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
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
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates
- ICS
- 11.040.20
- CCS
- 发布
- 2021-12-28
- 实施
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 1: Extractables in aqueous autoclavates
- ICS
- 11.040.20
- CCS
- 发布
- 2021-12-28
- 实施
