BS EN 556-2:2015
Current
The latest, up-to-date edition.
Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices
Hardcopy , PDF
English
30-09-2015
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 90/385/EEC on
active implantable medical devices
Annex ZB (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC on
medical devices
Annex ZC (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 98/79/EC on in
vitro diagnostic medical devices
Bibliography
Describes the requirements for an aseptically processed medical device to be designated 'STERILE'.
This European Standard specifies the requirements for an aseptically processed medical device to be designated \'STERILE\'. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is \'STERILE\' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes 02/560165 DC (02/2004) Supersedes 14/30273161 DC. (09/2015)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NBN EN 556-2 : 2015 | Identical |
| EN 556-2:2015 | Identical |
| DIN EN 556-2:2015-11 | Identical |
| NEN EN 556-2 : 2015 | Identical |
| UNI EN 556-2 : 2005 | Identical |
| UNE-EN 556-2:2016 | Identical |
| SN EN 556-2 : 2015 | Identical |
| NS EN 556-2 : 2003 | Identical |
| NF EN 556-2 : 2015 | Identical |
| I.S. EN 556-2:2015 | Identical |
| ISO 13408-4:2005 | Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| EN 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 11737-2:2009) |
| 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 13408-7:2012 | Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products |
| EN 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 14937:2009) |
| 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 |
| EN ISO 13408-3:2011 | Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) |
| EN ISO 13408-4:2011 | Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
| ISO 11135:2014 | Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
| EN ISO 13408-5:2011 | Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
| ISO 13408-2:2003 | Aseptic processing of health care products Part 2: Filtration |
| 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/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| EN ISO 13408-1:2015 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| 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 25424:2009 | Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
| CEN ISO/TS 17665-2:2009 | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |
| EN ISO 11135:2014 | 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) |
| ISO 13408-3:2006 | Aseptic processing of health care products Part 3: Lyophilization |
| EN ISO 25424:2011 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) |
| EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| EN ISO 13408-6:2011/A1:2013 | ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013) |
| 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) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN ISO 20857:2013 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) |
| ISO 13408-6:2005 | Aseptic processing of health care products Part 6: Isolator systems |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| EN ISO 11137-3:2017 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017) |
| EN 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 (ISO 14160:2011) |
| 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 13408-5:2006 | Aseptic processing of health care products Part 5: Sterilization in place |
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