C30 医疗器械综合 标准查询与下载

T/CSBME 027-2021 肌酸激酶同工酶（CKMB）定量测定试剂（盒） （荧光免疫层析法）

本文件规定了肌酸激酶同工酶（CKMB）定量测定试剂（盒）（荧光免疫层析法）的技术要求、试验方法、标志包装、运输和贮存。

Creatin Kinase Isoenzyme (CKMB) Quantitative Assay（kit） (fluorescence immunochromatography)

T/CSBME 028-2021 心肌肌钙蛋白Ⅰ定量测定试剂（盒）（荧光免疫层析法）

本文件规定了心肌肌钙蛋白I定量测定试剂（盒）（荧光免疫层析法）的技术要求、试验方法、标志、包装、运输和贮存。

Cardiac troponin-I quantitative Assay (kit) (fluorescence immunochromatography)

T/CSBME 025-2021 医疗设备可靠性管理规范

本文件适用于各种类型、不同规模和提供不同医疗设备产品生产组织的可靠性管理系统建设，由于组织及其产品的性质导致本标准的任何要求不适用时，可以考虑对其进行删减。

Reliability Management System of Medical Equipment

T/CSBME 035-2021 磁共振成像系统可靠性设计规范

本文件规定了磁共振成像系统（以下简称“MR系统”）的可靠性设计基本流程和方法。

Specification for reliability design of Nuclear Magnetic Resonance Imaging system

T/CSBME 031-2021 经食管超声探头消毒及存储规范

本文件规定了经食管超声探头的消毒及存储规范。

Specification for disinfection and storage of transesophageal echocardiography probe

ISO 10993-23:2021 医疗器械的生物学评价. 第23部分: 刺激性试验

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 This document includes: — pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure; — details of in vitro and in vivo irritation test procedures; — key factors for the interpretation of the results.

Biological evaluation of medical devices - Part 23: Tests for irritation

DIN 13459:2021 医疗器械. 带硬质合金镶件的Stratte型持针器

The project defines dimensions and marking of needle holders type Stratte with carbide inserts, as used in surgery and public health service.

Medical instruments - Needle holder type Stratte with carbide inserts

PNS ISO Guide 33:2021 参考材料.使用参考材料的良好实践

Reference materials - Good practice in using reference materials

PNS ISO 10993-7:2021 医疗器械的生物学评价.第7部分：环氧乙烷灭菌残留物

This part of PNS ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

PNS ISO 10993-9:2021 医疗器械的生物学评价.第9部分：潜在降解产物的识别和量化框架

This Standard provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies.

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

PNS ISO 10993-4:2021 医疗器械的生物学评价.第4部分：与血液相互作用试验的选择

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

PNS ISO 10993-3:2021 医疗器械的生物学评价.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

PNS ISO 10993-10:2021 医疗器械的生物学评价.第10部分：刺激和皮肤致敏试验

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

PNS ISO 10993-11:2021 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 - Part 11: Tests for systemic toxicity

PNS ISO 10993-2:2021 医疗器械的生物学评价.第2部分：动物福利要求

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

PNS ISO 10993-5:2021 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

PNS ISO 10993-6:2021 医疗器械的生物学评价.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

DB12/T 1016-2020 医疗器械追溯系统设计与实施通用要求

General requirements for design and implementation of medical device traceability system

MZ/T 151-2020 康复训练器械 砂磨桌

Rehabilitation training equipment sanding table

MZ/T 156-2020 低视力康复服务规范

Low vision rehabilitation service specifications