medical device allergy

medical device allergy, Total:143 items.

The international standard classification for "medical device allergy" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "medical device allergy" includes: Medical apparatus and devices in general .

Group Standards of the People's Republic of China

T/ZMDS 20002-2017 Guidance on the use of AGILE practices in the development of medical device

Jilin Provincial Standard of the People's Republic of China

DB22/T 3435-2023 TCM diagnosis and treatment norms for children with allergic purpura

Professional Standard - Medicine

YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0664-2008 Medical device software - Software life cycle processes

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
GB/T 42062-2022 Medical devices—Application of risk management to medical devices

未注明发布机构

ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices

国家药监局

YY/T 0664-2020 Medical device software—Software life cycle processes

国家食品药品监督管理局

YY/T 1474-2016 Medical devices－Application of risk management to medical devices

Professional Standard - Agriculture

GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization

RU-GOST R

GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R IEC 62304-2013 Medical device software. Software life cycle processes
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure

British Standards Institution (BSI)

BS EN ISO 10993-10:2023 Biological evaluation of medical devices. Tests for skin sensitization
BS EN ISO 10993-10:2013 Biological evaluation of medical devices. Tests for irritation and skin sensitization
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS PD IEC/TR 80002-3:2014 Medical device software. Process reference model of medical device software life cycle processes (IEC 62304)
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
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 14971:2001 Medical devices - Application of risk management to medical devices
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN 62304:2006 Medical device software - Software life-cycle processes
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure

GSO

GSO ISO 17664:2014 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
GSO ISO 17664-2:2023 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
BH GSO ISO 17664-2:2023 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

International Organization for Standardization (ISO)

ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-10:2002 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-10:2002/Amd 1:2006 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity; Amendment 1
IEC TR 80002-3:2014 Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
IEC/TR 80002-3:2014 Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
IEC TR 80002-3:2014 Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

Association Francaise de Normalisation

NF S99-510/A1:2006 Biological evaluation of medical devices - Part 10 : tests for irritation and delayed-type hypersensitivity.
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF C74-017*NF EN 62304:2006 Medical device software - Software life-cycle processes.
NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: skin sensitization testing
NF S98-116-2*NF ISO 17664-2:2021 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
NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.

VN-TCVN

TCVN 7391-10-2007 Biological evaluation of medical devices.Part 10: Tests for irritation and delayed-type hypersensitivity

GOST

GOST ISO 10993-10-2023 Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests
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

SCC

AS ISO 10993.10:2002 Biological evaluation of medical devices - Tests for irritation and sensitization
BS EN ISO 10993-10:1996 Biological evaluation of medical devices-Tests for irritation and sensitization
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
DANSK DS/ISO 10993-10:2023 Biological evaluation of medical devices – Part 10: Tests for skin sensitization
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
DIN 96056:2016 Medical instruments - Bone raspatory
DANSK DS/ISO 17664-2:2021 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
CSA ISO 17664-2:2023 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
AAMI/ISO 17664-2:2022 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
BS 5736-6:1983 Evaluation of medical devices for biological hazards-Methods of test for sensitization; assessment of the potential of medical devices to produce delayed contact dermatitis

CEN - European Committee for Standardization

EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"
EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices

European Committee for Standardization (CEN)

EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-10:2007 Biological evaluation of medical devices－Part 10：Tests for irritation and delayed-type hypersensitivity
KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure

Japanese Industrial Standards Committee (JISC)

JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
JIS T 2304:2012 Medical device software -- Software life cycle processes
JIS T 2304:2017 Medical device software -- Software life cycle processes

KR-KS

KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
KS P ISO 17664-2-2022 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

ZA-SANS

SANS 14971:2008 Medical devices - Application of risk management to medical devices

German Institute for Standardization

DIN EN 62304:2007 Medical device software - Software life-cycle processes (IEC 62304:2006); German version EN 62304:2006
DIN 58846:2017-11 Medical instruments - Raspatories
DIN EN ISO 10993-10:2023-04 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
DIN 58794:1982 Medical instruments; ear forceps
DIN 58852:2008 Medical instruments - Probes
DIN 13117:2013 Medical instruments.Bone shears

TH-TISI

TIS 14971-2013 Medical devices.application of risk management to medical devices

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
IEC 62304:2015 Medical device software - Software life cycle processes
IEC 62304:2006/AMD1:2015 Medical device software - Software life cycle processes

ES-UNE

UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

European Committee for Electrotechnical Standardization（CENELEC）

EN 62304:2006 Medical device software - Software life-cycle processes (Incorporating corrigendum November 2008)

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

Danish Standards Foundation

DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 17664-2:2022 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

CENELEC - European Committee for Electrotechnical Standardization

EN 62366:2008 Medical devices - Application of usability engineering to medical devices