Medical Analytical Instruments

Medical Analytical Instruments, Total:201 items.

The international standard classification for "Medical Analytical Instruments" includes: Medical equipment in general , Sterilization and disinfection in general .

The Chinese standard classification for "Medical Analytical Instruments" includes: Marking, packaing, transport and storage , Medical apparatus and devices in general , Public medical equipment .

Professional Standard - Medicine

YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY 0083-1992 Product nameplate for medical equipment
YY/T 0083-1992 Product nameplate for medical instruments and equipment

Group Standards of the People's Republic of China

T/ZSJL 012-2023 Hand push medical instrument casters and wheels
T/QGCML 4089-2024 Mongolian medicine mouse bath therapy device

国家药监局

YY/T 1737-2020 Analytical method for bioburden control level of medical device

国家质量监督检验检疫总局

SN/T 4445.2-2016 Technical requirements for the inspection of medical apparatus for import-Part 2: Patient monitor

海关总署

SN/T 5473.3-2022 Technical requirements for the inspection of export medical devices - Part 3: Infrared thermometer
SN/T 5473.2-2022 Technical requirements for the inspection of export medical devices - Part 2: Patient monitor

Japanese Industrial Standards Committee (JISC)

JIS T 7203:1989 Oxygen analyzers for medical use
JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
JIS T 1553:2005 Optics and optical instruments -- Medical endoscopes and endotherapy devices
JIS T 14971:2012 Medical devices -- Application of risk management to medical devices

SCC

NS-EN 1441:1997 Medical devices — Risk analysis
NS-EN 1639:1996 Dentistry — Medical devices for dentistry — Instruments
NS-EN 1639:2004 Dentistry — Medical devices for dentistry — Instruments
BS EN 1639:1997 Dentistry. Medical devices for dentistry. Instruments
DANSK DS/EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
DIN 96115 E:2010 Draft Document - Medical instruments - Gauges type Lexer
NS-EN 1639:2009 Dentistry — Medical devices for dentistry — Instruments
DIN 96135 E:2011 Draft Document - Medical instruments - Gauges type Alexander
08/30184602 DC BS EN 1639. Dentistry. Medical devices for dentistry. Instruments
DIN EN 1639 E:2008 Draft Document - Dentistry - Medical devices for dentistry - Instruments; German version prEN 1639:2008
DIN 13181-1 E:2012 Draft Document - Medical instruments - Instruments for brain clips type McKenzie - Part 1: Clips applying
06/30084270 DC ISO 11073-90101. Health informatics. Point-of-care medical device communication. Part 90101. Analytical instruments. Point of care test
CAN/CSA-ISO 14971-1-99:1999 Medical devices - Risk management - Part 1: Application of risk analysis
DIN 13181-2 E:2012 Draft Document - Medical instruments - Instruments for brain clips type McKenzie - Part 2: Clips and fitting dimensions
DIN 96298-3:2017 Medical instruments - Terms, measuring methods and tests - Part 3: Tests
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/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
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
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
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
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)
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
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
MIL MIL-C-36856-1972 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NONRIGID, NO. 3
MIL MIL-C-37066-1974 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NONRIGID, NO. 6
BS PD ISO/TR 11633-1:2009 Health informatics. Information security management for remote maintenance of medical devices and medical information systems-Requirements and risk analysis
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
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
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
BS PD ISO/TS 11633-1:2019 Health informatics. Information security management for remote maintenance of medical devices and medical information systems-Requirements and risk analysis

CEN - European Committee for Standardization

EN 1441:1997 Medical Devices - Risk Analysis
EN ISO 14971:2009 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 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices

CZ-CSN

CSN 36 4800-1966 Electrical medical insíruments
CSN 85 5925-1984 Medieal instrumenta. Surgical needles
CSN 85 5925-1974 Medical instrumente Surgical needles
CSN 85 5701-1986 Articulated medical instruments. Names and definitions
CSN 85 0002-1983 Medical instruments. Marking, packaging, transport and storage
CSN 85 6010-1980 Medical instruments. Dental handpieces for micromotors. Mounting dimensions

