SIST EN ISO 12836:2012/oprA1:2014
(Amendment)Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2012/DAM 1:2014)
Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2012/DAM 1:2014)
2013-11-04 GVN: Draft for // enquiry received at ISO/CS (see notification in dataservice on 2013-11-01)
Zahnheilkunde - Digitalisierungsgeräte für CAD/CAM-Systeme für indirekte dentale Restaurationen - Prüfverfahren zur Beurteilung der Genauigkeit (ISO 12836:2012/DAM 1:2014)
Médecine bucco-dentaire - Dispositifs de numérisation des systèmes de CFAO pour restaurations dentaires - Méthodes d'essai pour l'évaluation de l'exactitude (ISO 12836:2012/DAM 1:2014)
Zobozdravstvo - Digitalne naprave za uporabo sistemov CAD/CAM za posredne zobne restavracije/obnovo - Preskusne metode za ugotavljanje točnosti (ISO 12836:2012/DAM 1:2014)
General Information
Relations
Overview
EN ISO 12836:2012/prA1 (ISO 12836:2012/DAM 1:2014) is a CEN/ISO document addressing digitizing devices for CAD/CAM systems used in indirect dental restorations. The standard specifies test methods for assessing accuracy of intraoral and extraoral scanners and other digitizing equipment used to capture dental geometry for prostheses, crowns, bridges and related restorations. The published draft amendment (DAM 1) was developed under ISO/TC 106/SC 9 and circulated for parallel ISO/CEN processing. Note: the WI was cancelled in 2015 and the work was replaced by a minor revision (ISO ID 68414).
Key topics
- Scope and applicability: test methods targeted at digitizing devices used in dentistry for CAD/CAM workflows for indirect restorations.
- Accuracy assessment principles: evaluation of common accuracy metrics such as trueness and precision, and how these metrics apply to dental scan data.
- Test artifacts and calibration: guidance on using reference objects (test artifacts), controlled conditions and calibration procedures to produce repeatable measurement results.
- Measurement procedures: standardized steps for capturing scan data, aligning datasets to references, and quantifying deviations.
- Reporting and interpretation: recommended formats for reporting results, including statistical summaries and traceable documentation to support device comparison and regulatory submissions.
- Quality and reproducibility: emphasis on controlled test conditions, repeatable workflows and documentation to ensure comparability across devices and laboratories.
Applications
This standard is practical for professionals and organizations involved in digital dentistry and medical device evaluation:
- Dental device manufacturers (scanner and CAD/CAM system vendors) - for product development, performance verification and marketing claims.
- Dental laboratories and clinics - to assess and compare scanner performance for clinical workflows.
- Regulatory bodies and conformity assessment bodies - to evaluate accuracy claims and support device approval.
- Researchers and test laboratories - for reproducible methods when studying scanner performance, clinical implications and workflow optimization.
- Dental technicians and CAD/CAM specialists - to select appropriate digitizing hardware based on standardized performance metrics.
Related standards and context
- Aligned with ISO/TC 106/SC 9 activities for dental device standardization and produced under the Vienna Agreement (ISO/CEN parallel processing).
- Users should consult current ISO/CEN publications and the noted minor revision (ISO ID 68414) for the latest normative requirements and any updates following the cancellation of the original WI.
Keywords: dentistry, CAD/CAM, digitizing devices, dental restorations, scanner accuracy, ISO 12836, EN ISO 12836, test methods, trueness, precision.
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2014
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Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test
methods for assessing accuracy (ISO 12836:2012/DAM 1:2014)
Zahnheilkunde - Digitalisierungsgeräte für CAD/CAM-Systeme für indirekte dentale
Restaurationen - Prüfverfahren zur Beurteilung der Genauigkeit (ISO 12836:2012/DAM
1:2014)
Médecine bucco-dentaire - Dispositifs de numérisation des systèmes de CFAO pour
restaurations dentaires - Méthodes d'essai pour l'évaluation de l'exactitude (ISO
12836:2012/DAM 1:2014)
Ta slovenski standard je istoveten z: EN ISO 12836:2012/prA1
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT AMENDMENT
ISO 12836:2012/DAM 1
ISO/TC 106/SC 9 Secretariat: JISC
Voting begins on: Voting terminates on:
2014-01-09 2014-06-09
Dentistry — Digitizing devices for CAD/CAM systems for
indirect dental restorations — Test methods for assessing
accuracy
AMENDMENT 1
Médecine bucco-dentaire — Dispositifs de numérisation des systèmes de CFAO pour restaurations
dentaires — Méthodes d’essai pour l’évaluation de l’exactitude
AMENDEMENT 1
ICS: 11.060.01
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established
...
Frequently Asked Questions
SIST EN ISO 12836:2012/oprA1:2014 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2012/DAM 1:2014)". This standard covers: 2013-11-04 GVN: Draft for // enquiry received at ISO/CS (see notification in dataservice on 2013-11-01)
2013-11-04 GVN: Draft for // enquiry received at ISO/CS (see notification in dataservice on 2013-11-01)
SIST EN ISO 12836:2012/oprA1:2014 is classified under the following ICS (International Classification for Standards) categories: 11.060.01 - Dentistry in general; 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 12836:2012/oprA1:2014 has the following relationships with other standards: It is inter standard links to SIST EN ISO 12836:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 12836:2012/oprA1:2014 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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