HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY/T 1027-2018 English PDF

US$969.00 · In stock
Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1027-2018: Dentistry-Hydrocolloid impression materials
Status: Valid

YY/T 1027: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1027-2018English969 Add to Cart 6 days [Need to translate] Dentistry-Hydrocolloid impression materials Valid YY/T 1027-2018
YY/T 1027-2018English969 Add to Cart 6 days [Need to translate] Dentistry-Hydrocolloid impression materials Valid YY/T 1027-2018
YY 1027-2001English599 Add to Cart 4 days [Need to translate] Dental alginate impression material Obsolete YY 1027-2001

PDF similar to YY/T 1027-2018


Standard similar to YY/T 1027-2018

YY 1042   YY/T 0823   YY/T 0824   YY/T 1021.3   YY/T 1021.2   

Basic data

Standard ID YY/T 1027-2018 (YY/T1027-2018)
Description (Translated English) Dentistry-Hydrocolloid impression materials
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Classification of International Standard 11.060.10
Word Count Estimation 44,487
Date of Issue 2018-06-14
Date of Implementation 2019-07-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the performance requirements and test methods of elastic aqueous agar and alginate hydrocolloid dental impression materials in order to determine whether they can achieve the expected quality in use. It also stipulates the requirements for instructions for use and labels. This standard applies to elastic aqueous agar and alginate hydrocolloid dental impression materials.

YY/T 1027-2018: Dentistry-Hydrocolloid 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.
ICS 11:060:10 C33 Pharmaceutical Industry Standard of the People's Republic of China YY 1027-2018 Replace YY 1027-2001, YY 0494-2004 Dental Hydrocolloid Impression Materials (ISO 21563:2013, MOD) According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: 2018-06-14 release:2019-07-01 implementation Released by the State Drug Administration

table of contents

Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Classification of agar hydrocolloid impression materials 3 5 Requirements---Characteristics and Performance 3 6 Pre-test treatment 4 7 Test method 7 8 Requirements for labels and instructions for use18 Appendix A (Normative Appendix) Schematic diagram of test equipment and accessories 21 Appendix B (informative appendix) Preparation steps of an optional specimen clamping method for tear resistance test 34 Reference 38 YY 1027-2018

foreword

This standard is drafted in accordance with the rules given in GB/T 1:1-2009: This standard replaces YY 1027-2001 "Dental Alginate Impression Material" and YY 0494-2004 "Dental Agar-Based Hydrocolloid Impression Material": Compared with YY 1027-2001 and YY 0494-2004, the main technical changes in this standard are as follows except editorial revisions: --- Increased the classification of type 3A agar material, and added the sample preparation steps for type 3A materials to the involved items; --- Added test methods and requirements for tensile bond strength and linear dimensional change of 3A materials; ---Deleted the requirements and test methods for product appearance and blend appearance in YY 1027-2001 and YY 0494-2004, Check this part in Chapter 6 "Test Pretreatment" stage; ---Delete the requirements on the extrusion temperature, gel temperature and extrudability of agar material, and put this part in Chapter 6 "Before the test "Management" stage to check; --- Delete the item of compressive strength of alginate material, and add the item of tear resistance; --- Modified the details of the alginate material and agar material reproduction, and the test method was also modified accordingly: This standard uses the redrafted method to revise and adopt ISO 21563:2013 "Dentistry Hydrocolloid Impression Materials": The technical differences between this standard and ISO 21563:2013 and their reasons are as follows: --- Regarding the normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country and the adjustment situation The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows: a) ISO 3696 is replaced by GB/T 6682, which adopts the modified international standard: b) Replace ISO 1942 (all parts) with GB/T 9937 (all parts), the degree of consistency between the parts of the two standards as follows: ● GB/T 9937:1-2008 Oral Vocabulary Part 1: Basic and Clinical Terms (ISO 1942-1:1989, IDT); ● GB/T 9937:2-2008 Oral Vocabulary Part 2: Oral Materials (ISO 1942-2:1989, IDT); ● GB/T 9937:3-2008 Oral Vocabulary Part 3: Dental Devices (ISO 1942-3:1989, IDT); ● GB/T 9937:4-2005 Dental Terminology Part 4: Dental Equipment (ISO 1942-4:1989, IDT); ● GB/T 9937:5-2008 Oral vocabulary Part 5: Terms related to testing (ISO 1942-5:1989, IDT): c) Replaced ISO 6873 by modifying YY 0462 to adopt the international standard: Please note that some content of this standard may involve patents: The issuing authority of this standard assumes no responsibility for identifying these patents: This standard was proposed by the State Drug Administration: This standard is under the jurisdiction of the National Dental Materials and Devices Standardization Technical Committee (SAC/TC99): This standard is drafted by: State Drug Administration Peking University Medical Device Quality Supervision and Inspection Center: Participated in the drafting of this standard: Rijin Dental Materials (Kunshan) Co:, Ltd:, Shanghai Medical Devices Co:, Ltd: Dental Materials Factory: The main drafters of this standard: Bai Wei, Lin Hong, Yuan Shenpo, Shen Xiwei, Qin Jie, Xu Zhengguo, Du Zumin, Zheng Gang, Sun Zhihui: The previous editions of this standard are as follows: ---YY 1027-2001; ---YY 0494-2004: YY 1027-2018 Dental Hydrocolloid Impression Materials

