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    1. 11.040 Meditsiinivarustus
      1. 11.040.01 Meditsiinivarustus üldiselt
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Elektrooniline Paberkandjal 

CEN ISO/TR 14969:2005

Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003

Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003

Vaata / Osta

Inglise 
Kehtetu
alates
06.12.2016
22,15 EUR
Elektrooniline Paberkandjal 

CEN/CLC/TR 14060:2014

Medical device traceability enabled by unique device identification (UDI)

Medical device traceability enabled by unique device identification (UDI)

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Inglise 
Kehtiv
alates
12.01.2015
8,01 EUR
Elektrooniline Paberkandjal 

CEN/TR 15133:2005

Nomenclature - Collective terms and codes for groups of medical devices

Nomenclature - Collective terms and codes for groups of medical devices

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Inglise 
Kehtiv
alates
10.08.2005
9,49 EUR
Elektrooniline Paberkandjal 

CEN/TR 17223:2018

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Vaata / Osta

Inglise 
Kehtiv
alates
02.04.2018
22,15 EUR
Elektrooniline Paberkandjal 

EVS-EN 1041:2008

Tootja antav info meditsiiniseadmete kohta

Information supplied by the manufacturer with medical devices

Vaata / Osta

Inglise 
Kehtetu
alates
14.11.2013
12,51 EUR
Elektrooniline Paberkandjal 

EVS-EN 1041:2008+A1:2013

Tootja antav info meditsiiniseadmete kohta

Information supplied by the manufacturer of medical devices

Vaata / Osta

Inglise 
Kehtiv
alates
14.11.2013
12,51 EUR
Elektrooniline Paberkandjal 

EVS-EN 13718-1:2008

Meditsiinis kasutatavad liiklusvahendid ja nende varustus. Kiirabilennukid/helikopterid. Osa 1: Nõuded kiirabilennukites/helikopterites kasutatavatele meditsiiniseadmetele

Medical vehicles and their equipment - Air Ambulances - Part 1: Requirements of medical devices used in air ambulances

Vaata / Osta

Inglise 
Kehtetu
alates
06.10.2014
10,90 EUR
Elektrooniline Paberkandjal 

EVS-EN 13718-1:2014

Meditsiinis kasutatavad liiklusvahendid ja nende varustus. Aerokiirabi. Osa 1: Nõuded aerokiirabis kasutatavatele meditsiiniseadmetele

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

Vaata / Osta

Inglise 
Kehtiv
alates
06.10.2014
10,19 EUR
Elektrooniline Paberkandjal 

EVS-EN 13718-2:2008

Meditsiinis kasutatavad liiklusvahendid ja nende varustus. Kiirabilennukid/helikopterid. Osa 2: Kiirabilennukite/helikopterite tootmis- ja tehnilised nõuded

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements of air ambulances

Vaata / Osta

Inglise 
Kehtetu
alates
02.04.2015
13,92 EUR
Elektrooniline Paberkandjal 

EVS-EN 13718-2:2015

Meditsiinis kasutatavad liiklusvahendid ja nende varustus. Aerokiirabi. Osa 2: Aerokiirabi toimimis- ja tehnilised nõuded

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

Vaata / Osta

Inglise 
Kehtiv
alates
02.04.2015
14,69 EUR
Elektrooniline Paberkandjal 

EVS-EN 1441:2000

Meditsiiniseadmed. Riskianalüüs

Medical devices - Risk analysis

Vaata / Osta

Eesti 
Inglise 
Kehtetu 11,67 EUR
Elektrooniline Paberkandjal 

EVS-EN 15986:2011

Meditsiiniseadmete märgistamiseks kasutatav sümbol. Ftalaate sisaldavate meditsiiniseadmete märgistusnõuded

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

Vaata / Osta

Inglise 
Kehtiv
alates
05.04.2011
8,01 EUR
Elektrooniline Paberkandjal 

EVS-EN 45502-1:2000

Aktiivsed implanteeritavad meditsiiniseadmed. Osa 1: Üldised ohutusnõuded, tootja antav märgistus ja informatsioon

