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Research on Class II Medical Devices

Research on Class II Medical Devices, Total:117 items.

In the international standard classification, Research on Class II Medical Devices involves: Dentistry, Medical equipment, Hospital equipment, Laboratory medicine, Graphical symbols, Pharmaceutics, Sterilization and disinfection, Quality.

European Committee for Standardization (CEN), Research on Class II Medical Devices

prEN 540-1992 Clinical investigation of medical devices for human subjects
EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects Superseded by EN ISO 14155-1:2003
prEN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
FprEN ISO 20916 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
EN ISO 10993-16:1997 Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables ISO 10993-16: 1997
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)

Association Francaise de Normalisation, Research on Class II Medical Devices

NF S99-201:1993 Clinical investigation of medical devices for human subjects.
NF S92-082*NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
FD ISO/TR 21582:2021 Pyrogénicité - Principes et méthodes d'essai pour la recherche des pyrogènes sur les dispositifs médicaux
NF ISO 20916:2019 Dispositifs médicaux de diagnostic in vitro - Études des performances cliniques utilisant des prélèvements de sujets humains - Bonnes pratiques d'étude
NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
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 ISO 10993-16:2017 Évaluation biologique des dispositifs médicaux - Partie 16 : conception des études toxicocinétiques des produits de dégradation et des substances relargables
NF EN 60335-2-95:2017 Évaluation biologique des dispositifs médicaux - Partie 16 : conception des études toxicocinétiques des produits de dégradation et des substances relargables
NF S99-501-16*NF EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables
NF S99-516:1997 Biological evaluation of medical devices. Part 16 : toxicokinetic study design for degradation products and leachables.

未注明发布机构, Research on Class II Medical Devices

BS EN 540:1993(1998) Clinicalinvestigationof medical devices for human subjects
BS EN ISO 10993-16:2017(2020) Biological evaluation of medical devices Part 16 : Toxicokinetic study design for degradation products and leachables

NL-NEN, Research on Class II Medical Devices

NEN-EN 540-1994 Clinical investigation of medical devices for human subjects

Danish Standards Foundation, Research on Class II Medical Devices

DS/EN 540:1993 Clinical investigation of medical devices for human subjects
DS/EN ISO 14155:2013 Clinical investigation of medical devices for human subjects - Good clinical practice
DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DS/ISO/TS 19218-1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes

Korean Agency for Technology and Standards (KATS), Research on Class II Medical Devices

KS P ISO 14155-2-2007(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 14155-1-2007(2012) Clinical investigation of medical devices for human subjects－Part 1：General requirements
KS P ISO 10993-16:2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-16:2006 Biological evaluation of medical devices－Part 16：Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-16:2021 Biological evaluation of medical devices —Part 16: Toxicokinetic study design for degradation products and leachables

VN-TCVN, Research on Class II Medical Devices

TCVN 7740-2-2007 Clinical investigation of medical devices for human subjects.Part 2: Clinical investigation plans
TCVN 7740-1-2007 Clinical investigation of medical devices for human subjects.Part 1: General requirements
TCVN 7391-16-2007 Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables

RU-GOST R, Research on Class II Medical Devices

GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R ISO 10993.16-1999 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R 55746-2015 Medical devices. Hierarchical coding structure for adverse events. Part 1. Event-type codes
GOST R 55746-2013 Medical devices. Hierarchical coding structure for adverse events. Part 1. Event-type codes

ES-UNE, Research on Class II Medical Devices

UNE-EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
UNE-EN ISO 10993-16:2018 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

KR-KS, Research on Class II Medical Devices

KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice
KS P ISO 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
KS P ISO 10993-16-2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-16-2021 Biological evaluation of medical devices —Part 16: Toxicokinetic study design for degradation products and leachables

British Standards Institution (BSI), Research on Class II Medical Devices

BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Clinical investigation plans
18/30344902 DC BS EN ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
19/30378069 DC BS ISO 17664-2. 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
PD ISO/TS 11796:2023 Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
BS EN ISO 10993-16:2017 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-16:2010 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-16:1997 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
BS DD ISO/TS 19218-1:2011+A1:2013 Medical devices. Hierarchical coding structure for adverse events. Event-type codes
BS ISO 20916:2019 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

International Organization for Standardization (ISO), Research on Class II Medical Devices

ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
ISO/TR 10993-55:2023 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
ISO/TS 11796:2023 Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood

