UNE-EN ISO 11607-2:2017

Superseded

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Superseded date

09-23-2020

Language(s)

Spanish, Castilian, English

Published date

10-11-2017

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 111
DocumentType	Standard
Pages	27
PublisherName	Asociacion Espanola de Normalizacion
Status	Superseded
SupersededBy	UNE-EN ISO 11607-2:2020
Supersedes	UNE-EN ISO 11607-2:2007 UNE-EN ISO 11607-2:2007/A1:2014

Standards	Relationship
DIN EN ISO 11607-2:2014-11	Identical
NS EN ISO 11607-2 : 2017	Identical
BS EN ISO 11607-2 : 2006	Identical
NBN EN ISO 11607-2 : 2006 AMD 1 2014	Identical
EN ISO 11607-2:2017	Identical
ISO 11607-2:2006	Identical
UNI EN ISO 11607-2 : 2014	Identical
I.S. EN ISO 11607-2:2017 & LC:2017	Identical
ISO 11607-2:2006/Amd 1:2014	Identical
ONORM EN ISO 11607-2 : 2018	Identical
NF EN ISO 11607-2 : 2018	Identical
SN EN ISO 11607-2 : 2018	Identical
NEN EN ISO 11607-2 : 2017 + COR 2017	Identical

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