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

Vaata / Osta

Eesti 
Inglise 
Kehtetu
alates
08.06.2015
17,08 EUR
Elektrooniline Paberkandjal 

EVS-EN 45502-1:2015

Implantaadid kirurgias. Aktiivsed implanteeritavad meditsiiniseadmed. Osa 1: Üldnõuded ohutusele, märgistusele ja tootja antavale informatsioonile

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Vaata / Osta

Inglise 
Kehtiv
alates
08.06.2015
18,00 EUR
Elektrooniline Paberkandjal 

EVS-EN 475:1999

Meditsiiniseadmed. Elektriliselt genereeritud häiresignaalid

Medical devices - Electrically-generated alarm signals

Vaata / Osta

Inglise 
Kehtetu
alates
06.10.2014
10,19 EUR
Elektrooniline Paberkandjal 

EVS-EN 50103:2001

Juhised EN 29001, EN 46001, EN 29002 ja EN 46002 standardite rakendamiseks aktiivsete meditsiiniseadmete (sealhulgas aktiivsete implantaatide) tööstuses

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry

Vaata / Osta

Inglise 
Kehtetu
alates
06.11.2009
8,72 EUR
Elektrooniline 

EVS-EN 60601-1:2000

Elektrilised meditsiiniseadmed. Osa 1: Üldised ohutusnõuded

Medical electrical equipment. Part 1: General requirements for safety

Vaata / Osta

Eesti 
Inglise 
Kehtetu
alates
08.12.2006
29,18 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-1:2002

Elektrilised meditsiiniseadmed. Osa 1-1: Üldised ohutusnõuded. Kollateraalstandard: Ohutusnõuded elektrilistele meditsiinisüsteemidele

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)

Vaata / Osta

Eesti 
Inglise 
Kehtetu
alates
02.08.2012
14,69 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-11:2010

Elektrilised meditsiiniseadmed. Osa 1-11: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Nõuded koduses ravikeskkonnas kasutatavatele elektrilistele meditsiiniseadmetele ja -süsteemidele

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Vaata / Osta

Inglise 
Kehtetu
alates
08.06.2015
18,00 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-11:2015

Elektrilised meditsiiniseadmed. Osa 1-11: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Nõuded koduses ravikeskkonnas kasutatavatele elektrilistele meditsiiniseadmetele ja -süsteemidele

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Vaata / Osta

Inglise 
Kehtiv
alates
08.06.2015
19,05 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-2:2007

Elektrilised meditsiiniseadmed. Osa 1-2: Üldnõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Elektromagnetiline ühilduvus. Nõuded ja katsetused

Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Vaata / Osta

Eesti 
Inglise 
Kehtetu
alates
03.12.2015
25,03 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-2:2007/AC:2010

Elektrilised meditsiiniseadmed. Osa 1-2: Üldnõuded esmasele ohutusele ja seadmeomasele toimivusele. Kollateraalstandard: Elektromagnetiline ühilduvus. Nõuded ja katsetused

Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Vaata / Osta

Inglise
Kehtetu
alates
03.12.2015
0,00 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-2:2015

Elektrilised meditsiiniseadmed. Osa 1-2: Üldnõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Elektromagnetiline ühilduvus. Nõuded ja katsetused

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

Vaata / Osta

Inglise 
Kehtiv
alates
03.12.2015
22,15 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-3:2000

Elektrilised meditsiiniseadmed. Osa 1: Üldised ohutusnõuded. 3. kollateraalstandard: Kiirguskaitse üldnõuded rõntgendiagnostikaseadmetele

Medical electrical equipment - Part 1: General requirements for safety 3. Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment

Vaata / Osta

Eesti 
Inglise 
Kehtetu
alates
09.06.2008
18,00 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-4:2000

Elektrilised meditsiiniseadmed. Osa 1: Üldised ohutusnõuded 4. kollateraalstandard: Programmeeritavad elektrilised meditsiinisüsteemid

Medical electrical equipment - Part 1: General requirements for safety. 4. Collateral Standard: Programmable electronical medical systems

Vaata / Osta

Eesti
Inglise
Kehtetu
alates
02.08.2012
14,69 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-4:2000/A1:2002

