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YY/T 1117-2024 English PDF

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YY/T 1117-2024: Plaster of paris bandage
Status: Valid

YY/T 1117: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1117-2024289 Add to Cart 3 days Plaster of paris bandage Valid
YY/T 1117-2001179 Add to Cart 3 days Plaster of pairs bandage. Powder form Valid

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Basic data

Standard ID: YY/T 1117-2024 (YY/T1117-2024)
Description (Translated English): Plaster of paris bandage
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C48
Classification of International Standard: 11.120.20
Word Count Estimation: 14,149
Date of Issue: 2024-07-08
Date of Implementation: 2025-07-20
Older Standard (superseded by this standard): YY/T 1117-2001, YY/T 1118-2001
Issuing agency(ies): State Drug Administration

YY/T 1117-2024: Plaster of paris bandage

---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 CCSC48 Pharmaceutical Industry Standards of the People's Republic of China Replace YY/T 1117-2001, YY/T 1118-2001 Plaster bandage Released on 2024-07-08 2025-07-20 Implementation The State Drug Administration issued

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document replaces YY/T 1117-2001 "Powdered plaster bandage" and YY/T 1118-2001 "Adhesive plaster bandage". This document integrates the contents of YY/T 1117-2001 and YY/T 1118-2001 and is consistent with YY/T 1117-2001 and YY/T 1118-2001. In addition to structural adjustments and editorial changes, the main technical changes are as follows. a) The scope has been changed (see Chapter 1, Chapter 1 of YY/T 1117-2001 and YY/T 1118-2001); b) Added the terms and definitions of radial compressive strength, peak failure load and maximum deflection load (see Chapter 3); c) The composition of the viscose plaster bandage has been changed to specify that calcium sulfate dihydrate (or calcium sulfate hemihydrate) (see 4.1, YY/T 1118- 2001, 3.2); d) The specifications and dimensions of plaster bandages have been changed (see 4.2, 4.1 of YY/T 1117-2001 and YY/T 1118-2001); e) Added radial compressive strength requirements for plaster bandages (see 5.5.5); f) Added curing temperature requirements for plaster bandages (see 5.5.6); g) The test method for the mass per unit area of the supporting gauze of plaster bandages has been changed (see 6.3, YY/T 1117-2001 and YY/T 1118- 2001, 5.3); h) The test method for density of supporting gauze of plaster bandages has been changed (see 6.4, YY/T 1117-2001 and YY/T 1118-2001). 5.4); i) The immersion time test method for plaster bandages has been modified (see 6.5.2, YY/T 1117-2001 and YY/T 1118-2001). 5.6); j) The test method for plasticity of plaster bandages has been changed (see 6.5.3, YY/T 1117-2001 and YY/T 1118-2001). 5.7); k) The curing time test method for plaster bandages has been modified (see 6.5.4, YY/T 1117-2001 and YY/T 1118-2001). 5.8); l) Added radial compression strength test method for plaster bandages (see 6.5.5); m) Added the curing temperature test method for plaster bandages (see 6.5.6); n) The test method for weight loss on ignition of powdered plaster bandages has been changed (see 6.6.1, 5.9 of YY/T 1117-2001); o) The pH test method for powdered plaster bandages has been changed (see 6.6.2, 5.10 of YY/T 1117-2001); p) The test method for calcium sulfate hemihydrate content in plaster bandages has been changed (see 6.6.3, 5.11 of YY/T 1117-2001, 2001, May 9); q) The inspection rules requirements have been deleted (see Chapter 6 of YY/T 1117-2001 and YY/T 1118-2001); r) Changed the marking requirements (see Chapter 7, 7.1 of YY/T 1117-2001 and YY/T 1118-2001); s) The instruction manual requirements have been deleted (see 7.2 of YY/T 1117-2001 and YY/T 1118-2001); t) The packaging and storage requirements have been changed (see 8.1 and 8.3, 8.1 and 8.3 of YY/T 1117-2001 and YY/T 1118-2001). Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Medical Protective Equipment Standardization Working Group (SAC/SWG30). This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Anji Hongde Medical Supplies Co., Ltd., WenJian Medical Supplies Co., Ltd., Henan Tuoren Best Medical Equipment Co., Ltd., Yadu Medical Technology (Henan) Co., Ltd., Buchmann (Shanghai) TRADING LIMITED. The main drafters of this document are. Sun Yupeng, Wang Chenxiao, Zhang Yuegen, Li Haotian, Yang Weifang, Yang Jing, Liu Weihua, Duan Shuxia and Liu Yu. The previous versions of this document and the documents it replaces are as follows. ---First published in.2001 as YY/T 1117-2001 and YY/T 1118-2001; --- This is the first revision. YY/T 1117-2001 and YY/T 1118-2001 were revised together. Plaster bandage

1 Scope

This document specifies the type, composition and specifications of plaster bandages, as well as the requirements, marking, packaging, transportation, storage, etc., and describes the corresponding test Test method. This document applies to powdered plaster bandages and adhesive plaster bandages.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1.General requirements

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 The load per unit width borne by the annular specimen after being subjected to radial compression (perpendicular to the axis of the annular specimen). Note. The unit is Newton per millimeter (N/mm). [Source. YY/T 1697-2020, 3.1] 3.2 Peak failure load Before the radial deformation reaches 10 mm displacement, the specimen is damaged and the load value decreases. Maximum load. [Source. YY/T 1697-2020, 3.2] 3.3 The annular specimen was compressed from the initial load position and displaced 10 mm without significant damage or load reduction. Load. [Source. YY/T 1697-2020, 3.3] 4 Type, composition and specifications 4.1 Product type and composition The product form of plaster bandage is scroll type, which is divided into powdered plaster bandage and viscose plaster bandage. Powdered plaster bandages are generally made of hemihydrate calcium sulfate and absorbent cotton gauze. Viscose plaster bandages are generally made of calcium sulfate dihydrate (or calcium sulfate hemihydrate), colloid material and absorbent cotton gauze.
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