C40 医用光学仪器设备与内窥镜 标准查询与下载
共找到 284 条与 医用光学仪器设备与内窥镜 相关的标准，共 19 页
本文件规定了人工晶状体的生物相容性评价专用要求，包括其在生产过程条件下材料的生物相容性评价要求、与生物相容性相关的物理化学特性的评价及眼植入试验方法。本文件适用于人工晶状体。
Ophthalmic optical intraocular lenses Part 5: Biocompatibility
- ICS
- 11.040
- CCS
- C40
- 发布
- 2023-09-05
- 实施
- 2024-09-15
本文件规定了同视机的最低要求和试验方法。同视机用于检查、测量、训练和矫正患者双眼视觉以及测量不同凝视位置的水平、垂直和旋转偏差。本文件适用于同视机。
Ophthalmology equipment synopsis machine
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2023-09-05
- 实施
- 2024-09-15
本文件描述了一种用于评估具消毒功能的接触镜护理产品与水凝胶镜片及镜片盒相容性的抗微生物效力终点法。本文件适用于具有消毒功能的接触镜护理产品。本文件不适用于以双氧水为主要杀菌成分的护理产品。
Ophthalmic Optical Contact Lens Care Products Methods for Evaluating Bacterial and Fungal Challenges of Contact Lens Care Products and Contact Lenses in Lens Cases
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2023-09-05
- 实施
- 2024-09-15
本文件规定了有关眼内填充物的预期性能、设计属性、设计评价、灭菌、产品稳定性、输送系统的完整性及性能、包装、制造商提供的信息等通用要求。本文件适用于眼内填充物。
Ophthalmic optical intraocular fillers
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2023-03-14
- 实施
- 2024-05-01
本文件规定了动物源性生物材料中DNA残留量的测定方法。本文件适用于动物源性生物材料及其衍生物的终产品或中间产品、用于组织工程医疗产品基质或支架的动物源性支架材料，也可用于人源脱细胞基质材料。
Determination of DNA residues in animal-derived biological materials of tissue engineering medical products: Fluorescent staining method
- ICS
- 11.040.30
- CCS
- C40
- 发布
- 2023-01-13
- 实施
- 2024-01-15
本文件规定了评价组织工程医疗产品基质或支架所致哺乳动物细胞免疫反应的试验方法：淋巴细胞增殖试验。本文件适用于组织工程医疗产品基质或支架的生物学评价。
Test methods for evaluating the immune response of matrices and scaffolds in tissue-engineered medical products: Lymphocyte proliferation test
- ICS
- 11.040.30
- CCS
- C40
- 发布
- 2023-01-13
- 实施
- 2024-01-15
本文件规定了接触镜护理产品的安全和性能要求。
Ophthalmic optical contact lens care products Part 2: Basic requirements
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2022-10-17
- 实施
- 2025-11-01
本文件规定了用于观察眼底间接像的手持式、眼镜式、头戴式间接检眼镜的最低要求和试验方法。本文件适用于手持式、眼镜式、头戴式间接检眼镜。本文件不适用于间接检眼镜用的聚光镜和附件。本文件不适用于台面固定式的仪器，也不适用于主要用于图像捕捉和/或图像处理的检眼镜，如采用扫描激光技术的检眼镜。
Ophthalmic Instrument Indirect Ophthalmoscope
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2022-10-17
- 实施
- 2023-10-01
本文件规定了用于外科手术植入人眼前节所有类型人工晶状体的基本要求。本文件不适用于角膜植入物和移植物。
Ophthalmic Optical Intraocular Lenses Part 8: Basic Requirements
- ICS
- 11.040
- CCS
- C40
- 发布
- 2022-10-17
- 实施
- 2025-11-01
本文件规定了接触镜护理产品中保湿润滑剂（羟丙基甲基纤维素和聚乙烯吡咯烷酮）含量的测定方法。本文件适用于含保湿润滑剂（羟丙基甲基纤维素和/或聚乙烯吡咯烷酮）的接触镜护理产品。
Ophthalmic optical contact lens care products Part 10: Method for determination of moisturizing lubricants
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2022-10-17
- 实施
- 2023-10-01
Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 3: General Requirements for Data Labeling
- ICS
- CCS
- C40
- 发布
- 2022-08-17
- 实施
- 2023-09-01
Cardiovascular Implants Vascular Prostheses Tubular Vascular Grafts and Vascular Patches
- ICS
- 11.040.40
- CCS
- C40
- 发布
- 2021-12-06
- 实施
- 2022-12-01
Ophthalmic optical contact lens care products Part 9: Determination of chelating agents
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2021-09-06
- 实施
- 2022-09-01
General requirements for medical laser fibers
- ICS
- 11.404
- CCS
- C40
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Ophthalmic Optics Intraocular Lenses Part 1: Terminology
- ICS
- 11.040
- CCS
- C40
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Fibrin/fibrinogen degradation product determination kit (latex immunoturbidimetric method)
- ICS
- 11.040
- CCS
- C40
- 发布
- 2021-09-06
- 实施
- 2023-09-01
Ophthalmic Optical Intraocular Lenses Part 6: Expiration Date and Shipping Stability
- ICS
- 11.040
- CCS
- C40
- 发布
- 2021-09-06
- 实施
- 2022-09-01
Deafness gene mutation detection kit
- ICS
- 11.040.40
- CCS
- C40
- 发布
- 2021-09-06
- 实施
- 2023-03-01
This document specifies particular requirements for the biological evaluation of intraocular lenses, which apply in addition to the general requirements set forth in the horizontal standards for medical devices. The project further gives guidance on ocular implantation tests.
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020); German version EN ISO 11979-5:2020
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2021-05-01
- 实施
This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. It is also applicable to low vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. The standard does
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020); German version EN ISO 15004-1:2020
- ICS
- 11.040.70
- CCS
- C40
- 发布
- 2021-05-00
- 实施
- 2021-05-01
