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DIN EN ISO 11608-3:2013-01

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - Part 3: Finished containers (ISO 11608-3:2012)
Available format(s)

Hardcopy , PDF

Superseded date

08-29-2022

Language(s)

English, German

Published date

01-01-2013

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 Freedom from leakage
  4.2 Initiating force
  4.3 Sustaining force
  4.4 Dimensions
  4.5 Eccentricity
  4.6 Visibility of the medicinal product
  4.7 Meniscus
  4.8 Resealability
  4.9 Cap
  4.10 Plunger and disc
  4.11 Material of the cylinder
  4.12 Lubrication
  4.13 Dose accuracy
  4.14 Deliverable volume and last-dose
       accuracy
5 Test Methods
  5.1 Test apparatus
  5.2 Test conditions
  5.3 Test fluid
  5.4 Analytical approach
  5.5 Leakage (attribute)
  5.6 Forces required to initiate and
      sustain plunger movement (attribute)
  5.7 Dimensions (attribute)
  5.8 Eccentricity (attribute)
  5.9 Meniscus (attribute)
  5.10 Resealability (attribute)
  5.11 Dose accuracy (variable)
  5.12 Deliverable volume (attribute)
  5.13 Last-dose accuracy (variable)
6 Information supplied by the manufacturer
Bibliography

Describes the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1.

DocumentType
Standard
Pages
18
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

DIN EN ISO 11608-4:2016-03 (Draft) PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
DIN EN ISO 11608-2:2012-12 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)

DIN EN ISO 7864:2015-01 (Draft) STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO 7864:2016)
ISO 13926-1:2004 Pen systems Part 1: Glass cylinders for pen-injectors for medical use
DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
DIN ISO 13926-1:2005-10 PEN SYSTEMS - PART 1: GLASS CYLINDERS FOR PEN-INJECTORS FOR MEDICAL USE
ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
ISO 11040-3:2012 Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
DIN EN ISO 7886-1:2015-10 (Draft) STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 13926-2:2011 Pen systems Part 2: Plunger stoppers for pen-injectors for medical use
DIN EN ISO 9000:2015-11 QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
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
DIN EN ISO 8537:2008-10 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)

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Hardcopy - English
PDF - English
Hardcopy - German
PDF - German
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