Health Care Products

Health Care Products, Total:190 items.

The international standard classification for "Health Care Products" includes: Other standards related to sterilization and disinfection , Sterilization and disinfection in general , Sterilization and disinfection , Other standards related to nuclear energy .

The Chinese standard classification for "Health Care Products" includes: Public medical equipment , Medical isotopes .

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

GB/T 31995-2015 Sterilization of health care products―Radiation―Substantiation of a selected sterilization dose method VDmax
GB 18282.1-2000 Sterilization of health care products--Chemical indicators--Part 1:General requirements
GB 18280.2-2015 Sterilization of health care products―Radiation―Part 2:Establishing the sterilization dose
GB/T 24628-2009 Sterilization of health care products—Biological and chemical indicators—Test equipment
GB 18278-2000 Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
GB/T 18279.2-2015 Sterilization of health care products―Part 2:Guidance on the application of GB 18279.1
GB/T 18280.3-2015 Sterilization of health care products―Radiation―Part 3:Guidance on dosimetric aspects
GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization
GB/T 19971-2005 Sterilization of health care products-Vocabulary
GB/T 20367-2006 Sterilization of health care products - Requirement for validation and routine control of moist heat sterilization in health care facilities
GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1: General requirements
GB 18281.1-2000 Sterilization of health care products--Biological indicators--Part 1:General
GB/T 19971-2015 Sterilization of health care products―Vocabulary
GB 18282.1-2015 Sterilization of health care products―Chemical indicator―Part 1:General requirements

Shaanxi Provincial Standard of the People's Republic of China

DB61/T 1000.2-2015 Specifications for Compilation of Health Supplies Product Standards Part 2: Specifications for Compilation of Health Care Patch Products Standards

Taiwan Provincial Standard of the People's Republic of China

CNS 14623-2-2002 Sterilization of health care products-chemical indicators-Part 2：Test equipment and methods
CNS 14623.1-2002 Sterilization of health care products-chemical indicators-Part 1：General requirements
CNS 14622-1-2002 Sterilization of health care products-biological indicators-part 1：General
CNS 14709-2002 Sterilization of health care products-requirements for validation and routine control-radiation sterliization
CNS 14622.1-2002 Sterilization of health care products-biological indicators-part 1：General
CNS 14623.2-2002 Sterilization of health care products-chemical indicators-Part 2：Test equipment and methods
CNS 14623-1-2002 Sterilization of health care products-chemical indicators-Part 1：General requirements

Professional Standard - Medicine

YY/T 0567.1-2013 Aseptic processing of health care products - Part 1: General requirements
YY/T 0567.6-2022 Aseptic processing of health care products—Part 6:Isolator systems
YY/T 0567.4-2011 Aseptic processing of health care products—Part 4:Clean-in-place technologies
YY/T 0884-2013 Evaluation of materials of health care product subject to radiation sterilization
YY/T 0567.3-2011 Aseptic processing of health care products—Part 3:Lyophilization
YY/T 0567.6-2011 Aseptic processing of health care products—Part 6:Isolator systems
YY/T 0567.5-2011 Aseptic processing of health care products—Part 5:Sterilization in place

Group Standards of the People's Republic of China

T/HNJK 01-2020 Technical Code for production of paste health care products
T/HNJK 03-2020 Technical Code for production of health care articles for wiping
T/HNJK 002-2019 Specification for quality control of production of health supplies

国家药监局

YY/T 0567.2-2021 Aseptic processing of health care products-Part 2:Sterilizing filtration

British Standards Institution (BSI)

