Three types of medical reagents

Three types of medical reagents, Total:92 items.

The international standard classification for "Three types of medical reagents" includes: Medical materials , Sterilization and disinfection , Laboratory medicine , Sterilization and disinfection in general .

The Chinese standard classification for "Three types of medical reagents" includes: Medical sanitary products , , Sanitation in general , Medical laboratory equipment , Public medical equipment .

Professional Standard - Medicine

YY 91049-1999 Expanded classification method for three-level categories of medical device standard documents
YY/T 91049-1999 Third class category expansion variety method for medical devices standard literature
YY/T 1854-2022 Test method for trioctyl triphthalate (TOTM) released from PVC medical devices

Taiwan Provincial Standard of the People's Republic of China

CNS 12595-1989 Method of Test for Cutting and Durability for Surgical Knives
CNS 14624.3-2002 Infusion equipment for medical use-Part 3：Aluminum caps for infusion bottles
CNS 14624-3-2002 Infusion equipment for medical use-Part 3：Aluminum caps for infusion bottles

Group Standards of the People's Republic of China

T/ZGXX 0003-2019 Medical device cleaning agent
T/CMAM ZH2-2024 Construction and management standards for preparation rooms of ethnic minority medical institutions (Trial)
T/ZJHIA 14-2024 Specification for classification and grading of medical and health data
T/GDSYXH 001-2022 Standards for evaluation of medical quality control indicators in pathology departments of tertiary hospitals
T/ZYYX 001-2020 Third-Party Evaluation Requirements for Patient Satisfaction in Medical Institutions
T/HENANPA 011-2023 Evaluation index system for calcium channel blocker drugs in medical institutions

Professional Standard - Agriculture

200药典中药成方制剂卷-2010 Sections on Internal Medicine VII. Wind Dispelling Agents (3) Huatan Xifeng Yixian Pills

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

GB 27949-2011 General Requirements for Disinfectants for Medical Devices
GB/T 27949-2011 Hygienic requirements for medical items disinfection

国家市场监督管理总局、中国国家标准化管理委员会

GB 27949-2020 General requirements of disinfectant of medical instruments

国家药品监督管理局

YY/T 1579-2018 In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents

Shanghai Provincial Standard of the People's Republic of China

DB31/T 1344-2022 Specifications for classification and disposal of medical waste in animal diagnosis and treatment institutions

Shanxi Provincial Standard of the People's Republic of China

DB14/T 2254-2020 Regulations on cold storage and freezing management of clinical in vitro diagnostic reagents in medical institutions

国家药监局

YY/T 1733-2020 Radiation sterilization of medical devices—Guide for dose mapping in irradiation processing facilities

National Fire Protection Association (NFPA)

NFPA 1582H PART 5 CH 3-1997 Category A and Category B Medical Conditions

SCC

NS 683:1980 Medical test tubes
DANSK DS/EN 60580:2001 Medical electrical equipment – Dose area product meters
DANSK DS/EN IEC 60580:2020 Medical electrical equipment – Dose area product meters
CEI EN IEC 60580:2020 Medical electrical equipment - Dose area product meters
CAN/CGSB-43.125-2021 Packaging of Category A and Category B infectious substances (Class 6, Division 6.2) and clinical, (bio) medical or regulated medical waste
DANSK DS/EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
DIN 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
CAN/CSA Z8001-2013(R2023) Commissioning of health care facilities

US-FCR

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

AT-ON

ONORM M 7390 Teil.6-1987 Gas cylinder valves; special typesfor medical apparatus with cylinders up to 3 liters capacity (PIN-Index-System)

British Standards Institution (BSI)

DD ENV 12611-1998 Medical informatics. Categorical structure of systems of concepts. Medical devices
BS EN IEC 60580:2020 Medical electrical equipment. Dose area product meters
BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
BS EN 62353:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
BS EN 62353:2014 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
DD ENV 12611:1998 Medical informatics. Categorical structure of systems of concepts. Medical devices

CEN - European Committee for Standardization

DD ENV 12924-1997 Medical Informatics - Security Categorisation and Protection for Healthcare Information Systems

Spanish Association for Standardization (UNE)

