EN 556:1994 + A1:1998
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
Superseded date
01-10-2001
Superseded by
Published date
12-01-2013
Publisher
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Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
Annex
A (informative) Bibliography
Specifies the requirements for a terminally sterilized medical device to be labelled 'STERILE'. Also gives definitions.
| Committee |
TC 204
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 556 : 95 AMD 1 98 | Similar to |
| BS EN 556:1995 | Identical |
| UNI EN 556 : 2000 | Identical |
| NS EN 556 : 94 AMD 1 98 | Similar to |
| NF EN 556 : 95 AMD 1 98 | Identical |
| UNE-EN 556:1999 | Identical |
| SN EN 556 : 1999 | Identical |
| NEN EN 556 : 95 AMD 1 98 | Identical |
| I.S. EN 556:1994 | Identical |
| DIN EN 556:1999-01 | Identical |
| I.S. EN 1283:1996 | HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS |
| I.S. EN 1616:1997 | STERILE URETHRAL CATHETERS FOR SINGLE USE |
| I.S. EN 12022:1999 | BLOOD GAS EXCHANGERS |
| I.S. EN 13503-8:2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| 03/103294 DC : DRAFT JAN 2003 | BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES |
| 02/563808 DC : DRAFT SEP 2002 | BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| 02/563845 DC : DRAFT SEP 2002 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| CSA Z10651-4 : 2008 | LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS |
| CSA C22.2 No. 60601.2.12 : 2003 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| CSA ISO 5362 : 2014 | ANAESTHETIC RESERVOIR BAGS |
| 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 |
| BS EN 794-2:1997 | Lung ventilators Particular requirements for home care use |
| 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 |
| DIN EN 13867:2009-09 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| DIN EN 13867:2003-01 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
| EN 13503-8 : 2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| EN 12181:1998 | Oropharyngeal airways |
| EN 12022:1999 | Blood gas exchangers |
| EN 1283:1996 | Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits |
| EN 12347:1998 | Biotechnology - Performance criteria for steam sterilizers and autoclaves |
| EN ISO 5366-1:2009 | Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) |
| EN 12470-2:2000+A1:2009 | Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers |
| 11/30252448 DC : 0 | BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| ANSI/AAMI/ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| AAMI ISO 12417-1 : 2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
| ISO/TS 15539:2000 | Cardiovascular implants Endovascular prostheses |
| DIN EN 1782:2009-12 | TRACHEAL TUBES AND CONNECTORS |
| DIN EN 12470-2:2009-11 | Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers (includes Amendment A1:2009) |
| BS EN 1174-1:1996 | Sterilization of medical devices. Estimation of the population of micro-organisms on product Requirements |
| BS EN ISO 10651-4:2002 | Lung ventilators Particular requirements for operator-powered resuscitators |
| I.S. EN ISO 5366-1:2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS |
| DIN EN 794-1:2001-02 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
| I.S. EN 794-3:1998 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
| I.S. EN 12470-2:2000 | CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS |
| DIN EN ISO 5366-1:2009-07 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS |
| 05/30138123 DC : DRAFT AUG 2005 | BS ISO 8836 - SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| 01/563350 DC : DRAFT AUG 2001 | BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| 04/30109833 DC : 0 | ISO 8836 - SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| I.S. EN 12181:1998 | OROPHARYNGEAL AIRWAYS |
| BS 5724-2.202(1997) : 1997 + A2 2009 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
| BS ISO 25539-1 : 2003 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
| CSA Z10651-4 : 2008 : R2013 | LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS |
| CEI EN 60601-2-12 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| AAMI ISO 5362 : 2006 | ANAESTHETIC RESERVOIR BAGS |
| DIN EN ISO 10651-4:2009-08 | Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
| BS EN 12022:1999 | Blood-gas exchangers |
| ISO 5366-1:2000 | Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults |
| UNE-EN 1782:1998 | TRACHEAL TUBES AND CONNECTORS. |
| EN 1782:1998+A1:2009 | Tracheal tubes and connectors |
| UNI EN 12470-2 : 2009 | CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS |
| UNI EN ISO 5366-1 : 2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS |
| UNI EN 13867 : 2009 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
| 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 794-1 : 2009 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
| UNI EN 794-3 : 2009 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
| 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 1819:1998 | LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
| MEDDEV 2.5-7 : REV 1 : 1998 | GUIDELINES FOR CONFORMITY ASSESSMENT OF BREAST IMPLANTS ACCORDING TO DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES |
| 03/103293 DC : DRAFT JAN 2003 | BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| CAN/CSA-Z10651-4-08 (R2018) | Lung Ventilators - Part 4: Particular Requirements for Operator-Powered Resuscitators (Adopted ISO 10651-4:2002, first edition, 2002-03-01, with Canadian deviations) |
| AAMI ISO 10651-4 : 1999 | LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ISO 5366-3:2001 | Anaesthetic and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes |
| I.S. EN 60601-2-12:2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| BS EN 12181:1998 | Oropharyngeal airways |
| BS EN 1615:2000 | Enteral feeding catheters and enteral giving sets for single use and their connectors. Design and testing |
| BS EN ISO 10651-6:2009 | Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices |
| BS EN 1819:1998 | Laryngoscopes for tracheal intubation. Particular requirements |
| BS EN 13867 : 2002 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| BS EN 13503-8:2000 | Ophthalmic implants. Intraocular lenses Fundamental requirements |
| ISO 10651-6:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
| BS EN 12470-2 : 2001 | CLINICAL THERMOMETERS - PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS |
| BS EN 794-3 : 1999 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
| BS EN ISO 5366-1:2004 | Anaesthetic and respiratory equipment. Tracheostomy tubes Tubes and connectors for use in adults |
| EN ISO 10651-4:2009 | Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
| EN 1617:1997 | Sterile drainage catheters and accessory devices for single use |
| EN 13867:2002+A1:2009 | Concentrates for haemodialysis and related therapies |
| EN 12342:1998+A1:2009 | Breathing tubes intended for use with anaesthetic apparatus and ventilators |
| EN ISO 10651-6:2009 | Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
| EN 794-2 : 1997 | LUNG VENTILATORS - PARTICULAR REQUIREMENTS FOR HOME CARE USE |
| EN 1819 : 1997 | LARYNGOSCOPES FOR TRACHEAL INTUBATION - PARTICULAR REQUIREMENTS |
| EN 794-3:1998+A2:2009 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
| EN 794-1:1997+A2:2009 | Lung ventilators - Part 1: Particular requirements for critical care ventilators |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| 07/30147572 DC : DRAFT SEP 2007 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| CSA ISO 5367 : 2014 | BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ISO 5362:2006 | Anaesthetic reservoir bags |
| CSA Z5361 : 2003 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| DIN EN 794-3:2009-12 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators; German version EN 794-3:1998+A2:2009 |
| ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| BS EN 868-1:1997 | Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods |
| BS EN 12439:1999 | Sterile rectal catheters for single use |
| EN 1282-1 : 1996 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - TUBES FOR USE IN ADULTS |
| EN 12439:1998 | Sterile rectal catheters for single use |
| DIN EN ISO 25539-1:2017-09 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| EN 1615:2000 | Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing |
| EN 60601-2-12:2006 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| UNE-EN 794-3:1999 | LUNG VENTILATORS. PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS. |
| UNE-EN 13544-1:2007 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| EN 29002 : 1994 | QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN PRODUCTION & INSTALLATION |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| EN 29001 : 1994 | QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION & SERVICING |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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