11.040.20 输血、输液和注射设备 标准查询与下载
共找到 1423 条与 输血、输液和注射设备 相关的标准，共 95 页
IEC 60601-2-41:2021 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This particular standard does not apply to – headlights; – endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18; – luminaires used in dentistry, which are covered by ISO 9680; – luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4; – luminaires dedicated to therapeutic purposes; – special purpose lights with different conditions of use such as light sources intended solely for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; – lights connected to surgical instruments, such as luminous retractors; – luminaires for emergency lighting, which are covered by IEC 60598-2-22. SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment. IEC 60601-2-41:2021 cancels and replaces the second edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revised the statement of essential performance; b) added exposure limits, test conditions, calculation methods and safety warnings related to photobiological hazards; c) removed the terms “MINOR SURGICAL LUMINAIRES” and “MAJOR SURGICAL LUMINAIRES”; d) added definitions of MAXIMUM ILLUMINANCE DISTANCE and REFERENCE DISTANCE and allowed MANUFACTURERS to measure some performance characteristics at the REFERENCE DISTANCE that they specify; e) replaced the region of acceptable chromaticity in (x,y) colour space with a requirement for Du,v; f) added a requirement for acceptable drift of the lighthead when attached to the suspension system; g) added a requirement for fluid ingress protection; h) revised Table 201.101 of IEC 60601-2-41:2009 and IEC 60601-2-41:2009/AMD1:2013 and moved it to Annex BB; i) specified a new device for measuring SHADOW DILUTION in a simulated cavity; j) specified test conditions for luminaires equipped with distance sensors.
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
- ICS
- 11.040.20
- CCS
- 发布
- 2021-12-17
- 实施
- 2022-01-08 (7)
Electric motor driven blood pump for cardiopulmonary bypass
- ICS
- 11.040.20
- CCS
- 发布
- 20211208
- 实施
- 20211208
Stainless steel needle tubing for manufacture of medical devices
- ICS
- 11.040.20
- CCS
- 发布
- 20211208
- 实施
- 20211208
1、碘对比剂使用前流程：患者风险评估及特殊人群筛选；对比剂的选择、保管与使用前预处理。 2、碘对比剂使用时流程：碘对比剂注射的的标准护理流程。临床监测与观察护理流程；中重度对比剂药物不良事件处理应急预案。 3、碘对比剂使用后流程：患者检查后护理流程；碘对比剂外渗护理流程；碘对比剂药物不良事件上报及持续质量改进流程。 4、围碘对比剂使用期流程：对比剂肾病预防的护理流程。
The Nursing Standard of Intravenous Use of Iodine-based Contrast Media in Medical Imaging Examinations
- ICS
- 11.040.20
- CCS
- Q841
- 发布
- 2021-11-13
- 实施
- 2021-11-13
预灌封注射器是一种用于注射剂药物的包装储存并直接用于注射的，一次性使用的密闭容器包装系统。同时具有储存药物和普通注射两种功能，属于高风险包装容器。 本标准旨在规范其命名分类、生产制造工艺、生产环境、包装贮存、质量控制等生命周期要素，成为生产、使用各方面共同遵守的通用性技术要求，确保预灌封注射器生产规范、质量可控，降低存在的风险。
Taishan Quality-Prefillable syringe
- ICS
- 11.040.20
- CCS
- Q841
- 发布
- 2021-11-01
- 实施
- 2021-12-25
Transfer sets for pharmaceutical preparations - Requirements and test methods
- ICS
- 11.040.20
- CCS
- 发布
- 2021-10-21
- 实施
- 2021-10-21
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
- ICS
- 11.040.20
- CCS
- 发布
- 2021-10-01
- 实施
- 2021-10-01
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications (IEC 80369-5:2016/COR2:2021)
- ICS
- 11.040.20
- CCS
- 发布
- 2021-09-15
- 实施
- 2021-09-15
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
- ICS
- 11.040.20
- CCS
- 发布
- 2021-09-15
- 实施
- 2021-09-15
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
- ICS
- 11.040.20
- CCS
- K73
- 发布
- 2021-09-01
- 实施
This document applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021); German version EN ISO 22413:2021
- ICS
- 11.040.20
- CCS
- 发布
- 2021-09-00
- 实施
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
- ICS
- 11.040.20
- CCS
- 发布
- 2021-08-00
- 实施
- 2021-08-01
Infusion equipment for medical use -- Part 12: Check valves for single use (ISO 8536-12:2021)
- ICS
- 11.040.20
- CCS
- 发布
- 2021-07-26
- 实施
- 2021-07-26
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Standard Performance Specification for Foley Catheter
- ICS
- 11.040.20
- CCS
- 发布
- 2021-07-01
- 实施
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment. 1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies. 1.3 The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies. 1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.
Test Methods For Intervertebral Body Fusion Devices
- ICS
- 11.040.20
- CCS
- 发布
- 2021-07-01
- 实施
This specification covers the size, color and pattern, and type used on labels applied to unlabeled syringes filled by the users or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer. The size and background color requirements of drug labels are presented in details. The type and color requirements of printing for drug labels are presented in details.
Standard Specification for User Applied Drug Labels in Anesthesiology
- ICS
- 11.040.20
- CCS
- 发布
- 2021-07-01
- 实施
ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.
Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
- ICS
- 11.040.20
- CCS
- 发布
- 2021-07-01
- 实施
ISO 8536-13:2016 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-13:2016.
Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact
- ICS
- 11.040.20
- CCS
- 发布
- 2021-07-01
- 实施
ISO 1135-5:2015 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment. Secondary aims of ISO 1135-5:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components. Platelet components should not be transfused under pressure using these sets. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-5:2015.
Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus
- ICS
- 11.040.20
- CCS
- 发布
- 2021-07-01
- 实施
ISO 3826-4:2015 specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the integrated features identified in this part of ISO 3826. The integrated features refer to: needle stick protection device, leucocyte filter, sterile barrier filter, pre-collection sampling device, red blood cell storage bag, plasma storage bag, platelet storage bag, polymorphonucleic (e.g. stem) cell storage bag, post-collection sampling devices, and connections for storage solutions, anticoagulant, and replacement fluid. ISO 3826-4:2015 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. It can be used on automated or semi-automated blood collection systems.
Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features
- ICS
- 11.040.20
- CCS
- 发布
- 2021-07-01
- 实施
