C37 医疗设备通用要求 标准查询与下载

IEC 60601-1-6:2010 医用电气设备.基本安全和基本性能的一般要求.平行标准:可用性

Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability

ANSI/AAMI/ISO 15225:2010 命名法.医疗设备命名数据结构

Specifies requirements and guidance for the constitution of a nomenclature for medical devices in order to facilitate cooperation and exchange of regulatory data on an international level between interested parties such as: regulatory authorities, manufacturers, suppliers, health care providers, and end users.

Nomenclature - Medical device nomenclature data structure

ASTM F2554-10 计算机辅助外科系统定位精度的测量规程

The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems. The use of surgical navigation and robotic positioning systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions. In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.1.1 This practice addresses the techniques of measurement and reporting of basic static performance (accuracy, repeatability, and so forth) of surgical navigation and/or robotic positioning devices under defined conditions. The scope covers the tracking subsystem, testing only in this practice the accuracy and repeatability of the system to locate individual points in space. A point in space has no orientation; only multi-dimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the localization tool can produce errors. These errors and the orientation of the localization tool are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end-users can compare within (for example, different fixed reference frames or stylus tools) and between (for example, different manufacturers) different systems. Parameters to be evaluated include (based upon the features of the system being evaluated): (1) Location of a point relative to a coordinate system. (2) Relative point to point accuracy (linear). (3) Repeatability of coordinates of a single point. (4) For an optically based system, the range of visible orientations of the reference frames or tools. (5) This method covers all configurations of tool arrays in the system. 1.2 The system as defined in this practice includes only the tracking subsystem (optical, magnetic, mechanical, and so forth) stylus, computer, and necessary hardware and software. As such, this practice incorporates tests that can be applied to a prescribed phantom model in a laboratory or controlled setting. 1.3 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, standard deviation, maximum error). 1.4 This practice will serve as the basis for subsequent standards for specific tasks (cutting, drilling, milling, reaming, biopsy needle placement, and so forth) and surgical applications. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

ANSI/AAMI/IEC 80001-1:2010 IT网络合并医疗设备用风险管理应用程序.第1部分:作用,职责和行为

Defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address the key properties.

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities

ASTM F2819-10 测量医疗设备用棒材,条材,管材和线材的标准试验方法

Significance8212;With the birth of minimally invasive surgery in the 1960s, there has been a requirement for guide wires. The guide wires serve as the access line by which procedures like balloon angioplasty and stent placement are conducted. A guide wire typically consists of a mandrel, coil and in some cases a safety wire is used. The market for guide wires continues to grow as the number of procedures increases. For successful manufacturing of guide wires, linearity or straightness of 304 stainless steel and nitinol wire that is used for the manufacture of guide wire mandrels is critical to their end use performance. Users of guide wires require that they must navigate a tortuous anatomy. A second part of minimally invasive surgery is the use of machined or formed wire, tube, or rod. In this case, straightness of rod, tube, and wire that is going to be machined or subjected to a forming practice such as bending needs to be very linear or straight so it is accurately fed into the equipment that is used for the machining or forming practice. Laser machining is an example of a machining operation that requires a wobble-free piece of rod, tubing, or wire so that it can be properly fed into the alignment bushings of the laser. Wire forming equipment also requires wobble-free material for the same reason. Use8212;These test methods can be used by users and producers of medical grade bar, rod, tubing, and wire to specify requirements to evaluate and confirm the straightness of material. Depending upon the type of material and its metallurgical condition, it may be possible to reprocess the material to reduce its non-linearity.1.1 This standard covers the various test methods to be used for measurement of straightness of bar, rod, tubing, and wire. These test methods apply primarily to bar, rod, tubing, and wire that are ordered in the straightened and cut-to-length condition. It also applies to small diameter tubing and wire that has been specially processed to roll off a spool in the straightened condition. 1.2 These test methods apply to straightness of round wire that has a diameter between 0.05 and 4.78 mm (0.002 and 0.188 in.). They also apply to flatness (camber) of flat-shaped wire or ribbon with a maximum dimension between 0.05 and 4.78 mm (0.002 and 0.188 in.). For flatness (camber) measurement, refer to Test Method F2754/F2754M. Note 18212;The current version of Test Method F2754/F2754M covers a different diameter range (0.0127 to 4.78 mm (0.0005 to 0.188 in.)) and does not include superelastic NiTi. These exceptions would not affect the camber measurement as conducted by Test Method F2754/F2754M. 1.3 These test methods apply to straightness of round tubing that has an outer diameter between 0.05 and 6.35 mm (0.002 and 0.25 in.). 1.4 These test methods apply to straightness of round rod that has a diameter between 4.78 and 6.35 mm (0.188 and 0.25 in). It also applies to flatness (camber) of flat and shaped rod with a maximum dimension between 4.78 and 6.35 mm (0.188 and 0.25 in). For measurement of flatness (camber), refer to Test Method F2754/F2754M. Note 28212;The current version of Test Method F2754/F2754M covers a different diamete......

Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices

NF S99-501-4:2009 医疗设备的生物评估.第4部分:血统相互作用试验筛选

Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood.

NF S99-501-6:2009 医疗装置的生物学评估.第6部分:植入后局部效应的试验

Biological evaluation of medical devices - Part 6 : tests for local effects after implantation.

NF S99-501-3:2009 医疗设备的生物学评价.第3部分:遗传毒性、致癌性和生殖毒性试验

Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.

YY/T 0466.1-2009 医疗器械.用于医疗器械标签、标记和提供信息的符号.第1部分:通用要求

YY/T 0466的本部分确定了用于表达医疗器械安全和有效使用信息符号的制定和使用要求，也列出了满足YY/T 0466的本部分要求的符号。 YY/T 0466的本部分仅适用于在全球销售的范围广泛的医疗器械符号。这些符号可用在器械或包装或随附文件上。

Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements

ISO 10993-7:2008/cor 1:2009 医疗器械的生物学评价.第7部分:环氧乙烷灭菌残留物.勘误表1

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1

IEC TR 62354:2009 医疗电气设备的一般试验规程

General testing procedures for medical electrical equipment

SANS 60601-1-10:2009 医疗电气设备．第1-10部分:基本安全性和重要性能的通用要求．附属标准:发展理疗闭环控制器要求

Applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. Specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC

Medical electrical equipment Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

DIN EN ISO 11197:2009 医疗供应设备(ISO 11197-2004).德文版本EN ISO 11197-2009

Medical supply units (ISO 11197:2004); German version EN ISO 11197:2009

BS EN ISO 14971:2009 医疗器械.医疗器械风险管理的应用

This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

Medical devices - Application of risk management to medical devices

BS EN ISO 10993-5:2009 医疗器械生物学评价.第5部分:细胞毒性体外试验法(ISO 10993-5-2009)

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

BS EN ISO 10993-15:2009 医疗器械的生物评定.第15部分:金属与合金降解产物的识别与量化(ISO 10993-15-2000)

This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments. This part of ISO 10993 is not applicable to degradation products induced by applied mechanical stress. Where product-group standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards should be considered. Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

IEC 62467-1:2009 医用电气设备.近距放射疗法用剂量测定仪器.第1部分:安装在井型电离室的器械

Scope and object This part of IEC 62467 specifies the performance and some related constructional requirements of WELL-TYPE IONIZATION CHAMBERS and associated measurement apparatus@ as defined in Clause 3@ intended for the determination of a quantity@ such as AIR KERMA STRENGTH or REFERENCE AIR KERMA RATE in photon radiation fields or ABSORBED DOSE TO WATER at a depth@ in photon and beta radiation fields used in BRACHYTHERAPY@ after appropriate calibration for a given type of source. This International Standard covers the techniques for the quantification of the quantity appropriate for the BRACHYTHERAPY source under consideration. This quantity may be AIR KERMA STRENGTH or REFERENCE AIR KERMA RATE at 1 m@ or ABSORBED DOSE TO WATER at a depth (e.g. 2 mm or 5 mm). Measurement of these quantities may be accomplished by a variety of WELL-TYPE IONIZATION CHAMBERS or systems currently available for this purpose. This standard applies to products intended for low dose rate@ high dose rate@ intravascular@ both photon and beta@ BRACHYTHERAPY measurements. It does not apply to instruments for nuclear medicine applications. The application of the standard is limited to instruments that incorporate WELLTYPE IONIZATION CHAMBERS as detectors. The intended use is the measurement of the output of radioactive@ encapsulated sources for intracavitary (insertion into body cavities) or interstitial (insertion into body tissue) applications. The object of this standard is a) to establish requirements for a satisfactory level of performance for WELL-TYPE CHAMBER SYSTEMS@ and b) to standardize the methods for the determination of compliance with this level of performance. This standard is not concerned with the safety aspects of WELL-TYPE CHAMBER SYSTEMS. The WELL-TYPE CHAMBER SYSTEMS covered by this standard are not intended for use in patient environment. The electrical safety of WELL-TYPE CHAMBER SYSTEMS is covered in IEC 61010-1. The operation of the electrometer measuring system is covered in IEC 60731.

Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers

JIS T 0601-2-2 ERRATUM 2:2009 勘误表

ERRATUM

ISO/TR 13154:2009 医疗电气设备.筛选温度计用鉴定发热人群用部署、实施和操作指南

Medical electrical equipment - Deployment, implementation and operational guidelines for indentifying febrile humans using a screening thermograph

ISO 26722:2009 心血管应用及相关治疗的水处理设备

Water treatment equipment for haemodialysis applications and related therapies