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100 Newest Standards and Packages

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AAMI 80001-GS:2011

Getting Started with IEC 80001

Essential Information for Healthcare Providers Managing Medical IT-Networks

Available for Subscriptions

AAMI EQ93:2018 (PS)

Medical equipment - Vocabulary used in medical equipment programs

Specifies consensus terms relating to medical device servicing and repair.

Available for Subscriptions

AAMI ESM4 2015

Electrical Safety Manual

This document is directed toward those who are responsible for electrical safety in healthcare facilities.

Available for Subscriptions

AAMI HDR:1998

Current concepts in hemodialyzer reprocessing, 2ed

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.

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AAMI HDR:1998 (AAMI HDR:1998)

Current concepts in hemodialyzer reprocessing, 2ed

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.

Available for Subscriptions

AAMI HE48:1993

Human factors engineering guidelines and preferred practices for the design of medical devices

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.

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AAMI HE48:1993 (AAMI HE 48:1993)

Human factors engineering guidelines and preferred practices for the design of medical devices

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.

Available for Subscriptions

AAMI HIT1000-1 (PS):2018

Safety and effectiveness of health IT software and systems - Part 1: Fundamental concepts, principles, and requirements

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)

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AAMI MDS

Developing safe, effective, and reliable medical software, 1ed

Available for Subscriptions

AAMI NS4:1986

Transcutaneous electrical nerve stimulators, 1ed

Available for Subscriptions

AAMI NS4:1986 (R2009) (AAMI NS 4:1986 (R2009))

Transcutaneous electrical nerve stimulators

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.

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AAMI NS4:1986/(R)2002

Transcutaneous electrical nerve stimulators

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.

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AAMI NS4:1986/(R)2009

Transcutaneous electrical nerve stimulators

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.

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AAMI PROC:1996/2007

AAMI Standards Program National and International (US TAG) Policies and Procedures Manuals

Available for Subscriptions

AAMI RT2:2017

Radiation Therapy readiness check

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.

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AAMI RT3:2020

Radiation therapy machine characterization

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.

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AAMI SPHC3 2017

Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys, 3rd Edition

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.

Available for Subscriptions

AAMI SPVVQ 2014

Basic Concepts in Sterilization Processes: Verification, Validation, and Qualification

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.

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AAMI TIR11:1994

Selection of surgical gowns and drapes in health care facilities, 1ed

Available for Subscriptions

AAMI TIR11:2005

Selection and use of protective apparel and surgical drapes in health care facilities

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.

Available for Subscriptions

AAMI TIR11:2005 (AAMI TIR 11:2005)

Selection and use of protective apparel and surgical drapes in health care facilities

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.

Available for Subscriptions

AAMI TIR11:2005 (R2015)

Selection and use of protective apparel and surgical drapes in health care facilities

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

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AAMI TIR12:1994

Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, 1ed

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AAMI TIR12:2004

Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

Covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed.

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AAMI TIR12:2010 (AAMI TIR 12:2010)

Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

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

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AAMI TIR12:2010 and ANSI/AAMI ST81:2004 (R2010) (AAMI TIR 12:2010 and ANSI/AAMI ST 81:2004 (R2010))

AAMI TIR12 / ANSI/AAMI ST81 Set

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)

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AAMI TIR12:2010 RED LINE

(Red Line Version) Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

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.

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AAMI TIR13:1997

Principles of industrial moist heat sterilization, 1ed

Available for Subscriptions

AAMI TIR14:1997

"Contract sterilization for ethylene oxide, 1ed"

AAMI TIR14:1997 and AAMI TIR14:1997/A1:2004

Contract sterilization for ethylene oxide

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.

Available for Subscriptions

AAMI TIR14:2009

Contract sterilization using ethylene oxide

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.

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AAMI TIR14:2009 (AAMI TIR 14:2009)

Contract sterilization using ethylene oxide

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.

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AAMI TIR14:2016

Contract sterilization using ethylene oxide

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.

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AAMI TIR15:1997

Ethylene oxide sterilization equipment, process considerations and pertinent calculations, 1ed

Available for Subscriptions

AAMI TIR15:2009

Physical aspects of ethylene oxide sterilization

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.

Available for Subscriptions

AAMI TIR15:2009 (AAMI TIR 15:2009)

Physical aspects of ethylene oxide sterilization

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.

Available for Subscriptions

AAMI TIR15:2009 (R2013) (AAMI TIR 15:2009 (R2013))

Physical aspects of ethyleneoxide sterilization

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..

