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YY 0852-2023: Sterile surgical films for single use
Status: Valid YY 0852: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0852-2023 | English | 239 |
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Sterile surgical films for single use
| Valid |
YY 0852-2023
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| YY 0852-2011 | English | 479 |
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Sterile surgical films for single use
| Obsolete |
YY 0852-2011
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PDF similar to YY 0852-2023
Basic data | Standard ID | YY 0852-2023 (YY0852-2023) | | Description (Translated English) | Sterile surgical films for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.120.20 | | Word Count Estimation | 12,179 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2026-09-15 | | Older Standard (superseded by this standard) | YY 0852-2011 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the performance requirements for polyurethane surgical membranes and polyethylene surgical membranes that are adhered to surgical sites and provide sterile protection for surgical incisions, and describes the corresponding test methods. This standard applies to polyurethane surgical membranes and polyethylene surgical membranes. | YY 0852-2023: Sterile surgical films for single use---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.120.20
CCSC31
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0852-2011
Disposable sterile surgical membrane
Published on 2023-09-05
Implemented on 2024-09-15
Released by the State Drug Administration
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document replaces YY 0852-2011 "Disposable Sterile Surgical Membranes". Compared with YY 0852-2011, except for structural adjustment and compilation
In addition to editorial changes, the main technical changes are as follows.
a) Changed the requirements for “marking” (see 4.2, 3.2 of the.2011 version);
b) Changed the requirements for “size” (see 6.1, 5.1 of the.2011 edition);
c) Changed "cleanliness" to "appearance" and changed the corresponding technical content (see 6.2, 5.2 of the.2011 version);
d) Changed the requirements for "protective layer" (see 6.5, 5.5 of the.2011 version);
e) The requirements and test methods for “glue coating weight” are deleted (see 5.7 and Appendix C of the.2011 edition);
f) Changed the requirements for “stretchability” (see 6.8, 5.9 of the.2011 version);
g) Changed the requirements for “marking” (see Chapter 7, Chapter 6 of the.2011 edition);
h) Changed the requirements for “packaging” (see Chapter 8, Chapter 7 of the.2011 edition);
i) Changed the "viscosity test method" (see Appendix B, Appendix B of the.2011 version);
j) Changed the "Membrane Quality Test Method" (see Appendix C, Appendix C of the.2011 version);
k) The "Water Vapor Permeability Test Method" has been changed (see Appendix D, Appendix D of the.2011 edition).
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of Shandong Medical Device and Drug Packaging Inspection Institute.
The previous versions of this document and the documents it replaces are as follows.
---First released in.2011 as YY 0852-2011;
---This is the first revision.
Introduction
The disposable sterile surgical membrane (hereinafter referred to as "surgical membrane") specified in this document is mainly used to be attached to the surgical site during surgery. That
Its function is to prevent dander from the skin that may carry bacteria from spreading to the surgical wound, and to prevent microorganisms in the deep skin around the surgical incision.
Migrate to the skin surface and spread to the surgical incision to prevent infection. For some special surgical membranes, compliance with this document does not mean
Can meet clinical requirements. For other special requirements for surgical membranes, requirements other than those specified in this document may also be necessary.
Surgical membrane is an adhesive material in contact with the surgical wound and has the dual properties of surgical dressing and adhesive tape.
Disposable sterile surgical membrane
1 Scope
This document specifies the performance of polyurethane surgical membranes and polyethylene surgical membranes that are adhered to surgical sites to provide sterile protection for surgical incisions.
requirements, the corresponding test methods are described.
This document applies to polyurethane surgical membranes and polyethylene surgical membranes.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing during risk management process
GB/T 19633.1 Packaging of terminally sterilized medical devices Part 1.Requirements for materials, sterile barrier systems and packaging systems
YY/T 0466.1 Medical devices Symbols used for labeling, marking and providing information on medical devices Part 1.General requirements
YY/T 0471.3-2004 Test methods for contact wound dressings Part 3.Water barrier properties
YY/T 0471.4-2004 Test methods for contact wound dressings Part 4.Comfort
YY/T 0615.1 Requirements for marking "sterile" medical devices Part 1.Requirements for terminally sterilized medical devices
3 Terms and definitions
The terms and definitions defined in YY/T 0471.3-2004 and YY/T 0471.4-2004 apply to this document.
4 Types and markings
4.1 Type
The surgical membrane base material 1) is evenly coated with a synthetic adhesive material to form the adhesive surface of the surgical membrane. The pasting surface is covered with a protective layer. Remove the protective layer.
The adhesive material will not be removed after the protective layer is applied. The two sides of the surgical membrane can be free of adhesive material or attached with suitable material (such as paper) for hand-holding
operate.
4.2 Marking
The surgical membrane is marked with the product material code and the width × length of the adhesive surface.
Example 1.A surgical membrane with a base material of polyurethane (PU), an adhesive surface width of 30cm, and a length of 50cm is marked as.
PU30×50
Example 2.A surgical membrane with a base material of polyethylene (PE), an adhesive surface width of 30cm, and a length of 50cm is marked as.
PE30×50
1) The base materials applicable to this document are polyurethane (PU) film and polyethylene (PE) film. The production cost of polyethylene film is low, but its material has low water vapor permeability and
It is not as stretchable as polyurethane materials and is generally not accepted by developed countries.
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