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www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 0493-2022 English PDF

US$719.00 · In stock
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YY/T 0493-2022: (Dentistry Elastomeric Impression Materials)
Status: Valid

YY/T 0493: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 0493-2022	English	719	Add to Cart	6 days [Need to translate]	(Dentistry Elastomeric Impression Materials)	Valid	YY/T 0493-2022
YY 0493-2011	English	1319	Add to Cart	6 days [Need to translate]	Dentistry. Elastomeric impression materials	Obsolete	YY 0493-2011
YY 0493-2004	English	RFQ	ASK	6 days [Need to translate]	Dentistry - Elastomeric impression materials	Obsolete	YY 0493-2004

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Basic data

Standard ID	YY/T 0493-2022 (YY/T0493-2022)
Description (Translated English)	(Dentistry Elastomeric Impression Materials)
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C33
Word Count Estimation	39,384
Issuing agency(ies)	State Drug Administration

YY 0493-2011: Dentistry. Elastomeric impression materials

---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.
Dentistry.Elastomeric impression materials ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards YY 0493-2011/ISO 4823.2000 Replacing YY 0493-2004 Dentistry elastomeric impression material (ISO 4823.2000, IDT) Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Category 2 2 5 biocompatibility Performance Requirements 2 6 6.1 each component color 2 6.2 Harmonic time (manual or hand spatula reconcile reconcile Cuonie) 2 6.3 hours (only applies to materials 1,2,3) 2 6.4 Consistency 3 6.5 Detail reproduction 3 6.6 linear dimensional change 3 6.7 Compatibility with plaster 3 6.8 Elastic Recovery 3 6.9 compressive strain 3 7 sample 3 8 Test methods --- General requirements 4 8.1 laboratory environment 4 8.2 appliance school inspection function 4 8.3 material handling and sample preparation 4 8.4 Eligible determination 4/fail 8.5 test results presentation 4 9 Test methods --- the specific requirements of 4 9.1 Harmonic time trial 4 9.2 Consistency Test 5 9.3 hours Test 6 9.4 Detail reproduction test 7 9.5 change in linear dimensions Test 8 9.6 and plaster compatibility test 9 10 9.7 elastic recovery test 9.8 compressive strain test 11 10 manufacturers specification requirements 12 10.1 General requirements 12 10.2 identification information 12 10.3 Manual 12 YY 0493-2011/ISO 4823.2000 13 11 Packaging and Labeling Appendix A (informative) work part time tester --- 27 possible sources References 28 YY 0493-2011/ISO 4823.2000

Foreword

All the technical contents of this standard is mandatory. This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard replaces YY 0493-2004 "Dentistry elastomeric impression materials" and errata list, and YY 0493-2004 and errata Compared to a single, major technological changes are as follows. --- 6.3, according to ISO 4823.2000/Amd.1.2007 has been modified, removed the 0-type materials work time requirements. This standard uses the translation method identical with ISO 4823.2000 "Dentistry elastomeric impression materials", ISO 4823.2000/Cor.1. 2004 "Dentistry elastomeric impression material amendments 1" and ISO 4823.2000/Amd.1.2007 "Dentistry elastomeric impression materials Addendum 1 material. " This standard and ISO 4823.2000 in comparison, made the following editorial changes. --- "6 Performance Requirements", as expressly modified as follows. ● original contents are listed in the Table 1 listed separately as 6.4,6.5,6.6,6.8 and 6.9; ● original 6.4 to 6.7; ● Table 1, the original terms of number "9.2,9.4,9.5,9.6,9.7,9.8" to "6.4,6.5,6.6,6.7,6.8,6.9." --- 9.2.1.2 Add "or other suitable conveyor." --- 10 illustrates the M4.5 stainless steel to "M4 stainless steel." Correspondence between the consistency of the standards of international documents and normative references of the following documents. --- GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)]; --- YY 0462-2003 dental plaster products (ISO 6873.1998, MOD). Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee materials and oral appliances and equipment (SAC/TC99) centralized. This standard was drafted. Peking University School of Stomatology Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Lin Hong, Zheng Gang, Bai Wei, Yuan Shen slope, Sun Zhihui, Zhang Yan. This standard replaces the standards previously issued as follows. --- YY 0493-2004. YY 0493-2011/ISO 4823.2000 Dentistry elastomeric impression material

1 Scope

This standard specifies performance requirements and test methods for evaluation of dental elastomeric impression materials.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. ISO 1942 oral vocabulary (Dentistry-Vocabulary) ISO 6873.1998 Dental plaster products (Dentalgypsumproducts)

3 Terms and Definitions

As defined in ISO 1942 and the following terms and definitions apply to this document. 3.1 Consistency consistency The degree of particulate material adhered to each other together. When using the material can flow or resistance to flow, to achieve the desired use purpose. 3.2 Elastic recovery test elasticrecoverytest When used to determine the removal of the impression material formed from the oral cavity (elastomeric stamp) whether the material has the proper reply from the deformed state required Test Method elastic properties. Note. Here the use of "compression" compressionset, "permanent deformation" permanentdeformation, "strain recovery" recoveryfromdeformation is Inappropriate. 3.3 Extrusion reconcile extrusionmixing Two or multi-component material is extruded directly from the respective container through a dedicated mixer so that all components are homogeneously mixed into the mixture method. 3.4 Hand reconcile handmixing Yong Shounie rubbing with a spatula or the material components are mixed approach. 3.5 Direct container immediatecontainer Direct contact with the material or a component of a container. Note. Direct container can not be affixed to the container label, it has made more durable protection labeling packaging, packaging can be cans, cartons or barrels. Without Outsourcing Equipment, the strength of the immediate container is enough to protect the contents, the container can be directly used as inner packaging, it should also be labeled. 3.6 Harmonic time mixingtime According to manufacturer instructions to reconcile, from each of the component materials in contact with each other to become the starting time of a homogeneous mixture. Note. The time between the components of the material extruded reconcile the initial contact means to see the components of the material into the mixing head inlet time. YY 0493-2011/ISO 4823.2000

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