ISO 21649 Needle-free injectors for medical use Test Machine
ISO 21649:2006– Needle-free injectors for medical use — Requirements and test methods
ISO 21649:2006 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.
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
- ISO 3207:1975, Statistical interpretation of data — Determination of a statistical tolerance interval
- ISO 3746:1995, Acoustics — Determination of sound power levels of noise sources using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane
- ISO 10993 (all parts), Biological evaluation of medical devices
- ISO 11201:1995, Acoustics — Noise emitted by machinery and equipment — Measurement of emission sound pressure levels at a work station and at other specified positions — Engineering method in an essentially free field over a reflecting plane
- ISO 11202:1995, Acoustics — Noise emitted by machinery and equipment — Measurement of emission sound pressure levels at a work station and at other specified positions — Survey method in situ
- ISO 11204:1995, Acoustics — Noise emitted by machinery and equipment — Measurement of emission sound pressure levels at a work station and at other specified positions — Method requiring environmental corrections
- ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General requirements
- ISO 14155-2:2003, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
- ISO 14253-1:1998, Geometrical Product Specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for proving conformance or non-conformance with specifications
- IEC 60068-2-27:1987, Environmental testing — Part 2: Tests. Test Ea and guidance: Shock
- IEC 60068-2-30:2005, Environmental testing — Part 2-30: Tests. Test Db and guidance: Damp heat, cyclic (12 h + 12 h cycle)
- IEC 60068-2-32:1975, Environmental testing — Part 2: Tests. Test Ed: Free fall
- IEC 60068-2-64:1993, Environmental testing — Part 2: Test methods — Test Fh: Vibration, broad-band random (digital control) and guidance
- IEC 60601-1-1:2000, Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems
- IEC 60721-3-7:2002, Classification of environmental conditions — Part 3-7: Classification of groups of environmental parameters and their severities — Portable and non-stationary use
- IEC 61000-4-2:2001, Electromagnetic compatibility (EMC) — Part 4-2: Testing and measurement techniques — Electrostatic discharge immunity test
- IEC 61000-4-3:2002, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement techniques — Radiated, radio-frequency, electromagnetic field immunity test
- IEC 61672-1:2002, Electroacoustics — Sound level meters — Part 1: Specifications
- GUM:1995, Guide to the Expression of Uncertainty in Measurement (GUM). BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML — First edition 1993, corrected and reprinted 1995
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