YY/T 1293.2-2022 Contacting wound dressing - Part 2: Polyurethane foam dressing
1 Scope
This document specifies the requirements and test methods for polyurethane foam dressings.
This document is applicable to dressings that are supplied sterile and whose liquid absorption layer is made of polyurethane foam.
This document is not applicable to the polyurethane foam dressings containing antibacterial agents such as silver, containing active ingredients or substances capable of releasing active substances/energy, containing human/animal-derived materials, tissue engineering materials, degradable materials, etc., as well as the polyurethane foam dressings (sponges) used for negative-pressure wound drainage.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 19633.1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0471.1-2004 Test methods for primary wound dressing - Part 1: Aspects of absorbency
YY/T 0471.2-2004 Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
YY/T 0471.3-2004 Test methods for primary wound dressings - Part 3: Waterproofness
YY/T 0471.5-2017 Test methods for primary wound dressings - Part 5: Bacterial barrier properties
YY/T 0615.1 Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices
Pharmacopoeia of the People's Republic of China (Edition 2020, Volume IV)
3 Terms and definitions
No terms and definitions are defined in this document.
4 Structure
The typical structures of polyurethane foam dressings are shown in Figure 1.
a) Polyurethane foam dressing without adhesive edge b) Polyurethane foam dressing with adhesive edge
Key
1——outer layer, which may be waterproof or non-waterproof;
2——polyurethane foam layer;
3——adhesive layer, optional;
4——protective layer, optional.
Figure 1 Examples of typical polyurethane foam dressings
Contents
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Structure
5 Requirements
6 Test methods
7 Marking
8 Packaging
Bibliography
YY/T 1293.2-2022 Contacting wound dressing - Part 2: Polyurethane foam dressing
1 Scope
This document specifies the requirements and test methods for polyurethane foam dressings.
This document is applicable to dressings that are supplied sterile and whose liquid absorption layer is made of polyurethane foam.
This document is not applicable to the polyurethane foam dressings containing antibacterial agents such as silver, containing active ingredients or substances capable of releasing active substances/energy, containing human/animal-derived materials, tissue engineering materials, degradable materials, etc., as well as the polyurethane foam dressings (sponges) used for negative-pressure wound drainage.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 19633.1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0471.1-2004 Test methods for primary wound dressing - Part 1: Aspects of absorbency
YY/T 0471.2-2004 Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
YY/T 0471.3-2004 Test methods for primary wound dressings - Part 3: Waterproofness
YY/T 0471.5-2017 Test methods for primary wound dressings - Part 5: Bacterial barrier properties
YY/T 0615.1 Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices
Pharmacopoeia of the People's Republic of China (Edition 2020, Volume IV)
3 Terms and definitions
No terms and definitions are defined in this document.
4 Structure
The typical structures of polyurethane foam dressings are shown in Figure 1.
a) Polyurethane foam dressing without adhesive edge b) Polyurethane foam dressing with adhesive edge
Key
1——outer layer, which may be waterproof or non-waterproof;
2——polyurethane foam layer;
3——adhesive layer, optional;
4——protective layer, optional.
Figure 1 Examples of typical polyurethane foam dressings
Contents of YY/T 1293.2-2022
Contents
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Structure
5 Requirements
6 Test methods
7 Marking
8 Packaging
Bibliography