German Institute for Standardization

DIN 58852:2021-02 Medical instruments - Probes
DIN 58857:1976 Medical instruments; directors
DIN 96140:2011 Medical instruments - Chisels type Stille
DIN 96115:2010 Medical instruments - Gauges type Lexer
DIN 96148:2011 Medical instruments - Retractor type Jansen
DIN 96146:2011 Medical instruments - Retractors type Brunner
DIN 96146 E:2017-06 Medical instruments - Retractors type Brunner
DIN 96146:2017 Medical instruments - Retractors type Brunner
DIN 96164:2011 Medical instruments - Reamer type Perthes
DIN 96110:2006 Medical instruments - Technical specifications for evidence examples
DIN 96140:2017 Medical instruments - Osteotomes type Stille
DIN 96145:2011 Medical instruments - Tissue forceps type Gillies
DIN 96135:2011 Medical instruments - Gauges type Alexander
DIN 96165:2011 Medical instruments - Bone holding forceps type Lambotte
DIN 96142:2011 Medical instruments - Ligature needle type Kronecker
DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009
DIN 96166:2017 Medical instruments - Handle for wire saws type Gigli
DIN 58854:2023-03 Medical instruments - Myrtle leaf probes
DIN 96156:2011 Medical instruments - Retractor type Kocher, blade curved
DIN 96166:2011 Medical instruments - Handle for wire saws type Gigli
DIN 96141:2011 Medical instruments - Chisels and gauges type Partsch
DIN 96156 E:2017-06 Medical instruments - Retractor type Kocher, blade curved
DIN 96156:2017 Medical instruments - Retractor type Kocher, blade curved
DIN V ENV 12611:1997 Medical informatics - Categorial structure of systems of concepts - Medical devices; English version ENV 12611:1997
DIN 96298-3:2017-10 Medical instruments - Terms, measuring methods and tests - Part 3: Tests
DIN 96298-3 E:2017-04 Medical instruments - Terms, measuring methods and tests - Part 3: Tests
DIN EN 62467-1 E:2008-05 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
DIN 58318 E:2019-05 Medical instruments - Elevators Langenbeck's
DIN 58318:2008 Medical instruments - Elevators Langenbeck's
DIN EN 1639:2010 Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009
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 556-1:2002-03 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 13114-1:1980 Medical instruments; scissors type Mayo without carbide inserts
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 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 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Association Francaise de Normalisation

NF S90-304:1989 MEDICO-SURGICAL EQUIPMENT. HAEMODIALYSIS EQUIPMENT. OPERATING DATA.
NF S97-500*NF EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
NF S91-170:1996 Dentistry. Medical devices for denstistry. Instruments.
NF EN 1639:2009 Art dentaire - Dispositifs médicaux pour l'art dentaire - Instruments
NF S91-170*NF EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments.
NF S99-210:1998 MEDICAL DEVICES. RISK ANALYSIS. (EUROPEAN STANDARD EN 1441).
NF S90-305:1986 MEDICO-SURGICAL EQUIPMENT. PERITONEAL DIALYSIS CYCLER. FUNCTIONAL APTITUDE.
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 C74-327:2003 Medical electrical equipment - Part 2-39 : particular requirements for the safety of peritoneal dialysis equipment.
NF S99-211:2013 Medical devices - Application of risk management to medical devices
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
NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale

European Committee for Standardization (CEN)

EN 50072:1992 Medical electrical equipment; particular requirements for the safety of peritoneal dialysis equipment
EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments
EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
EN 1639:1996 Dentistry - Medical Devices for Dentistry - Instruments
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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)

PL-PKN

PN Z54059-1969 Medical instruments Closures Sizes
PN Z57054-1987 Medical instruments ood mouth spatula
PN Z54123-1988 Medical instruments Scissors Re?uirements and te?ts
PN Z55101-1988 Medical instruments Reusable needles Dimensions

Danish Standards Foundation

DS/EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments

Lithuanian Standards Office

LST EN 1639-2010 Dentistry - Medical devices for dentistry - Instruments
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

DIN

DIN EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments

Spanish Association for Standardization (UNE)

UNE-EN 1639:2010 Dentistry - Medical devices for dentistry - Instruments
UNE-EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments
UNE-EN 62467-1:2015 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers (Endorsed by AENOR in January of 2016.)
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

GSO

BH GSO EN 1639:2022 Dentistry — Medical devices for dentistry —Instruments
GSO EN 1639:2021 Dentistry — Medical devices for dentistry —Instruments
BH GSO ISO 22466:2023 Traditional Chinese medicine — Laser acupoint devices
GSO ISO 22466:2023 Traditional Chinese medicine — Laser acupoint 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
GSO IEC 62467-1:2013 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices

British Standards Institution (BSI)

