BS EN ISO 21649:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
6 Test methods
7 Test report
8 Information supplied by the manufacturer
Annex A (informative) - Two-sided tolerance limit
                        factors (k)
Annex B (informative) - Examples of accuracy limit
                        calculations and random settings
Annex C (informative) - Correspondence between ISO/IEC
                        standards and EN standards
Annex ZA (informative) - Relationship between this
                         International Standard and
                         the Essential Requirements
                         of EU Directive 93/42/EEC
Bibliography

Pertains to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.

This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.

The dose chamber of the injection system is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber also may be a permanent internal chamber designed to last through the claimed life of the device.

Excluded from this International Standard are drug delivery methods which:

• involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices);

• generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters);

• deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops);

• apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices);

• infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.