Elektrilised meditsiiniseadmed. Osa 1: Üldised ohutusnõuded 4. kollateraalstandard: Programmeeritavad elektrilised meditsiinisüsteemid

Medical electrical equipment - Part 1-4: General requirements for safety. 4. Collateral Standard: Programmable electronical medical systems

Vaata / Osta

Inglise
Kehtetu
alates
02.08.2012
10,19 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-8:2004

Elektrilised meditsiiniseadmed. Osa 1-8: Ohutuse üldnõuded. Koondstandard: Elektrilistes meditsiiniseadmetes ja -süsteemides kasutatavate häiresüsteemidele esitatavad üldnõuded, katsetamine ja juhised

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise 
Kehtetu
alates
05.12.2007
20,74 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-8:2006/A1:2006

Elektrilised meditsiiniseadmed. Osa 1-8: Ohutuse üldnõuded. Koondstandard: Elektrilistes meditsiiniseadmetes ja -süsteemides kasutatavate häiresüsteemidele esitatavad üldnõuded, katsetamine ja juhised

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise
Kehtetu
alates
05.12.2007
6,47 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-8:2007

Elektrilised meditsiiniseadmed. Osa 1-8: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Elektrilistes meditsiiniseadmetes ja -süsteemides kasutatavatele alarmsüsteemidele esitatavad üldnõuded, katsetamine ja juhised

Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise 
Kehtiv
alates
05.12.2007
20,74 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-8:2007/A1:2013

Elektrilised meditsiiniseadmed. Osa 1-8: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Elektrilistes meditsiiniseadmetes ja -süsteemides kasutatavatele alarmsüsteemidele esitatavad üldnõuded, katsetamine ja juhised

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006/A1:2012)

Vaata / Osta

Inglise
Kehtiv
alates
06.05.2013
13,22 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-8:2007/A1:2013/AC:2014

Elektrilised meditsiiniseadmed. Osa 1-8: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Elektrilistes meditsiiniseadmetes ja -süsteemides kasutatavatele alarmsüsteemidele esitatavad üldnõuded, katsetamine ja juhised

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise
Kehtiv
alates
05.06.2014
0,00 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-8:2007/A11:2017

Elektrilised meditsiiniseadmed. Osa 1-8: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Elektrilistes meditsiiniseadmetes ja -süsteemides kasutatavatele alarmsüsteemidele esitatavad üldnõuded, katsetamine ja juhised

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise
Kehtiv
alates
04.04.2017
5,62 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-8:2007/AC:2010

Elektrilised meditsiiniseadmed. Osa 1-8: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Elektrilistes meditsiiniseadmetes ja -süsteemides kasutatavatele alarmsüsteemidele esitatavad üldnõuded, katsetamine ja juhised

Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise
Kehtiv
alates
08.04.2010
0,00 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-1-8:2007+A1+A11:2017

Elektrilised meditsiiniseadmed. Osa 1-8: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Elektrilistes meditsiiniseadmetes ja -süsteemides kasutatavatele alarmsüsteemidele esitatavad üldnõuded, katsetamine ja juhised

Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise 
Kehtiv
alates
03.02.2020
22,15 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-2-22:2013

Elektrilised meditsiiniseadmed. Osa 2-22: Erinõuded kirurgiliste, kosmeetiliste, terapeutiliste ja diagnostiliste laserseadmete esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22:2007 + A1:2012)

Vaata / Osta

Inglise 
Kehtiv
alates
05.02.2013
13,22 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-2-30:2002

Elektrilised meditsiiniseadmed. Osa 2-30: Erinõuded automaatsirkulatsiooniga kehasse mitteviidava vererõhu seireseadmestiku ohutusele, sealhulgas olulisele jõudlusele

Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

Vaata / Osta

Inglise 
Kehtetu
alates
06.01.2014
16,10 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-2-31:2008/A1:2011

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Vaata / Osta

Inglise
Kehtiv
alates
06.09.2011
7,38 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-2-36:2015

Elektrilised meditsiiniseadmed. Osa 2-36: Erinõuded kehaväliselt indutseeritava põiekivide purustamise seadmete esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

Vaata / Osta

Inglise 
Kehtiv
alates
08.06.2015
10,90 EUR
Elektrooniline Paberkandjal 

EVS-EN 60601-2-62:2015

Elektrilised meditsiiniseadmed. Osa 2-62: Erinõuded kõrgintensiivse ultraheliraviseadme (HITU) esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

Vaata / Osta

Inglise 
Kehtiv
alates
08.06.2015
19,05 EUR
Elektrooniline Paberkandjal 

EVS-EN 61205:2002

Ultrasonics; dental descaler systems; measurement and declaration of the output characteristics

Ultrasonics; dental descaler systems; measurement and declaration of the output characteristics

Vaata / Osta

Inglise 
Kehtiv
alates
01.01.2003
9,49 EUR
Elektrooniline Paberkandjal 

EVS-EN 61847:2002

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

Vaata / Osta

Inglise 
Kehtiv
alates
01.11.2002
13,92 EUR
Elektrooniline Paberkandjal 

EVS-EN 724:1999

Suunised mitteaktiivset meditsiinitehnikat käsitlevate standardite EN 29001 ja 46001 ning EN 29002 ja EN 46002 rakendamiseks.

Guidance on the application of EN 29001 and 46001 and of EN 29002 and EN 46002 for non-active medical devices

Vaata / Osta

Inglise
Kehtetu 15,40 EUR
Elektrooniline Paberkandjal 

EVS-EN 80001-1:2011

Riskijuhtimise rakendamine meditsiiniseadmeid sisaldavates IT-võrkudes. Osa 1: Rollid, vastutus ja tegevused

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

Vaata / Osta

Inglise 
Kehtiv
alates
05.04.2011
16,10 EUR
Elektrooniline Paberkandjal 

EVS-EN 80601-2-35:2010/A1:2016

Elektrilised meditsiiniseadmed. Osa 2-35: Erinõuded meditsiinilises kasutuses soojendustekkide, -patjade ja –madratsite esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

Vaata / Osta

Inglise
Kehtiv
alates
03.01.2017
6,47 EUR
Elektrooniline Paberkandjal 

EVS-EN 80601-2-60:2015

Elektrilised meditsiiniseadmed. Osa 2-60: Erinõuded hambaravis kasutatavate seadmete esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

Vaata / Osta

Inglise 
Kehtiv
alates
08.06.2015
14,69 EUR
Elektrooniline Paberkandjal 

EVS-EN 980:2000/A2:2002

Meditsiiniseadmete märgistamiseks kasutatavad graafilised sümbolid. MUUDATUS 2

Graphical symbols for use in the labelling of medical devices - AMENDMENT 2

Vaata / Osta

Inglise
Kehtetu
alates
01.06.2003
4,78 EUR
Elektrooniline Paberkandjal 

EVS-EN IEC 60601-2-75:2019

Elektrilised meditsiiniseadmed. Osa 2-75: Erinõuded valgusraviseadme ja valgusdiagnostikaseadme esmasele ohutusele ja olulistele toimimisnäitajatele

Medical Electrical Equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

Vaata / Osta

Inglise 
Kehtiv
alates
01.11.2019
13,92 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 10993-10:1999

Meditsiiniseadmete bioloogiline hindamine. Osa 10: Ärrituse ja hilise ülitundlikkuse katsed

Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization

Vaata / Osta

Inglise 
Kehtetu
alates
01.12.2002
13,92 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 10993-7:1999

Meditsiiniseadmete bioloogiline hindamine. Osa 7: Jäägid etüleenoksiidiga steriliseerimisest

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization rediduals

Vaata / Osta

Inglise 
Kehtetu
alates
09.01.2009
15,40 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 11197:2009

Meditsiinilised toiteseadmed

Medical supply units

Vaata / Osta

Inglise 
Kehtetu
alates
04.04.2016
16,10 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 13485:2012

Meditsiiniseadmed. Kvaliteedijuhtimissüsteem. Normatiivsed nõuded

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

Vaata / Osta

Eesti 
Inglise 
Kehtetu
alates
02.03.2016
22,15 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 13485:2012/AC:2012

