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I.S. EN ISO 11608-5:2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012)
Available format(s)

Hardcopy , PDF

Superseded date

23-03-2023

Language(s)

English

Published date

01-01-2012

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
Annex ZA (informative) - Relationship between this
          European Standard and the Essential
          Requirements of EC Directive 93/42/EEC
          on medical devices

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.

DocumentType
Standard
Pages
29
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

Standards Relationship
ISO 11608-5:2012 Identical
EN ISO 11608-5:2012 Identical

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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$66.40
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