Author: Publisher:
ISBN: 9781570202865
Category : Ethylene oxide
Languages : en
Pages :
Book Description
Sterilization of Health Care Products: Requirements for development, validation and routine control of a sterilization process for medical devices
Author: Publisher:
ISBN: 9781570202865
Category : Ethylene oxide
Languages : en
Pages :
Book Description
Sterilization of Health Care Products
Author: Standards Australia (Organization)Publisher:
ISBN: 9780733779176
Category : Medical instruments and apparatus
Languages : en
Pages : 38
Book Description
Sterilization of Health Care Products
Author: Technical Committee ISO/TC 198, Sterilization of Health Care ProductsPublisher:
ISBN:
Category : Ethylene oxide
Languages : en
Pages : 78
Book Description
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1: 2006)
Author: Sterilization of Health Care Products - Radiation: Requirements for development, validation and routine control of a sterilization process for medical devices
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
Sterilization Validation and Routine Operation Handbook (2001)
Author: Anne F BoothPublisher: CRC Press
ISBN: 1351357565
Category : Medical
Languages : en
Pages : 155
Book Description
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. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.
Sterilization of Health Care Products
Author: Standards South AfricaPublisher:
ISBN: 9780626208455
Category :
Languages : en
Pages : 41
Book Description
Sterilization of Health Care Products. Radiation. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
Author: British Standards Institute StaffPublisher:
ISBN: 9780580907579
Category :
Languages : en
Pages : 54
Book Description
Medical equipment, Sterilization (hygiene), Radiation, Ionizing radiation, Gamma-radiation, Electron beams, X-rays, Radiation measurement, Verification, Quality control, Quality assurance, Medical technology, Process specification, Documents, Records (documents), Calibration, Maintenance, Medical instruments
Sterilization of Health Care Products. Ethylene Oxide. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
Author: British Standards Institute StaffPublisher:
ISBN: 9780580508806
Category :
Languages : en
Pages : 54
Book Description
Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Verification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management
Sterilization of Health-Care Products. Ethylene Oxide. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
Author: British Standards Institute StaffPublisher:
ISBN: 9780580749124
Category :
Languages : en
Pages : 94
Book Description
Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Verification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management