UNE-EN ISO 11608-5:2013

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 5: Automated functions (ISO 11608-5:2012)

Available format(s): Hardcopy, PDF

Superseded date: 04-10-2023

Language(s): Spanish, Castilian, English

Published date: 20-03-2013

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Committee	CTN 111
Document Type	Standard
ISBN
Pages
Published
Publisher	Asociacion Espanola de Normalizacion
Status	Superseded
Superseded By	UNE-EN ISO 11608-5:2023

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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Committee	CTN 111
Document Type	Standard
ISBN
Pages
Published
Publisher	Asociacion Espanola de Normalizacion
Status	Superseded
Superseded By	UNE-EN ISO 11608-5:2023

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)