Стандарты ISO. 11 Health care technology / Здравоохранение

ISO 13779-3:2018

Действует

Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity — 40 стр.

ISO 10079-1:2015/Amd.1:2018

Действует

Medical suction equipment -- Part 1: Electrically powered suction equipment -- Amendment 1: Changes to requirements for operating at extremes of temperature — 6 стр.

ISO 81060-2:2009/Cor.1:2011

Действует

Non-invasive sphygmomanometers -- Part 2: Clinical validation of automated measurement type -- Technical Corrigendum 1 — 2 стр.

ISO 8359:1996/Amd.1:2012

Действует

Oxygen concentrators for medical use -- Safety requirements -- Amendment 1 — 8 стр.

ISO 8980-1:2004

Действует

Ophthalmic optics -- Uncut finished spectacle lenses -- Part 1: Specifications for single-vision and multifocal lenses — 14 стр.

ISO 8980-1:2004/Cor.1:2006

Действует

Ophthalmic optics -- Uncut finished spectacle lenses -- Part 1: Specifications for single-vision and multifocal lenses -- Technical Corrigendum 1 — 1 стр.

ISO 10993-4:2017

Действует

Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood — 76 стр.

ISO 8980-2:2004

Действует

Ophthalmic optics -- Uncut finished spectacle lenses -- Part 2: Specifications for progressive power lenses — 14 стр.

ISO 8980-2:2004/Cor.1:2006

Действует

Ophthalmic optics -- Uncut finished spectacle lenses -- Part 2: Specifications for progressive power lenses -- Technical Corrigendum 1 — 1 стр.

ISO 9170-1:2008

Действует

Terminal units for medical gas pipeline systems -- Part 1: Terminal units for use with compressed medical gases and vacuum — 28 стр.

ISO 9917-2:2010

Действует

Dentistry -- Waterbased cements -- Part 2: Resinmodified cements — 26 стр.

ISO/IEC 10779:2008

Действует

Information technology -- Office equipment accessibility guidelines for elderly persons and persons with disabilities — 30 стр.

ISO/IEC 13066-1:2011

Действует

Information technology -- Interoperability with assistive technology (AT) -- Part 1: Requirements and recommendations for interoperability — 42 стр.

ISO/PAS 18761:2013

Действует

Use and handling of medical devices covered by the scope of ISO/TC 84 -- Risk assessment on mucocutaneous blood exposure — 8 стр.

ISO 11491:2017

Действует

Implants for surgery -- Determination of impact resistance of ceramic femoral heads for hip joint prostheses — 16 стр.

ISO 11070:2014/Amd.1:2018

Действует

Sterile single-use intravascular introducers, dilators and guidewires -- Amendment 1 — 8 стр.

ISO 11135:2014/Amd.1:2018

Действует

Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices -- Amendment 1: Revision of Annex E, Single batch release — 10 стр.

ISO 11137-1:2006/Amd.2:2018

Действует

Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices -- Amendment 2: Revision to 4.3.4 and 11.2 — 6 стр.

ISO 11137-3:2006

Действует

Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects — 22 стр.

ISO 11137-3:2017

Действует

Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects of development, validation and routine control — 48 стр.