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10/30213842 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 11608-5 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS
Available format(s)

Hardcopy , PDF

Superseded date

31-10-2012

Language(s)

English

Publisher

British Standards Institution

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
Annex ZA (informative) - Relationship between this
         International Standard and the Essential
         Requirements of EU Directive 93/42/EEC
Bibliography

BS EN ISO 11608-5

Committee
CH/84
DocumentType
Draft
Pages
28
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
PREN ISO 11608-5 : DRAFT 2010 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/IEC Guide 98:1993 Guide to the expression of uncertainty in measurement (GUM)
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 16269-6:2014 Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)

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Hardcopy - English
PDF - English
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