美国医疗器械促进协会_国内外标准网文献检索下载

1.[标准] Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)

医疗器械互操作性安全标准（ANSI/AAMI/UL 2800-1-2022）

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI 2800-1:2022

发布时间：
2022-06-10

中标分类：
-

国标分类：
-

实施时间：

摘要： Specifies a baseline set of requirements for assuring safe and secure interoperability for Interoperable Medical Systems.
2.[标准] Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices

保健产品的清洁验证.医疗器械清洁工艺的开发和验证要求

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI ST98:2022

发布时间：
2022-08-22

中标分类：
-

国标分类：
-

实施时间：

摘要： This standard covers the requirements to validate cleaning processes that are developed by the medical device manufacturer for processing medical devices. This document applies to all medical devices that require cleaning prior to each clinical use of that device. Clinical uses may be in health care facilities, home uses, or use by first responders, etc.
3.[标准] Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements

健康IT软件和系统的安全性和有效性第1部分:基本概念、原则和要求

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI HIT1000-1:2022

发布时间：
2022-03-01

中标分类：
-

国标分类：
-

实施时间：

摘要： The AAMI HIT1000 series of standards and provisional standards provides a framework for managing the safety and effectiveness of health IT (HIT) software and systems, for the purpose of promoting better patient outcomes.AAMI HIT1000, Part 1: Fundamental concepts, principles, and requirements, identifies the core concepts and principles needed to maintain safe and effective health IT software and systems. It also identifies roles and defines responsibilities, activities, and best practices that are necessary for managing that safety and effectiveness.This standard applies throughout the whole lifecycle of health IT software and systems and to all sizes and types of actors involved with that system-from developers and system integrators who create the systems, to healthcare delivery organizations (HDOs) who own, configure, implement, and use the systems, and to those responsible for operating and ultimately decommissioning health IT systems or health IT system components.
4.[标准] End-to-end microbiological quality and sterility assurance

端到端微生物质量和无菌保证

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI TIR100:2021

发布时间：
2022-05-10

中标分类：
-

国标分类：
-

实施时间：

摘要： This technical information report (TIR) provides guidance for a comprehensive framework that integrates and connects Microbiological Quality & Sterility Assurance (MQ&SA) into an organization's end-to-end process for the development, validation, and routine control of sterile health care products.
5.[标准] Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)

可互操作医疗产品的风险问题标准（ANSI/AAMI/UL 2800-1-1-2022）

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI 2800-1-1:2022

发布时间：
2022-06-10

中标分类：
-

国标分类：
-

实施时间：

摘要： Specifies a baseline set of requirements for assuring safe and secure interoperability for Interoperable Medical Systems.
6.[标准] Standard for Interoperable Item Integration Life Cycle (ANSI/AAMI/UL 2800-1-3:2022)

互操作项目集成生命周期标准（ANSI/AAMI/UL 2800-1-3-2022）

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI 2800-1-3:2022

发布时间：
2022-06-10

中标分类：
-

国标分类：
-

实施时间：

摘要： Specifies a baseline set of requirements for assuring safe and secure interoperability for Interoperable Medical Systems.
7.[标准] Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning

ISO 14971在人工智能和机器学习中的应用指南

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
历史

标准号：
AAMI CR34971:2022

发布时间：
2022-04-01

中标分类：
-

国标分类：
-

实施时间：

摘要： This document provides guidance and intends to serve as a companion to ANSI/AAMI/ISO 14971:2019 for those performing risk management for artificial intelligence (AI) or machine learning (ML) incorporating medical devices.This AAMI Consensus Report does not provide a new risk management process, nor does it expand the requirements of ISO 14971. Rather, it provides guidance to assist those who are applying ISO 14971 to regulated AI medical technologies.There are many different algorithms that can support AI, including technologies such as decision trees, genetic algorithms, and neural nets. Often, when people are discussing AI, they are specifically talking about Machine Learning systems. Since Machine Learning (ML) systems are often more complicated and more opaque than other approaches, this report focuses on ML-related risks.
8.[标准] Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD) CONSOLIDATED EDITION

