EN ISO 9997:1999

Dental cartridge syringes (ISO 9997:1999)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Revision of EN 29997:1992.

Zahnärztliche Ampullenspritzen (ISO 9997:1999)

Seringues à usage dentaire pour cartouches (ISO 9997:1999)

La présente Norme internationale spécifie les exigences et les méthodes d'essai s'appliquant aux seringues à usage dentaire réutilisables, du type à aspiration, sans aspiration et à auto-aspiration, destinées à être utilisées avec des cartouches d'anesthésique local dentaire.La présente Norme internationale ne s'applique pas aux seringues pour cartouches présentant l'avantage mécanique de créer une haute pression.

Dental cartridge syringes (ISO 9997:1999)

General Information

• Status: Withdrawn
• Publication Date: 14-Dec-1999
• Withdrawal Date: 11-Feb-2020
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 12-Feb-2020
• Ref Project: SIST EN ISO 9997:2000 - Dental cartridge syringes (ISO 9997:1999)

Relations

• Replaces: EN 29997:1992 - Dental cartridge syringes (ISO 9997:1990)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 9997:2020 - Dentistry - Cartridge syringes (ISO 9997:2020)
• Effective Date: 19-Feb-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2000
1DGRPHãþD
SIST EN 29997:2000
Dental cartridge syringes (ISO 9997:1999)
Dental cartridge syringes (ISO 9997:1999)
Zahnärztliche Ampullenspritzen (ISO 9997:1999)
Seringues a usage dentaire pour cartouches (ISO 9997:1999)
Ta slovenski standard je istoveten z: EN ISO 9997:1999
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

INTERNATIONAL ISO
STANDARD 9997
Second edition
1999-12-15
Dental cartridge syringes
Seringues à usage dentaire pour cartouches
Reference number
ISO 9997:1999(E)
©
ISO 1999
ISO 9997:1999(E)
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ii © ISO 1999 – All rights reserved

ISO 9997:1999(E)
Contents Page
Foreword.iv
Introduction.v
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 .3
5.3 Dimensions.3
6 Test methods.3
6.1 Visual inspection .3
6.2 Aspirating test for syringes of Type 2a .3
6.3 Aspirating test for syringes of Type 2b .4
6.4 Plunger rod tests .4
6.5 Boiling water test for corrosion .6
6.6 Autoclave test for corrosion.6
6.7 Thermal test (metal syringes only) .6
7 Information supplied by the manufacturer.6
8 Marking .6
8.1 Marking of unit pack.6
8.2 Marking of syringe.6
Annex A (informative) Imperial thread size.7
© ISO 1999 – All rights reserved iii

ISO 9997:1999(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 9997 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 4, Dental instruments.
This second edition cancels and replaces the first edition (ISO 9997:1990), which has been technically revised as
follows:
� the dental cartridge syringes are now classified into non-aspirating and aspirating types with a subclassification
according to aspiration of force produced by drawing the plunger or by the deflection of a diaphragm;
� improved description of plunger rod test;
� corrosion test in accordance with ISO 13402;
� marking now requires lot number.
iv © ISO 1999 – All rights reserved

ISO 9997:1999(E)
Introduction
This International Standard specifies requirements for dental cartridge syringes with ISO metric thread sizes only.
However, attention is drawn to the existence of a variety of syringes with Imperial thread sizes (see annex A).
© ISO 1999 – All rights reserved v

INTERNATIONAL STANDARD ISO 9997:1999(E)
Dental cartridge syringes
1 Scope
This International Standard specifies requirements and test methods for dental cartridge syringes which are
reusable dental syringes of the aspirating, non-aspirating and self-aspirating types using cartridges with dental local
anaesthetics.
This International Standard is not applicable to cartridge syringes having a mechanical-advantage action for
creating high pressure.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are en
...