Class II medical machinery

Class II medical machinery, Total:221 items.

The international standard classification for "Class II medical machinery" includes: Medical Sciences and health care facilities in general , Medical equipment in general , Medical equipment .

The Chinese standard classification for "Class II medical machinery" includes: Standardization and quality management , Medical apparatus and devices in general , General and microsurgical devices , Public medical equipment .

Shanghai Provincial Standard of the People's Republic of China

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

Jiangsu Provincial Standard of the People's Republic of China

DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions
DB32/T 4553-2023 Guidelines of adverse events monitoring for hospital medical device

Professional Standard - Medicine

YY/T 91049-1999 Third class category expansion variety method for medical devices standard literature
YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 0802.1-2024 Disposal of medical devices Information to be provided by the medical device manufacturer Part 1: Medium and high risk medical devices
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY 91055-1999 Paint coating for medical devices. Classification and speciation
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY 91049-1999 Expanded classification method for three-level categories of medical device standard documents

Group Standards of the People's Republic of China

T/SZZX 015-2023 Mechanically actuated micro-plunger pumps for medical devices
T/SAMD 0003-2023 Mechanically actuated micro-plunger pumps for medical devices

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

GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
GB/T 42062-2022 Medical devices—Application of risk management to medical devices

国家食品药品监督管理局

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

国家药监局

YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer

Guangdong Provincial Standard of the People's Republic of China

DB4420/T 45-2024 Specifications for registration management of Class I medical device products

Canadian Standards Association (CSA)

CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
CSA Z314.23-2012 Sterilization by chemical agent of reusable medical devices in healthcare establishments (first edition)
CSA ISO 13485-03-CAN/CSA:2003 Medical devices - Quality management systems - Requirements for regulatory purposes Second Edition
CAN/CSA-ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (Second Edition)
CAN/CSA-ISO 17664:2018 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices

US-FCR

FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES

Association Francaise de Normalisation

NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
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 S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
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 S99-211:2013 Medical devices - Application of risk management to medical devices
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 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 EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF E88-004*NF EN 14677:2008 Safety of machinery - Secondary steelmaking - Machinery and equipment for treatment of liquid steel
NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
XP ISO/TS 22421:2021 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings

RO-ASRO

STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology

South African Bureau of Standard

SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments
SANS 14971:2008 Medical devices - Application of risk management to medical devices

IX-EU/EC

MEDDEV 2.4/1 PART 2-2001 Guidelines for the Classification of Medical Devices Rev 8

GSO

BH GSO 2628:2022 Medical devices and supplies classification criteria
GSO 2628:2021 Medical devices and supplies classification criteria
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
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
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/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

EU/EC - European Union/Commission Legislative Documents

MEDDEV 2.14/1-2012 GUIDELINES ON MEDICAL DEVICES IVD Medical Device Borderline and Classification issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES (REV 2)

British Standards Institution (BSI)

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
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
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
BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices

SCC

09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
CAN/CSA-ISO 14971-2007(R2017) Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
CSA Z314-2023 Reprocessing of medical devices in Canada in all healthcare settings
DIN 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
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
CSA Z314.23-16:2016 Chemical sterilization of reusable medical devices in healthcare settings
DIN 58858 E:2020 Draft Document - Medical instruments - Director type KÃ¶nig
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
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
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
AAMI TIR12:2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
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
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to 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
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
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
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
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
CEI 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
AAMI/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
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
CAN/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
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
AAMI/ISO 17664-1:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
DIN 96056:2016 Medical instruments - Bone raspatory
DANSK DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
DIN 58857:2019 Medical instruments - Directors
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
SN-CR 14060:2000 Medical device traceability
NS-EN 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 (ISO 17664-2:2021)
DANSK DS/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)
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
CAN/CSA-ISO 17664-1-2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
DANSK DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
AENOR UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices

Spanish Association for Standardization (UNE)

UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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)
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
UNE-EN ISO 17664-1:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)

European Committee for Standardization (CEN)

EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

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 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
DS/CEN/CR 14060:2001 Medical device traceability

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 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

RU-GOST R

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 ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure

German Institute for Standardization

DIN 13199:2010 Medical instruments - Ethmoid rongeur forceps type Weil-Blakesley and Watson-Williams
DIN EN 15986 E:2009-08 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 14971:2022 Medical devices – applying risk management to medical devices
DIN 58846:2017-11 Medical instruments - Raspatories
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 58794:1982 Medical instruments; ear forceps
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN 58852:2008 Medical instruments - Probes
DIN 58794:2010 Medical instruments - Ear forceps
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 13117:1980 Medical instruments; bone shears
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 58852:2014 Medical instruments - Probes
DIN 58852:2021 Medical instruments - Probes
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 58857:2019-12 Medical instruments - Directors
DIN 13117:2013 Medical instruments.Bone shears
DIN 13119:1980 Medical instruments; bowel scissors
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 58852:1976 Medical instruments; probes
DIN 96056 E:2022-08 Medical instruments - Bone raspatory
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 556-1:2002-03 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 / Note: To be replaced by DIN EN 556-1 (2023-02).
DIN EN 556-1:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 556-2:2015-11 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 / Note: To be replaced by DIN EN 556-2 (2023-02).
DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 556-1 Berichtigung 1:2006-12 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1...
DIN EN ISO 14971:2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

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

Korean Agency for Technology and Standards (KATS)

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
KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure
KS P ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

CEN - European Committee for Standardization

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
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

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
KS P ISO 17664-1-2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

International Organization for Standardization (ISO)

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
ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

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 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

American National Standards Institute （ANSI)

AAMI TIR12:2004 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
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
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
ANSI/AAMI/ISO 17664-1:2022 Processing of health care products -Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1

Standard Association of Australia （SAA）

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

CN-CNCA

CNCA 08C-032-2001 Implementation Rules for Compulsory Certification of Medical Device Products ECG Machine

CENELEC - European Committee for Electrotechnical Standardization

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

DIN

DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements