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BSI - BS EN ISO 11608-1 - TC

Tracked Changes (Redline) - Needle-based injection systems for medical use — Requirements and test methods Part 1: Needle-based injection systems

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Organization: BSI
Publication Date: 25 February 2020
Status: active
Page Count: 108
ICS Code (Syringes, needles and catheters): 11.040.25

Document History

BS EN ISO 11608-1 - TC
October 17, 2023
Tracked Changes (Redline) - Needle-based injection systems for medical use — Requirements and test methods Part 1: Needle-based injection systems
A description is not available for this item.
BS EN ISO 11608-1 - TC
February 25, 2020
Tracked Changes (Redline) - Needle-based injection systems for medical use — Requirements and test methods Part 1: Needle-based injection systems
A description is not available for this item.

References

This document references:
IEC 60601-1-9 - Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design
Published by IEC on July 1, 2020
This International Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. MEDICAL ELECTRICAL SYSTEMS are excluded...
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:
IEC 60068-2-6 - Environmental testing – Part 2-6: Tests – Test Fc: Vibration (sinusoidal)
Published by IEC on December 1, 2007
This part of IEC 68 gives a method of test which provides a standard procedure to determine the ability of components, equipment and other articles, hereinafter referred to as specimens, to withstand...
This document references:
IEC 60601-1-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Published by IEC on September 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
This document references:
IEC 61000-4-2 - Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic discharge immunity test
Published by IEC on December 1, 2008
This International Standard relates to the immunity requirements and test methods for electrical and electronic equipment subjected to static electricity discharges, from operators directly, and to...
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