Sterile instrument industry

Sterile instrument industry, Total:136 items.

The international standard classification for "Sterile instrument industry" includes: Sterilization and disinfection in general , Implants for surgery, prosthetics and orthotics , Other standards related to sterilization and disinfection , Laboratory medicine .

The Chinese standard classification for "Sterile instrument industry" includes: Public medical equipment , Extracorporeal circulation, artificial organ and prosthesis device , Basic standards and general methods , Pharmaceutical processing machinery and equipment , Medical apparatus and devices in general .

Professional Standard - Medicine

YY/T 0615.2-2007 Requirements for medical devices to be designated“STERILE” - Part 2: Requirements for aseptically processed medical devices
YY 0489-2004 Sterile drainage catheters and accessory devices for single use
YY/T 0615.1-2007 Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
YY/T 0489-2004 Sterile drainage catheters and accessory devices for single use
YY/T 91051-1999 System table for standard of medical devices
YY/T 0489-2023 Disposable sterile drainage catheters and auxiliary devices

未注明发布机构

DIN EN ISO 11737-2 E:2018-07 Microbiological methods for sterilization of medical devices Part 2: Definition, effectiveness and maintenance of sterility tests during sterilization processes (draft)
ANSI/AAMI/ISO 11737-2:2019 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
IAPMO IGC 394-2023 Industry Standard for Tankless Water Heater Drain Pan

Group Standards of the People's Republic of China

T/QGCML 4381-2024 Mechanical sealing equipment for sterile products
T/CQAP 3001-2020 Requirements of parametric release for sterile products using terminal moist heat sterilization
T/CAMDI 015-2018 Good Manufacturing Practice for Primary Packaging of Sterile Medical Devices
T/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment
T/CAMDI 056-2020 Ethylene oxide sterilization process practice of sterile medical device

工业和信息化部

QB/T 5470-2019 Beer and beverage machinery-Aseptic water sterilizer machine

Professional Standard - Machinery

JB/T 20175-2017 Aseptic isolators
JB/T 20175-2016 Sterile isolator

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

GB/T 19973.2-2005 Sterilization of medical devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process

Professional Standard - Military and Civilian Products

WJ 2496.3-2005 Safety assessment of machinery factories in the weapon industry Part 3: Machinery

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
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
BS EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11737-2:2010 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11737-2:2020 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
18/30338923 DC BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BS EN ISO 11607-1:2020+A1:2023 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems

SCC

BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'
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
CSA Z314.5-1979 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
CAN/CSA Z314.4-1987 Industrial Sterilization of Medical Devices by the Steam Process
CSA Z314.4-M1979-1979 Industrial Sterilization of Medical Devices by the Steam Process
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
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
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
CAN/CSA-Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
CAN/CSA-Z314.4-1987 Industrial Sterilization of Medical Devices by the Steam Process
DIN 58953-8:2019 Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
CAN/CSA Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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"
DIN 58953-8 E:2018 Draft Document - Sterilization - Sterile supply - Part 8: Logistics of sterile 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 556-1:2024 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
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 3970-4:1990 Sterilizing and disinfecting equipment for medical products-Specification for transportable steam sterilizers for unwrapped instruments and utensils
NS-EN ISO 11737-2:2000 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998)
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
DANSK DS/ISO 11737-2:2020 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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
DIN 58952-3 E:2011 Draft Document - Sterilization - Transport baskets for sterile barrier systems - Part 3: Instrument trays for sterilizing goods made of metal
BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods-Tests of sterility performed in the validation of a sterilization process
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.
CAN/CSA Z314.15-2010(R2015) Warehousing, storage, and transportation of clean and sterile medical devices
NS-EN ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
CAN/CSA-Z314.15-2003(C2008) Storage, warehousing and transportation of clean and sterile medical devices
CAN/CSA-Z314.15-2003(R2008) Warehousing, Storage, and Transportation of Clean and Sterile Medical Devices
CSA Z314.15-10:2010 Warehousing, storage, and transportation of clean and sterile medical devices
DIN EN ISO 11737-2 E:2018 Draft Document - Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2018); German and English version prEN ISO 1173...
CAN/CSA Z314.15-2003(R2008) Warehousing, Storage, and Transportation of Clean and Sterile Medical Devices
DIN 11866 E:2016 Draft Document - Stainless steel components for aseptic applications in the chemical and pharmaceutical industry - Tubes
DIN 58953-6 E:2016 Draft Document - Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
BS 5081-1:1987 Sterile hypodermic syringes and needles-Specification for sterile hypodermic syringes for single use
UNE-EN ISO 11737-2:2000 STERILIZATION OF MEDICAL DEVICES. MICROBIOLOGICAL METHODS. PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS. (ISO 11737-2:1998)

