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Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
Superseded date
04-01-2006
Superseded by
Published date
01-12-2013
Publisher
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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Superseded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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