Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017)

ISO 20749:2017 specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable for the creation of a single dental restoration.
ISO 20749:2017 specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam and the capsule, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking.
ISO 20749:2017 is not applicable to dental amalgam alloys supplied as a free-flowing powder in bulk quantities or as powder compressed into tablets, or to dental mercury supplied in sachets or bulk quantities.
This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this document. For the assessment of possible biological hazards, reference can be made to ISO 10993‑1 and ISO 7405.
The scope of this document is restricted to dental amalgam products marketed in pre-capsulated form alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are within the scope of ISO 24234.

Zahnheilkunde - Gekapseltes zahnärztliches Amalgam (ISO 20749:2017)

Dieses Dokument legt die Anforderungen und Prüfverfahren für zahnärztliches Amalgam fest, das dem Anwender in vordosierten Kapseln in einer Menge ausgeliefert wird, mit der die zahnärztliche Amalgam¬legierung und das dentales Quecksilber zur Herstellung einer einzelnen dentalen Restauration geeignet ist.
Dieses Dokument legt Anforderungen an und Prüfverfahren für zahnärztliche Amalgamlegierungen, die zur Herstellung von zahnärztlichem Amalgam und der Kapsel geeignet sind fest, zusammen mit Anforderungen an und Prüfverfahren für diese dentalen Amalgame und Anforderungen an Verpackung und Kennzeichnung.
Dieses Dokument gilt nicht für zahnärztliche Amalgamlegierungen, die als frei fließendes loses Pulver oder als in Tablettenform gepresstes Pulver ausgeliefert werden und nicht für dentales Quecksilber, das in Beuteln oder lose ausgeliefert wird.
Dieses Dokument gilt nicht für andere metallische Legierungen, bei denen ein Legierungspulver mit einer Legierung reagiert, die bei Umgebungstemperaturen flüssig ist, um dadurch ein festes metallisches Material herzustellen, das für dentale Restaurationen vorgesehen ist.
Dieses Dokument enthält keine besonderen qualitativen und quantitativen Prüfverfahren zum Ausschluss nicht zulässiger biologischer Risiken. Zur Beurteilung möglicher biologischer Risiken wird empfohlen, ISO 10993 1 und ISO 7405 heranzuziehen.
Der Anwendungsbereich dieses Dokuments ist ausschließlich auf zahnärztliche Amalgame beschränkt, die in vordosierten Kapseln vertrieben werden. Andere Produkte für die Verwendung bei der Herstellung von dentalen Amalgamrestaurationen (zahnärztliches Amalgam als frei fließendes loses Pulver, zahnärztliches Amalgamlegierungspulver in Tablettenform gepresst und dentale Quecksilberbeutel) liegen im Anwen¬dungsbereich von ISO 24234.

Médecine bucco-dentaire - Amalgame dentaire en capsules prédosées (ISO 20749:2017)

L'ISO 20749:2017 spécifie les exigences et les méthodes d'essai applicables aux amalgames dentaires fournis à l'utilisateur sous forme de capsules, prédosées avec l'alliage pour amalgame dentaire et le mercure à usage dentaire dans des quantités appropriées pour créer une seule restauration dentaire.
L'ISO 20749:2017 spécifie les exigences et les méthodes d'essai applicables aux alliages pour amalgame dentaire utilisés dans la préparation des amalgames dentaires et des capsules, les exigences et les méthodes d'essai relatives à ces amalgames dentaires et les exigences d'emballage et de marquage.
L'ISO 20749:2017 n'est applicable ni aux alliages pour amalgame dentaire fournis sous forme de poudre fluide en vrac ou de poudre sous forme de comprimés ni au mercure à usage dentaire fourni sous forme de sachets ou en vrac.
L'ISO 20749:2017 n'est pas applicable à d'autres matériaux métalliques dans lesquels une poudre d'alliage réagit avec un alliage liquide à température ambiante pour produire un matériau métallique solide destiné à la restauration dentaire.
L'ISO 20749:2017 ne comporte aucune méthode d'essai qualitative et quantitative spécifique démontrant l'absence de dangers biologiques inacceptables. Pour évaluer la possibilité de tels dangers, il est possible de se référer à l'ISO 10993‑1 et à l'ISO 7405.
Le domaine d'application de l'ISO 20749:2017 est limité aux amalgames dentaires commercialisés sous forme de capsules prédosées uniquement. Les autres produits destinés à être utilisés pour la production de restaurations en amalgame dentaire (alliage d'amalgame dentaire sous forme de poudre fluide en vrac, poudre d'alliage pour amalgame dentaire sous forme de comprimés et sachets de mercure à usage dentaire) font partie du domaine d'application de l'ISO 24234.

Zobozdravstvo - Pripravljeni zobni amalgam (ISO 20749:2017)

Standard ISO 20749:2017 določa zahteve in preskusne metode za zobozdravstvene izdelke iz pripravljenega zobnega amalgama z vnaprej dodanimi količinami zobne amalgamske zlitine in živega srebra, ki so primerne za popravilo enega zoba.
ISO 20749:2017 določa zahteve in preskusne metode za zlitine zobnega amalgama, ki so primerne za izdelavo pripravljenega zobnega amalgama, skupaj z zahtevami in preskusnimi metodami za ta zobni amalgam ter zahtevami za pakiranje in označevanje.
ISO 20749:2017 se ne uporablja za zlitine zobnega amalgama, ki so dobavljene v večjih količinah kot sipki prah, kot prah, stisnjen v tablete ali kot zobno živo srebro, dobavljeno v vrečkah ali večjih količinah.
Ta dokument se ne uporablja za druge kovinske materiale, pri katerih zlitina prahu reagira z zlitino, ki je tekoča pri sobni temperaturi, pri čemer nastane trden kovinski material za popravilo zob.
Ta dokument ne zajema posebnih kvalitativnih in kvantitativnih preskusnih metod za dokazovanje neprisotnosti nesprejemljivih bioloških tveganj. Za oceno bioloških tveganj se lahko sklicuje na standarda ISO 10993‑1 in ISO 7405.
Področje uporabe tega dokumenta je omejeno na izdelke iz zobnega amalgama, ki se tržijo kot pripravljeni zobni amalgam. Drugi izdelki, ki so namenjeni popravilu zob s pomočjo amalgama (zlitina zobnega amalgama v obliki sipkega prahu, dobavljenega v večjih količinah, prah zlitine zobnega amalgama, dobavljen v obliki tablet in zobno živo srebro, dobavljeno v vrečkah) spadajo na področje uporabe standarda ISO 24234.

General Information

Status
Published
Publication Date
04-Sep-2018
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
05-Sep-2018
Completion Date
05-Sep-2018

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SLOVENSKI STANDARD
SIST EN ISO 20749:2018
01-oktober-2018
1DGRPHãþD
SIST EN ISO 24234:2015
Zobozdravstvo - Pripravljeni zobni amalgam (ISO 20749:2017)
Dentistry - Pre-capsulated dental amalgam (ISO 20749:2017)
Zahnheilkunde - Vorgefertigte Amalgamkapseln (ISO 20749:2017)
Médecine bucco-dentaire - Amalgame dentaire en capsules prédosées (ISO
20749:2017)
Ta slovenski standard je istoveten z: EN ISO 20749:2018
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 20749:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 20749:2018
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SIST EN ISO 20749:2018
EN ISO 20749
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2018
EUROPÄISCHE NORM
ICS 11.060.10
English Version
Dentistry - Pre-capsulated dental amalgam (ISO
20749:2017)

Médecine bucco-dentaire - Amalgame dentaire en Zahnheilkunde - Gekapseltes zahnärztliches Amalgam

capsules prédosées (ISO 20749:2017) (ISO 20749:2017)
This European Standard was approved by CEN on 22 July 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20749:2018 E

worldwide for CEN national Members.
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SIST EN ISO 20749:2018
EN ISO 20749:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 20749:2018
EN ISO 20749:2018 (E)
European foreword

The text of ISO 20749:2017 has been prepared by Technical Committee ISO/TC 106 "Dentistry” of the

International Organization for Standardization (ISO) and has been taken over as EN ISO 20749:2018 by

Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by March 2019, and conflicting national standards shall

be withdrawn at the latest by March 2019.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 20749:2017 has been approved by CEN as EN ISO 20749:2018 without any modification.

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SIST EN ISO 20749:2018
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SIST EN ISO 20749:2018
INTERNATIONAL ISO
STANDARD 20749
First edition
2017-03
Dentistry — Pre-capsulated dental
amalgam
Médecine bucco-dentaire — Amalgame dentaire en capsules
prédosées
Reference number
ISO 20749:2017(E)
ISO 2017
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SIST EN ISO 20749:2018
ISO 20749:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 20749:2018
ISO 20749:2017(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Requirements .......................................................................................................................................................................................................... 3

4.1 Package and capsule contamination .................................................................................................................................... 3

4.2 Chemical composition and purity of the dental amalgam alloy ................................................................... 3

4.3 Large particles in the dental amalgam alloy powder ............................................................................................. 3

4.4 Loss of mass from the capsule during mixing .............................................................................................................. 3

4.5 The yield of amalgam from the capsule ............................................................................................................................. 3

4.6 Consistency of the dental amalgam from capsule to capsule ......................................................................... 4

