Committee
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CTN 111 |
Document Type
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Standard |
ISBN
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|
Pages
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Published
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Publisher
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Asociacion Espanola de Normalizacion
|
Status
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Superseded |
Superseded By
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Supersedes
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EN 13795-1:2002+A1:2009
|
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products |
EN 868-5:2009
|
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods |
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
EN 868-6:2017
|
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods |
AAMI ST65:2008(R2018)
|
PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
ISO 186:2002
|
Paper and board — Sampling to determine average quality |
ISO/TS 11139:2006
|
Sterilization of health care products Vocabulary |
DIN 58953-8:2010-05
|
STERILIZATION - STERILE SUPPLY - PART 8: LOGISTICS OF STERILE MEDICAL DEVICES |
ISO 9001:2015
|
Quality management systems — Requirements |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
DIN 58953-7:2010-05
|
STERILIZATION - STERILE SUPPLY - PART 7: USE OF STERILIZATION PAPER, NONWOVEN WRAPPING MATERIAL, TEXTILE MATERIALS, PAPER BAGS AND SEALABLE POUCHES AND REELS |
DIN 58953-9:2010-05
|
Sterilization - Sterile supply - Part 9: Use of sterilization container |
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