DIN EN ISO 11608-1:2015-04
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
Hardcopy , PDF
29-08-2022
English, German
01-04-2015
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
6 Reagent and apparatus
7 Determination of dose accuracy
8 Preparation and operation of NISs
9 Test matrix
10 Test descriptions
11 Inspection
12 Test report
13 Information supplied by the manufacturer
Annex A (informative) - Dose replicates, accuracy
and testing rationale
Annex B (normative) - One- and two-sided tolerance
limit factors, k
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Bibliography
Defines requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers.
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 11608-1 : 2015 | Identical |
| NBN EN ISO 11608-1 : 2015 | Identical |
| SN EN ISO 11608-1 : 2015 | Identical |
| UNI EN ISO 11608-1 : 2012 | Identical |
| NS EN ISO 11608-1 : 2015 | Identical |
| I.S. EN ISO 11608-1:2015 | Identical |
| NF EN ISO 11608-1 : 2015 | Identical |
| ISO 11608-1:2014 | Identical |
| EN ISO 11608-1:2015 | Identical |
| UNE-EN ISO 11608-1:2015 | Identical |
| BS EN ISO 11608-1:2015 | Identical |
| NEN EN ISO 11608-1 : 2015 | Identical |
| DIN EN ISO 11608-4:2016-03 (Draft) | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| DIN EN ISO 11608-2:2012-12 | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012) |
| DIN EN ISO 11608-7:2015-08 (Draft) | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| ISO 11608-4:2006 | Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| VDE 0750-1-2 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES REQUIREMENTS AND TESTS (IEC 60601-1-2:2014) |
| DIN EN ISO 14253-1:2013-12 | GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - INSPECTION BY MEASUREMENT OF WORKPIECES AND MEASURING EQUIPMENT - PART 1: DECISION RULES FOR PROVING CONFORMITY OR NONCONFORMITY WITH SPECIFICATIONS (ISO 14253-1:2013) |
| DIN EN 62366 : 2016 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
| 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 |
| DIN EN 60068-2-6 : 1996 | ENVIRONMENTAL TESTING - PART 2-6: TESTS - TEST FC: VIBRATION (SINUSOIDAL) |
| VDE 0750-101 : 2016 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| DIN EN 60068-2-30:2006-06 | ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE) |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| VDE 0750-241 : 2016 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
| ISO 16269-6:2014 | Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| DIN ISO 16269-6:2009-10 | STATISTICAL INTERPRETATION OF DATA - PART 6: DETERMINATION OF STATISTICAL TOLERANCE INTERVALS |
| IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| DIN EN ISO 9000:2015-11 | QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015) |
| DIN EN 61000-4-3 : 2011 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 9001:2015 | Quality management systems — Requirements |
| DIN EN 60601-1-9 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007 + A1:2013) |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| DIN EN ISO 9001:2015-11 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
| DIN EN 62304 : 2016 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| DIN EN 61000-4-2 : 2009 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-2: TESTING AND MEASUREMENT TECHNIQUES - ELECTROSTATIC DISCHARGE IMMUNITY TEST |
| IEC 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| DIN EN 60601-1-11 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015) |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
| 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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