BS EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments
BS ISO 11073-90101:2008 Health informatics - Point-of-care medical device communication - Analytical instruments - Point-of-care test
BS EN ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
BS EN 62467-1:2015 Medical electrical equipment. Dosimetric instruments as used in brachytherapy. Instruments based on well-type ionization chambers
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to 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 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices

Korean Agency for Technology and Standards (KATS)

KS P 6124-2006(2016) Oxygen analyzers for medical use
KS P 6124-2021 Oxygen analyzers for medical use
KS P ISO 14971-1-2007 Medical devices－Risk management－Part 1：Application of risk analysis
KS P ISO 14971-1:2002 Medical devices－Risk management－Part 1：Application of risk analysis
KS C IEC 60601-2-8:2017 Medical electrical equipment — Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
KS C IEC 60601-2-8:2012 Medical electrical equipment－Part 2-8：Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
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 11137-1:2008 Sterilization of health care products－Radiation－Part 1：Requirements for development, validation and routine control of a sterilization process for 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

HU-MSZT

MSZ 17119-1987 Requirements for medical radiation equipment films

BE-NBN

NBN-EN 540-1993 Clinical investigation of medical devices for human subjects

RU-GOST R

GOST 24280-1980 Medical instrument. Dental hendpieces for micromitors. Coupling dimensions
GOST R 50444-1992 Medical instruments, apparatus and equipment. General specifications
GOST R 55991.4-2014 In vitro diagnostics medical devices. Part 4. Automatic analyzers for coagulation tests. Technical requirements for public procurement
GOST R 55991.2-2014 In vitro diagnostics medical devices. Part 2. Automatic analyzer for immunoassays. Technical requirements for public procurement
GOST R 55991.1-2014 In vitro diagnostics medical devices. Part 1. Automatic analyzers for biochemical assays. Technical requirements for public procurement
GOST R IEC 62467-1-2013 Medical electrical equipment. Dosimetric instruments as used in brachytherapy. Part 1. Instruments based on well-type ionization chambers
GOST R 55991.6-2014 In vitro diagnostics medical devices. Part 6. Automatic analyzers for hematology tests. Technical requirements for public procurement
GOST R 55991.3-2014 In vitro diagnostics medical devices. Part 3. Automatic analyzers for biomolecular assays. Technical requirements for public procurement
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R 55991.7-2014 In vitro diagnostics medical devices. Part 7. Automatic analyzers for general clinical tests. Technical requirements for public procurement
GOST R IEC/TO 61948-1-2009 Nuclear medicine instrumentation. Routine tests. Part 1. Radiation counting systems
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices

PT-IPQ

NP EN 1441-2000 Medical devices Risk analysis

International Organization for Standardization (ISO)

ISO/IEEE 11073-90101:2008 Health informatics — Point-of-care medical device communication — Part 90101: Analytical instruments — Point-of-care test
ISO 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
ISO 11073-90101:2008 Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments - Point-of-care test
ISO 14971:2019 Medical devices — Application of risk management 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
IEC/TR 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC TR 62366-2-2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices

South African Bureau of Standard

SANS 18812:2003 Health informatics - Clinical analyser interfaces to laboratory information systems - Use profiles
SANS 14971:2008 Medical devices - Application of risk management to medical devices

Australian/New Zealand Standard (AU-AS/NZS)

AS/NZS 4810.1:2000 Medical Devices - Risk Management Part 1: Application of Risk Analysis

KR-KS

KS P ISO 14971-1-2002 Medical devices－Risk management－Part 1：Application of risk analysis
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 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 14971-2021 Medical devices — Application of risk management 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
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

RO-ASRO

STAS 12939-1991 Medical use textile items. Analysis methods

American Society for Testing and Materials (ASTM)

ASTM F561-97(2003) Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
ASTM F561-04 Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues

U.S. Military Regulations and Norms

ARMY MIL-W-52875 B-1983 WATER QUALITY ANALYSIS SET: PREVENTIVE MEDICINE
ARMY MIL-W-52875 B NOTICE 1-1999 WATER QUALITY ANALYSIS SET: PREVENTIVE MEDICINE
ARMY MIL-W-52875 B (1)-1986 WATER QUALITY ANALYSIS SET: PREVENTIVE MEDICINE

International Electrotechnical Commission (IEC)

IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

US-FCR

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

TH-TISI

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

AT-ON

OENORM 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/FDIS 17664-1:2021)

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