What are the medical devices at minus 20 degrees?

What are the medical devices at minus 20 degrees?, Total:119 items.

The international standard classification for "What are the medical devices at minus 20 degrees?" includes: Implants for surgery, prosthetics and orthotics , Sterilization and disinfection in general .

The Chinese standard classification for "What are the medical devices at minus 20 degrees?" includes: Orthopedic devices , Public medical equipment .

未注明发布机构

ANSI/AAMI/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
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)
DIN EN 556-2 E:2014-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

国家食品药品监督管理局

YY/T 1623-2018 Test method of effectiveness of sterilization processes for reusable medical devices
YY 0989.6-2016 Implants for surgery―Active implantable medical devices―Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)

European Committee for Standardization (CEN)

EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements

RU-GOST R

GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST ISO 10993-17-2011 Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances
GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
GOST R 59293-2021 Air cleanliness in the manufacture of medical devices

SCC

NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
CSA Z314-2023 Reprocessing of medical devices in Canada in all healthcare settings
BS EN 20594-1:1994 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment-General requirements
NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
AENOR UNE-EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for labeling of medical devices containing phthalates
DANSK DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
NS-EN 45502-2-1:2003 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
DIN EN 15986 E:2009 Draft Document - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version prEN 15986:2009
CEI EN 45502-2-1:2005 Active implantable medical devices - Part 2: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
AENOR UNE-EN 45502-2-1:2005 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'
CEI UNI EN 45502-2-2:2019 Active implantable medical devices Part 2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
NS-EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
CEI UNI EN 45502-2-2/AB:2019 Active implantable medical devices Part 2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
AENOR UNE-EN 45502-2-2 CORR:2008 Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
CAN/CSA Z314-2023 Canadian medical device reprocessing in all health care settings, Includes Update No. 1 (2024)
DANSK DS/EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
AENOR UNE-EN 45502-2-2:2008 Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
CEI UNI EN ISO 14708-6:2023 Implants for surgery - Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
DANSK DS/ISO 14708-6:2022 Implants for surgery – Active implantable medical devices – Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
AS 1600.1:1988 Medical equipment - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - General requirements
AENOR UNE-EN 1707:1997 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
AENOR UNE 209001 IN:2002 Guide for the management and maintenance of non-implantable active medical devices.
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
DANSK DS/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
NS-EN ISO 14708-6:2022 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
08/30191609 DC BS ISO 14708-6. Implants for surgery. Active implantable medical devices. Part 6. Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
DIN EN ISO 14708-6:2022 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019); German version EN ISO 14708-...
DIN EN ISO 14708-6 E:2018 Draft Document - Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators); German and English version prE...
DANSK DS/EN ISO 14708-6:2022 Implants for surgery – Active implantable medical devices – Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
DANSK DS/EN 1707:1997 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Lock fittings
AAMI/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
DANSK DS/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 standard...
DANSK DS/ISO 594-1:1988 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General requirements

GOST

GOST R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

German Institute for Standardization

DIN EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003
DIN 58267:1974 Medical instruments; needle holder Mathieu's with inside catch
DIN EN 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN 58316:2008 Medical instruments - Abdominal spatulas, malleable
DIN EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015
DIN 58267:2010 Medical instruments - Needle holder type Mathieu with inside catch
DIN 96121:2011 Medical instruments - Needle holder type Crile-Wood with carbide inserts
DIN 58298-20:2003 Materials, finish and testing of medical instruments - Part 20: Instruments for use with trocars according to DIN 58298-19
DIN 58298-20:2003-11 Materials, finish and testing of medical instruments - Part 20: Instruments for use with trocars according to DIN 58298-19

Association Francaise de Normalisation

NF S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
NF EN 15986:2011 Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates
NF EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: special rules for active implantable medical devices intended to treat bradyarrhythmia (pacemakers)
NF EN 45502-2-2:2008 Dispositifs médicaux implantables actifs - Partie 2-2 : exigences particulières pour les dispositifs médicaux implantables actifs destinés au traitement des tachyarythmies (y compris les défibrillateurs implantables)
NF S90-535:1979 MEDICAL AND SURGICAL EQUIPMENT. COMPONENTS FOR ARTIFICIAL LIMBS AND JOINTS. ELBOW JOINT WITH FORK FITTING.
NF EN ISO 14708-6:2022 Surgical implants - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices designed to treat tachyarrhythmia (including implantable defibrillators)

DIN

DIN EN ISO 17664-2:2024 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German version EN ISO 17664-2:2023

US-CFR-file

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 21-803.21-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.21:Where can I find the reporting codes for adverse events that I use with medical device reports?
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?

Lithuanian Standards Office

LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
LST EN 45502-2-1-2004 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

Danish Standards Foundation

DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
DS/ISO 594-2:1992 Conical fittings with a 6%(Luer) taper for syinges,needles and certain other medical equipment.Part 2: Lock fittings
DS/EN 20594-1:1994 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General requirements

AENOR

UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNE-EN 45502-2-1:2005 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
UNE-EN 45502-2-2:2008 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
UNE 209001:2002 IN Guide for the management and the maintenance of active non implantable medical devices.

Standard Association of Australia （SAA）

AS 1600.1:2004 Medical equipment - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - General requirements

GOSTR

GOST R 58450-2019 Medical devices with measuring functions. Condition monitoring

British Standards Institution (BSI)

BS EN 45502-2-2:2008(2009) Active implantable medical devices — Part 2 - 2 : Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
BS EN ISO 14708-6:2022 Implants for surgery. Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
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 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...
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

ES-UNE

UNE-EN 45502-2-2:2008 CORR:2009 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
UNE-EN ISO 14708-6:2023 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)

IX-EU/EC

MEDDEV 2.1/1-1994 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES
COM(92) 356-1992 Amended Proposal for a Council Directive Relating to the Medical Devices
MEDDEV 2.2/3-1998 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385 EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES "USE-BY DATE" (Rev. 3)
97/C 149/04-1997 Commission Communication in the Framework of the Implementation of Council Directive 90/385/EEC of 20 June 1990 in Relation to Active Implantable Medical Devices and Council Directive 93/42/EEC of 14 June 1993 in Relation to Medical Devices
MEDDEV 2.1/3-2009 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES (Rev 3)
TEST/90/385-1996 List of Bodies Notified under Directive 90/385/EEC Active Implantable Medical Devices

GSO

GSO ISO 14708-6:2015 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
GSO ISO 14708-6:2024 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
BH GSO ISO 14708-6:2017 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
OS GSO ISO 14708-6:2015 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
GSO ISO 16142-2:2021 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
BH GSO ISO 16142-2:2022 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
BH GSO ISO 16142-1:2022 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 standard...
GSO ISO 16142-1:2021 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

KR-KS

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

Korean Agency for Technology and Standards (KATS)

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

American National Standards Institute （ANSI)

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

International Organization for Standardization (ISO)

ISO 14708-6:2019 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillato
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 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

US-FCR

FCR 21 CFR PART 26-2015 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
FCR 21 CFR PART 26-2014 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
FCR 21 CFR PART 26-2013 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

US-HHS

HHS 21 CFR PART 26-2011 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

RO-ASRO

SR ISO 594-1:1993 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements

Others: What are the medical devices at minus 20 degrees?