Standard: AAMI 10993-1
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
This standard is available for individual purchase.
IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).FEATURES & BENEFITS
- Maximize product development and R&D with direct access to over 1.6 million standards
- Discover new markets: Identify unmet needs and discover next-generation technologies
- Improve quality by leveraging consistent standards to meet customer and market requirements
- Minimize risk: Mitigate liability and better understand compliance regulations
- Boost efficiency: Speed up research, capture and reuse expertise
HOW TO SUBSCRIBE
This part of ISO 10993 describes:
— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyze the biological safety of the medical device;
— the assessment of the biological safety of the medical device.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests, as indicated in the Foreword.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 10993-1|
|Most Recent Revision:||YES|
|Document #||Change Type||Update Date||Revision||Status|
|AAMI 10993-1||Change Type: ERTM||Update Date: 2009-01-01||Revision: 09||Status: ACTV|
|AAMI 10993-1||Change Type: STCH||Update Date: 2009-01-01||Revision: 09||Status: ACTV|
This Standard References
Showing 10 of 25.