ISO 11040-1:2015 PDF

Name: ISO 11040-1:2015 — Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges
SKU: ISO 11040-1:2015
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Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges

Название (английский):

ISO 11040-1:2015

Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 4
Дата публикации:: 19 ноября 2015 г.
Издание:: ISO IS 11040 edition 2 version 1
ICS:: 11.040.10

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Описание (английский):

ISO 11040-1:2015 specifies the design, dimensions, materials, performance and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only. NOTE 1 Cartridges of 1,0 ml size are described in ISO 11499. It applies to primary packs used in direct contact with a drug. NOTE 2 The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 11040-1:2015 - Prefilled syringes, Part 1: Glass cylinders for dental local anaesthetic cartridges - specifies the design, dimensions, materials, performance and test methods for single‑use glass cylinders (cartridges) used to contain dental local anaesthetics. It covers glass cylinders with nominal volumes of 1.7 ml, 1.8 ml and 2.2 ml, and applies to primary packaging that is in direct contact with a drug. The standard links material and performance requirements to the safety, potency and stability of the contained drug.

Key topics and technical requirements

Design & dimensions

Typical lengths: 62.4 ± 0.4 mm (1.7/1.8 ml) and 75.0 ± 0.4 mm (2.2 ml).
Neck opening: 3.15 ± 0.15 mm over a depth of 5 ± 0.2 mm; truncated‑cone geometry allowed within specified tolerances.

Material

Colourless glass of hydrolytic resistance grain class ISO 720 HGA 1.
Manufacturers should notify users of glass composition changes at least nine months before implementation.

Performance & integrity

Internal surface hydrolytic resistance must meet ISO 4802 HC 1 (tested per ISO 4802‑1 or ISO 4802‑2). Before testing, the cylinder bottom shall be sealed (e.g., silicon rubber).
Sealing surface at neck must be flat and free from ripples to ensure sealing performance.
No seeds/bubbles or internal air lines that interfere with visual inspection or cause leakage.
If annealed, residual stress must not produce optical retardation exceeding 40 nm/mm of glass thickness (test method by agreement).

Marking & traceability

Outer packaging must be marked with size, quantity, cylinder designation, manufacturer name/symbol and lot number or production date.

Normative references

References include ISO 720, ISO 4802‑1, ISO 4802‑2 (hydrolytic resistance tests).

Applications and who uses this standard

Manufacturers of dental local anaesthetic cartridges and glass tubing - to design, produce and qualify compliant glass cylinders.

Quality control & testing laboratories - to perform hydrolytic resistance, visual inspection and residual stress checks.

Medical device regulators and auditors - to verify primary packaging meets material and performance requirements for drug contact.

Procurement and OEMs - for supplier specifications, acceptance criteria and traceability of single‑use cartridges.

Dental product designers ensuring cartridge compatibility with syringes and seals.

Related standards

ISO 11040 series (Parts 2–8) - covers stoppers, seals, barrels, plungers and packaging for prefilled syringes.

ISO 11499 - single‑use dental cartridges of 1.0 ml size.

ISO 720, ISO 4802‑1, ISO 4802‑2 - referenced test methods for hydrolytic resistance.

Keywords: ISO 11040-1:2015, prefilled syringes, glass cylinders, dental local anaesthetic cartridges, hydrolytic resistance, cartridge dimensions, single‑use dental cartridges.

ISO 11040-1:2015 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Технические детали

ISO 7206-13:2016/Amd 1:2022

Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of resistance to torqu…

ISO 4802-1:2010

Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by tit…

ISO 4802-2:2010

Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by fla…

BS ISO 11040-6:2019

Prefilled syringes. Plastic barrels for injectables and sterilized subassembled syringes ready for filling.

BS EN ISO 11499:2014

Dentistry. Single-use cartridges for local anaesthetics.