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

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
LST EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

DIN

DIN 58953-8:2003 Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN EN ISO 11737-2:2000 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998); English version of DIN EN ISO 11737-2
DIN 58953-6:2023 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

CEN - European Committee for Standardization

EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition@ validation and maintenance of a sterilization process

German Institute for Standardization

DIN 58953-8:2019-03 Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
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 58952-3:2012-04 Sterilization - Transport baskets for sterile barrier systems - Part 3: Instrument trays for sterilizing goods made of metal
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 58953-6:2016-12 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN 58953-6:2023-11 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
DIN 58953-6:2023-04 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized / Note: Date of issue 2023-03-17*Intended as replacement for DIN 58953-6 (2016-12).
DIN 11866:2016 Stainless steel components for aseptic applications in the chemical and pharmaceutical industry - Tubes
DIN 11866:2016-11 Stainless steel components for aseptic applications in the chemical and pharmaceutical industry - Tubes / Note: Applies in conjunction with DIN EN 10088-1 (2014-12), DIN EN 10216-5 (2014-03), DIN EN 10217-7 (2015-01).

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 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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
NF S93-306:1992 Extracorporeal circuits. Sterile, single-use units for filtration plasma separators (single-use, sterile plasmafilters).

European Committee for Standardization (CEN)

EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
EN ISO 11737-2:2000 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process ISO 11737-2: 1998
EN 556:1998 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994

VN-TCVN

TCVN 1023-1991 Medicine and apparatus.Test for stevility

International Organization for Standardization (ISO)

ISO 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 11737-2:2019 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

GSO

OS GSO ISO 11737-2:2015 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
BH GSO ISO 11737-2:2016 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
GSO ISO 9626:2013 Stainless steel needle tubing for the manufacture of medical devices
BH GSO ASTM F1980:2022 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
GSO ASTM F1980:2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Korean Agency for Technology and Standards (KATS)

KS P ISO 11737-2:2018 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS P ISO 11737-2:2012 Sterilization of medical devices－Microbiological methods－Part 2：Tests of sterility performed in the validation of a sterilization process

KR-KS

KS P ISO 11737-2-2018 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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

Japanese Industrial Standards Committee (JISC)

JIS T 3211:2005 Sterile infusion administration set
JIS T 3211:2011 Sterile infusion administration set
JIS T 3210:2022 Sterile injection syringes
JIS T 3210:2005 Sterile injection syringe
JIS T 3210:2011 Sterile injection syringes
JIS T 3224:2011 Sterile syringe filter
JIS T 3224:2005 Sterile syringe filter
JIS T 3224:2021 Sterile syringe filter
JIS T 3225:2011 Sterile transfusion filter
JIS T 3219:2011 Sterile infusion filter

AENOR

UNE-EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

American Society for Testing and Materials (ASTM)

ASTM F91-70(1996) Standard Practice for Testing for Leaks in the Filters Associated With Laminar Flow Clean Rooms and Clean Work Stations by Use of a Condensation Nuclei Detector
ASTM F91-70(2001)e1 Standard Practice for Testing for Leaks in the Filters Associated With Laminar Flow Clean Rooms and Clean Work Stations by Use of a Condensation Nuclei Detector
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Defense Logistics Agency

DLA A-A-30016 C REINST NOTICE 2-2007 APPLICATOR, DISPOSABLE (STERILE AND NONSTERILE)

TH-TISI

TIS 531-1984 THAI INDUSTRIAL STANDARD FOR PLASTICS CONTAINERS FOR STERILE PHARMACEUTICAL PRODUCTS
TIS 531-1984(en) THAI INDUSTRIAL STANDARD FOR PLASTICS CONTAINERS FOR STERILE PHARMACEUTICAL PRODUCTS

US-ASTM STP

ASTM STP 1630-21 Antimicrobial Combination Devices

Others: Medical device industry,Standard guide for accelerated aging of sterile barrier systems for medical devices,Medical device industry,Sterile medical device packaging,Sterilization Confirmation of Sterile Medical Devices,Class I medical device industry,Test Methods for Sterile Medical Device Packaging Part 18,Sterile medical device packaging,Medical device industry standard system table,Non-sterile product medical devices,Sterile Medical Devices,Test method for sterile medical device packaging part 1