Meditsiiniseadmed. Kvaliteedijuhtimissüsteem. Normatiivsed nõuded

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

Vaata / Osta

Eesti
Inglise
Kehtetu
alates
02.03.2016
0,00 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 13485:2016

Meditsiiniseadmed. Kvaliteedijuhtimissüsteemid. Normatiivsed nõuded

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Vaata / Osta

Eesti 
Inglise 
Kehtiv
alates
02.03.2016
19,05 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 13485:2016/AC:2016

Meditsiiniseadmed. Kvaliteedijuhtimissüsteemid. Normatiivsed nõuded

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Vaata / Osta

Inglise
Kehtetu
alates
03.05.2018
0,00 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 13485:2016/AC:2018

Meditsiiniseadmed. Kvaliteedijuhtimissüsteemid. Normatiivsed nõuded

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Vaata / Osta

Eesti
Inglise
Kehtiv
alates
03.05.2018
0,00 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 14971:2012

Meditsiiniseadmed. Riskijuhtimise rakendamine meditsiiniseadmetele

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

Vaata / Osta

Eesti 
Inglise 
Kehtetu
alates
02.01.2020
22,15 EUR
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EVS-EN ISO 14971:2019

Meditsiiniseadmed. Riskihalduse rakendamine meditsiiniseadmetele

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Vaata / Osta

Eesti 
Inglise 
Kehtiv
alates
02.01.2020
16,10 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 15195:2004

Laborimeditsiin. Nõuded võrdlusmõõtmisi teostavatele laboritele

Laboratory medicine - Requirements for reference measurement laboratories

Vaata / Osta

Inglise 
Kehtetu
alates
15.02.2019
10,90 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 15223-1:2012

Meditsiiniseadmed. Sümbolid, mida kasutatakse meditsiinseadme ja/või pakendi märgistuses ning muus kaasuvas teabes. Osa 1: Üldnõuded (ISO 15223-1:2012)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

Vaata / Osta

Inglise 
Kehtetu
alates
03.01.2017
13,92 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 15223-1:2016

Meditsiiniseadmed. Meditsiiniseadme märgisel, märgistusel ning kaasuvas teabes kasutatavad tingmärgid. Osa 1: Üldnõuded

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

Vaata / Osta

Eesti 
Inglise 
Kehtiv
alates
03.01.2017
15,40 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 15225:2016

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

Vaata / Osta

Inglise 
Kehtetu
alates
15.02.2018
10,19 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 15378:2015

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)

Vaata / Osta

Inglise 
Kehtetu
alates
01.11.2017
20,74 EUR
Elektrooniline Paberkandjal 

EVS-EN ISO 15378:2017

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)

Vaata / Osta

Inglise 
Kehtiv
alates
01.11.2017
22,15 EUR
Elektrooniline 

EVS-HD 395.1 S2:2003

Medical electrical equipment - Part 1: General requirements for safety

Medical electrical equipment - Part 1: General requirements for safety

Vaata / Osta

Inglise 
Kehtiv
alates
01.03.2003
26,50 EUR
Elektrooniline Paberkandjal 

IEC 60601-1/Amd 1/Cor 1:2014

Corrigendum 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Corrigendum 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Vaata / Osta

Inglise
Kehtiv 0,00 EUR
Elektrooniline 

IEC 60601-1/Amd 1:2012

Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Vaata / Osta

Inglise
Kehtiv 303,73 EUR
Elektrooniline Paberkandjal 

IEC 60601-1/Cor 1:2006

Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Vaata / Osta

Inglise
Kehtiv 0,00 EUR
Elektrooniline Paberkandjal 

IEC 60601-1/Cor 2:2007

Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Vaata / Osta

Inglise
Kehtiv 0,00 EUR
Elektrooniline Paberkandjal 

IEC 60601-1/IS 1:2008

Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Vaata / Osta

Inglise
Kehtiv 0,00 EUR
Elektrooniline Paberkandjal 

IEC 60601-1/IS 2:2009

Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Vaata / Osta

Inglise
Kehtiv 0,00 EUR
Elektrooniline 

IEC 60601-1:2005

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Vaata / Osta

Inglise 
Kehtiv 322,14 EUR
Elektrooniline Paberkandjal 

IEC 60601-1:2005+AMD1:2012 CSV/COR1:2012

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Vaata / Osta

Inglise
Kehtiv 0,00 EUR
Elektrooniline Paberkandjal 

IEC 60601-1:2010/IS 3:2013

Interpretation sheet 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Interpretation sheet 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Vaata / Osta

