1ed (ANSI/AAMI/ISO 10993-16:1997/(R)2003)
- Part
17: Establishment of allowable limits for leachable substances,
1ed (ANSI/AAMI/ISO 10993-17:2002
- Part 18:Chemical characterization of materials (ANSI/AAMI BE83:2006)
- Part 19: Physicochemical, morphological, and topographical characterization of materials (ANSI/AAMI/ISO 10993-19:2006)
- Part 20: Principles and methods for immunotoxicology testing of medical devices (ANSI/AAMI/ISO 10993-20:2006)
- Clinical
investigation of medical devices for human subjects - Part 1:
General requirements, 2ed (14155-1)
- Clinical
investigation of medical devices for human subjects - Part 2:
Clinical investigation plans, 1ed (14155-2)
- Guidance
for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical
devices-Part 7: Ethylene oxide sterilization residuals, 1ed and
Amendment (AAMI TIR19:1998; TIR19/A1:1999)
-
22442-1:2007, Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
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22442-2:2007, Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
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22442-3:2007, 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
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