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UNE-EN ISO 11608-3:2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

07-01-2022

Language(s)

Spanish, Castilian, English

Published date

03-20-2013

Questo Standard definisce metodi di prestazioni e test per multidose Single-chamber, si preriempito, finito cartucce impiegate come primario Contenitori in dispositivi a iniezione di penna. La progettazione e le dimensioni sono specificate Per cartucce di Tipo A. Questo Standard non è applicabile a Cartucce di multicamera, cartucce che sono riempite dall'utente E le cartucce hanno destinato a uso dentale.

Committee
CTN 111
DocumentType
Standard
Pages
18
PublisherName
Asociacion Espanola de Normalizacion
Status
Superseded
SupersededBy
Supersedes

ISO 13926-1:2004 Pen systems Part 1: Glass cylinders for pen-injectors for medical use
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
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
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
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

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