SIST-TP CEN/TR 16386:2013
(Main)Dentistry - Guidelines for handling methacrylate-based materials in the dental laboratory
Dentistry - Guidelines for handling methacrylate-based materials in the dental laboratory
This Technical Report gives guidance for handling methacrylate-based polymer materials for dental purposes used in dental laboratories. The intention is to lower the risk of adverse effects on skin and airways when working with such materials.
NOTE Aspects of this document may be applicable for other areas in Dentistry.
Zahnheilkunde - Leitlinien zur Handhabung von methacrylatbasierenden Materialien im zahntechnischen Labor
Dieser Fachbericht gibt eine Anleitung zur Handhabung von methacrylatbasierenden Materialien für dentale Zwecke im zahntechnischen Labor. Damit soll das Risiko für Haut und Atemwegserkrankungen bei der Arbeit mit diesen Materialien verringert werden.
Teile dieses Dokumentes können auf andere Bereiche der Zahnheilkunde anwendbar sein.
Médecine bucco-dentaire - Lignes directrices relatives à la manipulation des matériaux à base de méthacrylate en laboratoire dentaire
Le présent Rapport technique fournit des lignes directrices relatives à la manipulation, à des fins dentaires, de tous les matériaux à base de méthacrylate utilisés dans les laboratoires dentaires. L'objectif est de réduire les risques d'effets néfastes sur la peau et les voies respiratoires lors des travaux nécessitant ce type de matériau.
Des aspects de ce document peuvent s'appliquer à d'autres activités de pratique dentaire.
Zobozdravstvo - Smernice za ravnanje z materiali na osnovi metakrilata v zobozdravstvenem laboratoriju
To tehnično poročilo podaja smernice za ravnanje z vsemi materiali na osnovi metakrilata za zobozdravstvene namene v zobozdravstvenih laboratorijih. Namen je zmanjšati tveganje neugodnih vplivov na kožo in dihalne poti pri delu s takšnimi materiali. Posamezne smernice iz tega dokumenta se lahko uporabljajo na drugih področjih v zobozdravstvu.
General Information
- Status
- Published
- Public Enquiry End Date
- 30-Apr-2012
- Publication Date
- 14-Feb-2013
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 01-Feb-2013
- Due Date
- 08-Apr-2013
- Completion Date
- 15-Feb-2013
Overview
CEN/TR 16386:2013 - "Dentistry: Guidelines for handling methacrylate‑based materials in the dental laboratory" - provides practical guidance to reduce occupational risks from methacrylate monomers in dental laboratories. Developed by CEN/TC 55 WG8, the Technical Report focuses on preventing adverse effects to the skin and airways of dental personnel working with uncured and cured methacrylate‑based dental materials (e.g., denture base resins, orthodontic base materials, repair and tray materials).
Key topics and technical requirements
- Scope and intent
- Guidance covers all methacrylate‑based dental materials used in dental laboratories; aspects may apply to clinical dentistry.
- Risk management
- Compile documented risk assessments for each material and procedure, incorporating manufacturer instructions and Safety Data Sheets.
- Follow applicable European/national regulations and EN ISO 14971 where appropriate.
- Health surveillance & medical advice
- Implement regular health surveillance based on assessed risk.
- Seek medical advice for personnel with pre‑existing conditions or if disease is suspected after exposure.
- Exposure reduction measures
- Skin protection: avoid direct contact, use gloves, change after each procedure, do not reuse. Use barrier creams and avoid alcohol‑based disinfectants on contaminated skin.
- Glove guidance (Annex A): ordinary gloves can be permeable to monomers; follow manufacturer guidance on glove selection and change intervals. Current literature suggests many glove types may be ineffective after very short exposures (reported around minutes), so changing gloves frequently and avoiding solvent contact is advised. Double‑gloving can extend protection time.
- Airways protection: install and use local exhaust ventilation (LEV) to reduce dust and methacrylate vapour to below recommended occupational exposure limits.
- Eye protection: safety glasses, visors or goggles when handling uncured or cured materials.
- Training & signage
- Provide training, written handling instructions and display safety precautions at workstations.
Practical applications and users
Who should use this standard:
- Dental laboratory managers and dental technicians - for SOPs, PPE selection and work practices.
- Health & safety officers in dental labs - for risk assessments, ventilation specifications and surveillance programs.
