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ISO 11608-5

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions

active, Most Current
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Organization: ISO
Publication Date: 1 October 2012
Status: active
Page Count: 22
ICS Code (Syringes, needles and catheters): 11.040.25

Document History

11608-5
April 1, 2022
Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO). General requirements are provided for all...
ISO 11608-5
October 1, 2012
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
A description is not available for this item.

References

This document references:
ISO TR 19244 - Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of medicinal products and catheters
Published by ISO on August 15, 2014
This Technical Report outlines the recommended transition plans for all the TC 84 standards: - Needle-based Injection systems [ISO 11608 (all parts)]; - Sharps Injury Protection (ISO 23908); - Sharps...
This document references:
ISO 8537 - Sterile single-use syringes, with or without needle, for insulin
Published by ISO on March 15, 2016
This International Standard specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection...
This document references:
11608-1 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
Published by ISO on April 1, 2022
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be...
This document references:
IEC 60068-2-30 - Environmental testing – Part 2-30: Tests – Test Db: Damp heat, cyclic (12 h + 12 h cycle)
Published by IEC on August 1, 2005
This part of IEC 60068 determines the suitability of components, equipment or other articles for use, transportation and storage under conditions of high humidity – combined with cyclic temperature...
This document references:
ISO 9000 - Quality management systems — Fundamentals and vocabulary
Published by ISO on September 15, 2015
This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: — organizations seeking sustained success...
This document references:
11608-1 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
Published by ISO on April 1, 2022
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be...
This document references:
ISO 8537 - Sterile single-use syringes, with or without needle, for insulin
Published by ISO on March 15, 2016
This International Standard specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection...
This document references:
ISO TR 19244 - Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of medicinal products and catheters
Published by ISO on August 15, 2014
This Technical Report outlines the recommended transition plans for all the TC 84 standards: - Needle-based Injection systems [ISO 11608 (all parts)]; - Sharps Injury Protection (ISO 23908); - Sharps...
This document is referenced by:
ISO 11040-4 - Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Published by ISO on April 1, 2015
This part of ISO 11040 applies to — tubing-glass barrels (single-chamber design) for injection preparations, and — sterilized subassembled syringes ready for filling. It specifies materials,...
This document is referenced by:
DIN EN ISO 11608-1 - Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)
Published by DIN on September 1, 2022
A description is not available for this item.
This document is referenced by:
JIS T 3226-1 - Needle-based injection systems for medical use - Part 1: Needle-based injection systems - Requirements and test methods
Published by JSA on October 1, 2015
A description is not available for this item.
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