11.120.20 医用材料 标准查询与下载

KS P 8002-2006 绷带

이 규격은 의료용으로 사용하는 붕대에 대하여 규정한다.

Bandage

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/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

GOST R 52556-2006 血液透析用水.规范

Water for hemodialysis. Specifications

ASTM F1536-95(2005) 确定合成水活性聚氨酯玻璃纤维矫形胶带强度和凝固时间的标准试验方法

Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape

ASTM F2458-05(2010) 组织胶粘剂和封闭剂的伤口闭合强度的标准试验方法

Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures either as adjuncts to sutures and staples, or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient specific circumstances, all uses involve to some extent the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given adhesive composition can provide a useful means of determining product consistency for quality control or as a means for determining the effects of various surface treatments on the substrate prior to use of the device. The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure, which itself may vary depending on physical site and clinical intention) is such that the results of a single tensile strength test is not suitable for determining allowable design stresses without thorough analysis and understanding of the application, adhesive behaviors, and clinical indications. This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue, mode of failure, and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions. A correlation of the test method results with actual adhesive performance in live human tissue has not been established.1.1 This test method covers a means for comparison of wound closure strength of tissue adhesives used to help secure the apposition of soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of medical devices used as tissue adhesives. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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 Wound Closure Strength of Tissue Adhesives and Sealants

YY 0308-2004 医用透明质酸钠凝胶

Medical sodium hyaluronate gel

LST EN 13726-4-2004 无源医疗器械 初级伤口敷料的试验方法 第4部分：顺应性

Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability

LST EN 13726-6-2004 无源医疗器械 初级伤口敷料的试验方法 第6部分：气味控制

Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control

LST EN 13726-3-2004 无源医疗器械 初级伤口敷料的试验方法 第3部分：防水性

Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness

LST EN 14079-2004 无源医疗器械脱脂棉纱布和脱脂棉粘胶纱布的性能要求和试验方法

Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

YY/T 0471.6-2004 接触性创面敷料试验方法.第6部分:气味控制

YY/T 0471的本部分描述了评价接触性创面敷料阻抗气味透过的试验方法。

Test methods for primary wound dressings-Part 6:Odour control

YY/T 0471.2-2004 接触性创面敷料试验方法.第2部分:透气膜敷料水蒸气透过率

YY/T 0471本部分描述了评价渗透膜接触性创面敷料水蒸气透过率的推荐性试验方法。

Test methods for primary wound dressings-Part 2:Moisture vapour transmission rate of permeable film dressings

YY/T 0471.1-2004 接触性创面敷料试验方法.第1部分:液体吸收性

YY/T 0471本部分描述了评价接触性创面敷料液体吸收性方面的推荐性试验方法。

Test methods for primary wound dressing-Part 1:Aspects of absorbency

YY/T 0472.2-2004 医用非织造敷布试验方法.第2部分:成品敷布

YY/T 0472的本部分规定了评价成品非织造敷布的物理和化学试验方法。

Test methods for nonwoven compresses for medical use-Part 2:Finished compresses

YY/T 0471.4-2004 接触性创面敷料试验方法.第4部分:舒适性

本YY/T 0471的本部分描述了评价接触性创面敷料舒适性试验方法。

Test methods for primary wound dressing-Part 4:Conformability

YY/T 0471.5-2004 接触性创面敷料试验方法.第5部分:阻菌性

本YY/T 0471的本部分描述了评价接触性创面敷料阻菌性试验方法。

Test methods for primary wound dressing-Part 5:Bacterial barrier properties

YY/T 0471.3-2004 接触性创面敷料试验方法.第3部分:阻水性

本YY/T 0471的本部分描述了评价接触性创面敷料阻水性试验方法。

Test methods for primary wound dressings-Part 3:Waterproofness

NF S97-122-6*NF EN 13726-6:2003 非活性医疗器材.主要伤口敷料试验方法.第6部分:气味控制

Non-active medical devices - Test methods for primary wound dressings - Part 6 : odour control.

SANS 505:2003 带状，无粘着性，可伸展的纺织绷带弹性的规范

Specifies requirements for flat, non-adhesive, extensible bandages manufactured from woven or knitted fabrics and classifies them according to their function and performance.

Specification for the elastic properties of flat, non-adhesive, extensible fabric bandages