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EN 868-1 : 1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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 MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS

Superseded date

01-04-2006

Superseded by

EN ISO 11607-1:2020

Published date

12-01-2013

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1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Test methods
6 Documentation
7 Information
Annex A (informative) Guidance on clause 4
Annex B (informative) Microbial barrier evaluation scheme
Annex C (informative) Air impermeability - Test methods
Annex D (informative) Microbial barrier properties -
        Test methods for materials
Annex E (informative) Microbial barrier properties -
        Test methods for permeable closures (filter assembly,
        tortuous path)
Annex F (informative) Impermeability and continuity of seals
        formed by fusion or adhesion - Test methods
Annex G (informative) Impermeability of seals not formed by
        fusion or adhesion - Test methods - Test procedure
        for rigid containers
Annex H (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
        addressing essential requirements or other provision
        of EU Directives

Defines requirements and methods of test for packaging materials and systems for medical devices for terminal sterilization and for maintenance of sterility of the device.

Committee
TC 102
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
NBN EN 868-1 : 1997 Identical
UNI EN 868-1 : 1999 Identical
NS EN 868-1 : 1ED 1997 Identical
NF EN 868-1 : 1997 Identical
DIN EN 868-1:1997-05 Identical
UNE-EN 868-1:1997 Identical
AAMI ISO 11607 : 2ED 2000 Similar to
I.S. EN 868-1:1997 Identical
NEN EN 868-1 : 1997 Identical
SN EN 868-1 : 1997 Identical
BS EN 868-1:1997 Identical

02/124462 DC : DRAFT DEC 2002 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
00/563809 DC : DRAFT AUG 2000 BS EN 13328-2 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS
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
BS EN 1782 : 1998 TRACHEAL TUBES AND CONNECTORS
BS EN 1282-1:1997 Anaesthetic and respiratory equipment. Tracheostomy tubes Tubes for use in adults
ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
BS EN 12342 : 1998 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
DIN EN 1733:2003-02 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
DIN EN 12342:1998-09 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
DIN EN 12342:2010-01 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
I.S. EN ISO 10651-4:2009 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
EN 12181:1998 Oropharyngeal airways
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
AAMI ST77 : 2013 CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
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)
DIN EN 1782:2009-12 TRACHEAL TUBES AND CONNECTORS
BS EN ISO 10651-4:2002 Lung ventilators Particular requirements for operator-powered resuscitators
I.S. EN 14126:2003+AC:2004 PROTECTIVE CLOTHING - PERFORMANCE REQUIREMENTS AND TESTS METHODS FOR PROTECTIVE CLOTHING AGAINST INFECTIVE AGENTS
DIN EN 13328-2:2004-03 BREATHING SYSTEM FILTERS FOR ANESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS
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
I.S. EN 13328-2:2002 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS
I.S. EN 12181:1998 OROPHARYNGEAL AIRWAYS
ASTM F 2097 : 2016 : REDLINE Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
BS ISO 25539-1 : 2003 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
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
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
DIN EN ISO 10651-4:2009-08 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
UNE-EN 1782:1998 TRACHEAL TUBES AND CONNECTORS.
EN 1782:1998+A1:2009 Tracheal tubes and connectors
UNI EN 12342 : 2009 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
UNI EN ISO 10651-4 : 2009 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
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
UNI EN 1782 : 2009 TRACHEAL TUBES AND CONNECTORS
I.S. EN 794-2:1997 LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE
I.S. EN 1733:2002 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
I.S. EN 1819:1998 LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS
02/560790 DC : DRAFT FEB 2002 BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
01/563350 DC : DRAFT AUG 2001 BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
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
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)
AAMI ISO 10651-4 : 1999 LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
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)
BS EN 12181:1998 Oropharyngeal airways
BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat
BS EN 1819:1998 Laryngoscopes for tracheal intubation. Particular requirements
BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants. General requirements
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
BS EN 13328-2:2002 Breathing system filters for anaesthetic and respiratory use Non-filtration aspects
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
EN ISO 10651-4:2009 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
EN 1733 : 2002 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
EN 866-1 : 1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS
EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
EN 794-2 : 1997 LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE
EN 1819 : 1997 LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS
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)
DIN EN 14126:2004-01 Protective clothing - Performance requirements and test methods for protective clothing against infective agents
BS EN 14126:2003 Protective clothing. Performance requirements and tests methods for protective clothing against infective agents
BS EN 1733:2002 Suction catheters for use in the respiratory tract
EN 1282-1 : 1996 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - TUBES FOR USE IN ADULTS
EN 13328-2:2002/A1:2003 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTERATION ASPECTS

EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
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 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

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