医用电气设备.第1-11部分:基本安全和基本性能的一般要求.并列标准:家庭医疗环境中使用的医用电气设备和医用电气系统的要求（IEC 60601-1-11-2015 MOD）合并版

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI HA60601-1-11:2015 & A1:2021

发布时间：
2022-08-22

中标分类：
-

国标分类：
-

实施时间：

摘要： This standard applies to the safety and essential performance of medical electrical equipment and medical electrical systems, which are intended by the manufacturer for use in home care applications usually without continual professional supervision and temporarily in the clinicalenvironment. These medical electrical equipment and medical electrical systems will frequently be used in locations where driving power and safety means of the electrical installation is not reliable. The amendment addresses changes to terminology and references since the main document was finalized.
9.[标准] General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications

用于血管内应用的医疗设备中的鲁尔激活阀（LAV）的一般要求

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI/ISO CN27:2021

发布时间：
2021-12-06

中标分类：
-

国标分类：
-

实施时间：

摘要： This standard covers Luer activated valves (LAVs) for intravascular applications, which open and permit access to the fluid conduit when a male Luer connector is inserted.
10.[标准] Fluid delivery performance testing for infusion pumps

输液泵的流体输送性能测试

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI TIR 101:2021

发布时间：
2021-10-15

中标分类：
-

国标分类：
-

实施时间：

摘要： This document defines fluid delivery performance test methods that cover the full range of use conditions of an infusion pump in order to provide clinically relevant data of how the pump will perform in use. This document is applicable to syringe pumps, container pumps, and volumetric infusion pumps for all indicated delivery modes including enteral, patient controlled analgesia (PCA), or epidural and prescribed infusate sources (e.g., volumetric infusion pump drawing from a syringe). This document does not establish criteria for the clinical acceptability of infusion pump performance, provide guidance for test method validation, or address uncertainty of measurement.
11.[标准] Ultrapure dialysis fluid for hemodialysis and related therapies

血液透析及相关治疗用超纯透析液

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI TIR43:2021

发布时间：
2021-02-26

中标分类：
-

国标分类：
-

实施时间：

摘要： Addresses preparation and use of ultrapure fluids to perform hemodialysis. Fluids include water and dialysis fluid. Includes the definition of ultrapure fluids, the rationale for their use, and the means by which they can be prepared. Does not cover peritoneal dialysis fluids.
12.[标准] Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices

在质量体系和医疗设备中适当使用公共云计算

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI CR510:2021

发布时间：
2021-09-24

中标分类：
-

国标分类：
-

实施时间：

摘要： The purpose of this document is to provide guidance to multiple stakeholders regarding the appropriate use of public cloud computing both as a component of medical devices and in support of quality systems. Cloud technology providers, medical device manufacturers, regulatory professionals and regulators alike should be able to refer to this document to identify known best practices for ensuring that the public cloud computing component of any medical device (or quality system) works both within the spirit and the letter of regulations designed to ensure that medical devices improve patient outcomes and/or help manage healthcare costs, while also being safe and effective.
13.[标准] Water testing methodologies

水测试方法

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI TIR58:2021

发布时间：
2021-12-21

中标分类：
-

国标分类：
-

实施时间：

摘要： This Technical Information Report (TIR) includes common test methods used to monitor hemodialysis water treatment systems and product water. The TIR identifies numerous contaminants of interest in the care of ESRD patients or that could impact the safe and effective operations of water purifications systems used in the care or treatment of ESRD patients; provides the maximum allowable levels and action levels from various standards (AAMI/ISO) and other references as applicable; describes symptoms that hemodialysis patients might experience with exposure to the contaminant; describes effects of the contaminant on hemodialysis equipment and water treatment systems; lists common test methodologies used for analysis/detection of the contaminant at the laboratory and clinic level; notes test interferences that can be associated with a specific test method.
14.[标准] Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging

有源植入式医疗器械.接触磁共振成像的起搏器和ICD患者的安全性要求和试验协议

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI PC76:2021

发布时间：
2021-04-01

中标分类：
-

国标分类：
-

实施时间：

摘要： Provides requirements and test protocols for implantable pacemakers and ICDs exposed to magnetic resonance imaging. Physicians are increasingly using magnetic resonance imaging as tool for differential diagnostic, thus exposing pacemakers and ICD patients to such equipment. Current product standards for implantable pacemakers and ICDs do not include requirements and test protocols for implantable pacemakers and ICDs, which would ensure patient safety during such procedures.
15.[标准] Evaluation of particulate associated with vascular medical devices

血管医疗器械相关颗粒物的评价

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI TIR42:2021

发布时间：
2021-03-31

中标分类：
-

国标分类：
-

实施时间：

摘要： This document provides information for defining appropriate test methods, determining the source of particulate, assessing the clinical risk of particulate, and establishing product particulate limits. Particulate could arise from many sources including materials, environment, and clinical use. This TIR is intended to offer guidance to the medical device industry when evaluating the tendency for medical devices to release particulate, identifying particulate sources, applying analytical methods for particulate testing, and developing particulate limits based on clinical risk.
16.[标准] Clinical investigation of medical devices for human subjects - Good clinical practice

人体医疗器械的临床研究.良好临床实践

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI/ISO 14155:2020

发布时间：
2020-12-07

中标分类：
-

国标分类：
-

实施时间：

摘要： This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document can be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).This document specifies general requirements intended to:protect the rights, safety and well-being of human subjects;ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results;define the responsibilities of the sponsor and principal investigator, and;assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
17.[标准] Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

医用电气设备第2-78部分:康复、评估、补偿或缓解用医用机器人的基本安全和基本性能的特殊要求

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI/IEC 80601-2-78:2020

发布时间：
2020-08-03

中标分类：
-

国标分类：
-

实施时间：

摘要： Applies to the general requirements for basic safety and essential performance of medical robots that physically interact with a patient with an impairment to support or perform rehabilitation, assessment, compensation or alleviation related to the patient?s movement functions, as intended by the manufacturer.
18.[标准] Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

医用电气设备第2-16部分:血液透析、血液透析过滤和血液过滤设备的基本安全和基本性能的特殊要求

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI/IEC 60601-2-16:2018

发布时间：
2020-07-22

中标分类：
-

国标分类：
-

实施时间：

摘要： This standard specifies the minimum safety requirements for single-patient hemodialysis, hemodiafiltration and hemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including hemodialysis, hemodiafiltration and hemofiltration equipment operated by the patient.
19.[标准] Extracorporeal systems for blood purification - Part 3: Plasmafilters

血液净化体外系统.第3部分:血浆过滤器

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI/ISO 8637-3:2018

发布时间：
2020-07-01

中标分类：
-

国标分类：
-

实施时间：

摘要： Specifies safety and performance requirements for plasmafilters.AAMI adoption: This first edition of ISO 8637-3:2018 cancels and replaces the second edition of ISO 13960:2010, which has been technically revised.
20.[标准] Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

设计、测试和标记医疗设备供医疗机构加工:设备制造商指南

发布单位：
美国-美国医疗器械促进协会(US-AAMI)

标准状态：
现行

标准号：
AAMI TIR12:2020

发布时间：
2020-09-17

中标分类：
-

国标分类：
-

实施时间：

摘要： This technical information report (TIR) provides guidance to medical device manufacturers, who are required to provide instructions that detail the processing steps from pre-treatment at the point of use through the terminal process and storage to accompany reusable and single-use medical devices that are processed by a health care facility prior to clinical use. In addition, greater detail is provided about the processes and resources that a health care facility can have for processing devices. This should provide further assistance to medical device manufacturers (MDMs) in developing their processing instructions.Health care personnel have the responsibility to obtain and review manufacturers' data and recommendations and to ensure that they have the necessary resources to follow manufacturers' instructions thoroughly. This TIR can serve as a resource for identifying the questions health care personnel should ask manufacturers when considering a product for purchase or when devising a processing protocol for a product already being used.