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UNE-EN ISO 11607-2:2017

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)

Available format(s)

Hardcopy , PDF

Superseded date

23-09-2020

Superseded by

UNE-EN ISO 11607-2:2020

Language(s)

Spanish, Castilian, English

Published date

11-10-2017

€84.00
Excluding VAT

Committee
CTN 111
DocumentType
Standard
Pages
27
PublisherName
Asociacion Espanola de Normalizacion
Status
Superseded
SupersededBy
Supersedes

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 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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