4.7 Properties of the dental amalgam .......................................................................................................................................... 4

4.7.1 Creep .......................................................................................................................................................................................... 4

4.7.2 Dimensional changes during hardening ...................................................................................................... 4

4.7.3 Compressive strength at 1 h .................................................................................................................................. 4

4.7.4 Compressive strength at 24 h ............................................................................................................................... 4

4.8 Appearance of the mixed dental amalgam before setting ................................................................................. 4

4.9 Length tolerance for the capsule ............................................................................................................................................. 4

5 Sampling ........................................................................................................................................................................................................................ 5

6 Test methods ............................................................................................................................................................................................................. 5

6.1 Package and capsule contamination .................................................................................................................................... 5

6.1.1 Principle .................................................................................................................................................................................. 5

6.1.2 Test sample ........................................................................................................................................................................... 5

6.1.3 Apparatus ............................................................................................................................................................................... 5

6.1.4 Procedure ............................................................................................................................................................................... 5

6.1.5 Expression of the results ........................................................................................................................................... 5

6.1.6 Report ........................................................................................................................................................................................ 5

6.2 Chemical composition and purity of the dental amalgam alloy ................................................................... 5

6.2.1 Principle .................................................................................................................................................................................. 5

6.2.2 Test sample ........................................................................................................................................................................... 6

6.2.3 Apparatus ............................................................................................................................................................................... 6

6.2.4 Procedure ............................................................................................................................................................................... 6

6.2.5 Expression of results .................................................................................................................................................... 6

6.2.6 Report ........................................................................................................................................................................................ 6

6.3 Large particles in the dental amalgam alloy powder ............................................................................................. 6

6.3.1 Principle .................................................................................................................................................................................. 6

6.3.2 Test sample ........................................................................................................................................................................... 7

6.3.3 Apparatus ............................................................................................................................................................................... 7

6.3.4 Test procedure ................................................................................................................................................................... 7

6.3.5 Expression of the results ........................................................................................................................................... 7

6.3.6 Report ........................................................................................................................................................................................ 7

6.4 Loss of mass from the capsule during mixing .............................................................................................................. 8

6.4.1 Principle .................................................................................................................................................................................. 8

6.4.2 Test sample ........................................................................................................................................................................... 8

6.4.3 Apparatus ............................................................................................................................................................................... 8

6.4.4 Test procedure ................................................................................................................................................................... 8

6.4.5 Expression of the results ........................................................................................................................................... 9

6.4.6 Report ........................................................................................................................................................................................ 9

6.5 Yield of amalgam from the capsule ....................................................................................................................................... 9

6.5.1 Principle .................................................................................................................................................................................. 9

6.5.2 Test sample ........................................................................................................................................................................... 9

© ISO 2017 – All rights reserved iii
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SIST EN ISO 20749:2018
ISO 20749:2017(E)

6.5.3 Apparatus ............................................................................................................................................................................... 9

6.5.4 Test procedure ................................................................................................................................................................10

6.5.5 Expression of the results ........................................................................................................................................10

6.5.6 Report .....................................................................................................................................................................................10

6.6 Consistency of the dental amalgam from capsule to capsule ......................................................................10

6.6.1 Principle ...............................................................................................................................................................................10

6.6.2 Test sample ........................................................................................................................................................................11

6.6.3 Apparatus ............................................................................................................................................................................11

6.6.4 Test-piece production ...............................................................................................................................................12

6.6.5 Microhardness measurement ............................................................................................................................13

6.6.6 Expression of the results ........................................................................................................................................13

6.6.7 Report .....................................................................................................................................................................................14

6.7 Properties of the dental amalgam .......................................................................................................................................14

6.7.1 Principle ..............................................................................................................................................................................14

6.7.2 Sample....................................................................................................................................................................................14

6.7.3 Mould for the preparation of cylindrical test-pieces for determining creep,

dimensional change during hardening and compressive strength ...................................14

6.7.4 Preparation of cylindrical test-pieces to determine compliance with
the requirements for creep, dimensional change during hardening and

compressive strength ........................................................................................................................................... .....18

6.7.5 Determination of creep ...........................................................................................................................................20

6.7.6 Determination of dimensional change during hardening .........................................................21

6.7.7 Determination of compressive strength ...................................................................................................22

6.8 Appearance of the mixed dental amalgam before setting ..............................................................................23

6.8.1 Principle ...............................................................................................................................................................................23

6.8.2 Apparatus ............................................................................................................................................................................24

6.8.3 Test procedure ................................................................................................................................................................24

6.8.4 Expression of the results ........................................................................................................................................24

6.8.5 Report .....................................................................................................................................................................................25

6.9 Length tolerance for the capsule ..........................................................................................................................................25

