Non-medical device operation box

Non-medical device operation box, Total:329 items.

The international standard classification for "Non-medical device operation box" includes: Medical Sciences and health care facilities in general , Medical equipment in general , Medical equipment .

The Chinese standard classification for "Non-medical device operation box" includes: Standardization and quality management , Medical apparatus and devices in general , Public medical equipment , General and microsurgical devices .

Group Standards of the People's Republic of China

T/GXAS 239-2021 Specification for technical of leech therapy in Zhuang medicine
T/CPCPA 0012-2025 Technical operation specifications for TCM health care (non-medical) massage health healing services
T/CACM 1560.10-2023 Specification for operation technologies of traditional Chinese medicine health care services (non-medical)—Fumigation and steaming
T/CACM 1560.1-2023 Technical operation specifications of Chinese medicine health care services（non-medical）— Tuina (the traditional Chinese massage)
T/CMAM Z1-Z9-2019 Tibetan medical technical operation specification
T/CMAM M10-20-2019 Mongolian medical technical operation specification
T/CACM 1560.6-2023 Technical operation specifications for traditional Chinese medicine health care services (non-medical) — Acupoint application
T/CACM 1560.5-2023 Technical operation specifications for traditional Chinese medicine health care services (non-medical) — Auricle Tuina
T/CACM 1560.4-2023 Technical operation specifications of Chinese medicine health care services (Non-medical)—Moxibustion
T/CACM 1560.3-2023 Technical operation specifications of Chinese medicine health care services (Non-medical)—Cupping
T/CACM 1560.2-2023 Technical operation specifications of Chinese medicine health care services（non-medical）— Guasha
T/CRHA 079-2024 Practice specification for pretreatment of reusable medical devices
T/CRACM 0006-2021 Green therapy Chinese medicine application technology operation standard
T/CACM 1560.7-2023 Specification for health care of traditional Chinese medicine（Non-medical treatment）Tuina in pediatric
T/CMAM H1-H10-2019 Kazakh Medical Technical Operation Specifications
T/CPCPA 0010-2025 Traditional Chinese medicine health care service (non-medical) fire dragon cup comprehensive moxibustion technical operation specification
T/GXAS 951-2025 Pediatric TCM non-drug therapy operation specification Pediatric cough Fubei powder patch therapy
T/CACM 1560.8-2023 Specification for operation technologies of traditional Chinese medicine health care services (non-medical)—Herbal bath of TCM
T/*** ****--2025 Standard Operating Procedures for Aromatherapy Techniques in Traditional Chinese Medicine Health Preservation Services (Non-Medical)
T/CMAM T1-T18-2019 Tujia medical technical operation specification
T/CPCPA 0011-2025 Aromatherapy technology operation specifications for traditional Chinese medicine health care services (non-medical)
T/CACM 1560.9-2023 Specification for operation technologies of traditional Chinese medicine health care services (non-medical)—Foot bath
T/CMAM D1-D5-2019 Dai medical technical operation specification

Professional Standard - Commodity Inspection

SN/T 3061-2011 Rules of the Inspection of Packaging for Import Terminally Sterilized Medical Devices

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 4553-2023 Guidelines of adverse events monitoring for hospital medical device

Professional Standard - Medicine

YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0048-1991 Basic requirements for working drawings of medical device products
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 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 1474-2016 Medical devices－Application of risk management to medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices

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

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

Guangxi Provincial Standard of the People's Republic of China

DB45/T 2056-2019 Yao Medical Get Out Therapy Operating Specifications
DB45/T 1975-2019 Yao Medical Grinding Drug Therapy Operation Specification

Henan Provincial Standard of the People's Republic of China

DB41/T 2400-2023 Guidelines for Reporting Medical Device Adverse Events

Defense Logistics Agency

DLA MIL-C-37183-1975 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NON-RIGID, NO. 8
DLA MIL-C-36856 (1)-1986 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NON-RIGID, NO. 3
DLA MIL-C-303 C-1979 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NONRIGID, NO. 2
DLA MIL-C-36856-1972 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NON-RIGID, NO. 3
DLA MIL-C-37183 (1)-1986 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NON-RIGID, NO. 8

Military Standards (MIL-STD)

MIL MIL-C-36020-1959 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NONRIGID, NO. 5, EMPTY
MIL MIL-C-37183-1975 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NON-RIGID, NO. 8
MIL MIL-C-37066-1974 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NONRIGID, NO. 6
MIL MIL-C-36856-1972 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NONRIGID, NO. 3
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET

Underwriters Laboratories (UL)

