Essential Information for Healthcare Providers Managing Medical IT-Networks
Essential Information for Healthcare Providers Managing Medical IT-Networks
Specifies consensus terms relating to medical device servicing and repair.
Specifies consensus terms relating to medical device servicing and repair.
This document is directed toward those who are responsible for electrical safety in healthcare facilities.
This document is directed toward those who are responsible for electrical safety in healthcare facilities.
Covers the reprocessing of hemodialyzers, including a brief history, the monitoring of patients and dialyzers, anticoagulation strategies, effects of reprocessing on solute clearances, personnel qualifications and training, the monitoring and prevention of disease transmission in reuse facilities, common pitfalls of reuse programs, continuous quality improvement, and Health Care Financing Administration regulation.
Covers the reprocessing of hemodialyzers, including a brief history, the monitoring of patients and dialyzers, anticoagulation strategies, effects of reprocessing on solute clearances, personnel qualifications and training, the monitoring and prevention of disease transmission in reuse facilities, common pitfalls of reuse programs, continuous quality improvement, and Health Care Financing Administration regulation.
Covers the reprocessing of hemodialyzers, including a brief history, the monitoring of patients and dialyzers, anticoagulation strategies, effects of reprocessing on solute clearances, personnel qualifications and training, the monitoring and prevention of disease transmission in reuse facilities, common pitfalls of reuse programs, continuous quality improvement, and Health Care Financing Administration regulation.
Covers the reprocessing of hemodialyzers, including a brief history, the monitoring of patients and dialyzers, anticoagulation strategies, effects of reprocessing on solute clearances, personnel qualifications and training, the monitoring and prevention of disease transmission in reuse facilities, common pitfalls of reuse programs, continuous quality improvement, and Health Care Financing Administration regulation.
The purpose of this recommended practice is to provide ergonomic information and human factors engineering guidance so that optimum user and patient safety, system safety and performance, and operator effectiveness will be reflected in medical device design.
The purpose of this recommended practice is to provide ergonomic information and human factors engineering guidance so that optimum user and patient safety, system safety and performance, and operator effectiveness will be reflected in medical device design.
The purpose of this recommended practice is to provide ergonomic information and human factors engineering guidance so that optimum user and patient safety, system safety and performance, and operator effectiveness will be reflected in medical device design.
The purpose of this recommended practice is to provide ergonomic information and human factors engineering guidance so that optimum user and patient safety, system safety and performance, and operator effectiveness will be reflected in medical device design.
Identifies the fundamental concepts and principles for creating, integrating, and implementing health IT software and health IT systems to maintain safety and effectiveness. (Provisional Standard)
Identifies the fundamental concepts and principles for creating, integrating, and implementing health IT software and health IT systems to maintain safety and effectiveness. (Provisional Standard)
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators intended for use in the treatment of pain syndrome; also covered are labeling requirements for patient leads and electrodes. The standard includes an appendix providing labeling/user guidelines for TENS devices and an appendix providing the rationale for the provisions of the standard.
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators intended for use in the treatment of pain syndrome; also covered are labeling requirements for patient leads and electrodes. The standard includes an appendix providing labeling/user guidelines for TENS devices and an appendix providing the rationale for the provisions of the standard.
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators (TENS) intended for use in the treatment of pain syndrome.
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators (TENS) intended for use in the treatment of pain syndrome.
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators intended for use in the treatment of pain syndrome; also covered are labeling requirements for patient leads and electrodes. The standard includes an appendix providing labeling/user guidelines for TENS devices and an appendix providing the rationale for the provisions of the standard.
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators intended for use in the treatment of pain syndrome; also covered are labeling requirements for patient leads and electrodes. The standard includes an appendix providing labeling/user guidelines for TENS devices and an appendix providing the rationale for the provisions of the standard.
This standard defines specific patient safety features that can be made available in compliant radiotherapy equipment, if and as applicable to that equipment. It provides a mechanism by which manufacturers can provide information to operators, responsible organizations, and regulators detailing how the specific features of the products that they offer comply with this standard or rationale as to why a specific provision might not apply to a particular product.
This standard defines specific patient safety features that can be made available in compliant radiotherapy equipment, if and as applicable to that equipment. It provides a mechanism by which manufacturers can provide information to operators, responsible organizations, and regulators detailing how the specific features of the products that they offer comply with this standard or rationale as to why a specific provision might not apply to a particular product.
This standard defines a standard XML format for publishing and reporting the physical parameters of a C-Arm Radiation Therapy Linear Accelerator or the physical parameters in a software model of such a device.
