C37 医疗设备通用要求 标准查询与下载



共找到 713 条与 医疗设备通用要求 相关的标准,共 48

本标准适用于吻(缝)合器类产品。

Specifications for suture forceps

ICS
11.040.30
CCS
C37
发布
1988-02-13
实施
1988-10-01

本文件规定了用于表达提供医疗器械信息的符号。本文件适用于在全球范围内可获得的、需要符合不同法规要求的各种医疗器械所使用的符号。这些符号能用在医疗器械本身上、其包装上或随附信息中。本文件的要求预期不用于其他标准中规定的符号。

Symbols for medical devices used for information provided by manufacturers Part 1: General requirements

ICS
01.080.20;11.040.01
CCS
C37
发布
2023-09-05
实施
2025-09-15

Equipment configuration standards for county-level general hospitals

ICS
11.04
CCS
C37
发布
2023-07-26
实施
2024-01-01

本标准确立了各级妇幼保健机构医用设备配备的总体要求和基本原则,并对设备分类、品目和数量进行了规定。妇幼保健机构可结合功能任务、群众需求和机构业务发展需要,增配相应设备。 本标准适用于各级妇幼保健机构。

Medical equipment configuration standard for women and children healthcare institutions

ICS
11.040
CCS
C37
发布
2022-04-13
实施
2022-06-01

This amendment is the consequence of a voting result of IEC/SC 62A using undated references in future to prevent modifications of IEC 60601-1-6, if the basic standard 60601-1 will be revised.

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + A1:2013 + A2:2020); German version EN 60601-1-6:2010 + A1:2015 + A2:2021

ICS
11.040.01
CCS
C37
发布
2021-11-01
实施
2021-11-01

This Part of ISO 22442 applies to medical devices other than in-vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to investigate, usin

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020

ICS
CCS
C37
发布
2021-08-00
实施

The first edition of IEC 62366-1 was published in 2015. Since its publication, experts working in the field have identified several inaccuracies that warrant correction. In total, 22 issues were identified and presented to the National Committee members of IEC/SC 62A and to the M

Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020

ICS
11.040.01
CCS
C37
发布
2021-08-00
实施
2021-08-01

This Part of ISO 22442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin, other than in vitro diagnostic medical de

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020

ICS
CCS
C37
发布
2021-04-00
实施

Acceptance specification for medical laboratory ventilation system

ICS
11.100
CCS
C37
发布
2021-03-23
实施
2021-07-01

MEDICAL ELECTRICAL EQUIPMENT - Part 1: General requirements for basic safety and essential performance (Edition 3.2)

ICS
CCS
C37
发布
2021-03-01
实施

Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling

ICS
CCS
C37
发布
2020-12-14
实施
2020-12-14

Medical devices utilizing animal tissues and their derivatives. Application of risk management

ICS
CCS
C37
发布
2020-12-14
实施
2020-12-14

Domaine d'applicationLe présent document s'applique aux dispositifs médicaux autres que les dispositifs médicaux de diagnostic in vitro, dans la fabrication desquels entrent des matériaux d'origine animale non viables ou rendus non viables. Associé à l'ISO 14971, il spécifie un m

Medical devices utilizing animal tissues and their derivatives - Part 1 : application of risk management