UL 2800 BULLETIN-2017 UL Standard for Safety Medical Device Interoperability
UL 2800 BULLETIN-2014 UL Standard for Safety Medical Device Interoperability
UL 2800 BULLETIN-2015 UL Standard for Safety Medical Device Interoperability
UL 2800-1-2022 UL Standard for Safety Medical Device Interoperability
UL 2800 BULLETIN-2013 UL Standard for Safety Medical Device Interoperability
UL 2800 BULLETIN-2016 UL Standard for Safety Medical Device Interoperability
UL 2800-1-2019 UL Standard for Safety Medical Device Interoperability (First Edition)
UL 2800 BULLETIN-2018 UL Standard for Safety Medical Device Interoperability (COMMENTS DUE: AUGUST 3@ 2018)

Association Francaise de Normalisation

NF S99-170:2013 Maintenance of medical devices - Quality management system for the maintenance and management of risks associated with the operation of 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 S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF S90-351:1987 MEDICO-SURGICAL EQUIPMENT. PROCEDURES FOR INSPECTION AND CONTROL OF OPERATING THEATRES. AIR QUALITY.
NF S90-251:1986 Medico-surgical equipment. Syringe pumps. Operating characteristics.
NF EN ISO 14971:2019 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 S99-211/A11*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 S99-014-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements.
NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to obtain STERILE labeling - Part 1: Requirements for terminally sterilized medical devices
NF S99-401:1994 Medical Devices - Medical Grade Silicone Elastomer
NF S98-107-2*NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
NF EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices

American National Standards Institute （ANSI)

ANSI/AAMI UL 2800-1-1-2022 Risk Concerns for Interoperable Medical Products
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 14971:2019 Medical devices— Application of risk management to medical devices
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
ANSI/AAMI UL 2800-1-2022 Standard for Medical Device Interoperability
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

British Standards Institution (BSI)

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
DD ENV 13735-2001 Health Informatics - Interoperability of Patient Connected Medical Devices
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 ISO 14971:2012 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 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
BS EN ISO 15223-1:2017 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
BS 5724 Sec.3.129 Supplement 1:1994 Medical electrical equipment. Particular requirements for performance. Methods of declaring functional performance characteristics of radiotherapy simulators. Guide to functional performance values
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 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
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 ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
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 PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
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

Swedish Institute for Standards

SS-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)
SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
SS-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Korean Agency for Technology and Standards (KATS)

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 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 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 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
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

Ente Nazionale Italiano di Unificazione

UNI 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
UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2022 Medical devices - Application of risk management to medical devices
EC 1-2004 UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
UNI EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ?STERILE? - Requirements for terminally sterilized medical devices
UNI CEI EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
UNI 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
UNI EN ISO 17664:2018 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
UNI EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

GCC Standardization Organization

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 14971:2024 Medical devices — Application of risk management to medical devices
OS GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
BH GSO ISO 28620:2024 Medical devices — Non-electrically driven portable infusion devices
OS GSO ISO 28620:2024 Medical devices — Non-electrically driven portable infusion devices

Danish Standards Foundation

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
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)
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
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
DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DS/CEN/CR 14060:2001 Medical device traceability
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
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
DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Canadian Standards Association (CSA)

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
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
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (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
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

Kingdom of Bahrain Testing and Metrology Directorate

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 14708-2:2024 Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
BH GSO ISO 28620:2016 Medical devices - Non-electrically driven portable infusion devices
BH 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)

Association for the Advancement of Medical Instrumentation

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
AAMI 2800-1:2022 Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2022)
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2007(R2016) Medical Devices - Application of Risk Management to Medical Devices
AAMI/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to medical devices
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
AAMI EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs
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 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

Bureau of Indian Standards

IS 18742-2-2024 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
IS 18871-2024 Medical Devices-Non-Electrically Driven Portable Infusion Devices
IS/ISO 14971-2019 Medical devices - Application of risk management to medical devices First Revision

Standards Norway

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)
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
SN-CR 14060:2000 Medical device traceability
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
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
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized 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 ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices

National Standardisation Body (ASRO)

STAS 1484-1950 medical instruments. Boxes for storing first aid equipment and materials

COMMISSION FOR THE STANDARDS, METROLOGY AND QUALITY OF VIETNAM (STAMEQ)

TCVN 6916-2001 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied
TCVN 6916-1-2008 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied.Part 1: General requirements

International Organization for Standardization (ISO)

ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 15223:2000/Amd 2:2004 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
ISO 14971:2000 Medical devices - Application of risk management to medical devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
ISO 28620:2020 Medical devices — Non-electrically driven portable infusion devices
ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
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