BS EN ISO 11137-2:2012 Sterilization of health care Products. Radiation. Establishing the sterilization dose
BS EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - General requirements
BS DD CEN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Guidance on the application of ISO 17665-1
BS EN ISO 11140-1:2014 Sterilization of health care products. Chemical indicators. General requirements
BS EN ISO 11137-1:2015+A2:2019 Sterilization of health care products. Radiation. Establishing the sterilization dose
BS EN ISO 11137-2:2015 Sterilization of health care products. Radiation. Establishing the sterilization dose
BS EN ISO 11137-2:2013 Sterilization of health care products. Radiation. Establishing the sterilization dose
BS EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - General requirements
BS ISO 13408-7:2012 Aseptic processing of health care products. Alternative processes for medical devices and combination products
BS EN ISO 11137-3:2007 Sterilization of health care products - Radiation - Guidance on dosimetric aspects
BS PD ISO/TS 13004:2013 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
BS PD CEN ISO/TS 13004:2014 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
BS EN ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment and methods
BS DD CEN/ISO TS 11135-2:2009 Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1
BS ISO 18362:2016+A1:2022 Manufacture of cell-based health care products. Control of microbial risks during processing
BS EN ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes

SCC

BS PD CEN ISO/TS 11137-4:2023 Sterilization of health care products. Radiation-Guidance on process control
AAMI ST90:2017 Processing of health care products - Quality management systems for processing in health care facilities
DANSK DS/ISO/TS 11137-4:2020 Sterilization of health care products – Radiation – Part 4: Guidance on process control
AAMI/ISO 18472:2022 Sterilization of health care products - Biological and chemical indicators - Test equipment
CAN/CSA-Z11137-3-2007(R2012) Sterilization of Health Care Products - Radiation - Part 3: Guidance on Dosimetric Aspects
DANSK DS/EN ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)
NS-EN ISO 13408-6:2021 Aseptic processing of health care products — Part 6: Isolator systems (ISO 13408-6:2021)
DANSK DS/CEN ISO/TS 11135-2:2008 Sterilization of health care products – Ethylene oxide – Part 2: Guidance on the application of ISO 11135-1
12/30238553 DC BS EN ISO 11140-1. Sterilization of health care products. Chemical indicators. General requirements
DANSK DS/ISO 13004:2022 Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD
NS-EN ISO 13408-1:2024 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
07/30090385 DC ISO 13408-1. Aseptic processing of health care products. Part 1. General requirements
04/30090382 DC ISO 13408-5. Aseptic processing of health care products. Part 5. Cleaning in place
AAMI/ISO 13004:2022 Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
AAMI/ISO TIR 15844:1998 Sterilization of health care products - Radiation sterilization - Selection of a sterilization dose for a single production batch

International Organization for Standardization (ISO)

ISO 13408-5:2006 Aseptic processing of health care products - Part 5: Sterilization in place
ISO 13408-2:2018 Aseptic processing of health care products — Part 2: Sterilizing filtration
ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration
ISO 13408-3:2006 Aseptic processing of health care products - Part 3: Lyophilization
ISO 13408-6:2005 Aseptic processing of health care products - Part 6: Isolator systems
ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment
ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11140-1:1995 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO/TS 11137-4:2020 Sterilization of health care products — Radiation — Part 4: Guidance on process control
ISO 13408-1:1998 Aseptic processing of health care products - Part 1: General requirements
ISO 11138-1:1994 Sterilization of health care products - Biological indicators - Part 1: General
ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 18472:2018 Sterilization of health care products - Biological and chemical indicators - Test equipment
ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
ISO 13408-4:2005 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 13408-6:2021 Aseptic processing of health care products — Part 6: Isolator systems
ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
ISO 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
ISO 13683:1997 Sterilization of health care products - Requirements for validation and routine control of moist heat sterilization in health care facilities
ISO 11140-1:1995/Amd 1:1998 Sterilization of health care products - Chemical indicators - Part 1: General requirements; Amendment 1
ISO/TR 15844:1998 Sterilization of health care products - Radiation sterilization - Selection of sterilization dose for a single production batch
ISO 11134:1994 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
ISO 13408-6:2006/Amd 1:2013 Aseptic processing of health care products - Part 6: Isolator systems; Amendment 1
ISO 11137-2:2013/Amd 1:2022 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
ISO 15882:2003 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 13408-5:2006 Aseptic Processing of health care products - Part 5: Sterilization in place
ANSI/AAMI/ISO 13408-2:2003 Aseptic Processing of health care products - Part 2: Filtration
ANSI/AAMI/ISO 13408-3:2006 Aseptic Processing of health care products - Part 3: Lyophilization
ANSI/AAMI/ISO 13408-4:2005 Aseptic Processing of health care products - Part 4: Clean-in-place technologies
ANSI/AAMI/ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment
ANSI/AAMI/ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ANSI/AAMI/ISO 13408-6/A1:2013 Aseptic processing of health care products - Part 6: Isolator systems - Amendment 1
ANSI/AAMI/ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ANSI/AAMI/ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ANSI/AAMI ST 67-2003 Sterilization of Health Care Products - Requirements for products labeled "STERILE"
ANSI/AAMI/ISO 13408-1/A1:2013 Aseptic processing of health care products - Part 1: General requirements - Amendment 1

