C31 一般与显微外科器械 标准查询与下载
共找到 1323 条与 一般与显微外科器械 相关的标准，共 89 页
本文件规定了一次性使用无菌闭合夹（以下简称闭合夹）的结构和材料、要求、标签、说明书，描述了相应的试验方法。本文件适用于外科手术中夹闭血管或闭合管状组织（包括中小动静脉、胆管等，不适用于大动脉和大静脉）的闭合夹。本文件不适用于金属夹、可吸收性闭合夹、连发闭合夹和术中临时夹闭组织或血管、术后取出的闭合夹。
Disposable sterile closure clips
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2023-09-05
- 实施
- 2024-09-15
本文件规定了血液、静脉药液、灌洗液流体加温器的安全通用要求。本文件适用于血液、静脉药液、灌洗液流体加温器。本文件不适用于：非管路用流体加温器，如加温柜、新鲜冷冻血浆/新鲜红细胞解冻装置、电煲加热器；体外/心脏搭桥加温循环系统；集成到透析装置上的加温器。
General safety requirements for blood, intravenous solution, and lavage fluid warmers
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2023-03-14
- 实施
- 2025-05-01
本文件规定了预期在使用前保持最终灭菌医疗器械无菌的预成形屏障系统和包装系统的材料的要求和试验方法。本文件适用于预期为一次性使用的平纸包裹材料、皱纹纸包裹材料、非织造布包裹材料和预期为重复性使用的纺织包裹材料的性能测定。
Packaging materials for terminally sterilized medical devices Part 2: Requirements and test methods for sterilization packaging materials
- ICS
- 11.080.040
- CCS
- C31
- 发布
- 2022-10-17
- 实施
- 2023-10-01
General requirements for silicone rubber surgical implants
- ICS
- CCS
- C31
- 发布
- 2022-08-17
- 实施
- 2023-09-01
Dispensing syringe for single use
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2022-07-01
- 实施
- 2023-07-01
Disposable intravenous catheter
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2022-05-18
- 实施
- 2023-06-01
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
- ICS
- 11.040.40
- CCS
- C31
- 发布
- 2021-09-00
- 实施
This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series. This document is not applicable to the following: a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips; c) dental suction equipment; e) laboratory suction; b) syringes; d) anaesthetic gas scavenging systems; f) autotransfusion systems; g) mucus extractors including neonatal mucus extractors; h) suction equipment where the collection container is downstream of the vacuum pump; i) j) ventouse (obstetric) equipment; suction equipment marked for endoscopic use only; and k) plume evacuation systems.
Medical suction equipment - Part 4: General requirements
- ICS
- 11.040.10
- CCS
- C31
- 发布
- 2021-08-00
- 实施
This document specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This document also applies to instruments
Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021); German version EN ISO 16061:2021
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2021-06-00
- 实施
This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only. This document also specifies those components that are part of t
Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-6:2019)
- ICS
- CCS
- C31
- 发布
- 2021-05-00
- 实施
Test methods for sterile medical device packaging Part 4: Determination of seal leakage of breathable packaging by dye solution penetration method
- ICS
- 11.080.040
- CCS
- C31
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Requirements and test methods for medical needle injection systems Part 1: Needle injection systems
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Method for determination of dosage added in disposable human venous blood sample collection containers Part 5: Glycine
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Special Infusion Sets Part 5: Disposable Bottle and Bag Infusion Sets
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Disposable anesthesia needle
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Method for determination of dosage added in disposable human venous blood sample collection containers Part 6: Imidazolidinyl urea
- ICS
- 11.040.30
- CCS
- C31
- 发布
- 2021-03-09
- 实施
- 2022-04-01
Requirements and test methods for medical needle injection systems Part 2: Needles
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2021-03-09
- 实施
- 2022-04-01
