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
Cardiovascular Implants Endovascular Devices Part 1: Endovascular Prostheses
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Assistive products for walking manipulated by both arms. Requirements and test methods. Rollators
- ICS
- 11.180.10
- CCS
- C45
- 发布
- 2021-07-28
- 实施
- 2021-07-28
This document specifies requirements and test methods of rollators being used as assistive products for walking with wheels, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer including marking and labelling. The requirements and tests are based on every-day use of rollators as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes rollators specified for a user mass of no less than 35 kg. This document is not applicable to rollators with horizontal forearm supports, classified as walking tables, for which ISO 11199-3 is applicable.
Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators
- ICS
- 11.180.10
- CCS
- C45
- 发布
- 2021-07-00
- 实施
Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads; Amendment 1
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2021-05-00
- 实施
本文件规定了PET/CT 肺癌检查操作和应用。
The technique and application of PET/CT in lung cancer
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2021-03-27
- 实施
- 2021-06-01
本文件规定了头颈部CT检查的适应证、检查前准备、检查技术、图像后处理及图像质量控制要求，同时规定了头颈部CT扫描和重建参数以及CT诊断辐射剂量参考水平。
Requirements for head and neck CT examination and radiation dose management
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2021-03-27
- 实施
- 2021-06-01
Disposable peritoneal dialysis external catheter
- ICS
- 11.040
- CCS
- C45
- 发布
- 2021-03-09
- 实施
- 2022-10-01
Guidance for the preclinical evaluation of tissue engineered medical device products in critical size bone defects in the bone
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2021-03-09
- 实施
- 2022-04-01
This document has been prepared to provide minimum requirements for vascular stents. The normative requirements are provided in the main body. The rationale for the requirements for bench tests and analyses to assess device performance, guidance on the identification of appropria
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020); German version EN ISO 25539-2:2020
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2021-01-00
- 实施
This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable. NOTE A rationale for the provisions of ISO 5840-1 is given in Annex A.
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2021-01-00
- 实施
Monitoring radioactive gases in effluents from facilities producing positron emitting radionuclides and radiopharmaceuticals
- ICS
- 13.030.30
- CCS
- C45
- 发布
- 2021-01-00
- 实施
This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components. This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. For some heart valve substitutes (e.g. sutureless), the requirements of both this document and based on the results of the risk analysis.
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2021-01-00
- 实施
This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods. NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer. This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3). This document is not applicable to high-voltage systems with intended outputs greater than 1000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions. This document does not specify all connector features. This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system. NOTE Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2020-11-00
- 实施
Test method for dynamic fatigue performance of metal tibial tray components of unicondylar knee replacement prostheses
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2020-09-27
- 实施
- 2021-09-01
Disposable cardioplegia infusion set
- ICS
- 11.040.20
- CCS
- C45
- 发布
- 2020-06-30
- 实施
- 2021-12-01
Allograft Restorative Materials Part 2: Cryogenic and Freeze-Dried Bone
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2020-06-30
- 实施
- 2021-06-01
Characterization of ceramic and mineral scaffolds for tissue engineered medical device products
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2020-06-30
- 实施
- 2021-06-01
Iodine solution protective cap for peritoneal dialysis
- ICS
- 11.040
- CCS
- C45
- 发布
- 2020-06-30
- 实施
- 2021-06-01
Cardiopulmonary bypass system centrifugal pump pump head
- ICS
- 11.040.40
- CCS
- C45
- 发布
- 2020-06-30
- 实施
- 2021-12-01
Disposable hemodialysis catheter
- ICS
- 11.040
- CCS
- C45
- 发布
- 2020-06-30
- 实施
- 2021-06-01