Shanghai Provincial Standard of the People's Republic of China, Research on Class II Medical Devices

DB31/T 1378-2022 Service Specifications for Class II Medical Device Registration

German Institute for Standardization, Research on Class II Medical Devices

DIN EN ISO 14155:2021-05 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
DIN EN ISO 20916:2021-05 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German and English version prEN ISO 20916:2021 / Note: Date of issue 2021-04-09
DIN EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DIN EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); English version of DIN EN ISO 14155-2:2009-11
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 EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
DIN EN ISO 10993-16:2018-02 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
DIN EN 15986:2011 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 EN ISO 10993-16:2018 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

Canadian Standards Association (CSA), Research on Class II Medical Devices

CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
CSA PLUS 14971-2007 The ISO 14971:2007 essentials — A practical handbook for implementing the ISO 14971 Standard for medical devices (Second Edition)
CSA ISO 10993-16-00-CAN/CSA:2000 Biological Evaluation of Medical Devices - Part 16: Toxicokinetic Study Design for Degradation Products and Leachables First Edition; ISO 10993-16: 1997
CAN/CSA-ISO 14937:2011 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (Second Edition)

国家药监局, Research on Class II Medical Devices

YY/T 1754.1-2020 Preclinical Animal Studies for Medical Devices Part 1: General Requirements
YY/T 1754.2-2020 Medical Device Preclinical Animal Studies Part 2: Induced Diabetic Rat Skin Defect Model

AT-ON, Research on Class II Medical Devices

OENORM EN ISO 20916:2021 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)
OENORM EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
ONORM M 7390 Teil.6-1987 Gas cylinder valves; special typesfor medical apparatus with cylinders up to 3 liters capacity (PIN-Index-System)

US-AAMI, Research on Class II Medical Devices

ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ANSI/AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects-Good clinical practice
ANSI/AAMI/ISO 10993-16:2017 Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables

IT-UNI, Research on Class II Medical Devices

UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
EC 1-2020 UNI EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice

Lithuanian Standards Office , Research on Class II Medical Devices

LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

AENOR, Research on Class II Medical Devices

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNE-EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
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, Research on Class II Medical Devices

MEDDEV 2.7.2-2008 GUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN MAKING AN ASSESSMENT OF CLINICAL INVESTIGATION NOTIFICATION
MEDDEV 2.1/6-2012 GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES

PL-PKN, Research on Class II Medical Devices

PN-EN ISO 14155-2021-02 E Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2020)

Standard Association of Australia （SAA）, Research on Class II Medical Devices

AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements

American National Standards Institute （ANSI), Research on Class II Medical Devices

ANSI/AAMI/ISO 10993-16:1997 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

CEN - European Committee for Standardization, Research on Class II Medical Devices

EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
EN ISO 10993-16:2009 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

TH-TISI, Research on Class II Medical Devices

TIS 2395.16-2008 Biological evaluation of medical devices.part 16: toxicokinetic study design for degradation products and leachables

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Research on Class II Medical Devices

GB/T 16886.16-2003 Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables
GB/T 16886.16-2013 Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables

EU/EC - European Union/Commission Legislative Documents, Research on Class II Medical Devices

MEDDEV 2.14/2-2004 GUIDELINES ON MEDICAL DEVICES IVD GUIDANCE : Research Use Only products A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES (Rev 1)

国家药品监督管理局, Research on Class II Medical Devices

YY/T 1600-2018 Product families and process categories for moist heat sterilization of medical devices

国家市场监督管理总局、中国国家标准化管理委员会, Research on Class II Medical Devices

GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

Professional Standard - Medicine, Research on Class II Medical Devices

YY/T 0869-2013 Medical devices.Coding structure for adverse event type and cause
YY/T 0926-2014 Quantitative analysis of DEHP in PVC medical devices
YY/T 1852-2022 Determination of ammonium ions in the culture solution of medical devices for human assisted reproductive technology
YY/T 1754.3-2023 Preclinical Animal Studies of Medical Devices Part 3: An Animal Incisional Hernia Model for Evaluation of Mesh Histological Response and Biomechanical Properties

国家食品药品监督管理局, Research on Class II Medical Devices

YY/T 1570-2017 Terminology and classification of skin substitutes (materials) for tissue engineering medical device products

GOSTR, Research on Class II 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