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BS EN 1041:2008

Действует
Information supplied by the manufacturer of medical devices — 28 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

BS EN 980:2003
Заменен
Graphical symbols for use in the labelling of medical devices — 28 стр.
BS EN ISO 3166-1:2006
Заменен
Codes for the representation of names of countries and their subdivisions. Country codes — 84 стр.
BS ISO 639-1:2002
Действует
Codes for the representation of the names of languages. Alpha-2 code — 48 стр.
BS ISO 10007:2003
Заменен
Quality management systems. Guidelines for configuration management — 20 стр.
BS ISO 8601:2004
Действует
Data elements and interchange formats. Information interchange. Representation of dates and times — 42 стр.
BS EN 3759:1997
Действует
Screws, pan head, offset cruciform recess, threaded to head, in heat and corrosion resisting steel, passivated. Classification: 1100 MPa (at ambient temperature)/425$0DC — 14 стр.
BS EN 3769:1997
Действует
Electrolytic polishing of corrosion resisting steels and heat resisting alloys — 14 стр.
BS EN 556-1:2001
Действует
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices — 12 стр.
BS EN 556-2:2003
Заменен
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices — 12 стр.
BS EN 591:2001
Заменен
Instructions for use for in vitro diagnostic instruments for professional use — 14 стр.
BS EN 592:2002
Заменен
Instructions for use for in vitro diagnostic instruments for self-testing — 14 стр.
BS EN ISO 7808:1999
Действует
Plastics. Thermosetting moulding materials. Determination of transfer flow — 10 стр.
BS EN ISO 13485:2012
Заменен
Medical devices. Quality management systems. Requirements for regulatory purposes — 86 стр.
BS ISO 7000:2004
Действует
Graphical symbols for use on equipment. Index and synopsis — 212 стр.
BS EN ISO 14971:2012
Действует
Medical devices. Application of risk management to medical devices — 104 стр.
BS EN ISO 15225:2010
Заменен
Medical devices. Quality management. Medical device nomenclature data structure — 30 стр.
BS EN ISO 17664:2004
Заменен
Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices — 26 стр.
BS EN 1041:2008+A1:2013
Действует
Information supplied by the manufacturer of medical devices — 28 стр.
BS EN 1041:1998
Заменен
Information supplied by the manufacturer with medical devices — 20 стр.