UNE 111-551-1989 Medical materials. Classification and definition
UNE-EN IEC 60580:2020 Medical electrical equipment - Dose area product meters (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

RO-ASRO

STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology
STAS E 10719/2-1986 Medical instruments RESISTANCE TESTING AT CORROSION AND REPEATED STERILIZATIONS STAINLESS STEEL MEDICAL INSTIUMENTS

NATO - North Atlantic Treaty Organization

AMEDP-8 (A) VOL III-2001 VOLUME III – MEDICAL PLANNING GUIDE OF NBC BATTLE ASUALTIES CHEMICAL

IX-EU/EC

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

GSO

GSO IEC 60580:2014 Medical electrical equipment - Dose area product meters
BH GSO 2628:2022 Medical devices and supplies classification criteria
OS GSO IEC 60580:2014 Medical electrical equipment - Dose area product meters
BH GSO IEC 60580:2016 Medical electrical equipment - Dose area product meters
GSO 2628:2021 Medical devices and supplies classification criteria

Canadian General Standards Board （CGSB)

CAN/CGSB-43.125-2016 Packaging of Category A and Category B infectious substances (Class 6.2) and clinical, (bio) medical or regulated medical waste

Canadian Standards Association (CSA)

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

RU-GOST R

GOST R ISO 23640-2015 In vitro medical devices. Evaluation of stability of in vitro diagnostic reagents
GOST R 50325-2011 Medical products. Radiation sterilization. Dosimetric techniques
GOST R 53931-2010 Medical-social expertise. Basic types of services of medical-social expertise
GOST R IEC 60580-2006 Medical electrical equipment. Dose area product meters
GOST R IEC 60731-2001 Medical electrical equipment. Dosimeters with ionization chambers in radiotherapy
GOST R ISO 18472-2009 Sterilization of health care products. Biological and chemical indicators. Test equipment

Association Francaise de Normalisation

NF EN ISO 13120:2019 Health Informatics - Content Representation Syntax of Healthcare Classification Systems - Classification Marking Language (ClaML)
NF EN ISO 23640:2015 In vitro diagnostic medical devices - Assessment of the stability of in vitro diagnostic reagents
NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF C74-053:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment.
NF C74-053*NF EN 62353:2015 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF EN 62353:2015 Appareils électromédicaux - Essai récurrent et essai après réparation d'un appareil électromédical
NF EN 60731/A1:2022 Appareils électromédicaux - Dosimètres à chambres d'ionisation utilisés en radiothérapie
NF EN 60731:2012 Appareils électromédicaux - Dosimètres à chambre d'ionisation utilisés en radiothérapie

South African Bureau of Standard

SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments

German Institute for Standardization

DIN EN IEC 60580:2021-07 Medical electrical equipment - Dose area product meters (IEC 60580:2019); German version EN IEC 60580:2020
DIN EN ISO 23640:2015-12 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.
DIN EN 62353:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007); German version EN 62353:2008

KR-KS

KS P ISO 23640-2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS C IEC 60580-2018 Medical electrical equipment — Dose area product meters

Korean Agency for Technology and Standards (KATS)

KS P ISO 23640:2019 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS C IEC 60580:2018 Medical electrical equipment — Dose area product meters
KS P ISO 23640:2013 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

BE-NBN

NBN-EN 375-1992 In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for professional use

Standard Association of Australia （SAA）

AS 1169:1973 Rules for minimizing hazards arising from the use of flammable medical agents and non-flammable medical gases (known as SAA Medical agents and cases safety code)

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

AS/NZS 4957:2002 Medical electrical equipment - Dose area product meters
AS/NZS 4537:1999 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

International Electrotechnical Commission (IEC)

IEC 60580:2019 Medical electrical equipment - Dose area product meters
IEC 62353:2007 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

European Committee for Standardization (CEN)

EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

American Society for Testing and Materials (ASTM)

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

VN-TCVN

TCVN 5766-1993 Medical scalpels and knives.General technincal requirements and test methods

SE-SIS

SIS SS IEC 731:1988 Medical electrical equipment — Dos/meters with ionization chambers as used in radiotherapy