Medical device disposable sterile tubing

Medical device disposable sterile tubing, Total:93 items.

The international standard classification for "Medical device disposable sterile tubing" includes: Sterilization and disinfection in general , Implants for surgery, prosthetics and orthotics , Medical materials .

The Chinese standard classification for "Medical device disposable sterile tubing" includes: General and microsurgical devices , Public medical equipment , Extracorporeal circulation, artificial organ and prosthesis device , Medical sanitary products .

Professional Standard - Commodity Inspection

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

Professional Standard - Medicine

YY/T 0489-2004 Sterile drainage catheters and accessory devices for single use
YY 0489-2004 Sterile drainage catheters and accessory devices for single use
YY/T 0615.2-2007 Requirements for medical devices to be designated“STERILE” - Part 2: Requirements for aseptically processed medical devices
YY/T 0489-2023 Disposable sterile drainage catheters and auxiliary devices
YY/T 0615.1-2007 Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices

国家药监局

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

Group Standards of the People's Republic of China

T/CAMDI 056-2020 Ethylene oxide sterilization process practice of sterile medical device
T/CSBME 013-2019 Disposable sterile medical cotton stick
T/CSBME 010-2019 Disposable use of sterile medical pad/patic
T/CSBME 015-2019 Disposable sterile medical cap
T/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment
T/CSBME 014-2019 Disposable Sterile Medical Cotton Ball
T/CSBME 012-2019 Disposable sterile medical gauze blocks
T/CAMDI 015-2018 Good Manufacturing Practice for Primary Packaging of Sterile Medical Devices
T/CSBME 011-2019 Disposable use of sterile infusion tape

未注明发布机构

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
DIN EN ISO 20696:2019 Sterile, single-use urinary bladder catheters

Standard Association of Australia （SAA）

AS 2385:1990/Amdt 1:1993 Disposable (sterile) infusion set for general medical use

SCC

AS 1094:1981 Single-use syringes (sterile) for general medical use
AS 1094:1993 Medical equipment - Single-use syringes (sterile) for general medical use
AS 2696:1989 Medical equipment - Single-use urethral catheters (sterile) for general medical use
AS 2696:1984 Medical equipment - Single-use urethral catheters (sterile) for general medical use
AS T39:1969 Single-use syringes (sterile) for general medical use
AS 1094:1971 Single-use syringes (sterile) for general medical use
CAN/CGSB-20.27-M91-1991 Sterile or Non-Sterile Medical Examination Gloves for Single Use
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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
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
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
AS 1946:1976 Single-use hypodermic needles (sterile) for general medical use
UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
AS T48:1970 Single-use hypodermic needles (sterile) for general medical use
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 556-1:2024 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
AS 2385:1980 Single-use (sterile infusion sets for general medical use
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
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
AS 1946:1984 Hypodermic equipment - Single-use needles (sterile) for general medical use
NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)
BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'
DIN 58953-8:2019 Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
AENOR UNE-EN 556-1:2002 Sterilization of medical products. Requirements for medical devices to be designated "STERILE". Part 1: Requirements for sterilized medical devices in their terminal state.
AS 2485:1981 Single-use winged intravenous devices (sterile) for general medical use
DIN 58953-8 E:2018 Draft Document - Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices

NZ-SNZ

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

British Standards Institution (BSI)

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 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
23/30457240 DC BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed medical devices
BS EN 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices

ES-UNE

UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
UNE-EN ISO 20696:2019 Sterile urethral catheters for single use (ISO 20696:2018, Corrected version 2019-12)

European Committee for Standardization (CEN)

EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements

CEN - European Committee for Standardization

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

DIN

DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 58953-8:2003 Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices

Lithuanian Standards Office

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
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

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

Danish Standards Foundation

DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
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
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
DS/EN ISO 11070:1999 Sterile single-use intravascular catheter introducers

Association Francaise de Normalisation

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
NF EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique

German Institute for Standardization

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 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 556-2:2015-11 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 ISO 11070:1999 Sterile single-use intravascular catheter introducers (ISO 11070:1998); German version EN ISO 11070:1999
DIN 58953-8:2019-03 Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices

RU-GOST R

GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices