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BS EN ISO 14971:2009

Заменен
Medical devices. Application of risk management to medical devices — 96 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

BS ISO 15198:2004
Действует
Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer — 18 стр.
BS ISO 17593:2007
Действует
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy — 64 стр.
BS IEC 61882:2001
Заменен
Hazard and operability studies (HAZOP studies). Application guide — 60 стр.
ISO 9000:2005
Действует
Quality management systems -- Fundamentals and vocabulary — 30 стр.
BS EN ISO 14971:2012
Действует
Medical devices. Application of risk management to medical devices — 104 стр.

На этот документ ссылаются

BS EN 13544-1:2007
Действует
Respiratory therapy equipment. Nebulizing systems and their components — 44 стр.
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 1789:2007
Действует
Medical vehicles and their equipment. Road ambulances — 46 стр.
BS EN 285:2006+A1:2008
Действует
Sterilization. Steam sterilizers. Large sterilizers — 86 стр.
BS EN ISO 14155-2:2003
Заменен
Clinical investigation of medical devices for human subjects. Clinical investigation plans — 18 стр.
BS EN ISO 14155-2:2009
Заменен
Clinical investigation of medical devices for human subjects. Clinical investigation plans — 20 стр.
BS EN 1642:2009
Заменен
Dentistry. Medical devices for dentistry. Dental implants — 14 стр.
BS EN 1789:2007+A1:2010
Действует
Medical vehicles and their equipment. Road ambulances — 48 стр.
BS EN 14180:2003
Заменен
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing — 54 стр.
BS EN 12183:2009
Заменен
Manual wheelchairs. Requirements and test methods — 50 стр.
BS EN 12184:2009
Заменен
Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods — 62 стр.
BS EN 14180:2003+A2:2009
Заменен
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing — 56 стр.
BS EN 15908:2010
Заменен
Anaesthetic and respiratory equipment. Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases — 22 стр.
BS EN 13718-1:2008
Заменен
Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances — 22 стр.
BIP 0113:2012
Действует
Guide to European medical device trials and BS EN ISO 14155 — 104 стр.
PAS 84:2012
Действует
Cell therapy and regenerative medicine. Glossary — 58 стр.
BS EN 60601-1-6:2010+A1:2015
Действует
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability — 32 стр.
BS EN 60601-1-6:2010
Действует
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability — 26 стр.
BS EN ISO 14971:2012
Действует
Medical devices. Application of risk management to medical devices — 104 стр.
BS EN 80001-1:2011
Действует
Application of risk management for IT-networks incorporating medical devices. Roles, responsibilities and activities — 44 стр.
BS EN ISO 14971:2007
Заменен
Medical devices. Application of risk management to medical devices — 94 стр.