11.040.20 输血、输液和注射设备 标准查询与下载
共找到 1427 条与 输血、输液和注射设备 相关的标准，共 96 页
1.1 This practice outlines the irradiator installation qualification program and the dosimetric procedures to be followed during operational qualification and performance qualification of the irradiator. Procedures for the routine radiation processing of blood product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a specified range. 1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators) utilizing radionuclides such as 137 Cs and 60 Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy. 1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV. 1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated (see ISO/ASTM Guide 51539). 1.5 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for dosimetry performed for blood irradiation. It is intended to be read in conjunction with ISO/ASTM Practice 52628. 1.6 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. 1.7 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 Practice for Blood Irradiation Dosimetry
- ICS
- 11.040.20
- CCS
- 发布
- 2022-06-01
- 实施
Standard Practice for Blood Irradiation Dosimetry
- ICS
- 11.040.20
- CCS
- 发布
- 2022-06-01
- 实施
Disposable anesthesia puncture kit
- ICS
- 11.040.20
- CCS
- 发布
- 2022-05-18
- 实施
- 2023-06-01
Disposable injection needle identification color code
- ICS
- 11.040.20
- CCS
- 发布
- 2022-05-18
- 实施
- 2023-06-01
Disposable intravenous catheter
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2022-05-18
- 实施
- 2023-06-01
This document details suitable equipment, a test method, acceptance criteria and advisable limits to help to ensure that there is compatibility (by measuring the insertion force) between a transfusion set closure piercing device (referred to in this document by the abbreviation 'spike') and a blood bag outlet port. The test procedure in its entirety is complex and beyond the scope of each of the relevant transfusion set and blood bag standards. This document was therefore developed to support the implementation of the existing standards for blood bags and transfusion sets. The procedure described in this document can be used by manufacturers of blood bags to test the compatibility with transfusion set spikes available on the market or by manufacturers of the transfusion set spikes to test the compatibility with blood bags available on the market.
Medical devices — Transfusion set and blood bag compatibility test method
- ICS
- 11.040.20
- CCS
- 发布
- 2022-05-12
- 实施
本文件规定了一次性使用微孔过滤输液器（以下简称输液器）的术语和定义、通用要求、标记示例、基本要求、技术要求、试验方法、检验规则、标志、包装、运输及贮存和质量承诺。 本文件适用于带有标称孔径为0.22 μm、 1.2 μm、 2.0 μm～5.0 μm的药液过滤器的输液器。
Infusion sets for single use with micropore filters
- ICS
- 11.040.20
- CCS
- C358
- 发布
- 2022-03-25
- 实施
- 2022-04-08
This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”). This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.
Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022)
- ICS
- 11.040.20
- CCS
- 发布
- 2022-03-23
- 实施
- 2022-06-30
本文件适用于医疗机构临床使用输液信息采集系统的安全管理与质量控制。
Safety management and quality control specifications for clinical use of infusion information collection system
- ICS
- 11.040.20
- CCS
- C 31
- 发布
- 2022-03-18
- 实施
- 2022-04-18
本文件适用医疗机构临床使用连续肾脏替代治疗装置（CRRT）的安全管理和质量控制。
Safety management and quality control specifications for clinical use of continuous renal replacement therapy devices
- ICS
- 11.040.20
- CCS
- C 45
- 发布
- 2022-03-18
- 实施
- 2022-04-18
This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”). This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.
Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use
- ICS
- 11.040.20
- CCS
- 发布
- 2022-03-08
- 实施
Stopcocks, tubes and accessories for angiography
- ICS
- 11.040.20
- CCS
- 发布
- 2022-03-01
- 实施
Precision wet sieve analysis of nonplastic ceramic powders
- ICS
- 11.040.20
- CCS
- 发布
- 20211231
- 实施
- 20211231
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods
- ICS
- 11.040.20
- CCS
- 发布
- 2021-12-28
- 实施
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
- ICS
- 11.040.20
- CCS
- 发布
- 2021-12-28
- 实施
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
- ICS
- 11.040.20
- CCS
- 发布
- 2021-12-28
- 实施
