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ÖNORM EN ISO 11608-1:2015-03

Действует
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 10993-1:2009/Cor.1:2010
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process -- Technical Corrigendum 1 — 1 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 14253-1:2017
Действует
Geometrical product specifications (GPS) -- Inspection by measurement of workpieces and measuring equipment -- Part 1: Decision rules for verifying conformity or nonconformity with specifications — 30 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO/IEC Guide 98-3:2008/Suppl.1:2008
Действует
Uncertainty of measurement -- Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) -- Supplement 1: Propagation of distributions using a Monte Carlo method — 98 стр.
IEC 60068-2-6:2007 ed7.0
Действует
Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal) — 82 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 60601-1-2:2007 ed3.0
Заменен
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests — 122 стр.
IEC 62366:2007+AMD1:2014 CSV ed1.1
Заменен
Medical devices - Application of usability engineering to medical devices — 436 стр.
ÖNORM EN ISO 11608-1:2012-12
Заменен
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012)

На этот документ ссылаются

DIN EN ISO 11608-1:2015-04
Действует
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014); German version EN ISO 11608-1:2015 — 52 стр.
ÖNORM EN ISO 11608-1:2012-12
Заменен
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012)