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DSF/PREN ISO 11608-2

Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles (ISO/DIS 11608-2:2020)

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Organization: DS
Status: active
Page Count: 31
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

This document specifies requirements, test methods and compatibility requirements for singleuse, double-ended, sterile needles used with needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1. NOTE - Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608-3, and hypodermic needles provided separately are covered in ISO 7864. This document is not applicable to: - needles for dental use; - pre-filled syringe needles; - needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).

Document History

May 10, 2022
Needle-based injection systems for medical use – Requirements and test methods – Part 2: Double-ended pen needles (ISO 11608-2:2022)
This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated...
May 24, 2012
Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles
ISO 11608-2:2012 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.
March 21, 2001
Pen-injectors for medical use - Part 2: Needles - Requirements and test methods
This part of the standard specifies requirements and test methods for single use, double-ended, sterile needles for pen-injectors which fulfil the specifications of ISO 11608-1. It is not applicable...
DSF/PREN ISO 11608-2
Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles (ISO/DIS 11608-2:2020)
This document specifies requirements, test methods and compatibility requirements for singleuse, double-ended, sterile needles used with needle-based injection systems (NISs) that fulfil the...
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO/DIS 11608-2:2010)
A description is not available for this item.
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO/DIS 11608-2:2010)
This part of ISO 11608 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1....
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