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BS EN 1041:2008+A1:2013

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

Ссылочные документы

BS EN ISO 3166-1:2014
Действует
Codes for the representation of names of countries and their subdivisions. Country codes — 90 стр.
BS ISO 639-1:2002
Действует
Codes for the representation of the names of languages. Alpha-2 code — 48 стр.
ISO 10007:2017
Действует
Quality management -- Guidelines for configuration management — 18 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 14971:2012
Действует
Medical devices. Application of risk management to medical devices — 104 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
BS EN ISO 15225:2016
Действует
Medical devices. Quality management. Medical device nomenclature data structure — 22 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.
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 980:2008
Заменен
Symbols for use in the labelling of medical devices — 38 стр.
BS EN ISO 15223-1:2016
Действует
Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements — 44 стр.
ISO 8601:2004
Действует
Data elements and interchange formats -- Information interchange -- Representation of dates and times — 40 стр.
BS EN 3757:2009
Действует
Aerospace series. Nuts, anchor, self-locking, floating, self-aligning, two lugs, in heat resisting steel, MoS2 lubricated. Classification: 900 MPa (at ambient temperature)/315$0DC — 10 стр.
BS EN 3768:2012
Действует
Aerospace series. Nuts. anchor, self-locking, one lug, fixed, reduced series, with counterbore, in heat resisting steel, MoS2lubricated. Classification: 1 100 MPa (at ambient temperature)/315 $0DC — 10 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 556-2:2015
Действует
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices — 20 стр.
BS EN 591:2001
Заменен
Instructions for use for in vitro diagnostic instruments for professional use — 14 стр.
BS EN ISO 13485:2016
Действует
Medical devices. Quality management systems. Requirements for regulatory purposes — 66 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 7000:2014
Действует
Graphical symbols for use on equipment -- Registered symbols — 1 стр.
BS EN 1041:1998
Заменен
Information supplied by the manufacturer with medical devices — 20 стр.
BS EN 1041:2008
Действует
Information supplied by the manufacturer of medical devices — 28 стр.

На этот документ ссылаются

BS EN 1041:1998
Заменен
Information supplied by the manufacturer with medical devices — 20 стр.
BS EN 1041:2008
Действует
Information supplied by the manufacturer of medical devices — 28 стр.
17/30359567 DC
Действует
BS EN 14683. Medical face masks. Requirements and test methods — 26 стр.
18/30349834 DC
Действует
BS ISO 21802. Assistive products. Guidelines on cognitive accessibility. Daily time management. Part 1: Daily time management — 31 стр.
17/30360915 DC
Действует
BS EN 868-8. Packaging for terminally sterilized medical devices. Part 8. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods — 22 стр.
17/30360908 DC
Действует
BS EN 868-5. Packaging for terminally sterilized medical devices. Part 5. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods — 21 стр.
BS EN 62366-1:2015
Действует
Medical devices. Application of usability engineering to medical devices — 54 стр.
BS EN ISO 16671:2015
Заменен
Ophthalmic implants. Irrigating solutions for ophthalmic surgery — 32 стр.
BS EN 13718-1:2014
Действует
Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances — 20 стр.
BS EN 455-3:2015
Действует
Medical gloves for single use. Requirements and testing for biological evaluation — 38 стр.
BS EN 455-2:2015
Действует
Medical gloves for single use. Requirements and testing for physical properties — 16 стр.
BS ISO 18746:2016
Действует
Traditional Chinese medicine. Sterile intradermal acupuncture needles for single use — 20 стр.
17/30358661 DC
Действует
BS EN 13795-2. Surgical clothing and drapes. Requirements and test methods. Part 2. Clean air suits — 31 стр.
17/30358658 DC
Действует
BS EN 13795-1. Surgical clothing and drapes. Requirements and test methods. Part 1. Surgical drapes and gowns — 32 стр.
BS EN ISO 16672:2015
Действует
Ophthalmic implants. Ocular endotamponades — 24 стр.
BS EN 285:2015
Действует
Sterilization. Steam sterilizers. Large sterilizers — 104 стр.
BS EN ISO 16671:2015+A1:2017
Действует
Ophthalmic implants. Irrigating solutions for ophthalmic surgery — 32 стр.
BS EN 1865-2:2010+A1:2015
Действует
Patient handling equipment used in road ambulances. Power assisted stretcher — 16 стр.
BS EN 1865-3:2012+A1:2015
Действует
Patient handling equipment used in road ambulances. Heavy duty stretcher — 20 стр.
BS EN 1865-1:2010+A1:2015
Действует
Patient handling equipment used in road ambulances. General stretcher systems and patient handling equipment — 40 стр.
BS EN 1789:2007+A2:2014
Действует
Medical vehicles and their equipment. Road ambulances — 62 стр.
BS ISO 25841:2017
Действует
Female condoms. Requirements and test methods — 64 стр.