ICS
11.040.01
CCS
C37
发布
2020-12-09
实施
2021-02-06

5.1 This guide provides test methods for evaluating the performance characteristics of a brush part designed to clean internal channel(s) of a medical device. 5.1.1 The force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a parameter of cleaning effectiveness and should be measured. 5.1.2 The removal of soil from a tube by a brush part moved in a tube is a further indicator of the effectiveness of a brush to loosen and remove soil from a tube and should be measured. 5.2 By providing objective, repeatable methods for evaluating performance, this guide can improve the ability to assess the effectiveness, under test conditions, of various brush part designs. 1.1 Brushes used to clean a medical device after clinical use play an important role in effective reprocessing. This guide describes methods for characterizing, under prescribed laboratory conditions, the efficacy of brush parts designed to clean the internal channels of medical devices. The methods utilize a force tester to mechanically actuate a brush part within a channel: (1) Methods to measure, at an established speed, the force required to move a brush within a channel; (2) Methods utilize the same force tester and protocols to measure soil removal from a soiled tube, another indicator of performance. 1.2 Inclusions:  1.2.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part under prescribed laboratory conditions, with test methods that simulate the cleaning challenge of a defined target area(s) of a medical device. This also makes possible the comparison of one design of a brush part to another. 1.2.2 In this guide, a brush part is one that is intended to be moved within a tube. 1.2.3 Tubes used for testing described in this guide are cylindrical and uniform in diameter. The test methods describe may not apply to non-cylindrical tubes. 1.2.4 By use of this guide, medical device manufacturers can characterize the brush part designed for cleaning their device. 1.2.5 By use of this guide, manufacturers of cleaning brushes can evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s), including allowing a comparison with existing brush part designs offered on the market. Further, they are able to evaluate modifications to designs and construction that might improve performance. 1.2.6 This information can also be shared with the users of the brushes (medical device reprocessors) to h......

Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device

ICS
11.040.01
CCS
C37
发布
2019
实施

5.1 This guide provides two test methods for evaluating the performance characteristics of a brush part designed to clean external surface(s) of a medical device by utilizing force testers. 5.1.1 The first test method utilizes a force tester to measure the force required to actuate a brush part across a surface. This is an indicator of the friction a brush exerts on a surface, a parameter of cleaning effectiveness. 5.1.2 The second test method measures the removal of soil from a surface by a brush part actuated across the surface. This is a further indicator of the effectiveness of a brush part to loosen and remove soil from a surface. 5.2 By providing objective, repeatable methods for evaluating performance, under test conditions, this guide can improve the ability to assess the effectiveness of various brush part designs 1.1 This guide describes methods for characterizing the efficacy, under prescribed laboratory conditions, of a brush part designed to clean the external surface of a medical device. The method utilizes force testers to mechanically actuate a brush part across a surface at a constant rate and constant pressure. In the first method, the force required to actuate across the surface is measured. In the next method, which utilizes the same force testers and protocol (actuation motion), the brush part is actuated on a soiled surface and the amount of soil removed is measured, as another indicator of performance. 1.2 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices. 1.3 Inclusions:  1.3.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part, under prescribed laboratory conditions, with a test method that simulates the cleaning challenge of a defined target area(s) of a medical device. This also makes it possible to compare one brush part design to another. 1.3.2 By use of this guide, manufacturers of cleaning brushes will be able to evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s) and evaluate modifications to design and construction that might improve performance. 1.3.3 By use of this guide, this information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes. 1.4 Exclusions:  1.4.1 This guide does not assess potential damage that may be inflicted by the brush, or degradation of the brush that may occur during repeated use. Brushes with rigid bristles (e.g., stainless steel or other metals) are predicted to be more ......

Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device

ICS
11.040.01
CCS
C37
发布
2019
实施

Safety requirements of electrical installations for medically used rooms in hospitals and clinics

ICS
11.140
CCS
C37
发布
2018-01-22
实施

The project defines dimensions and marking of needle holder type Mayo-Hegar without carbide inserts, as used in surgery and public health service.

Medical instruments - Needle holder type Mayo-Hegar - Part 1: Without carbide inserts

ICS
11.040.30
CCS
C37
发布
2017-11-00
实施

本标准适用于大型医疗设备或系统的电磁兼容性现场测试。 注1:测试过程中有可能使被测设备造成损坏或其他装置受到不适当的影响,检测人员应向用户和制造商提示相关风险,经双方同意后再进行测试。 注2:其现场环境条件下得到的评估结果只对各个独立的大型医疗设备或系统在其特定安装场所的实际测量有效。

On-site test method for electromagnetic compatibility of large medical equipment or system

ICS
11.040.01
CCS
C37
发布
2017-08-28
实施
2017-11-28

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

ICS
11.040.01;11.100.20
CCS
C37
发布
2017-06-17
实施
2017-06-17

Biological evaluation of medical devices. Selection of tests for interactions with blood

ICS
11.100.20
CCS
C37
发布
2017-05-25
实施
2017-05-25



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