ÖNORM EN ISO 8537:2016-10

Действует

Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

Ссылочные документы

ISO 594-1:1986

Заменен

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements — 12 стр.

ISO 3696:1987

Действует

Water for analytical laboratory use; Specification and test methods — 8 стр.

ISO 7864:1993

Заменен

Sterile hypodermic needles for single use — 16 стр.

ISO 9626:1991/Amd.1:2001

Заменен

Stainless steel needle tubing for the manufacture of medical devices. Amendment 1 — 10 стр.

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 11608-1:2012

Заменен

Needle-based injection systems for medical use -- Requirements and test methods -- Part 1: Needle-based injection systems — 48 стр.

ISO 11608-5:2012

Действует

Needle-based injection systems for medical use -- Requirements and test methods -- Part 5: Automated functions — 22 стр.

ISO 14971:2007

Действует

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

ISO 15223-1:2012

Заменен

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements — 30 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.

IEC 62366-1:2015+AMD1:2020 CSV ed1.1

Действует

Medical devices - Part 1: Application of usability engineering to medical devices — 246 стр.

ÖNORM EN ISO 8537:2008-09

Заменен

Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)

На этот документ ссылаются

ÖNORM EN ISO 8537:2008-09

Заменен

Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)

ÖNORM EN 13718-2:2020-10

Действует

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances