Disposable Class I Medical Devices

Disposable Class I Medical Devices, Total:178 items.

The international standard classification for "Disposable Class I Medical Devices" includes: Medical materials , Transfusion, infusion and injection equipment , Rubber and plastics products , Hospital equipment , Pharmaceutics , Sterilization and disinfection , Medical equipment .

The Chinese standard classification for "Disposable Class I Medical Devices" includes: , General and microsurgical devices , Medical and foodstuff rubber products , Medical sanitary products , Medical apparatus and devices in general , Medical laboratory equipment .

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

GB 8368-1998 Medical infusion sets for single use
GB 10213-2006 Single-use medical rubber examination glove
GB 8369-2005 Transfusion sets for single use
GB 8369-1998 Medical transfusion sets for single use
SN/T 4508.2-2016 Technical requirements for the inspection of medical equipment on export - Part 2: Syringe for single use (with needles)
GB 15980-1995 Hygienic standard of disinfection for single use medical products

Professional Standard - Commodity Inspection

SN/T 0323.1-2007 Rules for the inspection of medical equipment for import and export - Part 1 : Infusion and transfusion sets for single use
SN/T 0323.2-2007 Rules for the inspection of medical equipment for import and export - Part 2 : Sterile hypodermic syringes for single use

Group Standards of the People's Republic of China

T/CRIA 19002-2023 Disposable medical protective rubber examination gloves
T/ZZB 2880-2022 Disposable medical isolation eye mask
T/CSBME 010-2019 Disposable use of sterile medical pad/patic
T/CSBME 014-2019 Disposable Sterile Medical Cotton Ball
T/QGCML 469-2022 single use sampler
T/GDMDMA 0033-2024 Disposable nebulizer
T/CSBME 015-2019 Disposable sterile medical cap
T/CAMDI 107-2023 Disposable nonwoven wrap for medical use
T/CSBME 011-2019 Disposable use of sterile infusion tape
T/CASME 302-2023 Single-use medical virus inactivation face mask
T/CSBME 012-2019 Disposable sterile medical gauze blocks
T/CAMDI 035-2020 Disposable three-way stopcock for infusion and transfusion equipments
T/CSBME 013-2019 Disposable sterile medical cotton stick

Gansu Provincial Standard of the People's Republic of China

DB62/T 518-1998 Disposable non-woven series of medical and sanitary products

Professional Standard - Medicine

YY/T 1474-2016 Medical devices－Application of risk management to medical devices
YY/T 0969-2013 Single-use medical face mask
YY/T 1633-2019 Single-use medical protective overboot
YY/T 1642-2019 Single-use medical protective hood
YY/T 0969-2023 Single-use medical face mask
YY 0970-2023 Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes
YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin―Validation and routine control of sterilization by liquid sterilants
YY/T 0970-2013 Validation and routine control of sterilization of liquid sterilants for sterilization of single-use medical devices containing materials of animal origin
YY 0327-2002 Human blood containers for UV rays transmission therapy for single use
YY 0115-1993 Disposable hemostix

Beijing Provincial Standard of the People's Republic of China

DB11/T 1032-2013 Medical waste disposable packing box

Hubei Provincial Standard of the People's Republic of China

DB42/T 822-2012 Disposable general medical mask

Guangdong Provincial Standard of the People's Republic of China

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

Fujian Provincial Standard of the People's Republic of China

DB3502/T 183-2025 Guidelines for the implementation and application of unique identification of medical devices in medical institutions

Standard Association of Australia （SAA）

AS T39:1969 Single-use syringes (sterile) for general medical use
AS 1094:1971 Single-use syringes (sterile) for general medical use
AS 2385:1990 Single-use (sterile) infusion sets for general medical use
AS 1094:1993 Medical equipment - Single-use syringes (sterile) for general medical use
AS 2385:1990/Amdt 1:1993 Disposable (sterile) infusion set for general medical use
AS 1094:1981 Single-use syringes (sterile) for general medical use
AS 4031:1992 Non-reusable containers for the collection of sharp medical items used in health care areas
AS 4031:1992(R1996) Non-reusable containers for the collection of sharp medical items used in health care areas
AS 2385:1980 Single-use (sterile infusion sets for general medical use
AS 2696:1989 Medical equipment - Single-use urethral catheters (sterile) for general medical use
AS 2485:1981 Single-use winged intravenous devices (sterile) for general medical use
AS 2696:1984 Medical equipment - Single-use urethral catheters (sterile) for general medical use
AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements
AS T48:1970 Single-use hypodermic needles (sterile) for general medical use
AS 1946:1976 Single-use hypodermic needles (sterile) for general medical use
AS 1946:1984 Hypodermic equipment - Single-use needles (sterile) for general medical use

