healthcare products

healthcare products, Total:83 items.

The international standard classification for "healthcare 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 "healthcare products" includes: Public medical equipment , Medical isotopes .

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 18280.2-2015 Sterilization of health care products―Radiation―Part 2:Establishing the sterilization dose
GB/T 18280.3-2015 Sterilization of health care products―Radiation―Part 3:Guidance on dosimetric aspects
GB/T 24628-2009 Sterilization of health care products—Biological and chemical indicators—Test equipment
GB/T 18279.2-2015 Sterilization of health care products―Part 2:Guidance on the application of GB 18279.1
GB/T 31995-2015 Sterilization of health care products―Radiation―Substantiation of a selected sterilization dose method VDmax
GB/T 19971-2015 Sterilization of health care products―Vocabulary
GB 18281.1-2000 Sterilization of health care products--Biological indicators--Part 1:General
GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1: General requirements
GB 18282.1-2000 Sterilization of health care products--Chemical indicators--Part 1:General requirements
GB 18282.1-2015 Sterilization of health care products―Chemical indicator―Part 1:General requirements
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

Professional Standard - Medicine

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

国家药监局

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

国家食品药品监督管理局

YY/T 0567.7-2016 Aseptic processing of health care products. Part 7: Alternative processes for medical devices and combination products

SCC

AAMI ST90:2017 Processing of health care products - Quality management systems for processing in health care facilities
BS PD CEN ISO/TS 11137-4:2023 Sterilization of health care products. Radiation-Guidance on process control
AAMI/ISO 18472:2022 Sterilization of health care products - Biological and chemical indicators - Test equipment
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
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
04/30090382 DC ISO 13408-5. Aseptic processing of health care products. Part 5. Cleaning in place
AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
AAMI/ISO 13004:2022 Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.

British Standards Institution (BSI)

BS EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - General requirements
BS PD CEN ISO/TS 13004:2014 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
BS PD ISO/TS 13004:2013 Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
BS EN ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Biological indicators for dry heat sterilization processes

Korean Agency for Technology and Standards (KATS)

KS P ISO 13408-2:2010 Aseptic processing of health care products-Part 2:Filtration
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

International Organization for Standardization (ISO)

ISO 13408-2:2003 Aseptic processing of health care products - Part 2: Filtration
ISO 11138-1:1994 Sterilization of health care products - Biological indicators - Part 1: General
ISO 13408-1:1998 Aseptic processing of health care products - Part 1: General requirements
ISO 11140-1:1995 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 13683:1997 Sterilization of health care products - Requirements for validation and routine control of moist heat sterilization in health care facilities
ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11140-1:1995/Amd 1:1998 Sterilization of health care products - Chemical indicators - Part 1: General requirements; Amendment 1
ISO 11134:1994 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 13408-2:2003 Aseptic Processing of health care products - Part 2: Filtration
ANSI/AAMI/ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ANSI/AAMI/ISO 13408-7:2012(2018) Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
ANSI/AAMI/ISO 17665-1:2005 Sterilization of health care products - Moist heat - Requirements for development, validation and routine control of a sterilization process for medical devices

CEN - European Committee for Standardization

EN ISO 13408-2:2018 Aseptic processing of health care products - Part 2: Sterilizing filtration

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 13408-6:2021 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
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 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

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

UNKNOWN

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

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 13408-1:2024 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

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

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

Canadian Standards Association (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
CAN/CSA-ISO 17664:2018 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices

Association Francaise de Normalisation

NF S98-004-1:2006 Sterilization of health care products - Biological indicators - Part 1 : general requirements.
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
NF EN ISO 13408-7:2015 Aseptic processing of healthcare products - Part 7: alternative processes for medical devices and combination products

Japanese Industrial Standards Committee (JISC)

JIS T 11140-1:2013 Sterilization of health care products.Chemical indicators.Part 1: General requirements

RU-GOST R

GOST R 56893-2016 Sterilization of health care products. Moist heat. Part 2. Guidance on the application of ISO 17665-1

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