JIS T 3226-1:2023
Current
The latest, up-to-date edition.
Needle-based injection systems for medical use -- Part 1: Needle-based injection systems -- Requirements and test methods
English
01-07-2023
This Standard specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this Standard include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.
| DocumentType |
Standard
|
| Pages |
45
|
| PublisherName |
Japanese Standards Association
|
| Status |
Current
|
| Supersedes |
| JIS T 3226-2:2011 | Pen-injectors for medical use -- Part 2: Needles -- Requirements and test methods Part 2: Needles - Requirements and test methods |
| JIS C 60068-2-30:2011 | Environmental testing -- Part 2-30: Tests -- Test Db: Damp heat, cyclic (12 h + 12 h cycle) |
| JIS T 62366-1:2022 | Medical devices -- Part 1: Application of usability engineering to medical devices |
| JIS C 60068-2-6:2010 | Environmental testing -- Part 2-6: Tests -- Test Fc: Vibration (sinusoidal) Part 2-6: Tests - Test Fc: Vibration (sinusoidal) |
| JIS Q 13485:2018 | Medical devices -- Quality management systems -- Requirements for regulatory purposes |
| JIS B 0641-1:2020 | Geometrical product specifications (GPS) -- Inspection by measurement of workpieces and measuring equipment -- Part 1: Decision rules for proving conformance or nonconformance with specifications |
| JIS T 14971:2020 | Medical devices -- Application of risk management to medical devices |
| JIS T 0601-1-2:2023 | Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests |
| JIS T 0993-1:2020 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process |
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