11.040.99 其他医疗设备 标准查询与下载

ISO/TR 20498-5:2019 中医计算机舌象分析系统第5部分:舌色和舌苔色的采集和表达方法

Traditional Chinese medicine — Computerized tongue image analysis system — Part 5: Method of acquisition and expression of tongue colour and tongue coating colour

DB61/T 1207-2018 在用医用电子内窥镜系统检验规范

本标准规定了在用医用电子内窥镜系统的术语和定义、技术要求、检验方法。 本标准适用于在用的医用电子内窥镜系统的检验，包括电子大肠内窥镜、电子上消化道内窥镜等

In-use medical electronic endoscope system inspection specification

YY/T 0070-2018 食管窥镜

Esophageal speculum

YY/T 0071-2018 直肠、乙状结肠窥镜

Rectal and sigmoidoscopy

DB53/T 899-2018 远程可视医疗系统设计施工规范

Specifications for design and construction of remote visual medical system

KS P ISO 19611-2018 抽气拔火罐装置

Air extraction cupping device

KS P ISO 19611:2018 抽气拔火罐装置

Air extraction cupping device

BS ISO 20493:2018 传统中医 红外线灸样仪器

Traditional Chinese medicine. Infrared moxibustion-like instrument

ISO 20493:2018 中医-红外线灸类仪器

This document specifies the requirements for infrared moxibustion-like instrument as a medical device.

Traditional Chinese medicine - Infrared moxibustion-like instrument

YY/T 1587-2018 医用内窥镜 电子内窥镜

Medical endoscope electronic endoscope

ASTM F3320-18 药物包衣气球包衣特性的标准指南

1.1 This guide describes recommended acute in-vitro characterization methods for drug coated balloon (DCB) coatings. These methods include: coating integrity, coating thickness, drug coating uniformity, and released particulates. Specifically, this guide details: 1.1.1 Characterization of integrity by inspection of the coated balloon surface. 1.1.2 Measurement of coating thickness. 1.1.3 Quantitation of drug coating uniformity (uniformity of drug distribution over the balloon surface) longitudinally and circumferentially. 1.1.4 Quantitation of the number of particulates released, in various size ranges, during simulated use testing (insertion, tracking, deployment, retraction, and withdrawal) along with chemical and crystallinity characterization of particulates. 1.2 This document does not address: 1.2.1 Mechanical testing of drug coated balloons (DCBs). 1.2.2 Drug substance evaluation (e.g., assay, related substances, uniformity of dosage units) of DCBs. 1.2.3 Production release and stability testing, although some sections may be applicable in whole or in part. 1.2.4 Standard analytical testing (e.g., drug content, drug related substances, drug uniformity of dosage). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Guide for Coating Characterization of Drug Coated Balloons

BS ISO 20495:2018 中药 皮肤电阻测量装置

1   Scope This document specifies performance and test methods for skin electrical resistance measurement devices. This document is applicable to skin electrical resistance measurement devices through which an electrical signal is applied on acupuncture points of the human body or specific points of the body surface in a non-invasive way so as to detect the resistance of the body. This document is not applicable to software or functions for medical analysis of the test results. Additional guidance and rationale are given in Annex A.

Traditional Chinese medicine. Skin electrical resistance measurement devices

ISO 20495:2018 中药-皮肤电阻测量装置

This document specifies performance and test methods for skin electrical resistance measurement devices. This document is applicable to skin electrical resistance measurement devices through which an electrical signal is applied on acupuncture points of the human body or specific points of the body surface in a non-invasive way so as to detect the resistance of the body. This document is not applicable to software or functions for medical analysis of the test results. Additional guidance and rationale are given in Annex A.

Traditional Chinese medicine - Skin electrical resistance measurement devices

IEC 60601-2-39:2018 医疗电气设备 - 第2-39部分:腹膜透析设备的基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

IEC 60601-2-39:2018 RLV 医用电气设备第2-39部分:腹膜透析设备基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

YY/T 1603-2018 医用内窥镜 内窥镜功能供给装置 摄像系统

Medical endoscope endoscope function supply device camera system

KS C IEC 60601-2-39:2017 医用电气设备 第2-39部分：腹膜透析仪基本安全和基本性能的特殊要求

Medical electrical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

KS C IEC 60601-2-39-2017 医疗电气设备 - 第2-39部分:腹膜透析设备的基本安全和基本性能的特殊要求

Medical electrical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

T/ZSA 5002.01-2017 可穿戴的健康类电气设备 第3部分：通过反射式光电容积脉搏波描记法测量脉率设备的性能和安全要求

本标准规定了预期通过反射式光电容积脉搏波描记法测量脉率的可穿戴的健康类电气设备的性能和安全要求。 本标准适用于通过反射式光电容积脉搏波描记法测量脉率的设备。

Wearable electrical equipment for health - Part 3: Performance and safety requirements for equipment for measuring pulse rate by reflective photoplethysmography

GSO ISO 18777:2017 医用可移动液氧系统 特殊要求

IEC 60601-1:1988, Clause 1, applies except as follows: Amendments (add at end of 1.1): 1.1 This International Standard specifies requirements for the safety and essential performance of transportable liquid oxygen systems which are used as a supply source for oxygen therapy. These devices usually consist of a portable unit to be carried by or with the patient whilst in use and the vessel used to refill the portable unit. These devices are mostly used in home care applications and in health care facilities/institutions. These devices are often used without professional supervision. Liquid oxygen vessels used as a supply source for oxygen pipeline systems are excluded from this International Standard. The requirements of this International Standard which replace or modify the requirements of IEC 60601-1:1998 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements. 1.4 Addition: NOTE Planning and design of products complying with this Internatinal Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.

Transportable liquid oxygen systems for medical use -- Particular requirements