BS EN ISO 11070:2014+A1:2018

Действует

Sterile single-use intravascular introducers, dilators and guidewires — 34 стр.

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 10993-1:2009

Заменен

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.

ISO 8601:2004

Действует

Data elements and interchange formats -- Information interchange -- Representation of dates and times — 40 стр.

ISO 594-2:1998

Заменен

Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings — 16 стр.

ISO 7886-1:2017

Действует

Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use — 36 стр.

ISO 9626:1991

Заменен

Stainless steel needle tubing for the manufacture of medical devices — 16 стр.

ISO 10555-1:2013/Amd.1:2017

Действует

Intravascular catheters -- Sterile and single-use catheters -- Part 1: General requirements -- Amendment 1 — 6 стр.

ISO 7864:2016

Действует

Sterile hypodermic needles for single use -- Requirements and test methods — 32 стр.

ISO 10555-4:2013

Действует

Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters — 18 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 17665-1:2006

Действует

Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices — 48 стр.

ISO 11135-1:2007

Заменен

Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — 48 стр.

ASTM F640-12

Заменен

Standard Test Methods for Determining Radiopacity for Medical Use — 4 стр.

ISO 10555-3:2013

Действует

Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters — 8 стр.

ISO 10555-5:2013

Действует

Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters — 16 стр.

ISO 11137-2:2013

Действует

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose — 76 стр.