Sterilization Of Medical Devices
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| Author | : Sophie Lerouge |
| Publisher | : Elsevier |
| Total Pages | : 347 |
| Release | : 2012-09-27 |
| Genre | : Medical |
| ISBN | : 0857096265 |
The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for 'self-sterilisation' and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. - Reviews established and commonly used technologies alongside new and emerging processes - Introduces and reviews the key concepts and challenges involved in sterilisation - Discusses future trends in the sterilisation of biomaterials and medical devices
| Author | : Anne Booth |
| Publisher | : Routledge |
| Total Pages | : 430 |
| Release | : 2018-12-12 |
| Genre | : Medical |
| ISBN | : 1351413805 |
This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.
| Author | : Jan Huys |
| Publisher | : |
| Total Pages | : 298 |
| Release | : 2010 |
| Genre | : |
| ISBN | : 9783886811021 |
| Author | : Barry P. Fairand |
| Publisher | : CRC Press |
| Total Pages | : 162 |
| Release | : 2001-09-26 |
| Genre | : Technology & Engineering |
| ISBN | : 9781587160745 |
Focusing on how the radiation process works and how it is applied in sterilizing medical devices and healthcare products, this book provides the latest developments in radiation technology in the form of e-beams, gamma rays, and x-rays. It covers the design and operation of irradiators as well as factors that affect cost and efficiency. It offers readers practical insights on this critical step in healthcare product manufacturing, its current uses, and its related cost concerns. Bringing all the information into one source, Radiation Sterilization for Health Care Products is a uniquely comprehensive resource.
| Author | : Aami |
| Publisher | : Association for the Advancement of Medical Instrumentation (AAMI) |
| Total Pages | : |
| Release | : 2013-10-01 |
| Genre | : Medical |
| ISBN | : 9780010671384 |
The AAMI recommended practice, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is a breakthrough standard in terms of its scope. AAMI has updated ST79 with the release of ST79:2010/A4:2013. Of particular importance, A4:2013 provides four new figures demonstrating the wrapping of items for steam sterilization and adds an annex focused on Moisture assessment. As of Oct. 25, 2013, purchasers of ST79 will receive ANSI/AAMI ST79:2010 and A1:2010 and A2:2011 and A3:2012 and A4:2014 as a single consolidated document. Among other changes from the 2006 edition of ST79, this revised and expanded second edition of ST79 includes guidance on the use and application of Class 6 emulating indicators, a chemical monitoring device fairly new to the United States. Because ST79 essentially consolidates five AAMI steam sterilization standards (whose content was reviewed and updated to reflect current good practice prior to being incorporated into ST79), it truly is a comprehensive guideline for all steam sterilization activities in healthcare facilities, regardless of the size of the sterilizer or the size of the facility, and provides a resource for all healthcare personnel who use steam for sterilization.
| Author | : Marimargaret Reichert |
| Publisher | : Jones & Bartlett Learning |
| Total Pages | : 328 |
| Release | : 1997 |
| Genre | : Education |
| ISBN | : 9780834208384 |
This Second Edition is a comprehensive resource on sterilization and disinfection of reusable instruments and medical devices
| Author | : Anne F. Booth |
| Publisher | : CRC Press |
| Total Pages | : 142 |
| Release | : 1999-09-01 |
| Genre | : Medical |
| ISBN | : 9781566767569 |
Stringent regulations require you to validate sterilization processes and step-by-step guidelines are needed to develop and implement a suitable validation program. Sterilization Validation and Routine Operation Handbook: Ethylene Oxide is the best practical guide available for the validation of EtO process. The information provided complies with ANSI/AAMI/ISO 11135: 1994, Medical devices-Validation and routine control of ethylene oxide sterilization which is based on a standard developed by the European Standardization Committee (CEN) entitled EN 550, Sterilization of medical devices- Validation and routine control of ethylene oxide sterilization. The text defines methods to assist you in the interpretation and understanding of the requirements in the standard and offers logical procedures for the validation and routine monitoring of your specific ethylene oxide process.
| Author | : Ebbing Lautenbach |
| Publisher | : Cambridge University Press |
| Total Pages | : 455 |
| Release | : 2018-04-19 |
| Genre | : Medical |
| ISBN | : 1107153166 |
A clear, hands-on outline of best practices for infection prevention that directly improve patient outcomes across the healthcare continuum.
| Author | : Y N Zhou |
| Publisher | : Elsevier |
| Total Pages | : 583 |
| Release | : 2013-05-31 |
| Genre | : Medical |
| ISBN | : 0857096427 |
As medical devices become more intricate, with an increasing number of components made from a wide range of materials, it is important that they meet stringent requirements to ensure that they are safe to be implanted and will not be rejected by the human body. Joining and assembly of medical materials and devices provides a comprehensive overview of joining techniques for a range of medical materials and applications.Part one provides an introduction to medical devices and joining methods with further specific chapters on microwelding methods in medical components and the effects of sterilization on medical materials and welded devices. Part two focuses on medical metals and includes chapters on the joining of shape memory alloys, platinum (Pt) alloys and stainless steel wires for implantable medical devices and evaluating the corrosion performance of metal medical device welds. Part three moves on to highlight the joining and assembly of medical plastics and discusses techniques including ultrasonic welding, transmission laser welding and radio frequency (RF)/dielectric welding. Finally, part four discusses the joining and assembly of biomaterial and tissue implants including metal-ceramic joining techniques for orthopaedic applications and tissue adhesives and sealants for surgical applications.Joining and assembly of medical materials and devices is a technical guide for engineers and researchers within the medical industry, professionals requiring an understanding of joining and assembly techniques in a medical setting, and academics interested in this field. - Introduces joining methods in medical applications including microwelding and considers the effects of sterilization on the resulting joints and devices - Considers the joining, assembly and corrosion performance of medical metals including shape memory alloys, platinum alloys and stainless steel wires - Considers the joining and assembly of medical plastics including multiple welding methods, bonding strategies and adhesives
| Author | : Tim Sandle |
| Publisher | : Elsevier |
| Total Pages | : 370 |
| Release | : 2013-10-31 |
| Genre | : Medical |
| ISBN | : 1908818638 |
Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. - Covers the main sterilisation methods of physical removal, physical alteration and inactivation - Includes discussion of medical devices, aseptically filled products and terminally sterilised products - Describes bacterial, pyrogenic, and endotoxin risks to devices and products
