美国铝协会_国内外标准网文献检索下载

1.[标准] Method for Assessing the Reduction Rate of Key Bioaerosols by Portable Air Cleaners Using an Aerobiology Test Chamber

使用空气生物学试验箱评估便携式空气滤清器关键生物气溶胶的减少率的方法

发布单位：
美国-家电制造商协会(US-AAAM)

标准状态：
现行

标准号：
AHAM AC-5-2022

发布时间：
2022-07-22

中标分类：
-

国标分类：
-

实施时间：

摘要： This document specifies a method to evaluate the capability of portable household air cleaners to reduce the concentration and viability of key experimentally-generated bioaerosols in a specified chamber.The test is applicable to portable air cleaners commonly used in single room spaces such as those based on mechanical filtration, ultraviolet (UV), ionizers, photocatalytic oxidation, and ozone generators in-unit technology.If the air cleaner does not claim to have the function of reducing microorganisms, this standard may not be applicable unless it is being used to simply evaluate the performance.Note: ANS/ASHRAE 185.3 is for commercial and industrial uses. ANS/AHAM AC-5 is used for Portable Household Air Cleaners and is not intended to conflict with or replace that standard for commercial or industrial consumers.Note: In this standard, we do not suggest performance test methods that measure the by-products of either the interaction between microbes or between the air cleaner and the microbes tested in this standard. The formation of by-products is an important subject. The subject of measuring by-products is under study, and AHAM will address this in future documents.Note: This standard does not apply to appliances intended for use in medical treatment locations, such as surgical suites, laboratories, medical treatment rooms, etc.
2.[标准] Guide for Installation of Pipe-Type Cable Systems - 3rd Edition

管道式电缆系统安装指南第3版

发布单位：
美国-爱迪生照明公司协会(US-AAIC)

标准状态：
现行

标准号：
AEIC CG3-21

发布时间：
2022-02-01

中标分类：
-

国标分类：
-

实施时间：

摘要： This guide is intended to outline various construction techniques relating to the installation of High-Pressure Fluid-Filled and High-Pressure Gas-Filled Pipe-Type cable systems. The purpose is to provide an aid in the preparation of installation specifications for these cable systems. The design of such systems is beyond the scope of this guide. Pipe-type cable manufacturers can provide additional information and instructions on the installation of their cable systems.The guide describes the various materials currently available, such as the several pipe coatings, etc., but makes no attempt to recommend one material over another. The varying installation techniques associated with different materials are set forth in the guide. Certain materials may be available which are not covered in the guide. However, this does not necessarily imply that these materials are unacceptable for pipe-type cable installations.The various installation and testing techniques covered in this guide must be considered as general in nature and may not be applicable to a particular installation. Local situations must be considered when applying this guide to specific projects.This guide is applicable to all commonly used pipe to be installed for use with high-pressure pipe-type cable systems, including the pipes associated with the pressurization and/or cooling systems.
3.[标准] Method of Assessing the Reduction Rate of Chemical Gases by a Room Air Cleaner

室内空气滤清器化学气体还原率的评估方法

发布单位：
美国-家电制造商协会(US-AAAM)

标准状态：
现行

标准号：
AHAM AC-4-2022

发布时间：
2022-07-22

中标分类：
-

国标分类：
-

实施时间：

摘要： This document specifies a method to evaluate the capability of a portable air cleaner to reduce the concentration of chemical gases in a specified chamber.The test is applicable to portable air cleaners commonly used in single room spaces such as those based on mechanical filtration, ultraviolet (UV), ionizers, photocatalytic oxidation, and ozone generators in-unit technology.This standard method includes definitions and performance characteristics of portable household electric room air cleaners of the types indicated.This standard method measures the relative reduction by the air cleaner of the concentration of chemical gases suspended in the air in a specified test chamber in new condition.In this standard, we do not suggest performance test methods to measure by-products of either the interaction between chemicals or between the air cleaner and the chemicals tested in this standard. The formation of by-products is an important subject. The subject of measuring by-products and chemicals is under study and AHAM will address this in future documents.
4.[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.
5.[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.
6.[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.
7.[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.
8.[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.
9.[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.
10.[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.
11.[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.
12.[标准] Standard Method of Test for Resistance of Concrete to Rapid Freezing and Thawing (ASTM Designation: C666/C666M-15)

混凝土抗冻融性的标准试验方法（ASTM名称:C666/C666M-15）

发布单位：
美国-美国公路与运输员工协会(US-AASHTO)

标准状态：
历史

标准号：
AASHTO T 161-21

发布时间：
2021-01-01

中标分类：
-

国标分类：
-

实施时间：

摘要： This method covers the determination of the resistance of concrete specimens to rapidly repeated cycles of freezing and thawing in the laboratory by two different procedures: Procedure A, Rapid Freezing and Thawing in Water, and Procedure B, Rapid Freezing in Air and Thawing in Water. Both procedures are intended for use in determining the effects of variations in the properties of concrete on the resistance of the concrete to the freezing and thawing cycles specified in the particular procedure. Neither procedure is intended to provide a quantitative measure of the length of service that may be expected from a specific type of concrete.All material in this test method not specifically designated as belonging to Procedure A or Procedure B applies to either procedure.The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.
13.[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.
14.[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.
15.[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.
16.[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.
17.[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.
18.[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.
19.[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.
20.[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.