C48 医用卫生用品 标准查询与下载

NF S97-167*NF EN ISO 22610:2006 病人、医护人员和器械用手术布帘、手术衣和洁净服.测定防潮湿细菌渗透的试验方法

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration.

KS P 3505-2006 洗眼盘

이 규격은 세안 수수기(이하 수수기라 한다.)에 대하여 규정한다.

Eye dressing trays

KS P 4906-2006 医疗设备生产者用不锈钢针管

이 규격은 치수 3.4 mm와 0.3 mm, 초박벽 치수 2.1∼0.6 mm 튜브의 표면과

Stainless steel needle tubing for manufacture of medical devices

KS P 4905-2006 气管内导管

이 규격은 콜형 튜브의 영아 적용에 따른 일반 요구 사항을 규정한 것이다.

Tracheal tubes－Cole type

ISO 11193-2:2006 一次性医用检查手套.第2部分:聚乙烯(氯乙烯)制成的手套规范

This part of ISO 11193 specifies requirements for packaged sterile, or bulked non-sterile, poly(vinyl chloride) gloves intended for use in medical examinations, and diagnostic or therapeutic procedures, to protect the patient and the user from cross-contamination. It also covers poly(vinyl chloride) gloves intended for use in handling contaminated medical materials. This part of ISO 11193 is intended as a reference for the performance and safety of poly(vinyl chloride) examination gloves. The safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of this part of ISO 11193.

Single-use medical examination gloves - Part 2: Specification for gloves made from poly(vinyl chloride)

SANS 1427:2006 弹性绷带

Covers two types of woven and four types of knitted conforming bandage for use as surgical dressings. Specifies type, width, structure and performance.

Conforming bandages

SANS 443:2006 白疏布绷带

Covers five types of white open-wove bandages suitable for surgical dressings.

White open-wove bandages

SANS 945-1:2006 支撑绷带和压力绷带．第1部分：机织绷带

Specifies requirements for two types of woven cr坧e bandages and one type of elasticated woven cr坧e bandage.

Support and compression bandages Part 1: Woven crêpe bandages

YY 0331-2006 脱脂棉纱布、脱脂棉粘胶混纺纱布的性能要求和试验方法

本标准规定了脱脂棉纱布、脱脂棉粘胶混纺纱布的要求和试验方法。本标准中不涉及含药物的纱布。

Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

YY/T 0331-2006 脱脂棉纱布、脱脂棉粘胶混纺纱布的性能要求和试验方法

Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

YY/T 0148-2006 医用胶带 通用要求

本标准规定了各类与体表或创面接触的医用胶带（又称粘贴绷带），包括粘贴敷料的通用要求。 本标准不包括： a) 医用胶带（包括粘贴敷料）的粘贴面保护层的要求； b) 粘贴敷料贴中敷料垫的要求； c) 医用胶带的包装要求。

Medical adhesive bandages-General requirements

YY 0594-2006 外科纱布敷料通用要求

本标准规定了以脱脂棉纱布或脱脂棉与粘胶混纺纱布制成的外科纱布敷料的通用要求及包装、标记的要求。本标准所规定的外科纱布敷料可以无菌供应也可以非无菌供应。其品种主要包括腹巾、纱布拭子（卷或球）、纱布块等。 本标准不涉及含有抗生素药物外科纱布中的抗生素种类及其含量的要求。

General requirements for surgical gauze dressings

SANS 5252:2006 外科绷带中氧化物质含量的测定

Specifies a method for the determination of the presence of oxidizing substances in surgical dressings.

