Dentistry - Cartridge syringes (ISO 9997:2020)

This document specifies requirements and test methods for cartridge syringes used in dentistry. These syringes are of the non-aspirating, aspirating and self-aspirating types using cartridges with dental local anaesthetics.
This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure.
This document specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).

Zahnheilkunde - Ampullenspritzen (ISO 9997:2020)

Dieses Dokument legt Anforderungen und Prüfverfahren fest für Ampullenspritzen, die in der Zahnheilkunde verwendet werden. Diese Spritzen sind vom nicht-aspirierenden, aspirierenden und selbst-aspirierenden Typ und verwenden Ampullen mit dentalen Lokalanästhetika.
Dieses Dokument gilt nicht für Ampullenspritzen, bei denen mit einer mechanischen Bewegungsvorrichtung ein hoher Druck erzeugt wird.
Dieses Dokument legt Anforderungen an Ampullenspritzen mit metrischen ISO-Gewindegrößen fest. Es wird darauf hingewiesen, dass es eine Anzahl von Spritzen mit englischen Gewindegrößen gibt (siehe Anhang A).

Médecine bucco-dentaire - Seringues pour cartouches (ISO 9997:2020)

Le présent document spécifie les exigences et les méthodes d'essai applicables aux seringues pour cartouches utilisées en médecine bucco-dentaire, qui sont des seringues du type à aspiration, sans aspiration et à auto-aspiration, utilisant des cartouches d'anesthésique local dentaire.
Le présent document n'est pas applicable aux seringues pour cartouches présentant l'avantage mécanique de créer une haute pression.
Le présent document spécifie les exigences applicables aux seringues pour cartouches à filetage métrique ISO. Cependant, l'attention est attirée sur l'existence d'un type de seringues à filetages en pouces (voir Annexe A).

Zobozdravstvo - Dodatek brizgalke (ISO 9997:2020)

General Information

Status
Published
Publication Date
11-Feb-2020
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
12-Feb-2020
Completion Date
12-Feb-2020

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SLOVENSKI STANDARD
SIST EN ISO 9997:2020
01-april-2020
Nadomešča:
SIST EN ISO 9997:2000
Zobozdravstvo - Dodatek brizgalke (ISO 9997:2020)
Dentistry - Cartridge syringes (ISO 9997:2020)
Zahnheilkunde - Ampullenspritzen (ISO 9997:2020)
Médecine bucco-dentaire - Seringues pour cartouches (ISO 9997:2020)
Ta slovenski standard je istoveten z: EN ISO 9997:2020
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
11.060.20 Zobotehnična oprema Dental equipment
SIST EN ISO 9997:2020 en

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

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SIST EN ISO 9997:2020
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SIST EN ISO 9997:2020
EN ISO 9997
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2020
EUROPÄISCHE NORM
ICS 11.040.25; 11.060.20 Supersedes EN ISO 9997:1999
English Version
Dentistry - Cartridge syringes (ISO 9997:2020)

Médecine bucco-dentaire - Seringues pour cartouches Zahnheilkunde - Ampullenspritzen (ISO 9997:2020)

(ISO 9997:2020)
This European Standard was approved by CEN on 21 January 2020.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, 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

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9997:2020 E

worldwide for CEN national Members.
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SIST EN ISO 9997:2020
EN ISO 9997:2020 (E)
Contents Page

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

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SIST EN ISO 9997:2020
EN ISO 9997:2020 (E)
European foreword

This document (EN ISO 9997:2020) has been prepared by Technical Committee ISO/TC 106 "Dentistry"

in collaboration with 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 August 2020, and conflicting national standards shall

be withdrawn at the latest by August 2020.

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.

This document supersedes EN ISO 9997:1999.

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, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 9997:2020 has been approved by CEN as EN ISO 9997:2020 without any modification.

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SIST EN ISO 9997:2020
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SIST EN ISO 9997:2020
INTERNATIONAL ISO
STANDARD 9997
Third edition
2020-01
Dentistry — Cartridge syringes
Médecine bucco-dentaire — Seringues pour cartouches
Reference number
ISO 9997:2020(E)
ISO 2020
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SIST EN ISO 9997:2020
ISO 9997:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 9997:2020
ISO 9997:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

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

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

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Classification ............................................................................................................................................................................................................ 2

5 Requirements .......................................................................................................................................................................................................... 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Materials ....................................................................................................................................................................................................... 2

5.3 Dimensions ................................................................................................................................................................................................. 2

5.4 Special requirements ......................................................................................................................................................................... 3

5.4.1 Loading and cartridge size ...................................................................................................................................... 3

5.4.2 Viewing of contents ....................................................................................................................................................... 4

5.4.3 Plunger rod ........................................................................................................................................................................... 4

5.4.4 Aspirating syringes ........................................................................................................................................................ 4

5.5 Resistance to reprocessing ........................................................................................................................................................... 5

6 Measurement and test methods ........................................................................................................................................................... 5

6.1 Visual inspection ................................................................................................................................................................................... 5

6.2 Dimensions ................................................................................................................................................................................................. 5

6.3 Secure loading ......................................................................................................................................................................................... 5

6.4 Aspirating test for cartridge syringes of Type 2 ......................................................................................................... 5

6.4.1 Reagent ...................................................................... ............................................................................................................... 5

6.4.2 Procedure ............................................................................................................................................................................... 5

6.4.3 Observation .......................................................................................................................................................................... 5

6.5 Aspirating test for cartridge syringes of Type 3 ......................................................................................................... 5

6.5.1 Reagent ...................................................................... ............................................................................................................... 5

6.5.2 Procedure ............................................................................................................................................................................... 5

6.5.3 Observation .......................................................................................................................................................................... 6

6.6 Plunger rod ................................................................................................................................................................................................. 6

6.6.1 Plunger rod movement ............................................................................................................................................... 6

6.6.2 Plunger rod displacement ........................................................................................................................................ 6

6.7 Resistance to reprocessing ........................................................................................................................................................... 6

7 Instructions for use ........................................................................................................................................................................................... 6

8 Marking .......................................................................................................................................................................................................................... 7

8.1 Labelling on the unit pack ............................................................................................................................................................. 7

8.2 Marking of syringe ............................................................................................................................................................................... 7

Annex A (informative) Imperial thread sizes .............................................................................................................................................. 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2020 – All rights reserved iii
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SIST EN ISO 9997:2020
ISO 9997:2020(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 subjec

...

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