C37 医疗设备通用要求 标准查询与下载

ASTM E2062-11(2017) PDD检查标准实施的标准指南

1.1 This guide establishes essential and recommended elements in the procedures for the conduct of a psychophysiological detection of deception (PDD) examination. 1.1.1 Other unique PDD applications are addressed separately. 1.2 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 PDD Examination Standards of Practice

KS P ISO 22442-3:2010 医疗设备用动物组织及其衍生物.第3部分:病毒和传染性海绵状脑病(TSE)试剂的销毁或失效的确认

이 표준은 무생육성이거나 무생육성으로 만들어진 동물 조직 또는 동물 조직에서 파생된 제품을

Medical devices utilizing animal tissues and their derivatives－Part 3：Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy(TSE) agents

KS P ISO 22442-2:2010 医疗设备用动物组织及其衍生物.第2部分:来源控制、采集和处理

이 표준은 생체외 진단의료기기 외 동물 기원 물질을 사용하는 의료기기의 제조를 목적으로 동

Medical devices utilizing animal tissues and their derivatives－Part 2：Controls on sourcing, collection and handling

KS P ISO 22442-1:2010 医疗设备用动物组织及其衍生物.第1部分:风险管理的应用

이 표준은 무생육성 또는 무생육적으로 만들어졌으며 동물에 기원을 둔 물질을 이용해 제조된

Medical devices utilizing animal tissues and their derivatives-Part 1:Application of risk management

ISO/TR 22442-4:2010 使用动物组织以及衍生产品的医疗设备.第4部分:传染性海绵状脑病(TSE)试剂的消灭和/或失效的原则以及那些过程的确认试验

This Technical Report offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non-viable animal tissues might serve to reduce the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs). The TSE-removal methods used to process animal tissues should also reduce the risk of transmitting TSE infections via non-viable tissues of human origin; this Technical Report does not address this issue. Some current information on human tissues and TSEs is presented which may be applied by analogy to other animal tissues. This Technical Report does not intend to imply a need for validation of methods involving specific materials identified as having a “negligible risk” of contamination with TSE agents as listed in Annex C of ISO 22442-1:2007. This Technical Report is intended to clarify final draft international standards included in the ISO 22442 series, as well as in ISO 14160. This Technical Report builds upon the specific discussion in ISO 22442-3 relative to TSE agents and attempts to summarize the current state of the art in the arena of TSE agent elimination. As the understanding of inactivation and elimination of TSE agents evolves, this document will be revised when possible.

Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

BS EN ISO 10993-10:2010 医疗设备的生物学评价.刺激和皮肤过敏化试验

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.

Biological evaluation of medical devices. Tests for irritation and skin sensitization

BS EN ISO 10993-13:2010 医疗器械的生物学评价.聚合物医疗器械降解产物的鉴定与定量

This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. This part of ISO 10993 considers only nonresorbable polymers. Similar but appropriately modified procedures may be applicable for resorbable polymers. This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity. NOTE An informative text discussing environmental stress cracking (ESC) of polymers is included as a potential aid to the design of degradation studies (see Annex B). The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but should be evaluated according to the principles of ISO 10993-1, ISO 10993-16 and ISO 10993-17. Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are identified or given preference. No specific requirements for acceptable levels of degradation products are provided in this part of ISO 10993.

Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices

DIN EN 60601-1-6:2010 医用电气设备.第1-6部分:基本安全性和必要性能的通用要求.汇编标准:可用性(IEC 60601-1-6-2010).德文版本EN 60601-1-6-2010

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010); German version EN 60601-1-6:2010

BS EN 60601-1-11:2010 医疗电气设备.基本安全性和必要性能的一般要求.附属标准.家庭保健环境中使用的医疗电气设备和医疗电气系统要求

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, which are intended by their MANUFACTURER for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.2, regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel.

Medical electrical equipment - 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

NF S99-501-5*NF EN ISO 10993-5:2010 医疗器械的生物学评价.第5部分:体外细胞毒性试验

Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity.

NF S99-501-16:2010 医疗设备的生物学评价.第16部分:对降解产物和可沥滤物的毒理动力学研究方案

Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables.

BS EN ISO 10993-1:2009 医疗器械的生物学评估.风险管理过程评估和测试

This part of ISO 10993 describes: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device. This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests, as indicated in the Foreword.

Biological evaluation of medical devices - Evaluation and testing within a risk management process

ISO 10993-1:2009/Cor 11:2010 医疗器械的生物学评价.第1部分: 在风险管理过程中的评价和测试

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

BS EN 60601-1-6:2010 医用电气设备.基本安全性和基本性能的一般要求.并列标准.可用性

This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).

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

BS EN ISO 10993-16:2010 医疗器械的生物学评定.降解产物和可滤取物的毒物动力学研究设计

This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables

BS ISO 28620:2010 医疗设备.非电驱动的便携式输液设备

Medical devices - Non-electrically driven portable infusion devices

NF S92-010-1:2010 体外诊断医疗器械.制造商提供的信息(标签).第1部分:术语、定义和一般要求

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements.

BS EN ISO 10993-4:2009 医疗器械的生物评估.与血液相互作用的试验选择

This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of the limitations in knowledge and precision of tests for interactions of devices with blood. Further, this part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The selection and design of test methods should take into consideration device design, materials, clinical utility, usage environment and risk benefit. This level of specificity can only be covered in vertical standards.

Biological evaluation of medical devices - Selection of tests for interactions with blood

BS EN ISO 18113-1:2009 体外诊断医疗器械.制造商提供的信息(标签).术语、定义和一般要求

This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a) IVD devices for performance evaluation (e.g., for investigational use only), b) instrument marking, c) material safety data sheets.

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Terms, definitions and general requirements

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