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BS EN ISO 11608-1:2015

Действует
Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems — 52 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

IEC 62304:2006 ed1.0
Действует
Medical device software - Software life cycle processes — 78 стр.
IEC 61000-4-3:2006 ed3.0
Заменен
Electromagnetic compatibility (EMC) - Part 4-3 : Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test — 111 стр.
IEC 61000-4-2:2008 ed2.0
Действует
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test — 129 стр.
IEC 60601-1-11:2010/COR1:2011 ed1.0
Заменен
Corrigendum 1 - 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 — 0 стр.
IEC 60601-1-9:2007 ed1.0
Действует
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design — 60 стр.
ISO 16269-6:2014
Действует
Statistical interpretation of data -- Part 6: Determination of statistical tolerance intervals — 54 стр.
ISO 11608-4:2006
Действует
Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors — 18 стр.
ISO 9001:2015
Действует
Quality management systems -- Requirements — 40 стр.
IEC 62366:2007 ed1.0
Заменен
Medical devices - Application of usability engineering to medical devices — 209 стр.
IEC 60601-1-2:2007/ISH1:2010 ed3.0
Заменен
Interpretation sheet 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests — 0 стр.
IEC 60068-2-30:2005 ed3.0
Действует
Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle) — 14 стр.
IEC 60068-2-6:2007 ed7.0
Действует
Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal) — 82 стр.
ISO/IEC Guide 98-3:2008/Suppl.2:2011
Действует
Uncertainty of measurement -- Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) -- Supplement 2: Extension to any number of output quantities — 84 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO 14253-1:2013
Заменен
Geometrical product specifications (GPS) -- Inspection by measurement of workpieces and measuring equipment -- Part 1: Decision rules for proving conformity or nonconformity with specifications — 22 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 11608-1:2012
Заменен
Needle-based injection systems for medical use -- Requirements and test methods -- Part 1: Needle-based injection systems — 48 стр.
ISO 10993-11:2006
Заменен
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 стр.
BS EN ISO 11608-1:2012
Заменен
Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems — 52 стр.

На этот документ ссылаются

BS EN ISO 11608-1:2012
Заменен
Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems — 52 стр.