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8552 General regulations and directions for articles for health service

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Released: 2015
CSN EN 16442
Controlled environment storage cabinet for processed thermolabile endoscopes
LANGUAGE
English
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Released: 2019
CSN EN ISO 11138-7
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
LANGUAGE
English
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Released: 2006
CSN EN ISO 11607-1
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
LANGUAGE
English
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Released: 2006
CSN EN ISO 11607-2
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
LANGUAGE
English
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Released: 2012
CSN EN ISO 13408-7
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
LANGUAGE
English
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Released: 2017
CSN EN ISO 15378
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
LANGUAGE
English
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Released: 2008
CSN EN ISO 15882
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)
LANGUAGE
English
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Released: 2016
CSN EN ISO 16409
Dentistry - Oral care products - Manual interdental brushes
LANGUAGE
English
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Released: 2018
CSN EN ISO 18472
Sterilization of health care products - Biological and chemical indicators - Test equipment
LANGUAGE
English
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Released: 2003
CSN EN ISO 8871-1
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
LANGUAGE
English
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Released: 2003
CSN EN ISO 8871-2
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
LANGUAGE
English
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Released: 2003
CSN EN ISO 8871-3
Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count
LANGUAGE
English