Standard requirements for moist heat method for sterilization of medical and health care products

Standard requirements for moist heat method for sterilization of medical and health care products, Total:85 items.

The international standard classification for "Standard requirements for moist heat method for sterilization of medical and health care products" includes: Other standards related to sterilization and disinfection , Sterilization and disinfection in general , Sterilization and disinfection .

The Chinese standard classification for "Standard requirements for moist heat method for sterilization of medical and health care products" includes: Public medical equipment .

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

GB 18278-2000 Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
GB 18281.3-2000 Sterilization of health care products--Biological indicators--Part 3:Biological indicators for moist heat sterilization
GB/T 19971-2005 Sterilization of health care products-Vocabulary
GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization
GB/T 19971-2015 Sterilization of health care products―Vocabulary
GB 18281.3-2015 Sterilization of health care products―Biological indicators―Part 3:Biological indicators for moist heat sterilization processes
GB/T 20367-2006 Sterilization of health care products - Requirement for validation and routine control of moist heat sterilization in health care facilities
GB 18278.1-2015 Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices

未注明发布机构

CAN/CSA-ISO/TS 17665-3:2017 Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
ANSI/AAMI/ISO 14937:2009(2013) 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
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

Taiwan Provincial Standard of the People's Republic of China

CNS 14621-2002 Sterilization of health care products-requirements for validation and routine control-industrial moist heat sterilization

International Organization for Standardization (ISO)

ISO 13683:1997 Sterilization of health care products - Requirements for validation and routine control of moist heat sterilization in health care facilities
ISO 11134:1994 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
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 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/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 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
ISO 11138-3:1995 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization
ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
ISO 11137:1995/Amd 1:2001 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Amendment 1: Selection of terms for dose setting
ISO/DIS 11135 Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 17665-3:2013 Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

Danish Standards Foundation

DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
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

SCC

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
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)
DIN EN ISO 17665 E:2022 Draft Document - 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
DANSK DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
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
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
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
AENOR UNE-EN ISO 17665-1:2007 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)
BS PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat-Guidance on the designation of a medical device to a product family and processing category for steam sterilization
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
AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
CAN/CSA-ISO 11134-1998(R2003) Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
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
AAMI/ISO 14937:2000 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
AAMI/ISO 13004:2022 Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD

Association Francaise de Normalisation

XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
XP ISO/TS 22421:2021 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings
NF S98-104*NF 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
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 S98-004-3:2006 Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes.
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

British Standards Institution (BSI)

BS EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
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 ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes
BS EN ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes
BS EN ISO 11138-3:2017 Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes
PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
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 ISO 11138-1:2006 Sterilization of health care products - Biological indicators - General requirements
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 ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes

US-AAMI

ANSI/AAMI/ISO TIR17665-3:2014 Sterilization of health care products - Moist heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization

German Institute for Standardization

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)
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...

GSO

GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BH GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
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 13408-5:2014 Aseptic processing of health care products -- part 5 : sterilization in place
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
BH GSO ISO/TS 17665-3:2017 Sterilization of health care products -- Moist heat -- Part 3:Guidance on the designation of a medical device to a product family and processing category for steam sterilization
GSO ISO/TS 17665-3:2015 Sterilization of health care products -- Moist heat -- Part 3:Guidance on the designation of a medical device to a product family and processing category for steam sterilization

European Committee for Standardization (CEN)

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)
EN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
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 ISO 11138-3:2017 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

Canadian Standards Association (CSA)

CSA ISO 11134-98-CAN/CSA:1998 Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization First Edition; ISO 11134: 1994; Supersedes CAN/CSA-Z214.4: 1987

KR-KS

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
KS P ISO 11134-2003 Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization

Korean Agency for Technology and Standards (KATS)

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
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 14937-2023 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

UNKNOWN

GB/T 18281.3-2015 Biological Indicators for Sterilization of Healthcare Products Part 3: Biological Indicators for Moist Heat Sterilization

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)

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

Others: