Boekhandel Douwes Den Haag

CRC Press Revivals

Revival: Sterilization Validation and Routine Operation Handbook (2001)

Revival: Sterilization Validation and Routine Operation Handbook (2001)

Anne F (Booth Scientific Inc., Hendersonville, North Carolina, USA) Booth

Revival: Sterilization Validation and Routine Operation Handbook (2001)

CRC Press Revivals

Revival: Sterilization Validation and Routine Operation Handbook (2001)

Revival: Sterilization Validation and Routine Operation Handbook (2001)

CRC Press Revivals: Revival: Sterilization Validation and Routine Operation Handbook (2001)

 

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation.


Nog te verschijnen

€ 44,55

Bezorgen: Zodra beschikbaar


Beschrijving CRC Press Revivals: Revival: Sterilization Validation and Routine Operation Handbook (2001)

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.


ISBN
9781138561939
Pagina's
170
Verschenen
Serie
CRC Press Revivals
NUR
820
Druk
1
Uitvoering
Paperback / softback
Taal
Engels
Uitgever
Taylor & Francis Ltd

Recht - DNJB