6.9.1 Principle ...............................................................................................................................................................................25

6.9.2 Test sample ........................................................................................................................................................................25

6.9.3 Apparatus ............................................................................................................................................................................25

6.9.4 Test procedure ................................................................................................................................................................25

6.9.5 Expression of the results ........................................................................................................................................25

6.9.6 Report .....................................................................................................................................................................................25

7 Marking, labelling and packaging ...................................................................................................................................................26

7.1 Packaging ..................................................................................................................................................................................................26

7.2 Marking and labelling ....................................................................................................................................................................26

7.2.1 Information........................................................................................................................................................................26

7.2.2 Labelling of a package for dental mercury .............................................................................................26

7.2.3 Labelling of the outer surface of package or container used for shipping ..................27

7.3 Manufacturer’s instructions .....................................................................................................................................................27

7.3.1 General instructions...................................................................................................................................................27

7.3.2 Precautionary notes ...................................................................................................................................................27

Bibliography .............................................................................................................................................................................................................................28

iv © ISO 2017 – All rights reserved
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SIST EN ISO 20749:2018
ISO 20749:2017(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO’s adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: w w w . i s o .org/ iso/ foreword .html.

This document was prepared by ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative

materials.
© ISO 2017 – All rights reserved v
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SIST EN ISO 20749:2018
ISO 20749:2017(E)
Introduction

This is the first edition of this document. Its scope is limited solely to dental amalgam alloy and dental

mercury that are supplied pre-capsulated in masses that are sufficient to produce a mass of dental

amalgam that is considered to be suitable for a single small or medium size restoration in a single tooth.

Dental amalgam alloy and dental mercury are the essential and only components of dental amalgam

restorative material. This document specifies the requirements and the test methods for dental

amalgam alloy that is suitable for the preparation of dental amalgam, together with those for the set

dental amalgam, those for the capsules themselves and the requirements for packaging and marking.

This document has been developed in response to the UNEP Minamata Convention on Mercury. The

objective of the Minamata Convention is to reduce anthropogenic mercury pollution by restricting

the use of mercury, products containing mercury and materials that release mercury during use. In

this convention, dental amalgam is classified as a “mercury-added product”, for which parties to the

agreement are to adopt two or more measures from a list of nine. One of these is “restricting the

use of dental amalgam to its encapsulated form”. In some countries, the term encapsulated has been

interpreted as the pre-capsulated form alone. Given the increased vigilance on the use of dental amalgam

products since 2013, when the Minamata Agreement was signed, this document will enable countries

that do not allow the use of products other than those that are pre-capsulated to adopt an ISO standard

on dental amalgam. Not all of the membership of the UN has signed the Minamata Convention and in

non-signatory countries, dental amalgam products outside the scope of this document, but within the

scope of ISO 24234, will continue to be marketed. Thus, both standards are required to provide full

global coverage for compliance.

Although this document is based on ISO 24234, there have been significant technical changes. Also, the

requirements for the capsule that were in ISO 13897 have been transferred to this document, treating

a product that falls within the scope as an entity. This document differs technically from ISO 24234 in

the following respects:
— The scope of this document is restricted to pre-capsulated products alone.

— A requirement for packaging and capsule to be free from contamination is present.

— The requirement concerning foreign matter in the dental amalgam alloy powder has been removed.

— A requirement for loss of mass from the capsule during mixing has been added.

— A requirement for the yield of dental amalgam from a capsule replaces the requirement for the

masses of dental mercury and dental amalgam powder present before mixing.

— A requirement for the consistency in the ratio of dental mercury to dental amalgam alloy powder

in capsules has been changed radically. Determination of the effect of variation in this ratio upon

properties replaces weighing the dental mercury and the dental amalgam alloy powder.

— Requirements for the capsule have been introduced and revised technically.

A decision was taken not to alter requirements upon which capsulation has no bearing, these being:

— the requirements on chemical composition and purity of the dental amalgam alloy;

— the requirements for the properties of dental amalgam;
— the requirement for the appearance of dental amalgam before setting.

As with ISO 24234, the inclusion of a requirement for corrosion resistance was considered. However, it

was agreed that the data available were insufficient to set a corrosion resistance requirement in this

edition of this document. A requirement for the corrosion resistance will be set and incorporated at the

earliest possible date. It is recommended that in assessing corrosion resistance of a dental amalgam

product (relative to other dental amalgam products), reference can be made to ISO/TS 17988.

vi © ISO 2017 – All rights reserved
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SIST EN ISO 20749:2018
INTERNATIONAL STANDARD ISO 20749:2017(E)
Dentistry — Pre-capsulated dental amalgam
1 Scope

This document specifies the requirements and test methods for dental amalgam products supplied to

the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities sui

...

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