Available for Subscriptions

AAMI TIR15:2016

Physical aspects of ethylene oxide sterilization

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

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AAMI TIR16:2000

Process development and performance qualification for ethylene oxide sterilization - Microbiological aspects

This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process

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AAMI TIR16:2009

Microbiological aspects of ethylene oxide sterilization

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.

Available for Subscriptions

AAMI TIR16:2009 (AAMI TIR 16:2009)

Microbiological aspects of ethylene oxide sterilization

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.

Available for Subscriptions

AAMI TIR16:2009 (R2013) (AAMI TIR 16:2009 (R2013))

Microbiological aspects of ethylene oxide sterilization

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.

Available for Subscriptions

AAMI TIR16:2017

Microbiological aspects of ethylene oxide sterilization

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.

Available for Subscriptions

AAMI TIR17: 2017

Compatibility of materials subject to sterilization

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.

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AAMI TIR17:1997

Radiation sterilization-Material qualification, 1ed

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AAMI TIR17:2008

Compatibility of materials subject to sterilization

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.

Available for Subscriptions

AAMI TIR17:2008 (AAMI TIR 17:2008)

Compatibility of materials subject to sterilization

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.

Available for Subscriptions

AAMI TIR18:1997

Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers-Part 1: Radiated radio-frequency electromagnetic energy, 1ed

Available for Subscriptions

AAMI TIR18:2010 (AAMI TIR 18:2010)

Guidance on electromagnetic compatibility of medical devices in healthcare facilities

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.

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AAMI TIR19/A1:1999

Amendment 1 to AAMI TIR19:1998, Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

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.

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AAMI TIR19:1998

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals, 1ed & Amendment

Available for Subscriptions

AAMI TIR19:1998 (AAMI TIR 19:1998)

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals, 1ed & Amendment

Available for Subscriptions

AAMI TIR19:1998/ A1:1999

Guidance for ANSI/AAMI/ISO 10993-7:1995, biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals

ANSI/AAMI/ISO 10993-7 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how this document is applied, is also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this standard.

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AAMI TIR20:2001

Parametric release for ethylene oxide sterilization

Available for Subscriptions

AAMI TIR20:2001 (AAMI TIR 20:2001)

Parametric release for ethylene oxide sterilization

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AAMI TIR21:1998

Systems used to forecast remaining pacemaker battery service life, 1ed

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AAMI TIR21:1998 (AAMI TIR 21:1998)

Systems used to forecast remaining pacemaker battery service life, 1ed

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AAMI TIR21:2017

Systems used to forecast remaining pacemaker battery service life

Discusses clinical expectations for performance of systems used to develop better tools to forecast the remaining battery service life of implantable cardiac pacemakers

Available for Subscriptions

AAMI TIR22:1998

Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices, 1ed

Available for Subscriptions

AAMI TIR22:1998/A1:2001

Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices

Available for Subscriptions

AAMI TIR22:2007

Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices- Part 1 and Part 2: 2006

This AAMI Technical Information Report (TIR) provides interpretive guidance for the application of ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems, and packaging as well as for ANSI/AAMI/ISO 11607-2:2006, Packaging for terminally sterilized medical devices-Part 2: Validation and requirements for forming, sealing, and assembly processes.

Available for Subscriptions

AAMI TIR22:2007 and AAMI TIR22:2007/A1:2008

Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006 (Now includes the 2008 amendment.)

Available for Subscriptions

AAMI TIR22:2007 and AAMI TIR22:2007/A1:2008 (AAMI TIR 22:2007 and AAMI TIR 22:2007/A1:2008)

Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006 (Now includes the 2008 amendment.)

Available for Subscriptions

AAMI TIR22:2007/A1:2008

Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006, Amendment 1

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AAMI TIR23:1999

Signal averaging, 1ed

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AAMI TIR23:1999 (AAMI TIR 23:1999)

Signal averaging, 1ed

NONE

Available for Subscriptions

AAMI TIR24:1999

Acquisition and use of physiologic waveform databases for testing of medical devices, 1ed

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AAMI TIR24:1999 (AAMI TIR 24:1999)

Acquisition and use of physiologic waveform databases for testing of medical devices, 1ed

NONE

Available for Subscriptions

AAMI TIR25:1999

"Chemical indicators-Guidance for the selection, use, and interpretation of results, 2ed"

AAMI TIR26:2000

Ventricular assist and heart replacement systems

This document is intended to be a guideline for gathering data and information to demonstrate the safety and effectiveness of ventricular assist and heart replacement systems for patients with heart dysfunction

Available for Subscriptions

AAMI TIR26:2000 (AAMI TIR 26:2000)

Ventricular assist and heart replacement systems

This document is intended to be a guideline for gathering data and information to demonstrate the safety and effectiveness of ventricular assist and heart replacement systems for patients with heart dysfunction

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AAMI TIR27:2001

Sterilization of health care products-Radiation sterilization-Substantiation of 25 kGy as a sterilization dose- Method VDmax

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AAMI TIR28: 2016

Product adoption and process equivalence for ethylene oxide sterilization

This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.

