GB/T 16886.11-1997
Replaced
T/ZMDS 30003-2026
Active
Group standards
T/ZMDS 30003-2026 Digitally produces dentures
T/ZMDS 30003-2026 Digitally produces dentures
Price:
$ 20.00
Basic Information
Standard Code:
T/ZMDS 30003-2026
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Integrated medical equipment
Publish Date:
2026-04-07
Implement Date:
2026-05-07
Scope
This document specifies the classification, design and manufacturing, performance indicators, testing methods, and marking requirements for "digitally produced dentures" (hereinafter referred to as "dentures"). This document applies to dentures produced using digital processes (additive and subtractive) with registered dental materials, which are used to repair dental defects, missing teeth, or complete dentures to restore chewing function and aesthetics. IV. Main Content of the Standard I) Main Content of the Standard: 1. Scope: Specifies the content structure and applicable objects of the document; 2. Normative referenced documents: Lists the standards and technical documents referenced in the document; 3. Terms and definitions: Lists the definitions of denture-related terms; 4. Product classification: Specifies the differences in the process structure of the product; 5. Design and manufacturing: Specifies the requirements for the design, modeling, and processing of digitally produced dentures; 6. Performance requirements: Specifies the performance indicators of the product; 7. Testing methods: Specifies the testing methods for the performance requirements of the product; 8. Packaging, marking, and accompanying documents: Specifies the requirements for the packaging marking, traceability marking, user manual, and inspection certificate of the product. II) Interpretation of the Standard Content This document is drafted in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization - Part 1: Structure and Drafting Rules for Standardization Documents". This document has no relationship with other standards. The Chinese name of this document is "Digitally Produced Dentures", and the English name is "Digitally Produced Dentures". 2. Scope of Application This document specifies the classification, design and manufacturing, performance requirements, testing methods, and marking of "digitally produced dentures" (hereinaf
Development Information
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced