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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.25 Syringes, needles and catheters>20/30382352 DC BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods Part 3. NIS containers and integrated fluid paths
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20/30382352 DC BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods Part 3. NIS containers and integrated fluid paths

20/30382352 DC

BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods Part 3. NIS containers and integrated fluid paths

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Standard number:20/30382352 DC
Pages:34
Released:2020-02-28
Status:Draft for Comment
DESCRIPTION

20/30382352 DC


This standard 20/30382352 DC BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:
  • 11.040.25 Syringes, needles and catheters

This document specifies requirements and test methods for design verification of containers and integrated fluid paths to be used with Needle-Based Injection Systems (NIS) that fulfil the requirements of ISO 11608-1 (and other subparts as appropriate). It is applicable to single and multi-dose containers (either filled by the manufacturer [primary container closure] or by the end-user [reservoir]) and fluid paths that are integrated with the NIS at the point of manufacture.

NOTE

Prefilled syringes (ISO 11040-8) are included in the scope when used with a NIS; see also scope of ISO 11608-1:20xx.

Products excluded from scope are:

  • sterile hypodermic needles for single use;

  • sterile hypodermic syringes for single use;

  • sterile single-use syringes, with or without needle, for insulin;

  • containers that can be refilled multiple times;

  • containers intended for dental use;

  • catheters or infusion sets that are attached or assembled separately by the user.


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