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AAMI TIR28:2001

Product adoption and process equivalency for ethylene oxide sterilization

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AAMI TIR28:2009

Product adoption and process equivalence for ethylene oxide sterilization

This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.

Available for Subscriptions

AAMI TIR28:2009 (AAMI TIR 28:2009)

Product adoption and process equivalence for ethylene oxide sterilization

This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.

Available for Subscriptions

AAMI TIR28:2009 (R2013) (AAMI TIR 28:2009 (R2013))

Product adoption and process equivalence for ethylene oxide sterilization

This TIR addresses medical devices that are processed by ethylene oxide (EO) sterilization using conventional or parametric product release. The document applies to the following situations for the sterilization of medical devices: a) a new product is being added to the previously validated process, b) changes to validated products are being evaluated, c) a previously validated process is being moved to a different facility or to different equipment, and d) equivalency of a sterilization process is being evaluated. 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.

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AAMI TIR29:2002

Guide for process control in radiation sterilization

This technical information report provides additional guidance for establishing and meeting the irradiator dose mapping, process qualification, and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137 for gamma and electron beam sterilization. Although bremsstrahlung irradiation has similar requirements, there is little experience in the design and operation of a bremsstrahlung irradiation facility at the time of this work was initiated, and therefore the requirements for bremsstrahlung irradiation are not included in the scope.

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AAMI TIR29:2002 (AAMI TIR 29:2002)

Guide for process control in radiation sterilization

This technical information report provides additional guidance for establishing and meeting the irradiator dose mapping, process qualification, and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137 for gamma and electron beam sterilization. Although bremsstrahlung irradiation has similar requirements, there is little experience in the design and operation of a bremsstrahlung irradiation facility at the time of this work was initiated, and therefore the requirements for bremsstrahlung irradiation are not included in the scope.

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AAMI TIR29:2012

Technical Information Report Guide for process characterization and control in radiation sterilization of medical devices

This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137-1 for gamma, electron beam, and X-ray sterilization. NOTE - This TIR is intended to be used in conjunction with ANSI/AAMI/ISO 11137-1, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Because a TIR is considered ôinformativeö and is not subject to the same formal approval process as a standard, the process steps are described in the TIR as ôshouldö rather than ôshall.ö Readers are reminded that many of this TIRÆs ôshouldsö are ôshallsö in ANSI/AAMI/ISO 11137-1

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AAMI TIR29:2012 (AAMI TIR 29:2012)

Technical Information Report Guide for process characterization and control in radiation sterilization of medical devices

This technical information report (TIR) provides additional guidance for establishing and meeting the irradiator Operational Qualification (OQ), Performance Qualification (PQ), and routine control requirements for radiation sterilization as defined in ANSI/AAMI/ISO 11137-1 for gamma, electron beam, and X-ray sterilization. NOTE - This TIR is intended to be used in conjunction with ANSI/AAMI/ISO 11137-1, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Because a TIR is considered ôinformativeö and is not subject to the same formal approval process as a standard, the process steps are described in the TIR as ôshouldö rather than ôshall.ö Readers are reminded that many of this TIRÆs ôshouldsö are ôshallsö in ANSI/AAMI/ISO 11137-1

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AAMI TIR30:2003

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

This report is intended as a resource for manufacturers of medical devices who must validate the instructions for reprocessing that they include with their devices. In addition to describing available processes, materials, test methods, and acceptance criteria for cleaning medical devices that are labeled by the manufacturer for reuse and reprocessing, the report also discusses some of the underlying problems and challenges associated with validating a cleaning method. Extensive references and an annotated bibliography on device design also are included.

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AAMI TIR30:2011

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

This technical information report (TIR) is a compilation of available information regarding test protocols, materials, test soils, and acceptance criteria that can be used by medical device manufacturers to validate cleaning processes for reusable medical devices.

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AAMI TIR30:2011 (AAMI TIR 30:2011)

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

This technical information report (TIR) is a compilation of available information regarding test protocols, materials, test soils, and acceptance criteria that can be used by medical device manufacturers to validate cleaning processes for reusable medical devices.

