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BS EN ISO 11608-2:2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Needle-based injection systems for medical use. Requirements and test methods Needles
Available format(s)

Hardcopy , PDF

Superseded date

15-07-2022

Language(s)

English

Published date

30-04-2012

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Sampling
6 Pre-conditioning of needles
7 Standard atmosphere and apparatus for tests
8 Determination of dislocation of measuring
   point at patient end
9 Bond between hub and needle tube
10 Packaging
11 Test method for validating the compatibility
   of needles and injector systems
12 Information supplied by the manufacturer
Annex A (normative) - Determination of flow rate
        through needle
Bibliography

Describes 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.

This part of ISO11608 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO11608-1.

It is not applicable to:

  • needles for dental use;

  • pre-filled syringe needles;

  • needles pre-assembled by the manufacturer;

  • needles not requiring assembly or attachment to the NIS.

Committee
CH/84
DevelopmentNote
Supersedes 97/563388 DC (03/2005) Supersedes 10/30209603 DC. (04/2012)
DocumentType
Standard
Pages
28
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

ISO 15510:2014 Stainless steels Chemical composition
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO/IEC Guide 98-1:2009 Uncertainty of measurement — Part 1: Introduction to the expression of uncertainty in measurement
ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels
IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)

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Hardcopy - English
PDF - English
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