Indonesia Standards

SNI ISO 17664-2:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 2: Alat kesehatan non-kritikal (ISO 17664-2:2021, IDT)
SNI IEC 62653:2014 Pedoman Keselamatan Pengoperasian Peralatan Medis pada Layanan Hemodialisis (IEC/TR 62653:2012, IDT)
SNI ISO 14971:2019 Healthcare Devices – Application of Risk Management to Healthcare Devices (ISO 14971:2019, IDT)

German Institute for Standardization

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
DIN EN ISO 17664-2 E:2023 Draft Document - 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 and English version prEN ISO 176...
DIN 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); German and English version prEN ISO 17664-2:2023
DIN EN ISO 17664-2:2024-04 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
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN 6876:2014 Operation of medical magnetic resonance systems
DIN 58846:2017-11 Medical instruments - Raspatories
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN ISO 17664-2 E:2023-09 Draft Document - 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 and English version prEN ISO 176...
DIN 58846:1988-07 Medical instruments; raspatories
DIN 96160:2011-12 Medical instruments - Wire guide
DIN EN ISO 17664-2:2023-09 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 and English version prEN ISO 17664-2:2023 / Note:...
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 13117:2013 Medical instruments.Bone shears
DIN 58852:2014-09 Medical instruments - Probes
DIN 58794:2010 Medical instruments - Ear forceps
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 13119:2010-02 Medical instruments - Bowel scissors
DIN 58852:2008 Medical instruments - Probes
DIN 96056:2016 Medical instruments - Bone raspatory
DIN EN 62304:2016-10*VDE 0750-101:2016-10 Medical device software
DIN 58852:2008-01 Medical instruments - Probes
DIN EN 1639:2004-09 Dentistry - Medical devices for dentistry - Instruments
DIN 58852:1976 Medical instruments; probes
DIN 96056 E:2022-08 Medical instruments - Bone raspatory
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 58857:2019 Medical instruments - Directors
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN 13119:1980 Medical instruments; bowel scissors
DIN 13117:2013-01 Medical instruments - Bone shears
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN 58794:1982 Medical instruments; ear forceps
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 58852:2014 Medical instruments - Probes
DIN 13117:1980 Medical instruments; bone shears
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 58852:2021 Medical instruments - Probes
DIN 13193:2016-12 Medical instruments - Rongeurs type Luer
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 13117:1980-06 Medical instruments; bone shears
DIN 96060:2009-12 Medical instruments - Elevator type Langenbeck
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 58857:2019-12 Medical instruments - Directors
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 13185:2005-12 Medical instruments - Onychia forceps
DIN 58846:2010-02 Medical instruments - Raspatories
DIN EN ISO 14971:2007-07 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN 13824:2005-02 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
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
DIN 58265:1974-09 Medical instruments; needle holder Finochietto's
DIN EN 556-1 E:2023 Draft Document - 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
DIN 58296:2008-01 Medical instruments - Raspatories Semb's
DIN EN ISO 15223-1 E:2009-06 Medical devices Symbols used for labeling, marking and providing information on medical devices Part 1: General requirements (draft)
DIN 58263:1973 Medical instruments; mouth gag Heister's
DIN 58319:2008-01 Medical instruments - Elevators Williger

Japanese Industrial Standards Committee (JISC)

JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
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 14971:2020 Medical devices -- Application of risk management to medical devices

European Committee for Standardization (CEN)

DD ENV 13735-2000 Health Informatics - Interoperability of Patient Connected Medical Devices
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)
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)
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)
EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

European Union/Commission

MEDDEV 2.15-2008 GUIDELINES ON MEDICAL DEVICES Committees/Working Groups contributing to the implementation of the Medical Device Directives (REV 3)
MEDDEV 2.15/1-1998 Committees/Working Parties Relevant for Medical Devices

Gosstandart of Russia

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
GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

South African Bureau of Standard

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

Czech Standards Institute (UNMZ)

CSN 36 4809-1982 Medical X-ray apparatus Symbols for operation

Thai Industrial Standards Institute (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 Medical devices - Application of usability engineering to medical devices
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

Spanish Association for Standardization (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)
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to 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 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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 ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
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
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
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)

Comitato Elettrotecnico Italiano

CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
CEI UNI EN/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
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

Standard Association of Australia （SAA）

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

European Committee for Electrotechnical Standardization（CENELEC）

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

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE)

ASHRAE/ASHE 43-2025 ASHRAE/ASHE Guideline 43-2025 Operations Guideline for Ventilation of Health Care Facilities

Lithuanian Standards Office

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
LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

Polski Komitet Normalizacyjny (PKN)

PN BN 7161-38-1967 Wooden transport packaging. Cardboard set and box for medical slime

Others: Non-medical device operation box