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  • BS EN ISO 11608-5:2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Needle-based injection systems for medical use. Requirements and test methods Automated functions

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-03-2023

    Language(s):  English

    Published date:  31-10-2012

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Test methods
    6 Test report
    7 Information to be supplied by the manufacturer
    Annex A (informative) - Rationale for requirements
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.

    Scope - (Show below) - (Hide below)

    This part of ISO11608 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans, including but not limited to: drug product preparation (e.g. reconstitution); needle preparation; air removal; priming; dose setting; actuation; needle insertion; injection of the medicinal product; disabling the NIS-AUTO; needle retraction; needle shielding; needle hiding; sharps injury protection; needle removal.

    General Product Information - (Show below) - (Hide below)

    Committee CH/84
    Development Note Supersedes 10/30213842 DC. (10/2012) Reviewed and confirmed by BSI, May 2018. (05/2018)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11608-4:2006 Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 14253-1:2017 Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
    ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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