This standard defines a standard XML format for publishing and reporting the physical parameters of a C-Arm Radiation Therapy Linear Accelerator or the physical parameters in a software model of such a device.
The purpose of this guidance document is to help healthcare professionals prepare for an accrediting agency survey as it relates to the reprocessing of surgical instruments, endoscopes, and other reusable medical devices in any healthcare setting.
The purpose of this guidance document is to help healthcare professionals prepare for an accrediting agency survey as it relates to the reprocessing of surgical instruments, endoscopes, and other reusable medical devices in any healthcare setting.
Introduces the reader to the basic principles of disinfection and sterilization science and then shows how this science is applied to develop and validate cleaning, disinfection, and sterilization processes.
Introduces the reader to the basic principles of disinfection and sterilization science and then shows how this science is applied to develop and validate cleaning, disinfection, and sterilization processes.
This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. Definitions of terms and informative annexes are also provided.
This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. Definitions of terms and informative annexes are also provided.
This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. Definitions of terms and informative annexes are also provided.
This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. Definitions of terms and informative annexes are also provided.
This technical information report (TIR) is intended to assist health care personnel in the selection of protective apparel and drapes that are listed by and have received marketing clearance from the Food and Drug Administration (FDA). These products are classified as medical devices and are subject to FDA’s labeling, premarket notification (510[k]),1 and medical device reporting (MDR) regulations. In addition, under FDA’s quality system regulation (QSR), good manufacturing practices (GMPs) must be used in the manufacture and commercial reprocessing of these devices
This technical information report (TIR) is intended to assist health care personnel in the selection of protective apparel and drapes that are listed by and have received marketing clearance from the Food and Drug Administration (FDA). These products are classified as medical devices and are subject to FDA’s labeling, premarket notification (510[k]),1 and medical device reporting (MDR) regulations. In addition, under FDA’s quality system regulation (QSR), good manufacturing practices (GMPs) must be used in the manufacture and commercial reprocessing of these devices
Covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed.
Covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed.
Includes the following topics : Design considerations: Assurance that a device can be safely and effectively reprocessed begins with the design of the device. Section 3 of the TIR describes categories of medical devices and the materials and other design characteristics that affect the ability of health care personnel to clean, disinfect, and/or sterilize devices adequately; Decontamination: A device cannot be disinfected adequately or sterilized to an adequate sterility assurance level (SAL) if it cannot be cleaned thoroughly. Section 4 addresses variables associated with cleaning and other decontamination processes used in health care facilities, as well as the minimum information that the device manufacturer should supply to health care personnel; Disinfection: Section 5 describes the levels of disinfection, the criteria for selecting chemical disinfectants, and the testing that device manufacturers should perform to establish the effectiveness of the disinfection processes recommended for their products; Sterilization: Section 6 describes the sterilization processes commonly used in health care facilities, the minimum information that device manufacturers should provide with their products, and the procedures that device manufacturers should use to qualify the sterilization parameters that they recommend
Includes the following topics : Design considerations: Assurance that a device can be safely and effectively reprocessed begins with the design of the device. Section 3 of the TIR describes categories of medical devices and the materials and other design characteristics that affect the ability of health care personnel to clean, disinfect, and/or sterilize devices adequately; Decontamination: A device cannot be disinfected adequately or sterilized to an adequate sterility assurance level (SAL) if it cannot be cleaned thoroughly. Section 4 addresses variables associated with cleaning and other decontamination processes used in health care facilities, as well as the minimum information that the device manufacturer should supply to health care personnel; Disinfection: Section 5 describes the levels of disinfection, the criteria for selecting chemical disinfectants, and the testing that device manufacturers should perform to establish the effectiveness of the disinfection processes recommended for their products; Sterilization: Section 6 describes the sterilization processes commonly used in health care facilities, the minimum information that device manufacturers should provide with their products, and the procedures that device manufacturers should use to qualify the sterilization parameters that they recommend
The AAMI TIR12 / ANSI/AAMI ST81 Set provides guidelines for designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers and ANSI/AAMI/ISO ST81:2004/(R)2010, Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices. AAMI TIR12 / ANSI/AAMI ST81 Set includes: AAMI TIR12:2010 ANSI/AAMI ST81:2004 (R2010)
The AAMI TIR12 / ANSI/AAMI ST81 Set provides guidelines for designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers and ANSI/AAMI/ISO ST81:2004/(R)2010, Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices. AAMI TIR12 / ANSI/AAMI ST81 Set includes: AAMI TIR12:2010 ANSI/AAMI ST81:2004 (R2010)
This technical information report (TIR) covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed. It also provides information on decontamination, cleaning, disinfection, and sterilization processes commonly used in health care facilities so that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided in the TIR, as well as a bibliography and other informative annex. Redline version notes changes from 2004 edition.