Available for Subscriptions

AAMI TIR31:2003

Process challenge devices/test packs for use in health care facilities

This technical information report (TIR) is intended to provide technical information that will assist health care facilities in the selection and use of process challenge devices (PCDs). It is to serve as a resource that health care personnel can use when directing questions to the manufacturer about the suitability, effectiveness, and safety of a specific PCD. Currently, there are no standards that evaluate the performance of these medical devices.

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AAMI TIR31:2008 (AAMI TIR 31:2008)

Process challenge devices/test packs for use in health care facilities

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AAMI TIR32:2004

Medical device software risk management

Effective Software Risk Management is a significant part of the overall risk management process for medical devices containing software. This Technical Information Report (TIR) provides information useful to performing effective software risk management.

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AAMI TIR32:2004 (AAMI TIR 32:2004)

Medical device software risk management

Effective Software Risk Management is a significant part of the overall risk management process for medical devices containing software. This Technical Information Report (TIR) provides information useful to performing effective software risk management.

Available for Subscriptions

AAMI TIR32:2004 (R2016)

Medical device software risk management

This AAMI technical information report provides information useful to performing effective software risk management, a significant part of the overall risk management process for medical devices containing software. It does this in the context of ANSI/AAMI/ISO 14971:2000, Medical devices - Application of risk management to medical devices, and in the context of ANSI/AAMI SW68:2001, Medical device software - Software life cycle processes.

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AAMI TIR33:2005

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax

This Technical Information Report is intended to prepare the industry for extending application of the VDmax method contained in ANSI/AAMI/ISO 11137-2:2006, which is for use with selected doses of 15 kGy and 25 kGy, to the following additional doses: 17.5, 20, 22.5, 27.5, 30, 32.5, and 35 kGy.

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AAMI TIR33:2005 (AAMI TIR 33:2005)

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax

This Technical Information Report is intended to prepare the industry for extending application of the VDmax method contained in ANSI/AAMI/ISO 11137-2:2006, which is for use with selected doses of 15 kGy and 25 kGy, to the following additional doses: 17.5, 20, 22.5, 27.5, 30, 32.5, and 35 kGy.

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AAMI TIR34:2007

Water for the reprocessing of medical devices

This technical information report (TIR) covers the selection and maintenance of effective water quality suitable for reprocessing medical devices. It provides guidelines for selecting the water quality necessary for the reprocessing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations.

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AAMI TIR34:2007 (AAMI TIR 34:2007)

Water for the reprocessing of medical devices

This technical information report (TIR) covers the selection and maintenance of effective water quality suitable for reprocessing medical devices. It provides guidelines for selecting the water quality necessary for the reprocessing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations.

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AAMI TIR34:2014

Water for the reprocessing of medical devices

This TIR addresses how to determine the water quality needs for reprocessing various categories of medical devices at various stages of reprocessing and how to assess, generate, monitor, and maintain water meeting those requirements.

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AAMI TIR34:2014 (R2017)

Water for the reprocessing of medical devices

This technical information report (TIR) covers the selection and maintenance of effective water quality suitable for reprocessing medical devices. It provides guidelines for selecting the water quality necessary for the reprocessing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations.

Available for Subscriptions

AAMI TIR35:2006

Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits

Describes approaches to the selection and auditing of a sterilization dose that economize in relation to the number of product units required while maintaining assurance of attaining the desired sterility assurance level (SAL). Supercedes ANSI/AAMI/ISO TIR 15843:2000.

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AAMI TIR35:2006 (AAMI TIR 35:2006)

Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits

Describes approaches to the selection and auditing of a sterilization dose that economize in relation to the number of product units required while maintaining assurance of attaining the desired sterility assurance level (SAL). Supercedes ANSI/AAMI/ISO TIR 15843:2000.

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AAMI TIR35:2016

Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

Describes approaches to the selection and auditing of a sterilization dose that may reduce the number of product items required while maintaining assurance of attaining the desired sterility assurance level (SAL). This approach addresses sampling plans for verification dose experiments and sterilization dose audits. In addition the approaches to adopting a product into an established product family are defined.

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AAMI TIR37:2007

Sterilization of health care products -- Radiation -- Guidance on sterilization of human tissue-based products

This Technical Information Report provides guidance on special considerations for sampling and testing techniques that are used in the validation of radiation sterilization of human tissue-based products.

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AAMI TIR37:2007 (AAMI TIR 37:2007)

Sterilization of health care products -- Radiation -- Guidance on sterilization of human tissue-based products

This Technical Information Report provides guidance on special considerations for sampling and testing techniques that are used in the validation of radiation sterilization of human tissue-based products.

Available for Subscriptions
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