EN 868-2:2017
Current
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
Published date
02-08-2017
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European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
Annex A (informative) - Details of significant technical
changes between this European Standard and the
previous edition
Annex B (informative) - Method for the determination
of drape
Annex C (normative) - Method for the determination
of water repellency
Annex D (normative) - Method for the determination
of pore size
Annex E (informative) - Repeatability and reproducibility
of test methods
Bibliography
This draft European Standard provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.The need for a protective packaging may be determined by the manufacturer and the user.This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1.As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply.The materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse.
| Committee |
CEN/TC 102
|
| DevelopmentNote |
Supersedes PREN 868-2. (02/2017)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN 868-2:2017-05 | Identical |
| UNI EN 868-2:2017 | Identical |
| PN EN 868-2 : 2017-03 | Identical |
| I.S. EN 868-2:2017 | Identical |
| NBN EN 868-2 : 2009 | Identical |
| SN EN 868-2:2017 | Identical |
| NF EN 868-2 : 2017 | Identical |
| UNE-EN 868-2:2009 | Identical |
| BS EN 868-2:2017 | Identical |
| DIN EN 868-2:2015-08 (Draft) | Identical |
| NEN EN 868-2 : 2017 | Identical |
| UNE-EN 868-2:2017 | Identical |
| UNI EN 868-2 : 2009 | Identical |
| NS EN 868-2 : 2017 | Identical |
| AAMI ISO 11607-1 : 2006 : R2010 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
| 02/124462 DC : DRAFT DEC 2002 | BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| UNI 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 |
| BS EN 868-5:2009 | Packaging for terminally sterilized medical devices Sealable pouches and reels of porous and plastic film construction. Requirements and test methods |
| 12/30261215 DC : 0 | BS EN 13060 - SMALL STEAM STERILIZERS |
| 11/30252448 DC : 0 | BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| PREN 14180 : DRAFT 2012 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| 17/30351717 DC : 0 | BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| PREN 13060 : DRAFT 2012 | SMALL STEAM STERILIZERS |
| AAMI ISO 11607-1 : 2006 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
| AAMI/ISO TIR17665-3:2014(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| I.S. 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 |
| CAN/CSA-ISO/TS 16775:17 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
| S.R. CEN ISO/TS 16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
| CSA Z17665-1 : 2009 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| UNE-EN ISO 11607-1:2017 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014) |
| BS EN ISO 14534:2015 | Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
| CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
| PREN 1422 : DRAFT 2011 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| 12/30262894 DC : 0 | BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| I.S. EN ISO 17665-1:2006 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| CSA Z17665-2 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| PD ISO/TS 17665-3:2013 | Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| 04/30048205 DC : DRAFT JUL 2004 | BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI ISO 17665-1 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| UNI CEN ISO/TS 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| NF 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 |
| CSA Z17665-2:09 (R2019) | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT) |
| DIN EN ISO 17665-1:2006-11 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| I.S. EN ISO 14534:2015 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011) |
| DIN EN ISO 11607-1:2014-11 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014) |
| 09/30207531 DC : 0 | BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
| ANSI/AAMI ISO 17665-1:2006(R2013) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| BS EN ISO 11607-1:2017 | Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems |
| UNI EN 13795-1 : 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 |
| CSA ISO 11607-1 : 2016 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| AAMI ISO TIR 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| 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 |
| ANSI/AAMI/ISO 11607-1:2006/(R)2015 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
| AAMI ISO TIR 17665-3:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| AAMI/ISO TIR17665-2:2009(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| CSA Z17665-1 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 17/30360908 DC : 0 | BS EN 868-5 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS |
| UNI EN ISO 11607-1 : 2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| BS EN ISO 11607-1:2020 | Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems |
| DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| BS EN 554:1994 | Sterilization of medical devices. Validation and routine control of sterilization by moist heat |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| BS EN ISO 17665-1:2006 | Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 14534:2011 | Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements |
| UNE-EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| UNI CEN ISO/TS 16775 : 2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| 04/30101211 DC : DRAFT APR 2004 | ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| DD CEN ISO/TS 17665-2:2009 | Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1 |
| DIN EN 868-5:2009-09 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS |
| S.R. CEN ISO TS 17665-2:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| PREN 868-5 : DRAFT 2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS |
| CSA Z17665-1:09 (R2019) | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations) |
| I.S. EN ISO 11607-1:2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014) |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| BS EN ISO 11607-1 : 2009 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| CEN ISO/TS 17665-2:2009 | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |
| ISO 1974:2012 | Paper — Determination of tearing resistance — Elmendorf method |
| ISO 5636-3:2013 | Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 13937-1:2000 | Textiles — Tear properties of fabrics — Part 1: Determination of tear force using ballistic pendulum method (Elmendorf) |
| EN 20811:1992 | Textiles - Determination of resistance to water penetration - Hydrostatic pressure test |
| ISO 6588-2:2012 | Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction |
| ISO 9237:1995 | Textiles — Determination of the permeability of fabrics to air |
| ISO 9073-3:1989 | Textiles — Test methods for nonwovens — Part 3: Determination of tensile strength and elongation |
| EN 1149-1:2006 | Protective clothing - Electrostatic properties - Part 1: Test method for measurement of surface resistivity |
| EN ISO 9073-9:2008 | Textiles - Test methods for nonwovens - Part 9: Determination of drapability including drape coefficient (ISO 9073-9:2008) |
| EN ISO 535:2014 | Paper and board - Determination of water absorptiveness - Cobb method (ISO 535:2014) |
| EN ISO 9237:1995 | Textiles - Determination of permeability of fabrics to air (ISO 9237:1995) |
| ISO 2758:2014 | Paper Determination of bursting strength |
| ISO 187:1990 | Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples |
| EN ISO 1974:2012 | Paper - Determination of tearing resistance - Elmendorf method (ISO 1974:2012) |
| ISO 9197:2016 | Paper, board and pulps Determination of water-soluble chlorides |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| EN ISO 1924-2:2008 | Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2:2008) |
| EN ISO 536:2012 | Paper and board - Determination of grammage (ISO 536:2012) |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 9073-9:2008 | Textiles Test methods for nonwovens Part 9: Determination of drapability including drape coefficient |
| ISO 1924-2:2008 | Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min) |
| EN 29073-3:1992 | Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation |
| EN 20187:1993 | Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990) |
| EN ISO 13938-1:1999 | Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:1999) |
| ISO 2470-2:2008 | Paper, board and pulps — Measurement of diffuse blue reflectance factor — Part 2: Outdoor daylight conditions (D65 brightness) |
| ISO 3781:2011 | Paper and board — Determination of tensile strength after immersion in water |
| EN 13795:2011+A1:2013 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels |
| ISO 536:2012 | Paper and board Determination of grammage |
| ISO 3689:1983 | Paper and board — Determination of bursting strength after immersion in water |
| ISO 811:1981 | Textile fabrics Determination of resistance to water penetration Hydrostatic pressure test |
| ISO 5725-2:1994 | Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method |
| EN ISO 2758:2014 | Paper - Determination of bursting strength (ISO 2758:2014) |
| ISO 13938-1:1999 | Textiles Bursting properties of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 535:2014 | Paper and board — Determination of water absorptiveness — Cobb method |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 9198:2001 | Paper, board and pulp Determination of water-soluble sulfates |
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