Inglise
Kehtiv 0,00 EUR
Elektrooniline 

IEC 60601-1:2012

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Vaata / Osta

Inglise 
Kehtiv 828,35 EUR
Lisafailid 

IEC 60601-1:2020 SER

Medical electrical equipment - ALL PARTS

Medical electrical equipment - ALL PARTS

Vaata / Osta

Inglise
Kehtiv 2 901,06 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-10/Amd 1:2013

Amendment 1 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Amendment 1 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Vaata / Osta

Inglise
Kehtiv 18,41 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-10:2007

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Vaata / Osta

Inglise 
Kehtiv 188,68 EUR
Elektrooniline 

IEC 60601-1-10:2013

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Vaata / Osta

Inglise 
Kehtiv 276,12 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-11:2015

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline 

IEC 60601-1-11:2015 RLV

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Vaata / Osta

Inglise 
Kehtiv 370,92 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-12:2014

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Vaata / Osta

Inglise 
Kehtiv 257,71 EUR
Elektrooniline 

IEC 60601-1-2:2014

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Vaata / Osta

Inglise 
Kehtiv 303,73 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-6/Amd 1:2013

Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Vaata / Osta

Inglise
Kehtiv 18,41 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-6:2010

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Vaata / Osta

Inglise 
Kehtiv 161,07 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-6:2013

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Vaata / Osta

Inglise 
Kehtiv 234,70 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-8/Amd 1:2012

Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise
Kehtiv 161,07 EUR
Elektrooniline 

IEC 60601-1-8:2006

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline 

IEC 60601-1-8:2012

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise 
Kehtiv 598,25 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-9/Amd 1:2013

Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Vaata / Osta

Inglise
Kehtiv 9,20 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-9:2007

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Vaata / Osta

Inglise 
Kehtiv 161,07 EUR
Elektrooniline Paberkandjal 

IEC 60601-1-9:2013

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Vaata / Osta

Inglise 
Kehtiv 220,89 EUR
Elektrooniline Paberkandjal 

IEC 60601-2-31:2020

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Vaata / Osta

Inglise 
Kehtiv 257,71 EUR
Elektrooniline 

IEC 60601-2-31:2020 RLV

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Vaata / Osta

Inglise 
Kehtiv 335,02 EUR
Elektrooniline Paberkandjal 

IEC 60601-2-36:2014

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

Vaata / Osta

Inglise 
Kehtiv 133,46 EUR
Elektrooniline Paberkandjal 

IEC 60601-2-62:2013

Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline Paberkandjal 

IEC 60601-2-75:2017

Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

Vaata / Osta

Inglise 
Kehtiv 161,07 EUR
Elektrooniline Paberkandjal 

IEC 61847:1998

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

Vaata / Osta

Inglise 
Kehtiv 188,68 EUR
Elektrooniline Paberkandjal 

IEC 62304/Amd 1:2015

Amendment 1 - Medical device software - Software life cycle processes

Amendment 1 - Medical device software - Software life cycle processes

Vaata / Osta

Inglise
Kehtiv 225,49 EUR
Elektrooniline 

IEC 62304:2006

Medical device software - Software life cycle processes

Medical device software - Software life cycle processes

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline 

IEC 62304:2015

Medical device software - Software life cycle processes

Medical device software - Software life cycle processes

Vaata / Osta

Inglise 
Kehtiv 644,27 EUR
Elektrooniline Paberkandjal 

IEC 62353:2014

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline Paberkandjal 

IEC 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices

Medical devices - Part 1: Application of usability engineering to medical devices

