BS EN ISO 11608-5:2012

Действует

Needle-based injection systems for medical use. Requirements and test methods. Automated functions — 24 стр.

Ссылочные документы

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 14971:2007

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

IEC 62366:2007 ed1.0

Заменен

Medical devices - Application of usability engineering to medical devices — 209 стр.

ISO/IEC Guide 98-3:2008/Suppl.1:2008/Cor.1:2009

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 -- Technical Corrigendum 1 — 2 стр.

ISO 8537:2016

Действует

Sterile single-use syringes, with or without needle, for insulin — 34 стр.

ISO 11608-2:2012

Действует

Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles — 24 стр.

ISO 11608-3:2012

Действует

Needle-based injection systems for medical use -- Requirements and test methods -- Part 3: Finished containers — 16 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 13485:2003

Заменен

Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 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 23908:2011

Действует

Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling — 18 стр.