- Dental clinical teams and educators - where lab activities intersect with clinical practice.
- Regulators and auditors - to evaluate compliance with occupational safety expectations.
Practical uses:
- Create documented risk assessments and training programs.
- Specify PPE policies (glove protocols, eye protection).
- Design or verify LEV and workplace signage.
- Define health surveillance triggers and medical referral pathways.
Related standards and references
- EN 374‑1 (protective gloves)
- EN ISO 14971 (risk management for medical devices)
- EN ISO 1942 (dentistry vocabulary)
- EU directives referenced in the report (e.g., PPE and occupational exposure limit directives)
Keywords: dentistry standard, methacrylate‑based materials, dental laboratory safety, PPE, glove guidance, risk assessment, local exhaust ventilation, methyl methacrylate, occupational health.
Frequently Asked Questions
SIST-TP CEN/TR 16386:2013 is a technical report published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Guidelines for handling methacrylate-based materials in the dental laboratory". This standard covers: This Technical Report gives guidance for handling methacrylate-based polymer materials for dental purposes used in dental laboratories. The intention is to lower the risk of adverse effects on skin and airways when working with such materials. NOTE Aspects of this document may be applicable for other areas in Dentistry.
This Technical Report gives guidance for handling methacrylate-based polymer materials for dental purposes used in dental laboratories. The intention is to lower the risk of adverse effects on skin and airways when working with such materials. NOTE Aspects of this document may be applicable for other areas in Dentistry.
SIST-TP CEN/TR 16386:2013 is classified under the following ICS (International Classification for Standards) categories: 11.060.10 - Dental materials. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST-TP CEN/TR 16386:2013 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2013
Zobozdravstvo - Smernice za ravnanje z materiali na osnovi metakrilata v
zobozdravstvenem laboratoriju
Dentistry - Guidelines for handling methacrylate-based materials in the dental laboratory
Zahnheilkunde - Leitlinien zur Handhabung von methacrylatbasierenden Materialien im
zahntechnischen Labor
Médecine bucco-dentaire - Lignes directrices relatives à la manipulation des matériaux à
base de méthacrylate en laboratoire dentaire
Ta slovenski standard je istoveten z: CEN/TR 16386:2013
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL REPORT
CEN/TR 16386
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
January 2013
ICS 11.060.10
English Version
Dentistry - Guidelines for handling methacrylate-based materials
in the dental laboratory
Médecine bucco-dentaire - Lignes directrices relatives à la Zahnheilkunde - Leitlinien zur Handhabung von
manipulation des matériaux à base de méthacrylate en methacrylatbasierenden Materialien im zahntechnischen
laboratoire dentaire Labor
This Technical Report was approved by CEN on 10 June 2012. It has been drawn up by the Technical Committee CEN/TC 55.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 16386:2013: E
worldwide for CEN national Members.
Contents Page
Foreword . 3
Introduction . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Risk management. 4
4.1 Risk assessment . 4
4.2 Health surveillance . 4
4.3 Medical advice . 4
4.4 Reduction of risks . 5
4.4.1 General . 5
4.4.2 Skin . 5
4.4.3 Airways . 5
4.4.4 Eye protection . 5
Annex A (informative) Use of gloves . 6
A.1 General . 6
A.2 Recommendations . 6
Bibliography. 7
Foreword
This document (CEN/TR 16386:2013) has been prepared by Technical Committee CEN/TC 055 “Dentistry”,
the secretariat of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared by Working Group 8 Occupational risk assessments of CEN/TC 55
Dentistry.
Introduction
In 2008 CEN/TC 55 established a new working group WG 8 Occupational risk assessments. The rationale for
the group was concern about occupational health issues for personnel working with methacrylate-based
products in dentistry. These materials (e.g. removable denture and orthodontic base materials, tray materials,
dental repair materials etc.) may pose a risk because of the presence of methacrylate monomers. The
objective of WG 8 was to review the present status regarding the prevalence and awareness of the risk of
methacrylate based materials among dental personnel. In addition the occupational health and safety
regulations in different countries were considered. Based on the results of the survey carried out by the group,
this Technical Report has been produced as a guideline for handling methacrylate based materials in dental
laboratories to maintain the safety of the occupational environment.
Aspects of this report may be applicable to dental practises.
After reviewing the scientific literature and making an investigation among European dental technicians,
adverse effects on the skin see
...
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