Vaata / Osta

Inglise 
Kehtiv 257,71 EUR
Elektrooniline Paberkandjal 

IEC 80001-1:2010

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

Vaata / Osta

Inglise 
Kehtiv 225,49 EUR
Elektrooniline Paberkandjal 

IEC 80601-2-26:2019

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph

Vaata / Osta

Inglise 
Kehtiv 188,68 EUR
Elektrooniline Paberkandjal 

IEC 80601-2-30:2018

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Vaata / Osta

Inglise 
Kehtiv 257,71 EUR
Elektrooniline 

IEC 80601-2-30:2018 RLV

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Vaata / Osta

Inglise 
Kehtiv 335,02 EUR
Elektrooniline Paberkandjal 

IEC 80601-2-35/Cor 1:2012

Corrigendum 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices usign blankets, pads or mattresses and intended for heating in medical use

Corrigendum 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices usign blankets, pads or mattresses and intended for heating in medical use

Vaata / Osta

Inglise
Kehtiv 0,00 EUR
Elektrooniline Paberkandjal 

IEC 80601-2-35/Cor 2:2015

Corrigendum 2 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of healing devices using blankets, pads or mattresses and intended for heating in medical use

Corrigendum 2 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of healing devices using blankets, pads or mattresses and intended for heating in medical use

Vaata / Osta

Inglise
Kehtiv 0,00 EUR
Elektrooniline Paberkandjal 

IEC 80601-2-35:2009

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline Paberkandjal 

IEC 80601-2-35:2009/AMD1:2016

Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

Vaata / Osta

Inglise
Kehtiv 18,41 EUR
Elektrooniline 

IEC 80601-2-35:2009+AMD1:2016 CSV

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

Vaata / Osta

Inglise 
Kehtiv 368,15 EUR
Elektrooniline Paberkandjal 

IEC 80601-2-60:2019

Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

Vaata / Osta

Inglise 
Kehtiv 225,49 EUR
Elektrooniline Paberkandjal 

IEC 80601-2-77:2019

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

Vaata / Osta

Inglise 
Kehtiv 257,71 EUR
Elektrooniline 

IEC 80601-2-78:2019

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline Paberkandjal 

IEC TR 60601-4-1:2017

Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy

Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline Paberkandjal 

IEC TR 60601-4-2:2016

Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise 
Kehtiv 257,71 EUR
Elektrooniline Paberkandjal 

IEC TR 60601-4-3:2018

Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

Vaata / Osta

Inglise 
Kehtiv 312,93 EUR
Elektrooniline 

IEC TR 60601-4-3:2018 RLV

Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

Vaata / Osta

Inglise 
Kehtiv 406,81 EUR
Elektrooniline Paberkandjal 

IEC TR 60601-4-4:2017

Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements

Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements

Vaata / Osta

Inglise 
Kehtiv 133,46 EUR
Elektrooniline Paberkandjal 

IEC TR 61289:2019

High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

Vaata / Osta

Inglise 
Kehtiv 161,07 EUR
Elektrooniline Paberkandjal 

IEC TR 61289:2019 RLV

High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

Vaata / Osta

Inglise 
Kehtiv 209,85 EUR
Elektrooniline Paberkandjal 

IEC TR 62366-2:2016

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

Vaata / Osta

Inglise 
Kehtiv 303,73 EUR
Elektrooniline Paberkandjal 

IEC TR 80001-2-8:2016

Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2

Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2

Vaata / Osta

Inglise 
Kehtiv 257,71 EUR
Elektrooniline Paberkandjal 

IEC TR 80001-2-9:2017

Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

Vaata / Osta

Inglise 
Kehtiv 188,68 EUR
Elektrooniline Paberkandjal 

IEC/TR 60513:1994

Fundamental aspects of safety standards for medical electrical equipment

Fundamental aspects of safety standards for medical electrical equipment

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline Paberkandjal 

IEC/TR 60930:2008

Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems

Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems

Vaata / Osta

Inglise 
Kehtiv 161,07 EUR
Elektrooniline Paberkandjal 

IEC/TR 61258:2008

Guidelines for the development and use of medical electrical equipment educational materials

