C30 医疗器械综合 标准查询与下载

YY/T 1643-2018 远程医用影像设备的功能性和兼容性检验方法

Functionality and compatibility testing methods for remote medical imaging equipment

YY/T 1630-2018 医疗器械唯一标识基本要求

Basic requirements for unique identification of medical devices

T/CSBME 001.4-2018 DEHCH增塑聚氯乙烯（PVC） 第4部分：医用硬质料

本标准规定了医用硬质料用环己烷 1,2 -二甲酸二异辛酯（DEHCH）增塑聚氯乙烯（PVC）的材料、技术要求、试验方法、标志、包装、运输和贮存。标准中对PVC粒料及其组成、DEHCH增塑剂鉴别、粒料的外观，硬度、拉伸强度、悬臂梁冲击强度、180℃热稳定时间等物理性能，粒料及水溶出物的化学性能，生物学性能及相应的试验方法，标志、包装、运输和贮存进行了具体的规定。

DEHCH plasticized polyvinyl chloride(PVC)—Part 4：Hard material for medical use

BS EN ISO 18472:2018 保健品灭菌 生物和化学指标 测验设备

Sterilization of health care products. Biological and chemical indicators. Test equipment

ISO 10993-1:2018 医疗器械的生物学评价. 第1部分: 在风险管理过程内的评价与试验

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

BS EN ISO 10993-11:2018 医疗器械的生物学评价.第11部分:全身毒性试验

Biological evaluation of medical devices. Tests for systemic toxicity

NF S99-501-11*NF EN ISO 10993-11:2018 医疗器械的生物学评价. 第11部分: 全身毒性试验

Le présent document spécifie des exigences et fournit des préconisations quant aux modes opératoires à suivre pour évaluer les éventuelles réactions systémiques défavorables causées par les matériaux de dispositifs médicaux.

Biological evaluation of medical devices - Part 11 : tests for systemic toxicity

ISO 11070:2014/Amd 1:2018 一次性使用的无菌管内导管, 扩张器和导丝.修改件1

Sterile single-use intravascular introducers, dilators and guidewires; Amendment 1

YY/T 0618-2017 医疗器械细菌内毒素试验方法常规监控与跳批检验

本标准规定了用于测定医疗器械、组件或原材料的细菌内毒素试验方法的基本准则。 注：虽然本标准的范围限定为医疗器械，但本标准规定的要求和给出的指南可能也适用于其他医疗产品。 本标准给出的细菌内毒素试验方法包括定性和定量两种方法。 本标准不适用于测定细菌内毒素之外的热原。 本标准未规定细菌内毒素的可接受水平。 注：细菌内毒素可接受水平应参照适用的标准。

Bacterial endotoxins.Test methodologies,routine monitoring,and alternatives to batch testing

T/CSBME 001.1-2017 DEHCH增塑聚氯乙烯（PVC） 第1部分：气管插管专用料

本部分规定了气管插管用环已烷-1，2-二甲酸二异辛酯（DEHCH）增塑聚氯乙烯（PVC）专用料的材料、技术要求、试验方法、标志、包装、运输和贮存。

DEHCH plasticized polyvinyl chloride ( PVC)-Part 1：Special material for tracheal intubation

YY/T 1591-2017 人类EGFR基因突变检测试剂盒

本标准规定了人类表皮生长因子受体(Human epidermal growth factor Receptor，EGFR)基因突变检测试剂盒的要求、试验方法、标签和使用说明书、包装、运输和贮存。 本试剂盒适用于定性检测EGFR基因突变。本试剂盒不适用于EGFR基因拷贝数变化检测。 本试剂盒适用于肿瘤组织或者细胞石蜡包埋切片、新鲜冰冻肿瘤组织提取的DNA样本中EGFR基因突变检测，外周血(浆)中EGFR基因突变检测可参照并制定符合外周血(浆)中EGFR基因突变检测所需的技术要求。 本试剂盒适用于人类EGFR基因突变检测试剂盒，采用的技术方法有荧光PCR法、流式荧光杂交法、荧光PCR熔解曲线法、焦磷酸测序法和Sanger测序法等。本试剂盒不适用于检测EGFR基因拷贝数变化的荧光原位杂交法；本试剂盒不适用于检测EGFR基因突变的高通量测序法。

Human epidermal growth factor receptor(EGFR) mutation detection kit

DIN EN ISO 10993-4:2017 医疗设备的生物评估.第4部分:与血液相互作用试验选择(ISO 10993-4-2017);德文版本EN ISO 10993-4-2017

This document provides general requirements for evaluating the interactions of medical devices with blood. It describes: a) a classification of medical 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.

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017

JIS T 3267:2017 血管内用导线

The guide wire for intravascular use

DIN EN ISO 10993-6:2017 医疗设备的生物学评价.第6部分:植入后局部效果试验(ISO 10993-6-2016);德文版本EN ISO 10993-6-2016

This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. The test specimen is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test specimen in terms of mechanical or functional loading. This part of ISO 10993 may also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by control materials used in medical devices of which the clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or resorption/degradation of the material. In particular for degradable/resorbable materials the degradation characteristics of the material and the resulting tissue response should be determined. This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity.

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016

ISO 10993-11:2017 医疗器械的生物学评价.第11部分:身体组织毒性试验

This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

YY/T 1512-2017 医疗器械生物学评价风险管理过程中生物学评价的实施指南

Implementation Guidelines for Biological Evaluation in the Risk Management Process of Biological Evaluation of Medical Devices

ISO 9170-1:2017 医用气体管道系统用终端设备.第1部分:与压缩医用气体和真空管道系统一起使用的终端设备

Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum

DIN EN ISO 13485 Berichtigung 1:2017 医疗器械. 质量管理体系. 管制目的要求(ISO 13485-2016); 德文版本EN ISO 13485-2016, DIN EN ISO 13485-2016-08勘误表; 德文版本EN ISO 13485-2016/AC-2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016

ISO/TR 18845:2017 牙科学.计算机辅助铣床加工精度的试验方法

Dentistry - Test methods for machining accuracy of computer-aided milling machines

ISO 10993-16:2017 医疗器械的生物学评估.第16部分:降解产物和可滤取物的毒物动力学研究设计

This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

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