European Committee for Standardization (CEN)

EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements [Superseded: CEN EN 13824]
EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
EN ISO 13408-6:2021 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
CEN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements
EN ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development@ validation and routine control
EN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
EN ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)
EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

Korean Agency for Technology and Standards (KATS)

KS B ISO 1340:2006 Cylindrical gears-Information to be given to the manufacturer by the purchaser in order to obtain the gear required
KS B ISO 1340:2013 Cylindrical gears－Information to be given to the manufacturer by the purchaser in order to obtain the gear required
KS P ISO 13408-2:2010 Aseptic processing of health care products-Part 2:Filtration
KS P ISO 13408-5:2010 Aseptic processing of healthcare products－Part 5：Sterilization in place
KS P ISO 13408-6:2010 Aseptic processing of health care products－Part 6：Isolator systems
KS P ISO 13408-6:2017 Aseptic processing of health care products－Part 6：Isolator systems
KS P ISO 11138-1:2012 Sterilization of health care products－Biological indicators－Part 1：General requirements
KS P ISO 13408-3:2010 Aseptic processing of health care products－Parts 3：Lyophilization
KS P ISO 18472:2020 Sterilization of health care products — Biological and chemical indicators — Test equipment
KS P ISO 13408-1:2017 Aseptic processing of health care products－Part 1：General requirements
KS P ISO 13408-1:2010 Aseptic processing of health care products-Part 1:General requirements
KS P ISO 11140-1:2018 Sterilization of health care products — Chemical indicators — Part 1: General requirements
KS P ISO 11137-2:2020 Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
KS P ISO 13408-4:2010 Aseptic processing of health care products－Part 4：Clean-in-place technologies
KS P ISO 11138-1:2018 Sterilization of health care products — Biological indicators — Part 1: General requirements
KS P ISO 11140-1:2012 Sterilization of health care products－Chemical indicators－Part 1：General requirements
KS P ISO 11737-1:2021 Sterilization of health care products — Microbiological methods —Part 1: Determination of a population of microorganisms on products
KS P ISO 14161:2018 Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results

KR-KS

KS P ISO 13408-1-2017 Aseptic processing of health care products－Part 1：General requirements
KS P ISO 13408-6-2017 Aseptic processing of health care products－Part 6：Isolator systems
KS P ISO 18472-2020 Sterilization of health care products — Biological and chemical indicators — Test equipment
KS P ISO 11140-1-2018 Sterilization of health care products — Chemical indicators — Part 1: General requirements
KS P ISO 13408-6-2022 Aseptic processing of health care products — Part 6: Isolator systems
KS P ISO 11137-2-2020 Sterilization of health care products — Radiation —Part 2: Establishing the sterilization dose
KS P ISO 11138-1-2018 Sterilization of health care products — Biological indicators — Part 1: General requirements
KS P ISO 14161-2018 Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results
KS P ISO 11737-1-2021 Sterilization of health care products — Microbiological methods —Part 1: Determination of a population of microorganisms on products

US-AAMI

ANSI/AAMI/ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
ANSI/AAMI/ISO 11137-2:2012 Sterilization of health care products.Radiation .Part 2: Establishing the sterilization dose
ANSI/AAMI/ISO 11137-2:2013 Sterilization of health care products.Radiation .Part 2: Establishing the sterilization dose

