Health product processing

Health product processing, Total:71 items.

The international standard classification for "Health product processing" includes: .

The Chinese standard classification for "Health product processing" includes: .

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 17664:2017 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices
ANSI/AAMI/ISO 13408-3:2006(2015) Aseptic processing of health care products — Part 3: Lyophilization
ANSI/AAMI/ISO 13408-5:2006(2015) Aseptic processing of health care products — Part 5: Sterilization in place
ANSI/AAMI/ISO 13408-2:2018 Aseptic processing of health care products—Part 2: Sterilizing filtration
ANSI/AAMI/ISO 13408-1:2008(2017)/A1:2013(2017) Aseptic processing of health care products—Part 1: General requirements
ANSI/AAMI/ISO 13408-4:2005(2014) Aseptic processing of health care products — Part 4: Clean-in-place technologies

British Standards Institution (BSI)

BS EN ISO 17664:2017 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
BS EN ISO 13408-1:2024 Aseptic processing of health care products - General requirements
BS EN ISO 13408-2:2011 Aseptic processing of health care products. Filtration
BS EN ISO 17664-1:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Critical and semi-critical medical devices
BS EN ISO 13408-1:2015 Aseptic processing of health care products. General requirements
BS EN ISO 13408-1:2011+A1:2013 Aseptic processing of health care products. General requirements
BS EN ISO 13408-6:2011 Aseptic processing of health care products. Isolator systems
BS EN ISO 13408-1:2011 Aseptic processing of health care products. General requirements
BS EN ISO 13408-3:2011 Aseptic processing of health care products. Lyophilization
BS EN ISO 13408-5:2011 Aseptic processing of health care products. Sterilization in place
BS EN ISO 13408-2:2018 Aseptic processing of health care products. Sterilizing filtration
BS EN ISO 13408-6:2011+A1:2013 Aseptic processing of health care products. Isolator systems
BS EN ISO 13408-6:2021 Aseptic processing of health care products. Isolator systems
BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
19/30378069 DC BS ISO 17664-2. Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Part 2. Non-critical medical devices
BS EN ISO 13408-4:2011 Aseptic processing of health care products. Clean-in-place technologies

Association for the Advancement of Medical Instrumentation

AAMI ST90:2017 Processing of health care products - Quality management systems for processing in health care facilities
ANSI/AAMI/ISO 13408-6:2005 Aseptic processing of health care products - Part 6:Isolator systems
AAMI/ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
AAMI 13408-2-2003 Aseptic Processing of health care products - Part 2: Filtration

Danish Standards Foundation

DANSK DS/EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization
DS/EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization
DS/EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration
DS/ISO 17664-2:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
DS/EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements
DS/EN ISO 13408-1/A1:2013 Aseptic processing of health care products - Part 1: General requirements
DS/ISO 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems
DS/EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place
DANSK DS/EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place
DANSK DS/EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements
DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
DS/EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 13408-3:2016 Aseptic processing of health care products -- part 3 :Lyophilization
BH GSO ISO 13408-2:2016 Aseptic processing of health care products -- part 2 : filtration
BH GSO ISO 13408-5:2016 Aseptic processing of health care products -- part 5 : sterilization in place
BH GSO ISO 13408-1:2016 Aseptic processing of health care products -- part 1 : general requirements
BH GSO ISO 13408-4:2016 Aseptic processing of health care products -- part 4 : clean-in-place technologies

Korean Agency for Technology and Standards (KATS)

KS P ISO 13408-3-2010(2016) Aseptic processing of health care products － Parts 3: Lyophilization
KS P ISO 13408-2-2010(2016) Aseptic processing of health care products － Part 2: Filtration
KS P ISO 13408-5-2010(2016) Aseptic processing of healthcare products－Part 5：Sterilization in place
KS P ISO 13408-4-2010(2016) Aseptic processing of health care products－Part 4：Clean-in-place technologies
KS P ISO 13408-1-2022 Aseptic processing of health care products — Part 1: General requirements

Bureau of Indian Standards

IS 18552-2024 Guidelines for Processing of Multiple-Use Healthcare Textiles

German Institute for Standardization

DIN EN ISO 13408-2:2018-06 Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018); German version EN ISO 13408-2:2018
DIN EN ISO 13408-1:2015-12 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015 / Note: To be replaced by DIN EN ISO 13408-1 (2022-06).
DIN EN ISO 13408-3:2011-09 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006); German version EN ISO 13408-3:2011
DIN EN ISO 13408-1 E:2022-06 Aseptic processing of health products Part 1: General requirements (draft)

Association Francaise de Normalisation

NF EN ISO 13408-6:2021 Aseptic processing of health products - Part 6: isolator systems
NF S98-117-2*NF EN ISO 13408-2:2018 Aseptic processing of health care products - Part 2 : sterilizing filtration
NF EN ISO 13408-3:2011 Aseptic processing of health products - Part 3: freeze-drying
NF EN ISO 13408-5:2011 Aseptic processing of healthcare products - Part 5: on-site sterilization

Gosstandart of Russia

GOST R ISO 13408-4-2011 Aseptic processing of health care products. Part 4. Clean-in-place technologies
GOST R ISO 13408-3-2011 Aseptic processing of health care products. Part 3. Lyophilization
GOST R ISO 13408-5-2011 Aseptic processing of health care products. Part 5. Sterilization in place

The Directorate General of Specifications and Metrology (DGSM)

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

International Organization for Standardization (ISO)

ISO 13408-1:2023 Aseptic processing of health care products — Part 1: General requirements
ISO/FDIS 13408-1 Aseptic processing of health care products — Part 1: General requirements

Spanish Association for Standardization (UNE)

UNE-EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
UNE-EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

Lithuanian Standards Office

LST EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

Ente Nazionale Italiano di Unificazione

UNI EN ISO 17664:2018 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
UNI EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization

Canadian Standards Association (CSA)

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

Standards Norway

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