Source: https://infostore.saiglobal.com/en-us/Standards/ISO-11607-1-2006-594864_SAIG_ISO_ISO_1362654/
Timestamp: 2020-08-07 01:32:14
Document Index: 419995593

Matched Legal Cases: ['ART 1', 'ART 4', 'ART 4', 'ART 4', 'ART 6', 'ART 1', 'ART 6', 'ART 2', 'ART 1']

ISO 11607-1 : 2006 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS | SAI Global
Available Formats: PDF - French, Hardcopy - French, PDF - French, Hardcopy - French, PDF - English - French, Hardcopy - English - French
5 Materials and preformed sterile barrier systems
6 Design and development requirements for packaging systems
7 Information to be provided
Annex A (informative) - Guidance on medical packaging
Annex B (informative) - Standardized test methods and
procedures that may be used to demonstrate compliance
with the requirements of this part of ISO 11607
Annex C (normative) - Test method for resistance of impermeable
Describes the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
ISO 11607-1 : 2019
EN ISO 11607-1:2017 Identical
SANS 11607-1 : 1ED 2007(R2014) Identical
SAC GB/T 19633.1 : 2015 Identical
NBR ISO 11607-1 : 2013 Identical
DIN EN ISO 11607-1 : 2014 Identical
CSA ISO 11607-1 : 2016 Identical
AAMI ISO 11607-1 : 2006 Identical
DIN EN ISO 11607-1 E : 2014 Identical
DS EN ISO 11607-1 : 2017 Identical
EN ISO 11607-1:2009 Identical
I.S. EN ISO 11607-1:2017&LC:2017 Identical
AAMI ISO 11607-1 : 2006 : INC : AMD 1 : 2014 : R201000 Identical
PN EN ISO 11607-1 : 2017 Identical
ANSI/AAMI/ISO 11607-1:2006/(R)2015 Identical
DIN EN ISO 11607-1 E : 2017 Identical
I.S. EN ISO 11607-1:2017 Identical
AAMI ISO 11607-1 : 2006 : R2010 Identical
BS EN ISO 11607-1 : 2017 Identical
CSA Z10651-4 : 2008 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
NBR ISO 5362 : 2012 ANAESTHETIC RESERVOIR BAGS
NBR ISO 5367 : 2017 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
NBR 16044 : 2012 DENTAL IMPLANTS - REQUIREMENTS GENERAL FOR ENDOSSEOUS UNCOATED METALLIC IMPLANTS
CSA Z10651-4 : 2008 : R2013 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
CSA Z10651-4 : 2008 : R2018 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
CSA ISO 5362 : 2014 ANAESTHETIC RESERVOIR BAGS
BIS IS/ISO 5364 : 2008 ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
AAMI ISO 5362 : 2006 ANAESTHETIC RESERVOIR BAGS
PREN ISO 11979-6 : DRAFT 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY (ISO/DIS 11979-6:2013)
UNI EN ISO 5364 : 2011 ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
NBR ISO 5366-1 : 2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
13/30254047 DC : 0 BS EN ISO 11979-6 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY
ASTM F 2981 : 2015 Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
ISO 5636-2 : 1984 PAPER AND BOARD - DETERMINATION OF AIR PERMEANCE (MEDIUM RANGE) - PART 2: SCHOPPER METHOD
ISO 5636-1 : 1984 PAPER AND BOARD - DETERMINATION OF AIR PERMEANCE (MEDIUM RANGE) - PART 1: GENERAL METHOD
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