CEN - European Committee for Standardization

EN ISO 13408-2:2018 Aseptic processing of health care products - Part 2: Sterilizing filtration
EN ISO 11137-2:2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
EN ISO 18472:2018 Sterilization of health care products - Biological and chemical indicators - Test equipment

BSI

AAMI/ISO 13408-1:2023 Aseptic processing of health care products—Part 1: General requirements
DANSK DS/ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements

Association Francaise de Normalisation

NF S98-005:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment.
NF CEN ISO/TS 17665-2:2009 Sterilization of healthcare products - Moist heat - Part 2: guidelines for the application of ISO 17665-1
NF S98-103-2*NF EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2 : establishing the sterilization dose
NF S98-103-2:2013 Sterilization of health care products - Radiation - Part 2: establishing the sterilization dose
NF S98-001-1:2005 Sterilization of health care products - Chemical indicators - Part 1 : General requirements.
NF S98-004-1:2006 Sterilization of health care products - Biological indicators - Part 1 : general requirements.
NF S98-001-1*NF EN ISO 11140-1:2015 Sterilization of health care products - Chemical indicators - Part 1 : general requirements
NF S98-001-1:2009 Sterilization of health care products - Chemical indicators - Part 1 : general requirements.
NF S98-117-6/A1:2013 Aseptic processing of health care products - Part 6: isolator systems - Amendment 1

German Institute for Standardization

DIN EN ISO 13408-2 E:2017-04 Sterile Processing of Healthcare Products Part 2: Filtration (Draft)
DIN EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); English version of DIN EN ISO 11138-1:2006-09
DIN EN ISO 18472 E:2016-12 Disinfection Biological and Chemical Indicator Test Devices for Healthcare Products (Draft)
DIN EN ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006); English version of DIN EN ISO 18472:2006-10
DIN EN ISO 18362:2018-11 Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018 / Note: Date of issue 2018-09-28
DIN EN ISO 13408-1:2024 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
DIN EN ISO 11137-2 E:2012-10 Sterilizing radiation for health care products Part 2: Determination of germicidal dose (draft)
DIN EN ISO 13408-7:2015-11 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015

UNKNOWN

GB/T 18282.1-2015 Chemical Indicators for Sterilization of Healthcare Products Part 1: General Rules

VN-TCVN

TCVN 7393-3-2009 Sterilization of health care products.Radiation.Part 3: Guidance on dosimetric aspects.
TCVN 7393-2-2009 Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose

GSO

GSO ISO 13408-5:2014 Aseptic processing of health care products -- part 5 : sterilization in place
GSO ISO 13408-4:2014 Aseptic processing of health care products -- part 4 : clean-in-place technologies

RU-GOST R

GOST ISO 11140-1-2011 Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST ISO 11137-2-2011 Sterilization of health care products. Radiation. Part 2. Establishing the sterilization dose
GOST R 56893-2016 Sterilization of health care products. Moist heat. Part 2. Guidance on the application of ISO 17665-1
GOST ISO 11140-2-2011 Sterilization of health care products. Chemical indicators. Part 2. Test equipment and methods

Japanese Industrial Standards Committee (JISC)

JIS T 0806-2:2010 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
JIS T 0806-2:2014 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
JIS T 11140-1:2013 Sterilization of health care products.Chemical indicators.Part 1: General requirements
JIS T 0806-3:2010 Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects

Canadian Standards Association (CSA)

CSA Z11137-2-07-CAN/CSA-2007 Sterilization of health care products ?Radiation ?Part 2: Establishing the sterilization dose First Edition [Superseded: CSA ISO 11137-98-CAN/CSA, CSA ISO 11137-98-CAN/CSA]
CSA ISO 14937-01-CAN/CSA: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 First Edition; ISO 14937:2000

Spanish Association for Standardization (UNE)

UNE-EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
UNE-EN ISO 13408-7:2015 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

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 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects