YY/T 1627-2018General requirements of acute adhesive wound dressing and woundplast (English PDF)

Foreword

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

Introduction

Adhesive dressings for acute wounds are divided into two categories depending on the application. One type is cleaning used in medical institutions, Dressings for acute wounds after disinfection or suture; one type is outside the medical institution (such as in the public, workshops, etc.)

A dressing for temporary dressing of unsterilized or unstitched acute wounds caused by accidental injury. The application of the two dressings is not The corresponding requirements are different. The main role of the application is to keep the sterilized or closed wound sterile and provide a suitable healing ring.

The main role of the creation is to provide temporary closure of hemostasis and isolation from uninsulated or unsewed wounds. This standard puts The former is named as a dressing, and the latter is named as a plaster to show the difference. These two terms apply only within the scope of this standard.

This standard only specifies the general requirements for these two types of dressings, and does not specify their own special requirements. General requirements for application and creation of acute wounds

1 Scope

This standard specifies the general requirements for the application and creation of acute wounds for surgical incisions, punctures or mechanical wounds.

This standard is applicable to acute wound dressing and plastering, which consists of adhesive layer, absorbent pad and release layer.

This standard does not apply to hydrocolloid application and creation of acute wounds.

This standard does not apply to the application and creation of specific substances (silver, chitosan, etc.) containing antibacterial and anti-inflammatory effects.

2 Normative references

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

GB/T 14233.1-2008 Methods of test for infusions, blood trans

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1- 2011, ISO 10993-1.:2009, IDT)

GB/T 19633.1 End-sterilized medical device packaging - Part 1. Requirements for materials, sterile barrier systems and packaging systems

YY/T 0148-2006 General requirements for medical tapes

YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements

YY/T 0471.1-2004 Test methods for contact wounds - Part 1. Fluid absorption

YY/T 0471.3-2004 Test methods for contact wound dressings - Part 3

YY/T 0471.4-2004 Test methods for contact wounds - Part 4. Comfort

YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for terminally sterilized medical devices

3 Terms and definitions

The following terms and definitions apply to this document.