1 Scope

This standard specifies the performance requirements and test methods for elastic aqueous agar and alginate hydrocolloid dental impression materials in order to determine their performance Whether to achieve the expected quality of use: It also stipulates the requirements for instructions for use and labels: This standard applies to elastic aqueous agar and alginate hydrocolloid dental impression materials: Note: This standard does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended that when evaluating the possible biological hazards of hydrocolloid impression materials, References ISO 10993 and ISO 7405:

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 pieces: For undated references, the latest version (including all amendments) applies to this document: GB/T 6682-2008 Analytical Laboratory Water Specifications and Test Methods (ISO 3696:1987, MOD) GB/T 9937:1-2008 Oral vocabulary Part 1: Basic and clinical terms (ISO 1942-1:1989, IDT) GB/T 9937:2-2008 Oral vocabulary Part 2: Oral materials (ISO 1942-2:1989, IDT) GB/T 9937:3-2008 Oral Vocabulary Part 3: Dental Devices (ISO 1942-3:1989, IDT) GB/T 9937:4-2005 Dental Terminology Part 4: Dental Equipment (ISO 1942-4:1989, IDT) GB/T 9937:5-2008 Oral vocabulary Part 5: Terms related to testing (ISO 1942-5:1989, IDT) YY 0462-2018 Dental plaster products (ISO 6873:2013, MOD)

3 Terms and Definitions

GB/T 9937:1-2008, GB/T 9937:2-2008, GB/T 9937:3-2008, GB/T 9937:4-2005, GB/T 9937:5- 2008 and the following terms and definitions apply to this document: 3:1 Adhesive bonding The viscous properties of the reversible and irreversible impression components in the impression material make each component used alone and needs to cooperate with each other to form A unified impression system to achieve the required degree of flexibility and effective impression and successful removal from the mouth: 3:2 bulk container bulkcontainer Labeled sales packages or immediate packaging containers containing bulk granules, liquids, powders or other loose substances in quantities usually The amount required for more than one oral clinical treatment or laboratory procedure: 3:3 Low-consistency agar material is first injected around the selected tooth, allowing it to communicate with the irreversible alginate impression material when the impression is made: Impression system for pressure bonding: 3:4 sales packaging consumer packaging; retail packaging; sales packaging A sales unit containing the package and its contents that can be offered to the end user or consumer at the time of retail sale: YY 1027-2018

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1027-2018_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1027-2018_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 6 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1027-2018_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1027-2018_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY/T 1027-2018?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1027-2018 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.