DIN EN ISO 14937:2010-03
Current
Current
The latest, up-to-date edition.
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 14937:2009)
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
01-03-2010
€162.43
Excluding VAT
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Standards | Relationship |
| ISO 14937:2009 | Identical |
| NEN EN ISO 14937 : 2009 | Identical |
| EN ISO 14937:2009 | Identical |
| NBN EN ISO 14937 : 2009 | Identical |
| NF EN ISO 14937 : 2009 | Identical |
| BS EN ISO 14937:2009 | Identical |
| I.S. EN ISO 14937:2009 | Identical |
| NS EN ISO 14937 : 2009 | Identical |
| 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/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 14160:2011 | Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| VDE 0411-2-040 : 2016 | 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 (IEC 61010-2-040:2015) |
| 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 |
| DIN EN ISO 14001:2015-11 | Environmental management systems - Requirements with guidance for use (ISO 14001:2015); German and English version EN ISO 14001:2015 |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| 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 |
| ISO 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11140-1:2014 | Sterilization of health care products — Chemical indicators — Part 1: General requirements |
| ISO 9004:2009 | Managing for the sustained success of an organization — A quality management approach |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| 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 |
| 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 |
| DIN EN ISO 11138-1:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
| 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 14161:2009 | Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results |
| DIN EN ISO 9001 E : 1994 | QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING |
| 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 61010-2-040 : 2016 | 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 (IEC 61010-2-040:2015) |
| 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 |
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