C45 体外循环、人工脏器、假体装置 标准查询与下载
共找到 1076 条与 体外循环、人工脏器、假体装置 相关的标准，共 72 页
Tissue engineering medical device product chitosan
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2020-02-21
- 实施
- 2021-01-01
Alloplastic Restorative Materials Part 3: Demineralized Bone
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2020-02-21
- 实施
- 2021-01-01
Evaluation of in vivo osteogenic induction properties of allograft prosthetic materials demineralized bone materials
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2020-02-21
- 实施
- 2021-01-01
Disposable hemoperfusion device
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2019-10-23
- 实施
- 2020-10-01
本标准规定了骨组织库质量管理的基本要求。 本标准适用于骨组织库及其产品质量控制。骨组织库产品主要包括同种异体骨、异体神经、异体肌腱、异体骨关节及附着组织、骨组织衍生成分骨等。
Allogeneic bone grafts.Part 1:The basic requirements for bone bank
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2019-10-23
- 实施
- 2020-10-01
Assistive products for walking -- Rollators and walking tables
- ICS
- 11.180.10
- CCS
- C45
- 发布
- 2019-06-20
- 实施
Tissue engineering medical device product sodium alginate
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2019-05-31
- 实施
- 2020-06-01
本标准规定了一次性使用空心纤维血浆分离器的术语和定义、要求、试验方法、检验规则、标志及包装、运输、贮存。 本标准适用于一次性使用空心纤维血浆分离器(简称血浆分离器)，本产品配合血浆分离装置用来治疗各种免疫、代谢失调及某些中毒等危重病人进行治疗性血浆置换。
Single use membrane plasmaseparator
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2019-05-31
- 实施
- 2020-06-01
5.1 Approximately 650,000 primary total knee arthroplasties (TKAs) and 50,000 revision TKAs are performed in the United States annually (7, 8). There are between 100,000 and 200,000 anterior cruciate ligament knee injuries per year in the United States (9). 1.1 This guide is intended as a resource for individuals and organizations when designing clinical trials and/or clinical registries and addresses the selection of patient-reported outcomes, safety outcomes, imaging outcomes and other topics related to knee reconstructive surgery (KRS) including: (1) knee replacement systems, (2) anterior cruciate ligament reconstruction, (3) knee meniscus implants or tissue engineered medical products (TEMPs), (4) articular cartilage implants or TEMPS, (5) peri-articular knee osteotomies, (6) peri-articular knee fractures (including distal femur, patella, and proximal tibia fractures), or other knee surgeries. 1.2 In this guide, methods to measure the efficacy, effectiveness, and safety of KRS devices through standardizing clinical outcome measures are provided for designing, reviewing, and accepting human clinical trial protocols. 1.3 This guide is intended to provide consistency in study design, review, regulatory approval, and health insurance coverage approval for knee reconstructive surgery to the health care market. 1.4 For the purpose of this guide, KRS pertains to any device or TEMP that is intended to replace, resurface, reconstruct, and/or provide fixation of the knee joint, in part or in total, as a treatment for joint disease, trauma, or dysfunction, where long-term improvement in function and pain relief without major adverse events are the desired outcomes. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 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 Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
- ICS
- 03.120.30;11.040.40
- CCS
- C45
- 发布
- 2019
- 实施
In vivo magnetic resonance evaluation method for tissue engineering medical device products to regenerate knee joint cartilage
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2018-12-20
- 实施
- 2020-01-01
本标准规定了开展心肺体外循环技术的医疗机构应具有的基本设备和材料配置的分类、组成、作用、要求等。标准中对心肺体外循环设备和材料分类、人工心肺机、变温设备、空氧混合器、固定支架、血液回收机（选配）、负压辅助静脉引流装置（选配）、应急电源等心肺体外循环专用设备，凝血和抗凝检测、氧代谢及组织灌注检测、血气电解质分析仪、血糖仪、胶体渗透压检测仪、游离血红蛋白测量仪，心脏除颤仪、临时心脏起搏器等心肺体外循环配套仪器，以及体外循环耗材等方面做出了相应的规定。
Configuration list of equipment and materials for extracorporeal circulation (heart and lung)
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2018-12-20
- 实施
- 2019-03-01
Rehabilitation training norms before assembly of lower limb prostheses
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2018-12-06
- 实施
- 2019-03-06
Performance and Testing Guidelines for Biomaterial Scaffolds for Tissue Engineering Medical Device Products
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2018-11-07
- 实施
- 2019-11-01
Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2018-10-03
- 实施
- 2018-10-03
Evaluation method of red blood cell damage in continuous bleeding pump of cardiopulmonary bypass system
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2018-09-28
- 实施
- 2019-10-01
Extracorporeal systems for blood purification - Part 2 : extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
- ICS
- 11.040.20;11.040.60
- CCS
- C45
- 发布
- 2018-08-22
- 实施
- 2018-10-19
Cardiovascular implants and artificial organs - Checklists for use of extracorporeal circulation equipment
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2018-07-01
- 实施
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this document. This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This document does not apply to: — haemodialysers, haemodiafilters or haemofilters; — plasmafilters; — haemoperfusion devices; — vascular access devices; — blood pumps; — pressure monitors for the extracorporeal blood circuit; — air detection devices; — systems to prepare, maintain or monitor dialysis fluid; — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3. NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2018-07-01
- 实施
This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included. It specifies requirements for sterile, single-use plasmafilters, intended for use on humans. This document does not cover matters related to toxicity. Such issues are covered in relevant parts of It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.
Extracorporeal systems for blood purification - Part 3: Plasmafilters
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2018-07-01
- 实施
