11.100.20 标准查询与下载

EN ISO 20776-2:2022 临床实验室测试和体外诊断试验系统.传染者的易感性测试和抗菌剂易感性试验装置的性能评估.第2部分:抗菌剂易感性试验装置的性能评估

This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories. This document specifies requirements for AST devices and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. This document has been developed to guide manufacturers in the conduct of performance evaluation studies.

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility t

EN ISO 10993-7:2008/A1:2022 医疗器械的生物评定.第7部分:环氧乙烷消毒残余物 包含修改件A1,2022

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

KS P ISO 10993-2-2021 医疗器械生物学评价第2部分：动物福利要求

Biological evaluation of medical devices－Part 2：Animal welfare requirements

KS P ISO 22442-3-2021 利用动物组织及其衍生物的医疗器械第3部分：病毒和传染性海绵状脑病（TSE）药物消除和/或灭活的验证

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

21/30379304 DC BS EN ISO 10993-17 医疗器械生物学评价第17部分：医疗器械成分毒理学风险评估

BS EN ISO 10993-17. Biological evaluation of medical devices - Part 17. Toxicological risk assessment of medical device constituents

21/30439273 DC BS EN ISO 10993-18 AMD1 医疗器械的生物学评估 第 18 部分：风险管理过程中医疗器械材料的化学特性

BS EN ISO 10993-18 AMD1. Biological evaluation of medical devices - Part 18. Chemical characterization of medical device materials within a risk management process

GSO ISO/TS 21726:2021 医疗器械的生物学评价 应用毒理学关注阈值（TTC）评估医疗器械成分的生物相容性

This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a medical device. The TTC values in this document can be used for: — comparing to a maximum concentration of an identified or unidentified constituent in an extract (see ISO 10993-18); — supporting toxicological equivalence; — comparing to a maximum exposure dose estimate of an identified constituent (see ISO 10993-17). NOTE Constituent is defined in 3.1. ISO 10993-18 specifies how to convert TTC (µg/d) into a concentration (µg/ml). TTC is not applicable to constituents with adequate toxicity data for deriving a tolerable intake (TI) value (see ISO 10993-17). The TTC values established in this document are protective for carcinogens, systemic toxicants, and reproductive toxicants (see Clause 5). This document does not include TTC values for other biological endpoints assessed as part of the biological evaluation of a medical device, per ISO 10993-1, for example: — cytotoxicity; — irritation; — sensitization; — hemocompatibility; — material mediated pyrogenicity; — local effects that occur in tissues at the site of contact between a medical device and the body (e.g. the observations from implantation studies). The TTC values in this document do not apply to potential exposure via gas pathways of medical devices. For application of TTC for constituents present/released from these devices, see the ISO 18562 series. The TTC values presented in this document are not applicable for the safety assessment of cohort of concern (see 5.3).

Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

GSO ISO/TR 10993-22:2021 医疗器械生物学评价 第22部分：纳米材料指南

ISO/TR 10993-22:2017 describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials. In addition, this guidance can also be used for the evaluation of nano-objects generated as products of degradation, wear, or from mechanical treatment processes (e.g. in situ grinding, polishing of medical devices) from (components of) medical devices that are manufactured not using nanomaterials. ISO/TR 10993-22:2017 includes considerations on the: - characterization of nanomaterials; - sample preparation for testing of nanomaterials; - release of nano-objects from medical devices; - toxicokinetics of nano-objects; - biological evaluation of nanomaterials; - presentation of results; - risk assessment of nanomaterials in the context of medical device evaluation; - biological evaluation report; - nanostructures on the surface of a medical device, intentionally generated during the engineering, manufacturing or processing of a medical device. The following are excluded from this document: - natural and biological nanomaterials, as long as they have not been engineered, manufactured or processed for use in a medical device; - intrinsic nanostructures in a bulk material; - nanostructures on the surface of a medical device, generated as an unintentional by-product during the engineering, manufacturing or processing of a medical device. NOTE Examples of unintentional nanostructures on the surface of a medical device are extrusion draw lines and machining/tool marks. ISO/TR 10993-22:2017 is intended to provide a general framework and highlights important aspects which need to be considered when assessing the safety of medical devices composed of, containing and/or generating nano-objects. Additionally, the document identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species. As a technical report (TR), this document represents the current technical knowledge related to nanomaterials. No detailed testing protocols are outlined or provided. This document can serve as a basis for future documents containing detailed protocols with a focus on nanomaterial testing.

Biological evaluation of medical devices — Part 22: Guidance on nanomaterials

GSO ISO/TR 10993-33:2021 医疗器械的生物学评价 第33部分：评估遗传毒性的试验指南 ISO 10993-3 的补充

There are differences between the views of regulatory bodies on the subject of genotoxicity testing. The purpose of this ISO/TR 10993-33: 2015 is to provide background information to facilitate the selection of tests and guidance on the performance of tests.

Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

GSO ISO/TS 16782:2021 临床实验室测试 用于抗菌药物敏感性测试的脱水 Mueller-Hinton 琼脂和肉汤可接受批次的标准

ISO/TS 16782:2016 provides a standard description of the physical properties of dehydrated Mueller-Hinton broth (dMHB) and Mueller-Hinton agar (dMHA) and performance criteria by which manufacturers can assess the performance characteristics of their production lots of dMHA and dMHB. Production lots of broth or agar can then be utilized by all users, including in vitro susceptibility testing device manufacturers, as the test medium for performance of antimicrobial susceptibility testing. ISO/TS 16782:2016 does not address supplements (e.g. blood or blood products) that are added to the medium to support growth of fastidious bacteria[3][4][5][6]. Those additives are provided after the dehydrated medium is prepared in its liquid state as a final product and fall outside of the scope of this Technical Specification. Although dMHA can be used for determination of MICs using the agar dilution method[4][6] or the gradient diffusion method, ISO/TS 16782:2016 only includes performance testing of dMHA using disc diffusion methodology as described by the Clinical and Laboratory Standards Institute (CLSI)[5] and European Committee on Antimicrobial Susceptibility Testing (EUCAST)[3].

Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

YY/T 1465.7-2021 医疗器械免疫原性评价方法 第7部分：流式液相多重蛋白定量技术

Methods for evaluating immunogenicity of medical devices Part 7: Flow liquid phase multiplex protein quantification technology

YY/T 1754.2-2020 医疗器械临床前动物研究 第2部分:诱导糖尿病大鼠皮肤缺损模型

Medical Device Preclinical Animal Studies Part 2: Induced Diabetic Rat Skin Defect Model

EN ISO 14155:2020 医学研究受验者用医疗器械的临床调查.药品优良临床试验规范

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 are intended to 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. NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply. NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD. This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

BS EN ISO 20776-1:2020 传染性病原体的敏感性测试和抗菌药物敏感性测试装置的性能评估 用于测试抗菌药物对快速生长的体外活性的肉汤微稀释参考方法......

What is ISO 20776 ‑ 1 about?    ISO 20776 discusses susceptibility testing of infectious agents and evaluation of the performance of antimicrobial susceptibility test devices. ISO 20776 ‑ 1 describes one reference method, broth microdilution, for the determination of minimum inhibitory concentrations (MICs).    The MIC can be a guide for the clinician and reflects the activity of the drug under the described test conditions, by considering other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows the categorisation of bacteria as “susceptible...

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing…

EN ISO 20776-1:2020 临床实验室测试和体外诊断测试系统——传染源的敏感性试验和抗菌剂敏感性试验设备性能的评估第1部分:抗菌剂对感染性疾病中快速生长的需氧菌体外活性试验的参考方法

This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobi

EN ISO 10993-18:2020 医疗器械的生物学评价.第18部分:材料的化学特性

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following: — the identification of its materials of construction (medical device configuration); — the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition); — the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues); — the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables); — the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables). This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact). This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

GSO ISO 10993-1:2020 医疗器械的生物学评估 第1部分：风险管理流程中的评估和测试

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical 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 document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. This document also gives guidelines for the assessment of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

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

YY/T 0771.2-2020 动物源医疗器械 第2部分：来源、收集与处置的控制

Medical devices of animal origin Part 2: Control of source, collection and disposal

YY/T 0771.1-2020 动物源医疗器械 第1部分：风险管理应用

Medical devices of animal origin Part 1: Risk management applications

BS EN ISO 10993-16:2017 医疗器械的生物学评价 降解产物和浸出物的毒代动力学研究设计

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