Dry heat sterilization verification

Dry heat sterilization verification, Total:109 items.

The international standard classification for "Dry heat sterilization verification" includes: Sterilizing equipment , Sterilization and disinfection in general .

The Chinese standard classification for "Dry heat sterilization verification" includes: Public medical equipment , Pharmaceutical processing machinery and equipment , Pharmaceutical, safety machinery and tool in general .

未注明发布机构

DIN EN ISO 11138-4 E:2014-10 Biological indicators for sterilization of health care products Part 4: Biological indicators for dry heat sterilization processes (draft)
ANSI/AAMI/ISO 17665-1:2006(2013) Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
CSA ISO 20857:2019 Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
CAN/CSA-ISO 11138-4:2017 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
ANSI/AAMI/ISO 11138-4:2017 Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes

Professional Standard - Machinery

JB/T 20163-2014 Pharmaceutical Dry Heating Sterilizer

Professional Standard - Medicine

YY/T 1263-2015 Evaluation of materials of medical device subject to dry heat sterilization
YY 1275-2016 Dry heat (heated air) sterilizers
YY 0217.3-1995 Tunnel sterilizing dryer

国家食品药品监督管理局

YY/T 1608-2018 Radiation sterilization of medical device—Sampling method for verification dose experiments and sterilization dose audits

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

GB/T 36036-2018 Verify guidance of cleaning and sterilization for pharmaceutical machinery
GB 18281.4-2015 Sterilization of health care products―Biological indicators―Part 4:Biological indicators for dry heat sterilization processes

GSO

GSO ISO 20857:2016 Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices
OS GSO ISO 20857:2016 Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices
BH GSO ISO 20857:2017 Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices
GSO ISO/TS 13004:2021 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
BH GSO ISO/TS 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
OS GSO ISO 17665-1:2014 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
GSO ISO 17665-1:2014 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
GSO ISO 11138-4:2021 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
BH GSO ISO 11138-4:2022 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
GSO ISO 14937:2015 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

SCC

DANSK DS/ISO 20857:2010 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
DANSK DS/EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
CAN/CSA-ISO 20857-2019 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
AS 2487:1981 Dry heat sterilizers (hot air type)
NS-EN 554:1994 Sterilization of medical devices — Validation and routine control of sterilization by moist heat
AAMI ST63:2002 Sterilization of health care products - Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices - Dry heat
UNE-EN 554:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
NS-EN ISO 20857:2013 Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
ADA ST40:2004(R2010) Table-top Dry Heat (heated air) Sterilization and Sterility Assurance in Health Care Facilities
AENOR UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
CAN/CSA-ISO 11134-1998(R2003) Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
07/30164697 DC ISO 20857. Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of an industrial sterilization process for medical devices
DIN EN ISO 20857 E:2012 Draft Document - Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version FprEN ISO 20857:2012
NS-EN 552:1994 Sterilization of medical devices — Validation and routine control of sterilization by irradiation
BS EN ISO 11737-2:2000 Sterilization of medical devices. Microbiological methods-Tests of sterility performed in the validation of a sterilization process
UNE-EN 552:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
CAN/CSA-ISO 11137-1998(R2003) Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
DANSK DS/EN 552/A1:1999 Sterilization of medical devices - Validation and routine control of sterilization by irradiation
CAN/CSA-ISO 11137-1998(C2003) Sterilization of medical devices - Requirements for validation and routine control - Sterilization by irradiation
NS-EN 550:1994 Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization
UNE-EN 550:1995 STERILIZATION OF MEDICAL DEVICES. VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
DANSK DS/EN ISO 17665:2024 Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices
DANSK DS/EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
AAMI/ISO 13004:2022 Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
CAN/CSA-Z17665-1-2009(R2014) Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
NS-EN 866-6:1999 Biological systems for testing sterilizers and sterilization processes — Part 6: Particular systems for use in dry heat sterilizers
AAMI/ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
UNE-EN 866-6:2001 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES. PART 6: PARTICULAR SYSTEMS FOR USE IN DRY HEAT STERILIZERS.
AAMI TIR35:2016(R2021) Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
NS-EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
DANSK DS/ISO/TS 15843:2001 Sterilization of healthcare products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
BS EN ISO 14937:2001 Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
NS-EN ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

Danish Standards Foundation

DS/EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes

German Institute for Standardization

DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013
DIN EN ISO 17665:2022-11 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022 / Note: Date of is...
DIN EN ISO 17665-1:2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006 / Note: To be replaced b...
DIN EN ISO 11138-4:2017-07 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017); German version EN ISO 11138-4:2017
DIN EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)

British Standards Institution (BSI)

BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 554:1994(1998) Sterilization ofmedical devices — Validation and routine control ofsterilization by moist heat
BS EN ISO 17665:2024 Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 552:1994(2001) Sterilization of medical devices — Validation and routine control of sterilization by irradiation
BS EN ISO 11138-4:2017 Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes
BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization
BS EN ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes
22/30409085 DC BS EN ISO 17665. Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 866-6:2000 Biological systems for testing sterilizers and sterilization processes - Part 6: Particular systems for use in dry heat sterilizers

European Committee for Standardization (CEN)

EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
prEN ISO 17665 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022)
EN 866-6:1999 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 6: Particular Systems for Use in Dry Heat Sterilizers
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)
FprEN ISO 17665 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 17665:2023)

American National Standards Institute （ANSI)

ANSI/AAMI ST40-2004 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
ANSI/AAMI ST50-2004 Dry heat (heated air) sterilizers
AAMI TIR35:2006 Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
ANSI/AAMI ST 67-2003 Sterilization of Health Care Products - Requirements for products labeled "STERILE"
AAMI TIR27:2001 Sterilization of health care products-Radiation sterilization-Substantiation of 25 kGy as a sterilization dose- Method VDmax
AAMI TIR35:2016 Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits
ANSI/AAMI ST27-1988 Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. Process Design, Validation, Routine Sterilization, and Contract Sterilization

Association Francaise de Normalisation

NF EN ISO 20857:2013 Sterilization of healthcare products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF EN ISO 11138-4:2017 Sterilization of healthcare products - Biological indicators - Part 4: biological indicators for dry heat sterilization
NF EN ISO 14937:2009 Sterilization of healthcare products - General requirements for the characterization of a sterilizing agent and for the development, validation and routine verification of a sterilization process for medical devices
NF EN ISO 17665-1:2006 Sterilization of healthcare products - Moist heat - Part 1: requirements for the development, validation and routine control of a medical device sterilization process
NF S98-004-4*NF EN ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4 : biological indicators for dry heat sterilization processes

Korean Agency for Technology and Standards (KATS)

KS P ISO 11134:2008 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
KS P ISO 11134:2003 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
KS P ISO 11134-2008 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
KS P ISO 11137:2008 Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
KS P ISO 11137-2008 Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
KS P ISO 11137:2003 Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
KS P ISO 17665-1:2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

KR-KS

KS P ISO 11134-2003 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
KS P ISO 11137-2003 Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
KS P ISO 17665-1-2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

AENOR

UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)

International Organization for Standardization (ISO)

ISO/DIS 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/FDIS 17665:2023 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 13409:2002 Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
ISO 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
ISO 17665:2024 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 15843:2000 Sterilization of health care products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits

CEN - European Committee for Standardization

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

UNKNOWN

GB/T 18281.4-2015 Biological Indicators for Sterilization of Healthcare Products Part 4: Biological Indicators for Dry Heat Sterilization

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