AAMI ISO TIR 16775 : 2014

Current

Current The latest, up-to-date edition.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2

Publisher: Association for the Advancement of Medical Instrumentation

Published: 01-01-2014

Available Formats: PDF - English - DRM, Hardcopy - English
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Table of Contents - (Show below) - (Hide below)

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
ISO/TS 16775:2014
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Guidance for health care facilities
4 Guidance for industry
Annex A (informative) - Selection, evaluation and
        testing of packaging materials and sterile
        barrier systems - Guidance for industry
        and health care facilities
Annex B (informative) - Sterilization
        considerations - Guidance for industry
        and health care facilities
Annex C (informative) - Examples of wrapping
        methods - Guidance for health care facilities
Annex D (informative) - Validation plan
        documents - Guidance for health care facilities
Annex E (informative) - Installation qualification
        documentation - Guidance for health care facilities
Annex F (informative) - Operational qualification
        documentation - Guidance for health care facilities
Annex G (informative) - Performance qualification
        documentation - Guidance for health care facilities
Annex H (informative) - Addressing worst-case
        requirements - Guidance for industry and
        health care facilities
Annex I (informative) - Generating a final packaging
        system validation protocol - Guidance for industry
Annex J (informative) - Design inputs - Medical device
        attributes - Guidance for industry
Annex K (informative) - Risk analysis tools - Guidance
        for industry and health care facilities
Annex L (informative) - Considerations for sampling
        plans - Guidance for health care facilities
Annex M (informative) - Stability testing
        (ISO 11607-1:2006, 6.4) - Guidance for industry
Annex N (informative) - Use of the Internet - Guidance
        for industry and health care facilities
Annex O (informative) - Test method validation - Guidance
        for industry
Annex P (informative) - Use of contract packagers - Guidance
        for industry and health care facilities
Annex Q (informative) - Guidance on establishing process
        parameters - Guidance for industry
Annex R (informative) - Investigation failure - Guidance
        for industry and health care facilities
Annex S (informative) - Packaging manufacturing process
        and packaging system design feasibility
        evaluation - Guidance for industry
Bibliography

Abstract - (Show below) - (Hide below)

Describes guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2.

General Product Information - (Show below) - (Hide below)

Published
Document Type	Standard
Status	Current
Publisher	Association for the Advancement of Medical Instrumentation
Pages
ISBN
Committee	WG 07
Supersedes	AAMI TIR22 : 2007

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO/TS 16775 : 2014(R2018)	Identical
ISO/TS 16775 : 2014(R2018)	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

AAMI CI86 : 2017	COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING
AAMI TIR17 : 2008	COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
AAMI TIR17 : 2017	COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION

Standards Referencing This Book - (Show below) - (Hide below)

