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YY/T 1467-2016Medical dressings—First aid bandage (English PDF)

医用包扎敷料救护绷带

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 1467-2016 is the English-translated version of 医用包扎敷料救护绷带.

YY/T 1467-2016 is the Chinese pharmaceutical industry standard for first aid bandages, the dressings carried in emergency kits and applied to the wounded at the scene.

It sets the requirements and the test methods for sterile bandaged dressings and sterile dressing pads, and for non-sterile gauze bandages, elastic bandages and triangular bandages, covering the materials, the dimensions and their tolerances, the absorbency and the strength of the fabric, the fixing of the pad to the bandage, sterility where the product is supplied sterile, and the marking. Issued on 26 January 2016, it has applied since 1 January 2017.

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Document preview — YY/T 1467-2016

National Standard of the People's Republic of China

ICS
11.120.20
Classification
C 48

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • Introduction
  • 1 Scope
  • 2 Normative reference documents
  • 3 General

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This standard by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.

The main drafting unit of this standard. Shandong Province, medical equipment product quality inspection center, Shaoxing Zhende medical dressing Limited.

Introduction

Ambulance bandages are ambulance dressings, which are formulated into all kinds of first aid luggage for injury site by ambulance personnel to carry out emergency ambulance to the wounded.

The purpose of the uniform provision for ambulance dressings is to facilitate the training of various ambulance personnel so that they can be used in all situations where the injury occurs With the fastest speed of the wounded to implement effective ambulance, which can minimize the casualties. Medical dressings dressings rescue bandages

1 Scope

This standard specifies the requirements and test methods for bandages used in ambulance use. Ambulance bandages include sterile bandaged bandages and square bandage Towels, as well as non-sterile gauze bandages, elastic bandages and triangular towels. Products for loading in a variety of first aid bags for the scene by the ambulance personnel Emergency care for the wounded.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 4668 Determination of woven fabric density Textiles - Determination of unit length and mass per unit area of woven fabrics

GB/T 6005 Test Screen Basic dimensions of wire mesh, perforated plate and electroformed sheet sieve

GB/T 6529 Standard atmosphere for textiles for humidity control and testing

GB/T 6682 Analytical laboratory water specifications and test methods

GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management

GB/T 19633.1-2015 Final sterilization of medical device packaging - Part 1. Requirements for materials, sterile barrier systems and packaging systems

GB/T 24218.3 Textile nonwovens - Test methods - Part 3. Determination of breaking strength and elongation at break (strip method)

YY 0331-2006 Performance requirements and test methods for absorbent gauze, absorbent cotton viscose blended gauze

YY/T 0471.1-2004 Test method for contact wound dressings - Part 1. Liquid absorption

YY/T 0472.1-2004 Test methods for medical nonwovens - Part 1. Nonwovens for fabric production Performance characteristics of medical elastic bandages - Characterization and test methods YY/T 0507-2009

YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for final sterilization of medical devices

YY 0854.1-2011 Cotton nonwovens surgical dressings - Performance requirements - Part 1. Nonwovens for dressing production Medical absorbent viscose fiber YY/T 0921-2015

3 General

3.1 Experimental environment

All tests shall be carried out in the standard environment specified in GB/T 6529.

3.2 Fluorescence

In the 365nm UV light inspection, the product should only show slightly brown purple fluorescence and a small amount of yellow particles, in addition to a small amount of isolated fibers, Should not be strong blue fluorescence. For nonwovens products, it shall comply with the requirements of 8.3 in YY 0854.1-2011.

3.3 Sterile

Bandaged bandages and square towels should be supplied aseptically and should meet the requirements of YY/T 0615.1.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

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