EN ISO 9997:2020

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
• Withdrawal Date: 30-Aug-2020
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 12-Feb-2020
• Completion Date: 12-Feb-2020
• Ref Project: SIST EN ISO 9997:2020 - Dentistry - Cartridge syringes (ISO 9997:2020)

Relations

• Replaces: EN ISO 9997:1999 - Dental cartridge syringes (ISO 9997:1999)
• Effective Date: 19-Feb-2020

Overview

EN ISO 9997:2020 - Dentistry - Cartridge syringes (ISO 9997:2020) specifies requirements and test methods for cartridge syringes used with dental local anaesthetic cartridges. It covers non‑aspirating, aspirating and self‑aspirating syringe types that use standard cartridges, and addresses materials, dimensions, functional tests and instructions for use. The standard applies to cartridge syringes with ISO metric thread sizes (Annex A notes the existence of imperial threads) and explicitly excludes syringes that use a mechanical‑advantage action to create high pressure.

Key topics and technical requirements

• Classification: Type 1 - non‑aspirating; Type 2 - aspirating (plunger‑drawn aspiration); Type 3 - self‑aspirating (diaphragm deflection).
• Materials: Metal and plastic components are permitted; manufacturers must demonstrate compliance through inspection and reprocessing tests.
• Dimensions and interfaces: Metric needle‑mounting hub threads must comply with ISO 261 and ISO 965‑1; syringe geometry (barrel, plunger rod, viewing port, finger grip) is specified for safe loading and use.
• Functional tests: Includes visual inspection, dimensional checks, secure loading, aspirating tests for Type 2 and Type 3, and plunger rod movement/displacement assessments.
• Resistance to reprocessing: New/strengthened requirements for the syringe’s ability to withstand cleaning, sterilization and reuse (where applicable) with associated test methods.
• Marking and information: Requirements for labelling on unit packs, syringe marking and instructions for use (including references to processing information in ISO 17664 and labelling symbols in ISO 15223‑1).
• Compatibility: Cartridge loading (side or breech), viewing of cartridge contents and plunger rod interaction with cartridge plunger are covered to ensure consistent performance with dental anaesthetic cartridges (see ISO 11499).

Applications and users

This standard is essential for:

• Manufacturers and designers of dental cartridge syringes - for product design, material selection, threaded interfaces and conformity assessment.
• Quality control and test laboratories - to perform dimensional, aspirating and reprocessing tests according to specified methods.
• Regulatory and procurement teams - to specify compliance in tenders, technical files and conformity documentation.
• Dental clinics and procurement departments - to understand compatibility, safe use, reprocessing expectations and labelling requirements.

Related standards

• ISO 11499 - Single‑use cartridges for local anaesthetics
• ISO 261 / ISO 965‑1 - Metric screw threads (general plan & tolerances)
• ISO 15223‑1 - Symbols for medical device labelling
• ISO 17664 - Information for processing (reprocessing) of medical devices

EN ISO 9997:2020 (adopted by CEN) supersedes the 1999 edition and includes updated normative references, added reprocessing requirements and tightened plunger rod tolerances.

Standards Content (Sample)

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

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.

Contents Page
European foreword . 3

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.

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
ISO 9997:2020(E)
© 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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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 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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