DIN EN ISO 11608-4:2016-03 (Draft)
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
Available format(s)
Hardcopy , PDF
Superseded date
07-03-2021
Language(s)
German
Published date
01-01-2016
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Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Symbole und Abkürzungen
5 Allgemeine Anforderungen
6 Prüfbedingungen
7 Vorbehandlung der Pen-Injektoren
8 Prüfflüssigkeit und Prüfgerät
9 Bestimmung der Dosiergenauigkeit
10 Mängelfreiheit
11 Bestimmung der elektromagnetischen Verträglichkeit
12 Elektrische Sicherheit
13 Sichtprüfung
14 Funktionsprüfung
15 Prüfbericht
16 Vom Hersteller zu liefernde Informationen
Literaturhinweise
Defines requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges.
| DevelopmentNote |
DRAFT 2016 issued in March 2016. (04/2016)
|
| DocumentType |
Draft
|
| Pages |
197
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 11608-4 : 2007 | Identical |
| NS EN ISO 11608-4 : 1ED 2007 | Identical |
| I.S. EN ISO 11608-4:2007 | Identical |
| BS EN ISO 11608-4:2007 | Identical |
| UNE-EN ISO 11608-4:2008 | Identical |
| ISO 11608-4:2006 | Identical |
| SN EN ISO 11608-4 : 2007 | Identical |
| NF EN ISO 11608-4 : 2007 | Identical |
| NEN EN ISO 11608-4 : 2008 | Identical |
| EN ISO 11608-4:2007 | Identical |
| NBN EN ISO 11608-4 : 2007 | Identical |
| DIN EN ISO 11608-3:2013-01 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012) |
| DIN EN ISO 11608-1:2015-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| DIN EN 60601-1-1 : 2002 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| IEC 61000-4-1:2006 | Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| DIN EN 60068-2-64 : 1995 | ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE |
| 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) |
| IEC 60721-3-7:1995+AMD1:1996 CSV | Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use |
| ISO 11608-1:2014 | Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| DIN EN 60068-2-30:2006-06 | ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE) |
| ISO 11608-2:2012 | Needle-based injection systems for medical use Requirements and test methods Part 2: Needles |
| DIN EN 60721-3-7:1995-09 | CLASSIFICATION OF ENVIRONMENTAL CONDITIONS - PART 3: CLASSIFICATION OF GROUPS OF ENVIRONMENTAL PARAMETERS AND THEIR SEVERITIES - SECTION 7: PORTABLE AND NON-STATIONARY USE |
| 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 |
| DIN EN 60068-2-27 : 1995 | ENVIRONMENTAL TESTING - PART 2-27: TESTS - TEST EA AND GUIDANCE: SHOCK |
| ISO 11608-3:2012 | Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| 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 61000-4-3 : 2011 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
| VDE 0750-1-1 : 2002 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY; 1 COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
| 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) |
| VDE 0847-4-3 : 2011 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
| VDE 0750-1 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| 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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