11.040.01 医疗设备综合 标准查询与下载

YY/T 1830-2022 电动气压止血仪

Electric pneumatic hemostasis instrument

YY/T 1843-2022 医用电气设备网络安全基本要求

Basic requirements for network security of medical electrical equipment

GSO ASTM F2503:2022 磁共振环境下医疗器械和其他物品安全标记的标准实践

1.1 This international standard applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. 1.2 The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking. 1.3 The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons. 1.4 MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice (see X1.5). 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

GSO EN 13718-2:2022 医疗车辆及其设备 空中救护车 第2部分：空中救护车的操作和技术要求

This part of EN 13718 specifies the requirements for performance and equipping for air ambulances, including requirements for interfaces to medical devices used for the transport and treatment of sick or injured persons. This part of EN 13718 is applicable to air ambulances capable of transporting at least one person on a stretcher. NOTE Requirements are specified for categories of air ambulances based on the different intended use. These are the helicopter emergency medical service (HEMS) the helicopter intensive care medical service (HICAMS) and the fixed wing air ambulance (FWAA).

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

GSO ASTM F3208:2022 选择测试土壤以验证可重复使用医疗器械清洁方法的标准指南

1.1 This guide describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical characteristics of the device, and the clinical use of the device. 1.2 This guide describes the preparation and use of some test soils for the validation of cleaning instructions for reusable medical devices. 1.3 Reusable medical devices such as endoscopes, arthroscopic shavers, surgical instruments, and suction tubes are exposed to biological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization as applicable. Adequate cleaning is the first step in a process intended to prevent contaminant transfer to the next patient and medical practitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performance of the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of the soil or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference with disinfection/ sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints for cleaning established in the scientific literature. 1.4 The test soils are designed to simulate the contaminants that medical devices are likely to come in contact with during clinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in human secretions, blood, tissue, and bone fragments/shavings as well as non-patient derived soil (e.g., bone cement, lubricants, and dyes) during clinical procedures. The test soils also simulate the physical parameters (e.g., viscosity, adhesion) of clinical material to which the medical devices will be exposed.

Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

GSO ASTM F2901:2022 选择评估医疗器械潜在神经毒性的测试的标准指南

1.1 Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with Practice F748, and may be helpful where neurotoxicity testing is needed to evaluate medical devices that contact central and/or peripheral nervous system tissue or cerebral spinal fluid (CSF). NOTE 1—The results of these in vitro and in vivo tests may not correspond to actual human response. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

GSO ISO 20416:2022 医疗器械 制造商的上市后监督

This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain experience from the post-production activities. The output of this process can be used: — as input into product realization; — as input into risk management; — for monitoring and maintaining product requirements; — for communicating to regulatory authorities; or — as input into improvement processes. This document does not address market surveillance activities to be performed by regulatory authorities. Neither does it specify a manufacturer's actions required by the applicable regulatory requirements resulting from their production or post-production activities, nor reporting to regulatory authorities. This document is not intended to replace or change applicable regulatory requirements for post-market surveillance.

Medical devices — Post-market surveillance for manufacturers

GSO IEC 80601-2-78:2022 医用电气设备 第2-78部分：用于康复、评估、补偿或缓解的医用机器人基本安全和基本性能的特殊要求

IEC 80601-2-78:2019 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. IEC 80601-2-78:2019 does not apply to • external limb prosthetic devices (use ISO 22523), • electric wheelchairs (use ISO 7176 (all parts)), • diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and • personal care ROBOTS (use ISO 13482).

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

T/ZGCMITT 005-2022 聚焦超声消融手术临床管理与应用要求

聚焦超声消融手术临床管理与应用要求

Clinical management and application requirements of focused ultrasound ablation

T/QGCML 264-2022 智能数字化血糖监测系统通用技术要求

本文件规定了智能数字化血糖监测系统的架构、血糖采集层、数据中间层和应用功能层等技术要求。 本文件适用于智能数字化血糖监测系统的设计、开发和运行维护。

General technical requirements for intelligent digital blood glucose monitoring system

JIS T 62366-1:2022 医疗器械 第1部分：可用性工程在医疗器械中的应用

Medical devices -- Part 1: Application of usability engineering to medical devices

EN IEC 81001-5-1:2022 健康软件和健康 IT 系统的安全性、有效性和安全性 第 5-1 部分：安全性 产品生命周期中的活动

This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1[11] – taking the specific needs for HEALTH SOFTWARE into account. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for secure HEALTH SOFTWARE LIFE CYCLE PROCESSES. An informal overview of activities for HEALTH SOFTWARE is shown in Figure 2. [Figure 2] [derived from IEC 62304:2006[8], Figure 2] Figure 2 - HEALTH SOFTWARE LIFE CYCLE PROCESSES The purpose is to increase the CYBERSECURITY of HEALTH SOFTWARE by establishing certain ACTIVITIES and TASKS in the HEALTH SOFTWARE LIFE CYCLE PROCESSES and also by increasing the SECURITY of SOFTWARE LIFE CYCLE PROCESSES themselves. It is important to maintain an appropriate balance of the key properties SAFETY, effectiveness and SECURITY as discussed in ISO 81001-1[17]. This document excludes specification of ACCOMPANYING DOCUMENTATION contents.

Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

T/CSBME 053-2022 定量CT骨密度检查扫描技术规范

本文件规定了定量CT（以下简称QCT）骨密检查扫描技术规范，包括适应证、禁忌证、扫描流程、受检者体位、体模放置、扫描范围、图像质量、CT机的扫描参数、重建参数、质量控制。 本文件适用于QCT骨密度检查。 本文件适用于3.1定义的骨密度检查。 本文件不适用于其他CT检查

Technical Specification of Quantitative CT Scanning for Bone Mineral Density

T/GDNS 001-2022 医疗设备安全规范

本标准规范了医疗设备的数据安全管理流程，在相关的国家标准基础上，从技术和管理手段方面对医疗设备的数据安全做了详细的规范指引。针对医疗机构如何做好医疗设备的信息安全管控提供了清晰的实施要求。

Safety code for medical devices

ASTM F3276-22 使用测力仪评估用于清洁医疗器械外表面的刷子部件性能的标准指南

1.1 This guide describes methods for characterizing the efficacy, under prescribed laboratory conditions, of a brush part designed to clean the external surface of a medical device. The method utilizes force testers to mechanically actuate a brush part across a surface at a constant rate and constant pressure. In the first method, the force required to actuate across the surface is measured. In the next method, which utilizes the same force testers and protocol (actuation motion), the brush part is actuated on a soiled surface and the amount of soil removed is measured, as another indicator of performance. 1.2 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices. 1.3 Inclusions: 1.3.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part, under prescribed laboratory conditions, with a test method that simulates the cleaning challenge of a defined target area(s) of a medical device. This also makes it possible to compare one brush part design to another. 1.3.2 By use of this guide, manufacturers of cleaning brushes will be able to evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s) and evaluate modifications to design and construction that might improve performance. 1.3.3 By use of this guide, this information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes. 1.4 Exclusions: 1.4.1 This guide is not intended to be used for brushes designed to clean medical devices using rotational motion. 1.4.2 This guide does not assess potential damage that may be inflicted by the brush, or degradation of the brush that may occur during repeated use. Brushes with rigid bristles (for example, stainless steel or other metals) are predicted to be more likely to damage medical devices than brushes with flexible bristles (for example, nylon); damage from rigidbristled brushes should be assessed. Assessing repeated use would require a greatly increased number of test repetitions than what is described in this guide. 1.4.3 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters that are tested (for example, test soil, drying time, surface area, and materials, etc.) that are tested. 1.4.4 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation. Separate medical device cleaning instruction validation studies must be conducted. 1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15 on Material Test Methods. Current edition approved Jan. 1, 2022. Published January 2022. Originally approved in 2019. Last previous edition approved in 2019 as F3276 – 19. DOI: 10.1520/F3276-22. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 2. Referenced Documents

Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device

ASTM F3275-22 使用测力仪评估用于清洁医疗器械内部通道的刷子部件性能的标准指南

1.1 Brushes used to clean a medical device after clinical use play an important role in effective reprocessing. This guide describes methods for characterizing, under prescribed laboratory conditions, the efficacy of brush parts designed to clean the internal channels of medical devices. The methods utilize a force tester to mechanically actuate a brush part within a channel: (1) Methods to measure, at an established speed, the force required to move a brush within a channel; (2) Methods utilize the same force tester and protocols to measure soil removal from a soiled tube, another indicator of performance. 1.2 Inclusions: 1.2.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part under prescribed laboratory conditions, with test methods that simulate the cleaning challenge of a defined target area(s) of a medical device. This also makes possible the comparison of one design of a brush part to another. 1.2.2 In this guide, a brush part is one that is intended to be moved within a tube. 1.2.3 Tubes used for testing described in this guide are cylindrical and uniform in diameter. The test methods describe may not apply to non-cylindrical tubes. 1.2.4 By use of this guide, medical device manufacturers can characterize the brush part designed for cleaning their device. 1.2.5 By use of this guide, manufacturers of cleaning brushes can evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s), including allowing a comparison with existing brush part designs offered on the market. Further, they are able to evaluate modifications to designs and construction that might improve performance. 1.2.6 This information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes. 1.3 Exclusions: 1.3.1 This guide does not assess potential damage that may be inflicted by the brush. For instance, brushes with rigid bristles (for example, stainless steel or other metals) or other abrasive materials are more likely to damage medical devices than brushes with flexible bristles (for example, nylon) or more pliable materials. Potential damage from more abrasive materials should be assessed. 1.3.2 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters (for example, test soil, drying time, channel inside diameter and material, and so forth) that are tested. 1.3.3 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including the use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation. 1.3.4 If a brush is intended to clean a specific device(s), cleaning validation shall include testing with that device(s). 1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15 on Material Test Methods. Current edition approved Jan. 1, 2022. Published January 2022. Originally approved in 2019. Last previous edition approved in 2019 as F3275 – 19. DOI: 10.1520/F3275-22. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 2. Referenced Documents

Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device

KS C IEC 60601-1-8-2021 医用电气设备第1-8部分:基本安全和基本性能的一般要求附带标准:医用电气设备和医用电气系统报警系统的一般要求、试验和指南

Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard:General requirements, tests and guidance for alarm systems in medical ele

KS C IEC 60601-1-6:2021 医用电气设备.第1-6部分:基本安全和基本性能的一般要求.附带标准:可用性

Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance —Collateral standard: Usability

KS C IEC 80601-2-26-2021 医用电气设备第2-26部分:脑电图仪基本安全和基本性能的特殊要求

Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

KS C IEC 60601-2-31-2021 医用电气设备第2-31部分:带内部电源的体外心脏起搏器基本安全和基本性能的特殊要求

Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source