DIN EN ISO 11135:2014-10
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
Available format(s)
Hardcopy , PDF
Withdrawn date
01-30-2021
Language(s)
German, English
Published date
10-01-2014
This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
| Committee |
TC 198
|
| DevelopmentNote |
Supersedes DIN EN ISO 11135-1 & DIN ISO/TS 11135-2. (10/2014) DRAFT AMD 1 issued in September 2017. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
92
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 11135:2014 | Identical |
| ISO 11135:2014 | Identical |
| DIN EN ISO 1135-3:2014-12 (Draft) | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
| DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| DIN EN ISO 7199:2015-06 (Draft) | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
| DIN EN ISO 11070:2015-03 | STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014) |
| DIN EN ISO 1135-5:2016-06 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
| DIN EN ISO 1135-4:2016-06 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| DIN EN ISO 16672:2015-12 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| VDI/VDE 3516 Blatt 2:1981-07 | Process analytical equipment for fluids |
| DIN EN ISO 5840-1:2015-12 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
| DIN EN ISO 8536-10:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
| DIN EN ISO 8536-9:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
| DIN EN ISO 7198:2017-07 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| DIN EN ISO 8536-11:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| DIN HDBK 169 : 6ED 2015 | |
| DIN EN ISO 11138-1:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
| DIN EN ISO 11138-2:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017) |
| DIN EN ISO 8536-8:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |
| DIN EN ISO 5840:2009-08 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| 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) |
| 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 |
| DIN EN ISO 15883-4:2016-07 (Draft) | WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES |
| AS/NZS 4187:2014 | Reprocessing of reusable medical devices in health service organisations |
| AAMI ST41 : 2008 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| DIN EN ISO 10993-7:2009-02 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
| 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 |
| DIN EN ISO 15883-7:2016-10 | WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016) |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| DIN EN ISO 17664:2016-06 (Draft) | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 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 |
| DIN EN ISO 14001:2015-11 | ENVIRONMENTAL MANAGEMENT SYSTEMS - REQUIREMENTS WITH GUIDANCE FOR USE (ISO 14001:2015) |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| DIN EN ISO 14161:2010-03 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| DIN EN ISO 11138-2:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017) |
| DIN EN ISO 14040:2009-11 | Environmental management - Life cycle assessment - Principles and framework (ISO 14040:2006); German and English version EN ISO 14040:2006 |
| AAMI TIR28 : 2016 | PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| AAMI TIR15 : 2016 | PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
| DIN EN ISO 15883-2:2009-09 | WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC. |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| 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 |
| DIN EN ISO 11607-2:2014-11 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014) |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| DIN EN ISO 11737-2:2010-04 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
| DIN EN ISO 9000:2015-11 | QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015) |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| DIN EN ISO 22442-2:2016-05 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015) |
| 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 |
| DIN EN ISO 11138-1:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
| DIN EN ISO 22442-3:2008-03 | 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 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| DIN EN ISO 9001:2015-11 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
| DIN EN 61010-1 : 2011 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| 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 |
| DIN EN ISO 15883-1:2014-10 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014) |
| DIN EN ISO 11737-1:2009-09 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
| 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 |
| DIN EN ISO 15883-6:2016-04 | Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011) |
| 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 |
| DIN EN ISO 11140-1:2015-03 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
| DIN EN ISO 22442-1:2016-05 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| 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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Hardcopy - German
PDF - German
Hardcopy - English
PDF - English
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