Three types of medical device research

Three types of medical device research, Total:174 items.

In the international standard classification, Three types of medical device research involves: Dentistry, Medical equipment, Hospital equipment, Laboratory medicine, Information sciences. Publishing, Pharmaceutics, Sterilization and disinfection, Quality.

SCC, Three types of medical device research

AS ISO 14155:2002 Clinical investigation of medical devices
BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
NS-EN 540:1993 Clinical investigation of medical devices for human subjects
BS EN 540:1993 Clinical investigation of medical devices for human subjects
BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects-General requirements
UNE-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
NS-EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
DANSK DS/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155:2020 Plus Redline Clinical investigation of medical devices for human subjects - Good clinical practice
DANSK DS/ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice
AAMI/ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
NS-EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
DANSK DS/EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
DANSK DS/EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements
NS-EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
NS-EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
DANSK DS/EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
AENOR UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
DANSK DS/ISO 20916:2019 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
08/30116059 DC BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice
BS PD ISO/TR 10993-55:2023 Biological evaluation of medical devices-Interlaboratory study on cytotoxicity
AAMI/ISO 10993-16:1997(R2009) Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
UNE-EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
UNE-EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
NS-EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
DIN EN ISO 14155 E:2018 Draft Document - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2018); German and English version prEN ISO 14155:2018
NS-EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003)
AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (Includes Erratum, 2011)
BS 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
DANSK DS/ISO/TR 10993-55:2023 Biological evaluation of medical devices – Part 55: Interlaboratory study on cytotoxicity
DANSK DS/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 10993-16:2009 Biological evaluation of medical devices-Toxicokinetic study design for degradation products and leachables
DANSK DS/EN ISO 10993-16:2017 Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables
CAN/CSA-ISO 10993-16-00:2000 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
AAMI/ISO TIR19218:2005 Medical devices - Coding structure for adverse event type and cause
NS-EN ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
NS-EN ISO 10993-16:2009 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
UNE-EN ISO 10993-16:2009 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
NS-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 ISO 10993-16:1998 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES. (ISO 10993-16:1997).
NS-EN ISO 10993-16:1997 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
AENOR UNE-EN ISO 10993-16:2018 Biological evaluation of medical devices. Part 16: Design of the toxicokinetic study of degradation products and leachable substances. (ISO 10993-16:2017).
08/30187781 DC BS EN ISO 10993-16. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
DIN EN ISO 10993-16 E:2016 Draft Document - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO/DIS 10993-16:2016); German and English version prEN ISO 10993-16:2016

Association Francaise de Normalisation, Three types of medical device research

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 Pyrogenicity - Principles and test methods for the detection of pyrogens on medical devices
NF ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using samples from human subjects - Good study practices
NF S99-201*NF EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
NF EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: design of toxicokinetic studies of degradation products and leachable substances
NF EN 60335-2-95:2017 Biological evaluation of medical devices - Part 16: design of toxicokinetic studies of degradation products and leachable substances
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

British Standards Institution (BSI), Three types of medical device research

BS EN 540:1993(1998) Clinicalinvestigationof medical devices for human subjects
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
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 EN ISO 10993-16:2017(2020) Biological evaluation of medical devices Part 16 : 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
BS EN ISO 20916:2024 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

NL-NEN, Three types of medical device research

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

Danish Standards Foundation, Three types of medical device research

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

Korean Agency for Technology and Standards (KATS), Three types of medical device research

KS P ISO 14155-2-2007(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 14155-2-2019 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, Three types of medical device research

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

European Committee for Standardization (CEN), Three types of medical device research

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 20916:2024 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 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

未注明发布机构, Three types of medical device research

DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
DIN EN ISO 14155-2 E:2001-08 Clinical Studies of Medical Devices for Human Use Part 2: Clinical Study Protocol (Draft)
DIN EN ISO 20916 E:2021-05 Good research practices for clinical performance studies of in vitro diagnostic medical devices using human samples (draft)
YY 91049-1999 Expanded classification method for three-level categories of medical device standard documents

RU-GOST R, Three types of medical device research

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, Three types of medical device research

GOST ISO 10993-23-2023 Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies
GOST ISO 10993-10-2023 Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests
GOST R ISO 10993-1-2009 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R ISO 10993-11-2009 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST ISO 10993-11-2021 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
GOST R ISO 10993.11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST R ISO 10993-18-2009 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R ISO 10993-6-2009 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-6-2021 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R ISO 10993.6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-12-2023 Medical devices. Biological evaluation of medical devices. Part 12. Selection and preparation of samples for research
GOST R ISO 10993-10-2009 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST R ISO 10993.10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST R ISO 10993-5-2009 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST R ISO 10993-4-2009 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-1-2021 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process
GOST ISO 10993-5-2023 Medical devices. Biological evaluation of medical devices. Part 5. Cytotoxicity studies by in vitro methods
GOST ISO 10993-16-2021 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R ISO 10993-16-2009 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R ISO 10993-3-2009 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

ES-UNE, Three types of medical device research

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, Three types of medical device research

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

GSO, Three types of medical device research

OS GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice
GSO ISO 20916:2021 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
GSO ISO 10993-16:2015 Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice

International Organization for Standardization (ISO), Three types of medical device research

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

German Institute for Standardization, Three types of medical device research

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 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 ISO 10993-16:2018 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

国家药监局, Three types of medical device research

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, Three types of medical device research

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)

Professional Standard - Medicine, Three types of medical device research

YY/T 91049-1999 Third class category expansion variety method for medical devices standard literature
YY/T 0869-2013 Medical devices.Coding structure for adverse event type and cause

US-AAMI, Three types of medical device research

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, Three types of medical device research

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

IX-EU/EC, Three types of medical device research

MEDDEV 2.7.2-2008 GUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN MAKING AN ASSESSMENT OF CLINICAL INVESTIGATION NOTIFICATION

Lithuanian Standards Office , Three types of medical device research

LST EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

AENOR, Three types of medical device research

UNE-EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
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)

Canadian Standards Association (CSA), Three types of medical device research

CSA ISO 14971:2021 Medical devices - Application of risk management to medical devices (Adopted ISO 14971:2019, third edition, 2019-12)
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

PL-PKN, Three types of medical device research

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

American National Standards Institute （ANSI), Three types of medical device research

ANSI/AAMI/ISO 10993-16:2020(R2022) Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
ANSI/AAMI/ISO 10993-16:1997 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

American Society for Testing and Materials (ASTM), Three types of medical device research

ASTM F1088-23 Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices

Standard Association of Australia （SAA）, Three types of medical device research

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

CEN - European Committee for Standardization, Three types of medical device research

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, Three types of medical device research

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, Three types of medical device research

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, Three types of medical device research

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, Three types of medical device research

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, Three types of medical device research

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

VDE - VDE Verlag GmbH@ Berlin@ Germany, Three types of medical device research

VDE-AR-E 2750-200-2013 Approach to the classification of medical devices and the selection of conformity assessment procedures

国家食品药品监督管理局, Three types of medical device research

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