EN ISO 11135-1:2007
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
Superseded date
01-07-2014
Superseded by
Published date
01-05-2007
Publisher
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement - Control
of nonconforming product
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Material effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 Process characterization
6.2 Equipment characterization
7 Product definition
7.1 General
7.2 Product safety and performance
7.3 Microbiological quality
7.4 Documentation
8 Process definition
9 Validation
9.1 Installation qualification
9.2 Operational qualification
9.3 Performance qualification
9.4 Varying load configurations
9.5 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment
12.3 Requalification
12.4 Assessment of change
Annex A (normative) Determination of lethal rate of the
sterilization process - Biological
indicator/bioburden approach
Annex B (normative) Conservative determination of lethal
rate of the sterilization process -
Overkill approach
Annex C (informative) General guidance
Annex ZA (informative) Relationship between this European
Standard and the Essential
Requirements of EU Directive
93/42/EEC Medical devices
Bibliography
Describes requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
| Committee |
CEN/TC 204
|
| DevelopmentNote |
Supersedes EN 550. (06/2007)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NS EN ISO 11135-1 : 1ED 2007 | Identical |
| DIN EN ISO 11135-1:2007-08 | Identical |
| BS EN ISO 11135-1:2007 | Identical |
| I.S. EN ISO 11135-1:2007 | Identical |
| SN EN ISO 11135-1 : 2007 | Identical |
| NF EN ISO 11135-1 : 2007 | Identical |
| NEN EN ISO 11135-1 : 2007 | Identical |
| UNI EN ISO 11135-1 : 2008 | Identical |
| PN EN ISO 11135-1 : 2009 | Identical |
| UNE-EN ISO 11135-1:2007 | Identical |
| ISO 11135-1:2007 | Identical |
| NBN EN ISO 11135-1 : 2007 | Identical |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 11/30252448 DC : 0 | BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| DIN EN 1642:2012-06 | Dentistry - Medical devices for dentistry - Dental implants |
| UNE-EN ISO 16672:2016 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| EN 12182:2012 | Assistive products for persons with disability - General requirements and test methods |
| EN 13544-1:2007+A1:2009 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| PREN 1422 : DRAFT 2011 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| PREN 12182 : 2009-06 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| DIN EN 1639:2010-02 | Dentistry - Medical devices for dentistry - Instruments |
| DIN EN 12182:2012-07 | Assistive products for persons with disability - General requirements and test methods |
| BS EN 45502-1:2015 | Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer |
| BS EN 1639:2009 | Dentistry. Medical devices for dentistry. Instruments |
| I.S. EN 12182:2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| I.S. EN 1642:2011 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| I.S. EN 1639:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| I.S. EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| UNI EN 1642 : 2012 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| VDI/VDE 3516 Blatt 2:1981-07 | Process analytical equipment for fluids |
| PREN 556-2 : DRAFT 2014 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 08/30184602 DC : DRAFT SEP 2008 | BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| 09/30201992 DC : 0 | BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| 08/30184615 DC : DRAFT SEP 2008 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| 12/30254927 DC : 0 | BS EN 16372 - AESTHETIC SURGERY SERVICES |
| I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| DIN EN 13544-1:2009-12 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| I.S. EN 13544-1:2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| UNI EN 1639 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| UNI EN 13544-1 : 2009 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNI EN 12182 : 2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| 13/30233325 DC : 0 | BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| I.S. EN ISO 15798:2013 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| BS EN 60601-1 : 2006 | MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| BS EN 13544-1 : 2007 | RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
| UNE-EN 1642:2012 | Dentistry - Medical devices for dentistry - Dental implants |
| BS EN 12182:2012 | Assistive products for persons with disability. General requirements and test methods |
| EN 1642:2011 | Dentistry - Medical devices for dentistry - Dental implants |
| EN 1639:2009 | Dentistry - Medical devices for dentistry - Instruments |
| PREN 45502-1 : DRAFT 2013 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| 14/30273161 DC : 0 | BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED ''STERILE'' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| BS EN 1642:2011 | Dentistry. Medical devices for dentistry. Dental implants |
| EN 45502-1 : 2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| UNE-EN 13544-1:2007 | Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
| IEC 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO 14971:2007 | 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 |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| ISO 14040:2006 | Environmental management Life cycle assessment Principles and framework |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| 1994/9/EC : 1994 | DIRECTIVE 94/9/EC OF THE EUROPEAN PARLIAMENT AND THE COUNCIL OF 23 MARCH 1994 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES |
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