British Standards Institution (BSI)

BS EN ISO 8536-4:2013+A1:2013 Infusion equipment for medical use. Infusion sets for single use, gravity feed
BS EN ISO 8536-13:2016 Infusion equipment for medical use. Graduated flow regulators for single use with fluid contact
BS EN ISO 1135-4:2004 Transfusion equipment for medical use-Transfusion sets for single use
22/30415500 DC BS ISO 22587. Traditional Chinese Medicine. Acupoint magnetotherapy plaster for single use
BS EN ISO 8536-4:2004 Infusion equipment for medical use-Infusion sets for single use, gravity feed
BS EN ISO 8536-4:2007 Infusion equipment for medical use-Infusion sets for single use, gravity feed
BS EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied-General requirements
PAS 29:1999 Disposable pulp products for use in healthcare
BS EN ISO 8536-15:2022+A1:2023 Infusion equipment for medical use - Light-protective infusion sets for single use
BS EN ISO 8536-15:2022 Infusion equipment for medical use-Light-protective infusion sets for single use
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN ISO 6717:2021 In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
PD CEN/TR 16953:2017 Medical gloves for single use - Guidance for selection
09/30176675 DC BS EN ISO 15223-1. Medical devices. Symbols to be used with medical device labels , labelling and information to be supplied. Part 1. General requirements

European Committee for Standardization (CEN)

EN ISO 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
EN ISO 14160:1998 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin - Validation and Routine Control of Sterilization by Liquid Chemical Sterilants ISO 14160: 1998
EN ISO 1135-4:2011 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
FprEN ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO/FDIS 8871-5:2024)
EN ISO 1135-4:2010 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices

Association Francaise de Normalisation

NF S90-303:1984 MEDICO-SURGICAL EQUIPMENT. DIALYSIS APPARATUS. SINGLE-USE,STERILE LINES AND CONNECTIONS.
NF S93-253-4:2012 Transfusion equipment for medical use - Part 4 : transfusion sets for single use.
NF EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for collecting samples of human origin other than blood
NF S92-036*NF EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
NF S93-253-4:2005 Transfusion equipment for medical use - Part 4 : transfusion sets for single use.
NF S90-240:1990 Medico-surgical equipment. Single-use containers for biological samples. Evacuated tubes.
NF S90-307:1990 Medico-surgical equipment. Centrifuge-type blood cell and plasma separators (monitors and single-use kits) suitability for use.
NF S93-123-15*NF EN ISO 8536-15:2022 Infusion equipment for medical use - Part 15 : light-protective infusion sets for single use
NF S99-172:2017 Use and maintenance of medical devices - Risk management système for risks associated with the use of medical devices

Canadian Standards Association (CSA)

CSA Z314.15-15:2015 Storage, transportation and distribution of reusable and single-use medical devices
CSA Z314.23-2012 Sterilization by chemical agent of reusable medical devices in healthcare establishments (first edition)
CSA Z314.15-2015 Storage, transportation, and distribution of single use and reusable medical devices (Third Edition; Incorporating Errata: October 2015)
CSA Z316.6-2007(R2012) Evaluation of Single-Use and Reusable Medical Sharps Containers for Biohazardous and Cytotoxic Waste

International Organization for Standardization (ISO)

ISO 1135-4:2015 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
ISO 1135-4:2010 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
ISO 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 1135-5:2015 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus
ISO 8536-4:2010/Amd 1:2013 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; Amendment 1
ISO/FDIS 22587 Traditional Chinese medicine — Acupoint magnetotherapy plasters for single use
ISO 1135-4:1998 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
ISO 1135-4:2004 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
ISO 11193-1:2002 Single-use medical rubber examination gloves

Spanish Association for Standardization (UNE)

UNE-EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
UNE-EN ISO 6717:2022 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
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