Determination of the presence of oxidizing substances in surgical dressings

ASTM D5151-06 医用手套漏孔检测的标准试验方法

This test method is designed to detect holes that leak water and thereby compromise the usefulness of the glove. This test method is suitable and designed as a reference method to evaluate samples of medical gloves.1.1 This test method covers the detection of holes in medical gloves.1.2 This test method is limited to the detection of holes that allow water leakage under the conditions of the test.1.3 The smallest hole size that will allow water leakage in a medical glove has not been determined and is beyond the scope of this test method.1.4 The safe and proper use of medical gloves is beyond the scope of this test method.1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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 Test Method for Detection of Holes in Medical Gloves

ASTM D5250-06 医用聚氯乙烯手套的标准规范

1.1 This specification covers certain requirements for poly(vinyl chloride) gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers poly(vinyl chloride) gloves used in handling contaminated medical material.1.2 This specification provides for poly(vinyl chloride) gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or nonsterile or bulk nonsterile poly(vinyl chloride) gloves.1.3 This specification does not cover two-dimensional heat sealed poly(vinyl chloride) gloves.1.4 This specification is similar to that of Specification D 3578 for rubber examination gloves.

Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

ASTM D5250-06e1 医用聚氯乙烯手套的标准规范

The specification is intended as a referee procedure for evaluating the performance and safety of poly(vinyl chloride) examination gloves. The safe and proper use of poly(vinyl chloride) examination gloves is beyond the scope of this standard. 1.1 This specification covers certain requirements for poly(vinyl chloride) gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers poly(vinyl chloride) gloves used in handling contaminated medical material. 1.2 This specification provides for poly(vinyl chloride) gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or nonsterile or bulk nonsterile poly(vinyl chloride) gloves. 1.3 This specification does not cover two-dimensional heat sealed poly(vinyl chloride) gloves. 1.4 This specification is similar to that of Specification D 3578 for rubber examination gloves.

Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

ASTM D5250-06(2011) 医用聚乙烯手套的标准规格

The specification is intended as a referee procedure for evaluating the performance and safety of poly(vinyl chloride) examination gloves. The safe and proper use of poly(vinyl chloride) examination gloves is beyond the scope of this standard. 1.1 This specification covers certain requirements for poly(vinyl chloride) gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers poly(vinyl chloride) gloves used in handling contaminated medical material. 1.2 This specification provides for poly(vinyl chloride) gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or nonsterile or bulk nonsterile poly(vinyl chloride) gloves. 1.3 This specification does not cover two-dimensional heat sealed poly(vinyl chloride) gloves. 1.4 This specification is similar to that of Specification D3578 for rubber examination gloves.

Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

ASTM D5151-06(2011) 医用手套漏孔检测的标准试验方法

This test method is designed to detect holes that leak water and thereby compromise the usefulness of the glove. This test method is suitable and designed as a reference method to evaluate samples of medical gloves.1.1 This test method covers the detection of holes in medical gloves. 1.2 This test method is limited to the detection of holes that allow water leakage under the conditions of the test. 1.3 The smallest hole size that will allow water leakage in a medical glove has not been determined and is beyond the scope of this test method. 1.4 The safe and proper use of medical gloves is beyond the scope of this test method. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 Test Method for Detection of Holes in Medical Gloves

SANS 5257:2005 织物外科绷带中灰分含量

Specifies a method for the determination of the ash content of textile surgical dressings.

Ash content of textile surgical dressings

ASTM D7161-05(2010) 在常规仓库条件下到期医用手套实时有效期测定的标准实施规程

This practice provides a study design for determining shelf life of medical gloves using product in its final packaging configuration that has been stored under typical warehouse conditions.1.1 This practice covers all surgeon''s and examination gloves, made from either synthetic or natural rubber latex, marketed at the time this practice is published, for which there is no previous real time aging data available, and for which there are at least 12 months of storage as finished goods under typical warehouse conditions. This practice describes how to develop real time aging data for gloves that are part of finished goods inventory (including gloves that may no longer be manufactured) in order to verify the estimated expiration date (see Note 1). Manufacturers may use this data as a starting point for real time aging studies as described in Practice D7160. Note 18212;Accelerated aging for three-year shelf life is described in Practice D7160. 1.2 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 Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions