Author: Jane Erin Severin
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 354

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Book Description

Author:
Publisher:
ISBN:
Category : Dissertations, Academic
Languages : en
Pages : 902

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Book Description

Author: Aami
Publisher: Association for the Advancement of Medical Instrumentation (AAMI)
ISBN: 9780010671384
Category : Medical
Languages : en
Pages :

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Book Description
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: Silvia I. Acosta-Gnass
Publisher: Pan Amer Health Org
ISBN: 9789275129265
Category : Medical
Languages : en
Pages : 167

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Book Description
This updated sterilisation manual informs health workers about the simple protocols and procedures that have been developed to prevent hospital-acquired infections both inside and outside the sterilisation plant. The guidelines included in this manual show the steps to follow in cleaning, preparing, sterilizing, storing and transporting hospital equipment so as to obtain sterile material. It is very important to be aware of this information in order to provide patients with safe health care.

Author: United States Food and Drug Administration
Publisher: Createspace Independent Publishing Platform
ISBN: 9781976578670
Category :
Languages : en
Pages : 92

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Book Description
Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.

Author: Byron J. Lambert
Publisher: Academic Press
ISBN: 0128050829
Category : Technology & Engineering
Languages : en
Pages : 266

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Book Description
Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design.

Author: S. Ananthi
Publisher: New Age International
ISBN: 8122415725
Category : Medical instruments and apparatus
Languages : en
Pages : 15

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Book Description
About the Book: This book has therefore subdivided the realm of medical instruments into the same sections like a text on physiology and introduces the basic early day methods well, before dealing with the details of present day instruments currently in

Author: NHS Estates
Publisher: The Stationery Office
ISBN: 9780113224920
Category : Architecture
Languages : en
Pages : 88

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Book Description
Provides guidance to help health planners, estates and facilities managers, sterile services managers and capital planning and design teams to plan and design a sterile services department. It discusses the objectives of a sterile services department (SSD) and service requirements, particularly focusing on: raising standards in decontamination services by optimising the built environment: service requirements strategy: calculating the optimum capacity of an SSD to eradicate bottlenecks: determining the most appropriate location of an SSD. Design guidance based on the above service objectives is outlined. Finally, the finer details of the individual spaces within an SSD are discussed.

Author: Laurence W. McKeen
Publisher: William Andrew
ISBN: 0128145129
Category : Technology & Engineering
Languages : en
Pages : 470

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Book Description
The Effect of Sterilization Methods on Plastics and Elastomers, Fourth Edition brings together a wide range of essential data on the sterilization of plastics and elastomers, thus enabling engineers to make optimal material choices and design decisions. The data tables in this book enable engineers and scientists to select the right materials and sterilization method for a given product or application. The book is a unique and essential reference for anybody working with plastic materials that are likely to be exposed to sterilization methods, be it in medical device or packaging development, food packaging or other applications. - Presents essential data and practical guidance for engineers and scientists working with plastics in applications that require sterile packaging and equipment - Updated edition removes obsolete data, updates manufacturers, verifies data accuracy, and adds new plastics materials for comparison - Provides essential information and guidance for FDA submissions required for new medical devices

Author: Michael K. Akers
Publisher: CRC Press
ISBN: 0824745663
Category : Medical
Languages : en
Pages : 401

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Book Description
Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to test