Lima, Ohio, USA

Contact Us

Address:
Address: 
Synergy Health
500 West 4th Street
OH 45804-1900
United States of America
Telephone:
Telephone: 
+1 (419) 225-1288
Fax:
Fax: 
+1 (419) 224-6680
Email:

Site details/Further Information

Electron Beam processing site

Energy: 10 MeV
Carrier Dimensions: 40" (L) x 30" (H) x 29.5" (W)
Guidelines and Standards ISO 13485: 2003, Medical Devices - Quality Managment Systems - Requirements for Regulatory Purposes
AAMI/ANSI/ISO 11137-1:2006, Sterilization of health care products - Radiation - Part I: Requirements for development, validation and routine control of a sterilization process for medical devices.
AAMI/ANSI/ISO 11137-2:2006, Sterilization of healthcare products - Radiation - Part 2: Establishing the sterilization dose.
AAMI/ANSI/ISO 11137-3:2006, Sterilization of healthcare products - Radiation - Part 3: Guidance on dosimetric aspects.
AAMI/ANSI/ISO 11737-1:1995, Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products.
ANSI/AAMI /ISO 11737-2:1998, Sterilization of medical devices - Microbiological methods - Part 2:Tests of sterility performed in the validation of a sterilization process.
AAMI TIR No. 17 - 1997, Radiation Sterilization - Material qualification.
AAMI TIR33:2005, Sterilization of health care products – Radiation – Substantiation of a selected sterilization dose – Method VDmax

 

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You are contacting:

Synergy Health Americas Home Office

Synergy Health Americas
12425 Race Track Road
Tampa FL 33626
(USA)

Telephone:+1 (813) 891-9550

 

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