Guidelines for the development and use of medical electrical equipment educational materials

Vaata / Osta

Inglise 
Kehtiv 64,43 EUR
Elektrooniline Paberkandjal 

IEC/TR 62296:2009

Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements

Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline Paberkandjal 

IEC/TR 62348:2012

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

Vaata / Osta

Inglise 
Kehtiv 303,73 EUR
Elektrooniline 

IEC/TR 62354:2014

General testing procedures for medical electrical equipment

General testing procedures for medical electrical equipment

Vaata / Osta

Inglise 
Kehtiv 322,14 EUR
Elektrooniline Paberkandjal 

IEC/TR 80001-2-1:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Pratical applications and examples

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Pratical applications and examples

Vaata / Osta

Inglise 
Kehtiv 285,32 EUR
Elektrooniline Paberkandjal 

IEC/TR 80001-2-2:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

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Kehtiv 257,71 EUR
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IEC/TR 80001-2-3:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

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Kehtiv 225,49 EUR
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IEC/TR 80001-2-4:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations

Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations

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Kehtiv 133,46 EUR
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IEC/TR 80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

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Kehtiv 188,68 EUR
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IEC/TR 80002-1:2009

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

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Kehtiv 285,32 EUR
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IEC/TR 80002-3:2014

Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

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Kehtiv 161,07 EUR
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ISO 13485 - Medical devices

ISO 13485:2016 – Medical devices – A practical guide

ISO 13485:2016 – Medical devices – A practical guide

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Kehtiv 80,99 EUR
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ISO 13485:2016

Medical devices -- Quality management systems -- Requirements for regulatory purposes

Medical devices -- Quality management systems -- Requirements for regulatory purposes

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Kehtiv 145,42 EUR
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ISO 14971:2019

Medical devices -- Application of risk management to medical devices

Medical devices -- Application of risk management to medical devices

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Kehtiv 145,42 EUR
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ISO 15223-1:2016

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements (Corrected version 2017-03)

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements (Corrected version 2017-03)

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Kehtiv 108,61 EUR
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ISO 15223-2:2010

Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation

Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation

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Kehtiv 80,99 EUR
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ISO 15378:2017

Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

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Kehtiv 163,83 EUR
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ISO 16142-1:2016

Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

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Kehtiv 145,42 EUR
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ISO 16142-2:2017

Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

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Kehtiv 145,42 EUR
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ISO 20069:2019

Guidance for assessment and evaluation of changes to drug delivery systems

Guidance for assessment and evaluation of changes to drug delivery systems

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Kehtiv 145,42 EUR
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ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

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Kehtiv 108,61 EUR
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ISO/PAS 18761:2013

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

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

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Kehtiv 34,97 EUR
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ISO/TR 19244:2014

Guidance on transition periods for standards developed by ISO/TC 84 -- Devices for administration of medicinal products and catheters

Guidance on transition periods for standards developed by ISO/TC 84 -- Devices for administration of medicinal products and catheters

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Kehtiv 34,97 EUR
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ISO/TR 24971:2013

Medical devices -- Guidance on the application of ISO 14971

Medical devices -- Guidance on the application of ISO 14971

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Kehtiv 53,38 EUR
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ISO/TR 80001-2-6:2014

Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements

Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements

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Kehtiv 80,99 EUR
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ISO/TR 80001-2-7:2015

Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

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Kehtiv 182,24 EUR
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ISO/TR 80002-2:2017

Medical device software -- Part 2: Validation of software for medical device quality systems

Medical device software -- Part 2: Validation of software for medical device quality systems

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Kehtiv 182,24 EUR
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ISO/TS 19218-1:2011

Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes

Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes

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Kehtiv 80,99 EUR
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ISO/TS 19218-1:2011/Amd 1:2013

ISO/TS 19218-1:2011 - Amendment

ISO/TS 19218-1:2011 - Amendment

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Kehtiv 14,73 EUR
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ISO/TS 19218-2:2012

Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes

Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes

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Kehtiv 80,99 EUR

Kokku: 156

Koolitus ISO 10002 ISO 14971