YY 0714.1-2009Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (English PDF)

Foreword

The technical content of this standard is mandatory. YY 0174 "Dental denture soft lining material" consists of the following two parts. - Part 1. short-term use of materials; - Part 2. Long - term use of materials. This section is part 1 of YY 0174. This part is equivalent to ISO 10139-1..2005 "Dental Activity Denture Soft Lining Material Part 1. Short-term Use of Materials" and ISO 10139-1..2005/Cor. 1..2006 "Dentistry denture soft lining materials Part 1. Short-term use of materials Technical Errata Table 1 ". This part is redrafted according to ISO 10139-1..2005 and differs from ISO 10139-1..2005 as follows:

--- normative reference document ISO 3639. 1987 to modify the use of the standard of our standard GB/T 6682-2008 "analysis Laboratory water specifications and test methods ". -

7.2.4 will be replaced by "the first safety recommended in the production plant from the mouth of the time (see the instructions) before 1min" to "in production Factory specified 10% elastic recovery time (see instructions) before 1min ", and in

h) should be listed in the production plant Prescribed 10% elastic recovery time ". This section does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended that in assessing possible biological hazards, See YY/T 0268 "Dental Oral Medical Device Biological Evaluation Unit 1. Evaluation and Test". This part is made by the State Food and Drug Administration. This part of the National Dental Materials and Equipment Standardization Technical Committee. This part of the State Food and Drug Administration Beida Medical Device Quality Supervision and Inspection Center drafted. This part of the main drafters. Zheng Gang, Bai Wei, Sun Zhihui, Yuan Shenpo, Zheng Rui. YY 0714.1-2009/ISO 10139-1..2005 Dental activity denture soft lining material Part 1. short-term use of materials

1 Scope

YY 0714.1 is the mandatory Chinese standard for short-term soft denture lining materials, the tissue conditioners and temporary liners placed inside a denture to let inflamed or recently operated tissue recover before a definitive prosthesis is made. They are expected to stay in the mouth for days or weeks rather than months, which changes what matters: initial flow and adaptation to the tissue, the cushioning it provides, and the ease with which it is removed afterwards, rather than long-term stability. The standard sets those requirements and the test methods that verify them, together with Part 2 which covers long-term materials. Being a YY standard without the /T suffix, compliance is compulsory in China.

This part of YY 0174 specifies the physical properties of the short-term denture soft lining material, test methods, packaging, labeling, use of the manufacturer The requirements of the manual.

2 Normative reference documents

The terms of this document are the terms of this part by reference to this part of

YY 0174. Any reference to the date of the document, All subsequent amendments (excluding corrigenda) or revisions do not apply to this part, however, it is encouraged to enter into an agreement under this Part Of the parties to study whether the latest version of these documents can be used. For undated references, the latest edition applies to this section.

GB/T 6682-2008 Analytical laboratory water specifications and test methods ( ISO 3639. 1987, MOD)

3 Terms and definitions

The following terms and definitions apply to this part of YY 0174.

3.1 Soft lining material, placed in the denture tissue surface, and denture support tissue mucosal contact, usually wear time within 7d, the purpose is to help Dentures support tissue to restore health.

3.2 In a limited time, can improve the denture adhesion, retention and comfort of the use of denture soft lining materials.

4 Classification

4.1 Model Short-term materials should be classified according to the elastic recovery measured in

--- type A. before taking out, need a short time in the mouth placed (5min or less than 5min);

--- B type. before taking out, need to be placed in the mouth for a long time (more than 5min).

4.2 Categories The initial resistance of the indentation can be measured according to 7.3 (see 5.2) to further classify the resulting initial plasticity.

--- Class 1. high initial plasticity; Class 2. Low initial plasticity.

5 Request

5.1 elastic recovery The displacement of the specimen shall be determined by 7.2. At least two of the three specimens shall comply with the requirements of the corresponding model in Table 1. Table 1 elastic recovery model min YY 0714.1-2009/ISO 10139-1..2005