ISO 11499:2014 PDF

Name: ISO 11499:2014 — Dentistry — Single-use cartridges for local anaesthetics
SKU: ISO 11499:2014
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Dentistry — Single-use cartridges for local anaesthetics

Название (английский):

ISO 11499:2014

Dentistry — Single-use cartridges for local anaesthetics

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 21 мая 2014 г.
Издание:: ISO IS 11499 edition 3 version 1
ICS:: 11.040.10

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Описание (английский):

ISO 11499:2014 gives specific performance requirements for single-use dental cartridges of 1,0 ml, 1,7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics. ISO 11499:2014 specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall dimensions to ensure that the cartridge will fit dental cartridge syringes. Labelling requirements are also specified.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview - ISO 11499:2014 (Dentistry - Single-use cartridges for local anaesthetics)

ISO 11499:2014 specifies performance, testing and labelling requirements for single‑use dental cartridges (1.0 ml, 1.7 ml, 1.8 ml and 2.2 ml nominal capacity) used with dental cartridge syringes. The standard ensures cartridges reliably deliver local anaesthetics by defining tests for leakage, plunger movement, extractable volume, air‑bubble control, dimensional limits and labelling. It supports compatibility with cartridge syringes complying with ISO 9997 and ISO 21533 and recommends biocompatibility assessment with ISO 10993-1/ISO 7405.

Key topics and technical requirements

Nominal capacities covered: 1.0 ml, 1.7 ml, 1.8 ml, 2.2 ml.

Leakage: Cartridges must be free from leakage. Test applies a 30 N axial force to the plunger for 1 minute and inspects for failure.

Plunger movement (force requirements):

Force to initiate movement ≤ 30 N.
Force to sustain movement throughout effective length: 2 N ≤ F ≤ 20 N.

Extractable volume: Measured by emptying cartridge into a graduated container (or gravimetrically); extractable volume must be at least the stated nominal volume.

Air bubble control: Air bubble must not be visible below the rim of the metal cap when cartridge is held vertically and tapped.

Dimensions:

Max overall lengths: 1.0 ml = 44.0 mm; 1.7/1.8 ml = 65.0 mm; 2.2 ml = 77.5 mm.
Max overall diameter (including label): 9.0 mm.

Colour coding (optional): If used, two indelible bands indicate anaesthetic agent/concentration and vasoconstrictor/concentration with specified positions, widths and Pantone color guidance.

Sampling and test conditions: Sample size 10 cartridges per batch; tests at (20 ± 5) °C.

Marking and labelling: Primary and secondary container labelling requirements include manufacturer, extractable volume, active ingredients/concentrations, lot number, expiry date, storage recommendations and latex warnings.

Practical applications - who uses ISO 11499:2014

Manufacturers of dental cartridges and components - for product design, quality control and regulatory compliance.

Testing laboratories and quality assurance teams - to perform standardized leakage, force and extractable volume tests.

Regulatory bodies and notified bodies - to evaluate conformity for market approval.

Dental clinics and procurement specialists - to select compatible, safe single‑use cartridges for cartridge syringes.

R&D and product engineers - for designing cartridges that meet dimensional and functional performance criteria.

Related standards

ISO 9997 (Dental cartridge syringes)

ISO 21533 (Reusable cartridge syringes, intraligamentary)

ISO 7885 (Sterile injection needles)

ISO 15223-1 (Medical device labelling symbols)

ISO 1942 (Dental vocabulary)

ISO 10993-1 / ISO 7405 (biocompatibility guidance)

Keywords: ISO 11499:2014, dental cartridges, single‑use cartridges, local anaesthetics, leakage test, plunger force, extractable volume, color coding, cartridge dimensions, dental cartridge syringes.

ISO 11499:2014 PDF

Abstract

Похожие стандарты

Overview - ISO 11499:2014 (Dentistry - Single-use cartridges for local anaesthetics)

Key topics and technical requirements

Practical applications - who uses ISO 11499:2014

Related standards

Технические детали

SIST EN ISO 9997:2020

Dentistry - Cartridge syringes (ISO 9997:2020)

SIST EN ISO 21533:2018

Dentistry - Reprocessable cartridge syringes for intraligamentary injections (ISO 21533:2018)

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

SIST EN ISO 7405:2025

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025)

SIST EN ISO 7885:2010

Dentistry - Sterile injection needles for single use (ISO 7885:2010)

SIST EN ISO 15223-1:2021/A1:2026

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General re…

BS ISO 19426-3:2018

Structures for mine shafts. Sinking stages.