C48 医用卫生用品 标准查询与下载

YY/T 0720-2009 一次性使用产包.自然分娩用

本标准规定了用于产科的一次性使用产包（以下简称产包）的性能要求和包装要求。 本标准不适用于剖腹产专用的手术产包。 本标准未推荐产包中各组成的规格和尺寸（见引言）。

Single-use maternity kits,for spontaneous labor

YY/T 0729.2-2009 组织粘合剂粘接性能试验方法.第2部分:T-剥离拉伸承载强度

YY/T 0729的本部分规定的试验方法预期为用于组织粘合的组织粘合剂或密封剂在软组织上的粘合强度提供可比手段。方法中选择适用的基材，本部分可用于组织粘合剂的制造中的质量控制。

Test methods for bonding properties of tissue adhestives.Part 2:Strength in T-peel by tension loading

YY/T 0729.3-2009 组织粘合剂粘接性能试验方法.第3部分:拉伸强度

YY/T 0729的本部分规定的试验方法预期为用于组织粘合的组织粘合剂或密封剂在软组织上的粘合强度提供可比手段。方法中选择适用的基材，本部分可用于组织粘合剂的制造中的质量控制。

Test methods for bonding properties of tissue adhesive.Part 3:Tension strength

YY/T 0729.1-2009 组织粘合剂粘接性能试验方法 第1部分:搭接-剪切拉伸承载强度

YY/T 0729的本部分规定的试验方法预期为用于组织粘合的组织粘合剂或密封剂在软组织上的粘合强度提供可比手段。方法中选择适用的基材，本部分可用于组织粘合剂制造中的质量控制。

Test methods for boning properties of tissue adhesives.Part 1:Strength in lap-shear by tension loading

YY/T 0729.4-2009 组织粘合剂粘接性能试验方法.第4部分:伤口闭合强度

YY/T 0729的本部分包括一个比较用于保护附着软组织的组织粘合剂伤口闭合强度的方法。通过选择适用的基材，本部分可用于组织粘合剂的医疗器械制造中的质量控制。

Test methods for bonding properties of tissue adhesives.Part 4:Wound closure strength

CKS 312-2009 脐带式束紧件

Covers plastics umbilical cord clamps and three types of cotton tape suitable for use as umbilical cord ties.

Umbilical cord fasteners

CKS 462-2009 骨科绒布绷带

Covers two types of orthopaedic flannelette bandages suitable for use as surgical dressings.

Orthopaedic flannelette bandages

NF S98-105-2*NF CEN ISO/TS 17665-2:2009 卫生护理用品的消毒.湿热法.第2部分:ISO 17665-1应用指南

Sterilization of health care products - Moist heat - Part 2 : guidance on the application of ISO 17665-1.

DIN 58313:2009 医疗器械.直型药棉棒

Medical instruments - Cotton carrier, straight

ASTM F624-09 评定医学用热塑性聚氨基甲酸乙酯固体及溶液的标准指南

This guide is intended to aid device fabricators in the selection of proper commercially available polyurethane solids and solutions for their application. The polyurethanes covered by this guide may be thermoformed or solution cast into biomedical devices for use as surgical aids or for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data.1.1 This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical applications. The polymers have been reacted to completion and require no further chemical processing. 1.2 The tests and methods listed in this guide may be referenced in specification containing minimum required values and tolerances for specific end-use products. 1.3 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be construed as an endorsement of implantability. Since many compositions, formulations, and forms of thermoplastic polyurethanes in solid and solution forms are within this material class, the formulator or fabricator must evaluate the biocompatibility of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization. 1.4 Purchase specifications may be prepared by agreement between the buyer and seller by selection of appropriate tests and methods from those listed applicable to the specific biomedical end use. 1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

ANSI/ASTM/ISO 14408:2009 激光外科手术用气管导管.作标记和附加信息的要求

Tracheal Tubes Designed for Laser Surgery - Requirements for Marking and Accompanying Information

ASTM F639-09 医疗设备用聚乙烯塑料的标准规范

Significance Top X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated.1.1 This specification covers polyethylene plastics (as defined in Terminology D 883) intended for use in medical device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product. 1.2 This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth. 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 and health practices and determine the applicability of regulatory limitations prior to use. X1.1.1 This practice covers the analysis of extractable metals from plastics intended for use in medical device application. X1.1.2 Formulated raw materials or finished products may be used.

Standard Specification for Polyethylene Plastics for Medical Applications

ASTM F665-09 生物医学用氯乙烯塑料的标准分类

This classification was developed to permit the addition of descriptive symbols and values for further new formulations with improved properties without complete reorganization of the standard and to facilitate the incorporation of future new test methods to keep pace with changing industry requirements.1.1 This classification provides guidance to engineers and users in the selection of practical vinyl chloride plastics for medical applications and further provides a method for specifying these materials by use of a simple line call-out designation. This classification excludes vinyl chloride plastics used in long-term implants. 1.2 Use is made of a classification scheme based on the premise that the composition of vinyl chloride plastics, copolymers, fillers, plasticizers, stabilizers, and other additives in these systems can be arranged into characteristic material designations. 1.3 In all cases where the provisions of this classification system would conflict with those of the detailed specification for a particular device, the latter shall take precedence. Note 18212;For cases in which the vinyl chloride plastic may be used for purposes where the requirements are too specific to be completely described by this classification system, it is advisable for the purchaser to consult the supplier to secure adjustment of the properties to suit the actual conditions to which the device is to be subjected. 1.4 The biocompatibility of vinyl chloride plastics as a class of materials has not been established. Since many compositions and formulations fall under this class, it is essential that the fabricators/device manufacturers assure the safety and efficacy of the specific composition or formulation, in its intended application, using state-of-the-art test methods. 1.5 This classification is to assist the interface between the material supplier and the device manufacturer (fabricator) who purchases a formulated vinyl chloride plastic for a component. For those device manufacturers (fabricators) who do their own formulating, compounding, extrusion, molding, and so forth, this classification does not apply. 1.6 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application

SANS 1866:2008 手术用面罩

Covers the materials and make of five types of face masks.

Surgical face masks

DIN 13151:2008 外科敷料剂.敷料剂包装

Surgical dressings - Dressing packs

YY/T 1119-2008 医用高分子制品术语

本标准规定了用医用高分子材料制成、且直接或间接与人体接触的医用高分子制品术语。本标准不包括人工器官术语。

Terminology relating to medical polymer products

KS P 2607-2008 医用电梯

이 표준은 의료용 엘리베이터(이하 엘리베이터라 한다.)에 대하여 규정한다.

Medical elevators

KS P 8005-2008 纱布

이 표준은 거즈에 대하여 규정한다.

Gauze

KS P 1234-2008 供氧帐篷

이 표준은 의료용 전동 온도 조절식 산소 텐트(이하 산소 텐트라 한다.)에 대하여 규정한다

Oxygen tents

KS P 2603-2008 医用吊钩

이 표준은 의료용 후크(이하 후크라 한다.)에 대하여 규정한다.

Medical hooks