Review of Changes to the New ANSI/AAMI/ISO 11137-2006 (Parts 1, 2, & 3) Sterilization of health care products - requirements for validation and routine control - Radiation Sterilization
Instructor:
Lisa Foster
Product ID: 700174
Training Level: Advanced
- Duration: 60 Min
The new version of ANSI/AAMI/ISO 11137-2006 is complete and published May 2006. Healthcare companies using radiation sterilization must transition to this new ISO standard within the next 3 years.In addition, the revised standard offers new methods of radiation validation that may be of benefit to many device manufacturers. This presentation will review all the changes included in the new standard and how they will affect the device manufacturer.
Areas Covered in the seminar:
- Review the layout of the standard
- Review of ANSI/AAMI/ISO 11137-1 - Requirements for Validation and Routine Control
- Review of ANSI/AAMI/ISO 11137-2 - Establishing the Sterilization dose
- Review of ANSI/AAMI/ISO 11137-3 - Guidance on Dosimetry Aspects
Who Will Benefit:
This webinar will provide valuable assistance to all regulated healthcare manufacturers that are using radiation to sterilize their medical products. The employees who will benefit include:
- End-users responsible for sterility assurance
- QA Managers and personnel
- Validation specialists
- Sterilization Consultants
- Quality System Auditors
- Regulatory personnel
Ms. Foster began her medical device career at Sterigenics International in 1989. Throughout her tenure, Ms. Foster has held various quality assurance positions at both the facility and Corporate levels where she has served as Vice President of Quality Assurance responsible for Sterigenics.
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