C30 医疗器械综合 标准查询与下载
共找到 1389 条与 医疗器械综合 相关的标准，共 93 页
Tissue engineering medical device product collagen Part 3: Collagen content detection based on characteristic peptide determination - liquid chromatography-mass spectrometry
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2022-01-13
- 实施
- 2022-08-01
本文件适用于基于GS1标准的医疗器械唯一标识的实施。
Assignment Rules for Medical Device Product Identification
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-12-23
- 实施
- 2022-01-01
本文件适用于基于GS1 标准的医疗器械唯一标识的实施。
Implementation Specification for Unique Identification of Medical Devices
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-12-23
- 实施
- 2022-01-01
本文件适用于基于GS1 标准的医疗器械追溯体系的建立和实施。
Medical device traceability system logo design and application specification
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-12-23
- 实施
- 2022-01-01
Methods for performance evaluation of in vitro diagnostic test systems Part 2: Accuracy
- ICS
- 11.100.10
- CCS
- C30
- 发布
- 2021-12-06
- 实施
- 2023-05-01
This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement, and provided by the manufacturers as part of, or to be used together with, in vitro diagno
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021
- ICS
- CCS
- C30
- 发布
- 2021-11-01
- 实施
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2021-11-00
- 实施
Small bore connections for medical liquids and gases Part 1: General requirements
- ICS
- 11.040.10；11.040.20
- CCS
- C30
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Metal powder cleaning and cleaning effect verification method in medical additive manufacturing powder bed fusion forming process
- ICS
- 11.040.40
- CCS
- C30
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Biocompatibility evaluation of respiratory gas pathways in medical applications Part 1: Evaluation and testing during risk management
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Methods for evaluation of in vitro degradation properties of biomedical materials Part 2: Mussel mucin
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-09-06
- 实施
- 2022-09-01
In vitro skin irritation test for medical devices
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Test methods for axial, bending and torsional durability of vascular stents in vitro
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Evaluation method for in vitro degradation performance of biomedical materials Part 1: Degradable polyesters
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Tissue engineering medical device product collagen Part 2: Type I collagen molecular weight detection-sodium dodecyl sulfate polyacrylamide gel electrophoresis method
- ICS
- 11.040.30
- CCS
- C30
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Methods for performance evaluation of in vitro diagnostic test systems Part 1: Precision
- ICS
- 11.100
- CCS
- C30
- 发布
- 2021-09-06
- 实施
- 2023-03-01
Biological evaluation of medical devices - Part 12 : sample preparation and reference materials
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-06-16
- 实施
- 2021-08-28
In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
- ICS
- CCS
- C30
- 发布
- 2021-06-07
- 实施
- 2021-06-07
Specification for in vitro diagnostic reagent temperature control logistics service
- ICS
- 11.040.01
- CCS
- C30
- 发布
- 2021-05-31
- 实施
- 2021-07-01
本文件规定了肢体功能障碍辅助器具（以下简称“辅具”）适配服务的服务对象、服务机构、服务流程、服务内容和要求、档案管理及服务质量控制。
Adaptation service specification for assistive devices for limb dysfunction
- ICS
- 11.180
- CCS
- C30
- 发布
- 2021-03-12
- 实施
- 2021-03-18