На этот документ ссылаются

BS EN 1639:2004
Заменен
Dentistry. Medical devices for dentistry. Instruments — 18 стр.
BS EN 1640:2004
Заменен
Dentistry. Medical devices for dentistry. Equipment — 16 стр.
BS EN 1641:2004
Заменен
Dentistry. Medical devices for dentistry. Materials — 14 стр.
BS EN 1642:2004
Заменен
Dentistry. Medical devices for dentistry. Dental implants — 14 стр.
BS EN ISO 14534:2009
Заменен
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements — 22 стр.
BS EN ISO 16061:2008
Заменен
Instrumentation for use in association with non-active surgical implants. General requirements — 28 стр.
BS EN ISO 7376:2009
Заменен
Anaesthetic and respiratory equipment. Laryngoscopes for tracheal intubation — 28 стр.
DD ENV 12718:2001
Действует
Medical compression hosiery — 46 стр.
DD ENV 12719:2001
Действует
Medical thrombosis prophylaxis hosiery — 40 стр.
BS EN 12181:1998
Заменен
Oropharyngeal airways — 12 стр.
BS EN 12182:1999
Заменен
Technical aids for disabled persons. General requirements and test methods — 42 стр.
BS EN 1060-1:1995+A2:2009
Действует
Non-invasive sphygmomanometers. General requirements — 18 стр.
BS EN 1060-2:1995+A1:2009
Действует
Non-invasive sphygmomanometers. Supplementary requirements for mechanical sphygmomanometers — 26 стр.
BS EN ISO 11979-4:2008
Действует
Ophthalmic implants. Intraocular lenses. Labelling and information — 12 стр.
BS EN 13795:2011
Действует
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels — 26 стр.
BS EN ISO 7396-1:2007+A2:2010
Действует
Medical gas pipeline systems. Pipeline systems for compressed medical gases and vacuum — 152 стр.
BS EN 12470-4:2000+A1:2009
Заменен
Clinical thermometers. Performance of electrical thermometers for continuous measurement — 22 стр.
BS EN 12470-5:2003
Заменен
Clinical thermometers. Performance of infra-red ear thermometers (with maximum device) — 32 стр.
BS EN 980:2008
Заменен
Symbols for use in the labelling of medical devices — 38 стр.
BS EN 13795-1:2002+A1:2009
Заменен
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. General requirements for manufacturers, processors and products — 18 стр.
BS EN 1041:1998
Заменен
Information supplied by the manufacturer with medical devices — 20 стр.
BS EN ISO 11979-10:2006
Действует
Ophthalmic implants. Intraocular lenses. Phakic intraocular lenses — 28 стр.
BS EN ISO 11979-9:2006
Действует
Ophthalmic implants. Intraocular lenses. Multifocal intraocular lenses — 28 стр.
BS EN 14683:2005
Заменен
Surgical masks. Requirements and test methods — 20 стр.
BS EN 1782:1998
Заменен
Tracheal tubes and connectors — 28 стр.
BS EN 1782:1998+A1:2009
Заменен
Tracheal tubes and connectors — 36 стр.
BS EN 1283:1996
Заменен
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits — 20 стр.
BS EN 1789:2007+A1:2010
Действует
Medical vehicles and their equipment. Road ambulances — 48 стр.
BS EN 13718-1:2008
Заменен
Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances — 22 стр.
BS EN ISO 8836:2009
Заменен
Suction catheters for use in the respiratory tract — 20 стр.
BS EN 12342:1998+A1:2009
Заменен
Breathing tubes intended for use with anaesthetic apparatus and ventilators — 28 стр.
BS EN 1865-1:2010
Действует
Patient handling equipment used in road ambulances. General stretcher systems and patient handling equipment — 38 стр.
BS EN 1865-2:2010
Действует
Patient handling equipment used in road ambulances. Power assisted stretcher — 16 стр.
BS EN 1865-3:2012
Действует
Patient handling equipment used in road ambulances. Heavy duty stretcher — 18 стр.
BS EN 455-3:2006
Заменен
Medical gloves for single use. Requirements and testing for biological evaluation — 40 стр.
BS EN ISO 16061:2009
Заменен
Instrumentation for use in association with non-active surgical implants. General requirements — 28 стр.
BS EN 45502-1:1998
Заменен
Active implantable medical devices. General requirements for safety, marking and information to be provided by the manufacturer — 32 стр.
BS EN 1865:2000
Заменен
Specifications for stretchers and other patient handling equipment used in road ambulances — 28 стр.
BS EN 868-7:2009
Заменен
Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods — 26 стр.
BS EN 868-6:2009
Заменен
Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods — 20 стр.
BS EN 868-2:2009
Заменен
Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods — 24 стр.
BS EN 868-3:2009
Заменен
Packaging for terminally sterilized medical devices. Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methods — 20 стр.
BS EN 868-4:2009
Заменен
Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods — 16 стр.
BS EN 62366-1:2015
Действует
Medical devices. Application of usability engineering to medical devices — 54 стр.
BS EN ISO 7396-1:2016
Действует
Medical gas pipeline systems. Pipeline systems for compressed medical gases and vacuum — 192 стр.
BS ISO 17218:2014
Действует
Sterile acupuncture needles for single use — 36 стр.
BS EN 16844:2017
Заменен
Aesthetic medicine services. Non-surgical medical treatments — 54 стр.
BS ISO 27427:2013
Действует
Anaesthetic and respiratory equipment. Nebulizing systems and components — 58 стр.
BS EN 1041:2008+A1:2013
Действует
Information supplied by the manufacturer of medical devices — 28 стр.