C47 公共医疗设备 标准查询与下载
共找到 1175 条与 公共医疗设备 相关的标准，共 79 页
This standard specifies requirements and test methods for sterile, single-use urethral catheters, with and without a balloon. This standard does not include drainage catheters covered by ISO 20697 "Sterile Drainage catheters for single use" e. g. ureteral catheters, nephrostomy catheters, suprapubic catheters. This standard also excludes ureteral stents.
Sterile urethral catheters for single use (ISO 20696:2018); German version EN ISO 20696:2018
- ICS
- 11.040.25
- CCS
- C47
- 发布
- 2018-10-00
- 实施
Characteristics and control requirements of medical device irradiation sterilization process
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2018-09-28
- 实施
- 2019-10-01
Test method for medical sterilization steam quality
- ICS
- 11.080.10
- CCS
- C47
- 发布
- 2018-09-28
- 实施
- 2019-10-01
Test method for effectiveness of sterilization processes for reusable medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2018-09-21
- 实施
- 2019-09-26
On-site rapid detection of surface cleaning effect in medical institutions - ATP bioluminescence method
- ICS
- 11.080.99
- CCS
- C47
- 发布
- 2018-09-04
- 实施
- 2018-11-24
Sterile drainage catheters and accessory devices for single use
- ICS
- 11.040.25
- CCS
- C47
- 发布
- 2018-07-13
- 实施
- 2018-07-13
Sterile urethral catheters for single use
- ICS
- 11.040.25
- CCS
- C47
- 发布
- 2018-07-11
- 实施
- 2018-07-11
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation; Amendment 2
- ICS
- 11.040.10
- CCS
- C47
- 发布
- 2018-07-00
- 实施
Sampling methods for radiation sterilization verification dose experiments and sterilization dose audits of medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2018-06-26
- 实施
- 2019-07-01
Method for setting radiation sterilization dose of medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2018-06-26
- 实施
- 2019-07-01
Basic requirements for the configuration of rehabilitation aids in nursing homes
- ICS
- 11.180
- CCS
- C47
- 发布
- 2018-06-14
- 实施
- 2018-10-01
This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon. This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents. NOTE Ureteral stents are covered in ASTM F1828-97.
Sterile urethral catheters for single use
- ICS
- 11.040.25
- CCS
- C47
- 发布
- 2018-06-00
- 实施
This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior. The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation. This document is not applicable to: a) suction catheters; c) urethral catheters; b) tracheal catheters; NOTE NOTE d) ureteral stents, biliary stents, and other stents; e) f) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique; neuraxial catheters used for removal of cerebrospinal fluid; NOTE NOTE g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract; h) coatings.
Sterile drainage catheters and accessory devices for single use
- ICS
- 11.040.25
- CCS
- C47
- 发布
- 2018-06-00
- 实施
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. The provisions of this document are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: - non-critical medical devices not intended for direct patient contact; - textile devices used in patient draping systems or surgical clothing;- medical devices specified by the manufacturer for single-use only and supplied ready for use.
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017); German version EN ISO 17664:2017
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2018-04-01
- 实施
本标准规定了气管支气管导管的规格设计和标签的要求，包括支气管套囊及其指示球囊的颜色标识的要求。本标准不适用于带支气管阻塞器的气管支气管导管。
Tracheobronchial tubes-Recommendations for size designation and labelling
- ICS
- 11.040.10
- CCS
- C47
- 发布
- 2018-04-01
- 实施
- 2018-04-01
Product families and process categories for moist heat sterilization of medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2018-01-19
- 实施
- 2019-01-01
Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators
- ICS
- 11.040.10
- CCS
- C47
- 发布
- 2018-01-00
- 实施