German Institute for Standardization

DIN EN ISO 1135-4 E:2013-10 Medical devices for infusion Part 4: Disposable gravity infusion set (draft)
DIN EN ISO 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012); German version EN ISO 1135-4:2012
DIN EN ISO 15223-1/A1:2019 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016); German and English version EN ISO 15223-1:2016/prA1:2019
DIN EN ISO 15223-1:2013-02 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
DIN EN ISO 1135-5 E:2013-11 Medical devices for infusion Part 5: Disposable infusion sets with pressure infusion devices (Draft)
DIN EN ISO 15223-1:2020 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
DIN EN ISO 11070 A1 E:2018-01 Sterile single-use intravascular introducers, dilators and guidewires
DIN EN ISO 8536-4 E:2018-04 Medical Infusion Equipment Part 4: Disposable Gravity Infusion Infusion Sets (Draft)
DIN EN ISO 6717:2020 In vitro diagnostic medical devices - Single-use containers for the collection of specimens, other than blood, from humans (ISO/DIS 6717:2020); German and English version prEN ISO 6717:2020
DIN EN ISO 6717:2021-12 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021); German version EN ISO 6717:2021
DIN EN ISO 15223-1:2017-04 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
DIN EN ISO 1135-4:2016 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015); German version EN ISO 1135-4:2015

Gosstandart of Russia

GOST R EN 14254-2010 In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans
GOST R 57629-2017 Medical devices. General safety and compatibility requirements for single use infusion sets
GOST 22967-1990 Injection medical syringes of repeatid application. General technical requirements and test methods
GOST R ISO 1135-5-2022 Transfusion equipment for medical use. Part 5. Transfusion sets for single use with pressure infusion apparatus
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R 58551-2019 Disposable medical devices from nonwovens materials. Surgery disposable clothes from nonwovens materials. Technical requirements for governmental purchases

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

AS/NZS 2485:1995 Medical Equipment - Single-Use Winged Intravenous Devices (Sterile) for General Medical Use

Korean Agency for Technology and Standards (KATS)

KS P ISO 15223-2007(2012) Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO 15223-2019 Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO 15223-1:2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
KS P ISO 15223-1-2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

International Electrotechnical Commission (IEC)

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

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 15223-1:2020 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

Danish Standards Foundation

DS/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
DANSK DS/ISO 22236:2020 Traditional Chinese medicine – Thread-embedding acupuncture needle for single use
DANSK DS/ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
DS/EN ISO 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
DANSK DS/EN ISO 6717:2021 In vitro diagnostic medical devices – Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
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
DS/ISO 8536-12:2021 Infusion equipment for medical use – Part 12: Check valves for single use

US-AAMI

ANSI/AAMI/ISO 15223-1:2012 Medical devices.Symbols to be used with medical device labels, labeling, and information to be supplied.Part 1: General requirements

GCC Standardization Organization

GSO ISO 15223-1:2020 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
GSO ISO 6717:2024 In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood
GSO 2680:2021 Halal medical device – General requirements

American National Standards Institute （ANSI)

ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1
ANSI/AAMI/ISO 14160:2011(2016) Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization pr
ANSI/AAMI/IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
ANSI/AAMI/ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

Bureau of Indian Standards

IS/ISO 14971-2019 Medical devices - Application of risk management to medical devices First Revision
IS/ISO 15223-1-2016 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part — General Requirements ( Second Revision )
IS/ISO 13485-2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (First Revision)

SCC

AAMI/ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
AAMI/ISO 15223-1:2022 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
AAMI/ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

Indonesia Standards

SNI 16-6654-2002 Single-use sterile infusion sets for general medical
SNI 16-6642-2002 Medical equipment single use winged intravenous devices (sterile) for general medical use

Canadian General Standards Board （CGSB)

CAN/CGSB-20.27-M91-1991 Sterile or Non-Sterile Medical Examination Gloves for Single Use

Ente Nazionale Italiano di Unificazione

UNI CEI 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
EC 1-2017 UNI CEI EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
UNI CEI EN ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
UNI EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood

Swedish Institute for Standards

SS-EN 14254:2005 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
SS-EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
SS-EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

Lithuanian Standards Office

LST 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 (ISO 15223-1:2012)

PT-IPQ

NP 3361-1988 Equipments for medical-pharmaceutic use Sterile hypodermic syringes for single use. Characteristics and test methods

Standards Norway

NS-EN 14254:2004 In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans
NS-EN ISO 6717:2021 In vitro diagnostic medical devices – Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

PL-PKN

PN Z55202-1991 Medical equipment. Transfusion sets for single use. Requirements and test methods

BE-NBN

NBN-EN 455-1-1994 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

TH-TISI

TIS 720-2003 Blood transfusion sets for single.use

CEN - European Committee for Standardization

EN ISO 1135-4:2004 Transfusion equipment for medical use - Part 4: Transfusion sets for single use

South African Bureau of Standard

SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

CENELEC - European Committee for Electrotechnical Standardization

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

Comitato Elettrotecnico Italiano

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

CH-SNV

SN EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO 2680:2022 Halal medical device – General requirements

Others: Disposable Class I Medical Devices