This technical information report (TIR) covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed. It also provides information on decontamination, cleaning, disinfection, and sterilization processes commonly used in health care facilities so that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided in the TIR, as well as a bibliography and other informative annex. Redline version notes changes from 2004 edition.
This AAMI Technical Information Report (TIR) provides additional guidance to augment ANSI/AAMI/IS0 11135, Medical devices-Validation and routine control of ethylene oxide sterilization for both medical device manufacturers that use contract sterilization facilities and contract sterilization operations. The TIR addresses how ANSI/AAMI/ISO 11135 applies to ethylene oxide sterilization operations for devices marketed in the United States.
This AAMI Technical Information Report (TIR) provides additional guidance to augment ANSI/AAMI/IS0 11135, Medical devices-Validation and routine control of ethylene oxide sterilization for both medical device manufacturers that use contract sterilization facilities and contract sterilization operations. The TIR addresses how ANSI/AAMI/ISO 11135 applies to ethylene oxide sterilization operations for devices marketed in the United States.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical device manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135-1:2007 applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical device manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135-1:2007 applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical device manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135-1:2007 applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical device manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135-1:2007 applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.
This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.
This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135û1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence. Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135û1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence. Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135-1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence. Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135-1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence. Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135û1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence..
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135û1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence..
This technical information report (TIR) provides additional guidance to augment the ANSI/AAMI/ISO 11135 series. Topics covered in this TIR are sterilization equipment, considerations for preconditioning, calculations for relative humidity, calculations of ethylene oxide concentration, and flammability
This technical information report (TIR) provides additional guidance to augment the ANSI/AAMI/ISO 11135 series. Topics covered in this TIR are sterilization equipment, considerations for preconditioning, calculations for relative humidity, calculations of ethylene oxide concentration, and flammability
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations. Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations. Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations. Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations. Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO 11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO 11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO 11135:2014 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO 11135:2014 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.
his technical information report provides guidance for health care product manufacturers in thequalification of polymeric materials, ceramics, and metals for use in health care products that are sterilized by the following modalities: a) radiation (gamma, electron beam, or x-ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; f) nitrogen dioxide, g) peracetic acid vapor, h) liquid peracetic acid, and i) hydrogen peroxide–ozone. Annexes address the specific sterilization modality concerns.
his technical information report provides guidance for health care product manufacturers in thequalification of polymeric materials, ceramics, and metals for use in health care products that are sterilized by the following modalities: a) radiation (gamma, electron beam, or x-ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; f) nitrogen dioxide, g) peracetic acid vapor, h) liquid peracetic acid, and i) hydrogen peroxide–ozone. Annexes address the specific sterilization modality concerns.
Provide guidance for health care manufacturers in the qualification of polymeric materials, ceramics, and metals in health care products that are sterilized by the following modalities: a)radiation (gamma, electron beam, or x ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; and f) ozone. Annexes address the specific sterilization modality concerns.
Provide guidance for health care manufacturers in the qualification of polymeric materials, ceramics, and metals in health care products that are sterilized by the following modalities: a)radiation (gamma, electron beam, or x ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; and f) ozone. Annexes address the specific sterilization modality concerns.
Provide guidance for health care manufacturers in the qualification of polymeric materials, ceramics, and metals in health care products that are sterilized by the following modalities: a)radiation (gamma, electron beam, or x ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; and f) ozone. Annexes address the specific sterilization modality concerns.
Provide guidance for health care manufacturers in the qualification of polymeric materials, ceramics, and metals in health care products that are sterilized by the following modalities: a)radiation (gamma, electron beam, or x ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; and f) ozone. Annexes address the specific sterilization modality concerns.
This AAMI Technical Information Report (TIR) provides information, guidance, and general recommendations regarding electromagnetic compatibility (EMC) of medical devices and the use of RF wireless technology in healthcare facilities to promote patient safety.
This AAMI Technical Information Report (TIR) provides information, guidance, and general recommendations regarding electromagnetic compatibility (EMC) of medical devices and the use of RF wireless technology in healthcare facilities to promote patient safety.
Amends clause 4 to add specific guidance for blood cell separators used in donor and patient blood collection as well as related sections of TIR19:1998. Also includes editorial correction to 7.c and minor revision of A.6 to clarify intent.
Amends clause 4 to add specific guidance for blood cell separators used in donor and patient blood collection as well as related sections of TIR19:1998. Also includes editorial correction to 7.c and minor revision of A.6 to clarify intent.
As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.