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What are the first class medical devices?

What are the first class medical devices?, Total:28 items.

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

US-CFR-file, What are the first class 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?

BE-NBN, What are the first class 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)

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

Danish Standards Foundation, What are the first class 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

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

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

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

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

未注明发布机构, What are the first class 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

Lithuanian Standards Office , What are the first class 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

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

NF EN 45502-1:2016 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 1 : exigences générales de sécurité, marquage et informations fournies par le fabricant

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

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

ES-UNE, What are the first class 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 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