BS EN ISO 11608-5:2023 – TC

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Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods – Automated functions

Published By	Publication Date	Number of Pages
BSI	2023	82

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Categories: 11.040.25 - Syringes, needles and catheters, BSI

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Description

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PDF Pages	PDF Title
1	30472380
49	A-30461612
50	undefined
52	European foreword Endorsement notice
54	Foreword
55	Introduction
57	1 Scope 2 Normative references
58	3 Terms and definitions
60	4 Requirements 4.1 General requirements
61	4.2 Medicinal product preparation
62	4.3 Needle preparation 4.4 Needle hiding 4.5 Priming 4.6 Dose setting 4.7 Needle insertion 4.8 Injection depth control
63	4.9 Dose delivery 4.10 Recording of device functions 4.11 Needle retraction 4.11.1 Completion of dose delivery 4.11.2 Needle retraction distance 4.11.3 Communication of completion 4.12 Disabling the NIS-AUTO
64	4.13 Needle shielding 4.13.1 General 4.13.2 Needle shielding before injection 4.13.3 Needle shielding after injection 4.14 Needle removal from the NIS-AUTO 5 Test methods 5.1 General
65	5.2 Test conditions 5.3 Actuation 5.4 Medicinal product preparation 5.5 Needle inspection 5.6 Needle hiding
66	5.7 Priming 5.8 Needle extension 5.9 Injection time
67	5.10 Dose accuracy 5.11 Retracted position 5.12 Disabling the NIS-AUTO 5.13 Needle shielding 5.13.1 Needle shielding before and after injection 5.13.2 Needle shielding after free fall 6 Information supplied with the NIS-AUTO
68	Annex A (informative) Rationale for requirements
70	Annex B (informative) Example of a test method for dose accuracy at intended injection depth
72	Annex C (informative) Needle extension and intended injection depth
78	Bibliography

Additional information

Status	Definitive
Pages	82
Publication Date	2023-04-13
ISBN	978 0 539 26647 4
Standard Number	BS EN ISO 11608-5:2023 – TC
Title	Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods – Automated functions
Descriptors	Injection guns, Medical equipment, Performance, Syringes, Drug administration, Parenteral infusion equipment, Performance testing, Injection instruments, Electrical medical equipment, Medical instruments
Publisher	BSI
Committee	CH/84
ICS Codes	11.040.25 - Syringes, needles and catheters

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BS EN ISO 11608-5:2023 – TC

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