C38 普通诊察器械 标准查询与下载
共找到 209 条与 普通诊察器械 相关的标准，共 14 页
이 규격은 마취 및 의료 내시경 업무시 사용되는 경성 기관지경 및 내시경 부속품의 정의 및
Optics and optical instruments-Medical endoscopes and endoscopic accessories-Part 2:Particular requirements for rigid bronchoscopes
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2006-06-09
- 实施
- 2006-06-09
この規格は，次の内容をもつガラス製体温計(以下，体温計という。)について規定する。
Clinical Thermometers, mercury-in-glass, with maximum device
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2005-03-25
- 实施
この規格は，膨張可能なカフを用いて非侵襲的に動脈血圧を測定する非観血式電子血圧計又は非観血式自動血圧計(以下，血圧計という。)，及び附属品の一般原則，性能，有効性並びに機械的・電気的な安全性の要求事項について規定する。また，この規格は，型式承認のための試験方法も規定する。
Non-invasive Automated Sphygmomanometers
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2005-03-25
- 实施
This part of ISO 8600 defines terms for endoscopes and endotherapy devices commonly used in the endoscopic area.
Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
- ICS
- 01.040.37;11.040.55;37.020
- CCS
- C38
- 发布
- 2005-03
- 实施
This part of ISO 8600 specifies a test method for determining the optical resolution of endoscopes for type testing. It is applicable to rigid endoscopes with optics designed for use in the practice of medicine for type testing. It is not applicable to endoscopes having a fibre-optic or opto-electronic imaging system.
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
- ICS
- 11.040.55;37.020
- CCS
- C38
- 发布
- 2005-03
- 实施
이 규격은 호흡용 보호구에 관해서 사용되는 주된 용어와 그 정의에 대하여 규정한다.또한
Glossary of terms relating to respiratory protective equipments
- ICS
- 11.040.10
- CCS
- C38
- 发布
- 2004-12-22
- 实施
- 2004-12-22
This standard specifies requirements and recommended test methods for measuring the field of view and direction of view of endoscopes.
Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics (ISO 8600-3:1997 + AMD 1:2003)
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2004-12
- 实施
This European Standard describes test procedures for investigations to determine the overall system accuracy of automated non-invasive sphygmomanometers, designed for the indirect measurement of blood pressure.#,,#
Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers; German version EN 1060-4:2004
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2004-12
- 实施
This document describes test procedures for investigations to determine the overall system accuracy of automated non-invasive sphygmomanometers, designed for the indirect measurement of blood pressure.
Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2004-10-06
- 实施
- 2004-10-06
This International Standard describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. This International Standard applies to all in vitro diagnostic medical devices.
Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2004-07-26
- 实施
- 2004-07-26
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
- ICS
- 11.040.55;11.100.10
- CCS
- C38
- 发布
- 2004-06-01
- 实施
- 2004-06-05
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Amendment 1 to ISO 8600-3:1997 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 5, Microscopes and endoscopes.
Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics; Amendment 1
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2003-12-01
- 实施
Clinical thermometers - Part 5 : performance of infra-red ear thermometers (with maximum device).
- ICS
- 17.200.20
- CCS
- C38
- 发布
- 2003-10-01
- 实施
- 2003-10-20
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-testing by laypersons for management of diabetes mellitus. This International Standard is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems. This International Standard does not ? provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, ? pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus, ? address the medical aspects of diabetes mellitus management, or ? apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2003-05-27
- 实施
- 2003-05-27
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-testing by laypersons for management of diabetes mellitus. This International Standard is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems. This International Standard does not — provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, — pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus, — address the medical aspects of diabetes mellitus management, or — apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100.30
- CCS
- C38
- 发布
- 2003-05
- 实施
この規格は，人眼の屈折補正量の測定及び両眼視機能検査を，被検者の応答によって行うレフラクターへッドについて規定する。
Refractor heads
- ICS
- 11.040.70
- CCS
- C38
- 发布
- 2002-08-01
- 实施
This part of ISO 8600 specifies definitions and requirements for rigid bronchoscopes and their endoscopic accessories used in the practice of anaesthesia and medical endoscopy.
Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 2: Particular requirements for rigid bronchoscopes
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2002-08
- 实施
This European Standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents for use in self-testing including reagent products, calibrators, control materials and kits, which hereafter are called IVD reagents. NOTE This standard can also be applied to accessories.
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2002-05-07
- 实施
- 2002-05-07
