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What are the first class of medical devices

What are the first class of medical devices, Total:41 items.

In the international standard classification, What are the first class of medical devices involves: Laboratory medicine, Medical equipment, Radiation measurements.

US-CFR-file, What are the first class of medical devices

CFR 21-803.33-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.33:If I am a user facility, what must I include when I submit an annual report?
CFR 21-803.42-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.42:If I am an importer, what information must I submit in my individual adverse event reports?
CFR 21-803.52-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.52:If I am a manufacturer, what information must I submit in my individual adverse event reports?
CFR 21-803.32-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.32:If I am a user facility, what information must I submit in my individual adverse event reports?
CFR 21-803.11-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.11:What form should I use to submit reports of individual adverse events and where do I obtain these forms?
CFR 21-803.50-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.50:If I am a manufacturer, what reporting requirements apply to me?
CFR 21-803.30-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.30:If I am a user facility, what reporting requirements apply to me?
CFR 21-803.56-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.56:If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?

Standard Association of Australia （SAA）, What are the first class of medical devices

AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements
AS 1600.1:2004 Medical equipment - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - General requirements
AS EN 45502.1:2002(R2014)
AS ISO 14708.1:2015 Implants for surgery — Active implantable medical devices, Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

RO-ASRO, What are the first class of medical devices

STAS 12902-1990 Human being medical instruments. Dental extracting forceps. General technical requirements for quality
SR ISO 594-1:1993 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
SR ISO 594-2:1993 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings

American National Standards Institute （ANSI), What are the first class of medical devices

ANSI/AAMI/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

BE-NBN, What are the first class of medical devices

NBN-EN 20594-1-1994 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General requirements (ISO 594-1:1986)

Korean Agency for Technology and Standards (KATS), What are the first class of medical devices

KS P ISO 16142-2:2020 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 d
KS P ISO 16142-1:2019 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 medic
KS P ISO 14708-1:2018 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

KR-KS, What are the first class of medical devices

KS P ISO 16142-1-2019 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 medic
KS P ISO 16142-2-2020 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 d
KS P ISO 14708-1-2018 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

British Standards Institution (BSI), What are the first class of medical devices

BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BS ISO 16142-1:2016 Tracked Changes. Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of s...

International Organization for Standardization (ISO), What are the first class of medical devices

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 d
ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood

Danish Standards Foundation, What are the first class of medical devices

DS/EN 20594-1:1994 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General requirements
DS/EN 45502-1:1998 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

European Committee for Standardization (CEN), What are the first class of medical devices

EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

GOSTR, What are the first class of medical devices

GOST R EN 14254-2010 In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans

AENOR, What are the first class of medical devices

UNE-EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

IX-EU/EC, What are the first class of medical devices

90/385/EEC-1990 COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices

RU-GOST R, What are the first class of medical devices

GOST R 59745-2021 Active implantable medical devices. Axial pumps for auxiliary blood circulation. General technical requirements

未注明发布机构, What are the first class of medical devices

DIN EN 20594-1 Ber-1:1996 Tapered connections with a 6% (Luer) taper for syringes, cannulas and certain other medical devices – Part 1: General requirements (ISO 594-1: 1986)
BS EN 20594-1:1994(1999) Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1 : General requirements

Association Francaise de Normalisation, What are the first class of medical devices

NF EN ISO 6717:2021 Dispositifs médicaux de diagnostic in vitro - Récipients à usage unique pour le prélèvement d'échantillons d'origine humaine autres que le sang
NF EN 45502-1:2016 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 1 : exigences générales de sécurité, marquage et informations fournies par le fabricant

Lithuanian Standards Office , What are the first class of medical devices

LST EN 45502-1-2000 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

ES-UNE, What are the first class of medical devices

UNE-EN 45502-1:2015 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (Endorsed by AENOR in July of 2015.)

German Institute for Standardization, What are the first class of medical devices

DIN EN 50527-2-1:2012 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers; German version EN 50527-2-1:2011