EN 13430 : 2004	PACKAGING - REQUIREMENTS FOR PACKAGING RECOVERABLE BY MATERIAL RECYCLING
ASTM D 5264 : 1998	PRACTICE FOR ABRASION RESISTANCE OF PRINTED MATERIALS BY THE SUTHERLAND RUB TESTER
ASTM F 1327 : 2005	Standard Terminology Relating to Barrier Materials for Medical Packaging (Withdrawn 2007)
ISO 11137-1:2006(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI TIR19 : 1998	GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
ASTM D 1894 : 2014 : REDLINE	Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
ASTM D 4169 : 2016 : REDLINE	Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM D 3420 : 2014 : REDLINE	Standard Test Method for Pendulum Impact Resistance of Plastic Film
ISO 11607-2 : 2006(R 2015)	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
98/79/EC : 1998 AMD 3 2011	DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 27 OCTOBER 1998 ON IN VITRO DIAGNOSTIC MEDICAL DEVICES
AAMI ST58 : 2013(R2018)	CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
ASTM F 2475 : 2011 : REDLINE	Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
ASTM F 372 : 1999	TEST METHOD FOR WATER VAPOR TRANSMISSION RATE OF FLEXIBLE BARRIER MATERIALS USING AN INFRARED DETECTION TECHNIQUE
EN 60118-13 : 2011	ELECTROACOUSTICS - HEARING AIDS - PART 13: ELECTROMAGNETIC COMPATIBILITY (EMC)
CFR 21(PTS170-199) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 170-199
IEC 60601-1:2005+AMD1:2012 CSV	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
EN 13427 : 2004	PACKAGING - REQUIREMENTS FOR THE USE OF EUROPEAN STANDARDS IN THE FIELD OF PACKAGING AND PACKAGING WASTE
ASTM D 1938 : 2014-12	TEST METHOD FOR TEAR-PROPAGATION RESISTANCE (TROUSER TEAR) OF PLASTIC FILM AND THIN SHEETING BY A SINGLE-TEAR METHOD
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
ASTM F 1140 : 2007	TEST METHODS FOR INTERNAL PRESSURIZATION FAILURE RESISTANCE OF UNRESTRAINED PACKAGES
DIN 58921 : 2011	TEST METHOD TO DEMONSTRATE THE SUITABILITY OF A MEDICAL DEVICE SIMULATOR DURING STEAM STERILISATION - MEDICAL DEVICE SIMULATOR TESTING
IEC 60118-13 : 4.0	ELECTROACOUSTICS - HEARING AIDS - PART 13: ELECTROMAGNETIC COMPATIBILITY (EMC)
ISO TS 17665-2 : 2009(R2015)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
ASTM D 3985 : 2005	TEST METHOD FOR OXYGEN GAS TRANSMISSION RATE THROUGH PLASTIC FILM AND SHEETING USING A COULOMETRIC SENSOR
ASTM F 2097 : 2016 : REDLINE	Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
EN 868-8 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
DIN 58953-6 : 2016	STERILIZATION - STERILE SUPPLY - PART 6: MICROBIAL BARRIER TESTING OF PACKAGING MATERIALS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED
ASTM D 3776 : 2009-02	TEST METHODS FOR MASS PER UNIT AREA (WEIGHT) OF FABRIC
ASTM F 2029 : 2016 : REDLINE	Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength
CFR 21(PTS800-1299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
AAMI TIR35 : 2016	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT ADOPTION AND ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS
ASTM D 4321 : 2015 : REDLINE	Standard Test Method for Package Yield of Plastic Film
EN 13429 : 2004	PACKAGING - REUSE
ASTM F 2252 : 2013-06	PRACTICE FOR EVALUATING INK OR COATING ADHESION TO FLEXIBLE PACKAGING MATERIALS USING TAPE
AAMI TIR33 : 2005	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE - METHOD VDMAX
ASTM F 2096 : 2011	Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
EN 868-2 : 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
AAMI TIR28 : 2016	PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION
AAMI TIR16 : 2009	MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
ASTM D 4754 : 2012-01	TEST METHOD FOR TWO-SIDED LIQUID EXTRACTION OF PLASTIC MATERIALS USING FDA MIGRATION CELL
ASTM F 88 : 2007-12	TEST METHOD FOR SEAL STRENGTH OF FLEXIBLE BARRIER MATERIALS
ISO 11135-1 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ASTM F 2054 : 2007	TEST METHOD FOR BURST TESTING OF FLEXIBLE PACKAGE SEALS USING INTERNAL AIR PRESSURIZATION WITHIN RESTRAINING PLATES
AAMI TIR15 : 2016	PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
ASTM F 2825 : 2010	PRACTICE FOR CLIMATIC STRESSING OF PACKAGING SYSTEMS FOR SINGLE PARCEL DELIVERY
ASTM D 2457 : 2013 : REDLINE	Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics
ASTM F 392 : 1993	TEST METHOD FOR FLEX DURABILITY OF FLEXIBLE BARRIER MATERIALS
ASQ Z1.4:2003	Sampling Procedures And Tables For Inspection By Attributes
ASTM D 1709 : 2016-05	TEST METHODS FOR IMPACT RESISTANCE OF PLASTIC FILM BY THE FREE-FALLING DART METHOD
ASTM F 1929 : 2015 : REDLINE	Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ISO 14708-2 : 2012	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2: CARDIAC PACEMAKERS
AAMI TIR17 : 2008	COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
ASTM F 2217 : 2002	PRACTICE FOR COATING/ADHESIVE WEIGHT DETERMINATION
ISO 14708-1 : 2014	IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
ISO 20857 : 2010(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 1924-2:2008(R2018)	PAPER AND BOARD - DETERMINATION OF TENSILE PROPERTIES - PART 2: CONSTANT RATE OF ELONGATION METHOD (20 MM/MIN)
ISO TS 11139 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
ISO 11137-3 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL
EN 13431 : 2004	PACKAGING - REQUIREMENTS FOR PACKAGING RECOVERABLE IN THE FORM OF ENERGY RECOVERY, INCLUDING SPECIFICATION OF MINIMUM INFERIOR CALORIFIC VALUE
93/42/EEC : 1993 AMD 5 2007	COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES
EN 13428 : 2004	PACKAGING - REQUIREMENTS SPECIFIC TO MANUFACTURING AND COMPOSITION - PREVENTION BY SOURCE REDUCTION
DIN 58953-8 : 2010	STERILIZATION - STERILE SUPPLY - PART 8: LOGISTICS OF STERILE MEDICAL DEVICES
ISO 10993-7 : 2008(R2016)	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
ASTM D 1003 : 2013 : REDLINE	Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
ISO 11137-2 : 2013(R2018)	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
94/62/EC : 1994 AMD 6 2015	EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 94/62/EC OF 20 DECEMBER 1994 ON PACKAGING AND PACKAGING WASTE
ASTM F 2203 : 2013-06	TEST METHOD FOR LINEAR MEASUREMENT USING PRECISION STEEL RULE
ASTM F 1886 : 1998	Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
ISO 10993-1 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
EN 60601-1:2006/A1	MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005)
ISO 534 : 2011(R2017)	PAPER AND BOARD - DETERMINATION OF THICKNESS, DENSITY AND SPECIFIC VOLUME
ASTM D 882 : 2012-09	TEST METHOD FOR TENSILE PROPERTIES OF THIN PLASTIC SHEETING
ASTM D 1922 : 2015 : REDLINE	Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
EN 13432 : 2000 COR 2005	PACKAGING - REQUIREMENTS FOR PACKAGING RECOVERABLE THROUGH COMPOSTING AND BIODEGRADATION - TEST SCHEME AND EVALUATION CRITERIA FOR THE FINAL ACCEPTANCE OF PACKAGING
ASTM F 1980 : 2016 : REDLINE	Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ISO ASTM 51649 : 2015	PRACTICE FOR DOSIMETRY IN AN ELECTRON BEAM FACILITY FOR RADIATION PROCESSING AT ENERGIES BETWEEN 300 KEV AND 25 MEV
ASTM F 2251 : 2013-10	TEST METHOD FOR THICKNESS MEASUREMENT OF FLEXIBLE PACKAGING MATERIAL
ISO TS 11135-2 : 2008	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
ISO 14971 : 2007(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
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	STERILIZATION - STERILE SUPPLY - PART 7: USE OF STERILIZATION PAPER, NONWOVEN WRAPPING MATERIAL, TEXTILE MATERIALS, PAPER BAGS AND SEALABLE POUCHES AND REELS
ASTM D 3078 : 2002	TEST METHOD FOR DETERMINATION OF LEAKS IN FLEXIBLE PACKAGING BY BUBBLE EMISSION
ASTM F 17 : 2017-07	TERMINOLOGY RELATING TO FLEXIBLE BARRIER PACKAGING
ASTM F 2250 : 2013-06	PRACTICE FOR EVALUATION OF CHEMICAL RESISTANCE OF PRINTED INKS AND COATINGS ON FLEXIBLE PACKAGING MATERIALS
AAMI ST63 : 2002	STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES - DRY HEAT
ISO 15747 : 2010	PLASTIC CONTAINERS FOR INTRAVENOUS INJECTIONS
ASTM F 1306 : 2016 : REDLINE	Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
ASTM F 904 : 2016 : REDLINE	Standard Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials
AAMI TIR 29 : 2012	GUIDE FOR PROCESS CHARACTERIZATION AND CONTROL IN RADIATION STERILIZATION OF MEDICAL DEVICES
ASTM F 1249 : 2013 : REDLINE	Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
ISO 17665-1 : 2006(R2016)	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ASQ Z1.9:2003 (R2013)	Sampling Procedures And Tables For Inspection By Variables For Percent Nonconforming
ASTM D 589 : 1997	Standard Test Method for Opacity of Paper (15°Diffuse Illuminant A, 89% Reflectance Backing and Paper Backing)
AAMI TIR20 : 2001	PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION

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AAMI ISO TIR 16775 : 2014

Table of Contents - (Show below) - (Hide below)

Abstract - (Show below) - (Hide below)

General Product Information - (Show below) - (Hide below)

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Standards Referenced By This Book - (Show below) - (Hide below)

Standards Referencing This Book - (Show below) - (Hide below)

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