BS EN 556-1:2001
BS EN 556-1:2001 specifies the requirements for a terminally-sterilized medical device to bedesignated STERILE. Part 2 of BS EN 556-1:2001 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), designation of a medical device as STERILE is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.
A sterile product item is one which is free of viable micro-organisms. European Standards for medicaldevices require, when it is necessary to supply a sterile product item, that adventitious microbiologicalcontamination of a medical device from all sources is minimized by all practical means. Even so, productitems produced under standard manufacturing conditions in accordance with their requirements for qualitysystems for medical devices (see EN ISO 13485:2000 or EN ISO 13488:2000) may, prior to sterilization,have micro-organisms on them, albeit in low numbers. Such product items are non-sterile. The purpose ofsterilization processing is to inactivate the microbiological contaminants and thereby transform thenon-sterile items into sterile ones.
The inactivation of a pure culture of micro-organisms by physical and/or chemical agents used to sterilizemedical devices often approximates to an exponential relationship; inevitably this means that, regardless ofthe extent of treatment applied, there is always a finite probability that a micro-organism will survive. For agiven treatment, the probability of survival is determined by the number and resistance of micro-organismsand by the environment in which the organisms exist during treatment. It follows that the sterility of any oneitem subjected to sterilization processing cannot be guaranteed and the sterility of the processed items has tobe defined in terms of the probability of the existence of a surviving micro-organism on/in an item. Thestandards for quality management systems recognize that there are processes used which cannot be fullyverified by subsequent inspection and testing of product. Sterilization is an example of such a process.Sterilization processes have to be validated before use, the performance of the process monitored routinelyand the equipment maintained.
It is important to be aware that exposure to a properly validated and accurately controlled sterilization processis not the only factor associated with the provision of assurance that the product item is sterile and, in thisrespect, suitable for its intended use. Attention has also to be given to a number of factors including themicrobiological status (bioburden) of incoming raw materials and/or components, their subsequent storageand to the control of the environment in which the product is manufactured, assembled and packaged.
Cross References:
EN ISO 13485:2000
EN ISO 9001
EN ISO 13488:2000
ISO 13485:1996
ISO 13488:1996
EN ISO 9001:1994
ISO 9001
EN ISO 9002:1994
ISO 9002:1994
EN 550
EN 552
EN 554
EN 980
EN ISO 14971:2000
ISO 14971:2000
EN ISO 14160:1998
EN ISO 14937:2000
ISO 14937:2000
90/385/EC
93/42/EC
98/79/EC
Keywords: Medical equipment; Medical instruments; Sterile equipment; Sterilization (hygiene); Quality assurance; Quality control; Marking ; Microorganisms
Product Code(s): 30158296,30158296
- This product references:ISO 9001:2000 - Quality management systems -- Requirements
BS EN ISO 9001:1994 - Quality systems. Model for quality assurance in design, development, production, installation and servicing
BS EN ISO 9002:1994 - Quality systems. Model for quality assurance in production, installation and servicing
BS EN ISO 14160:1998 - Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid chemical sterilants
ISO 13485:1996 - Quality systems - Medical devices - Particular requirements for the application of ISO 9001
ISO 14937:2000 - 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 13488:1996 - Quality systems - Medical devices - Particular requirements for the application of ISO 9002
ISO 14971:2000 - Medical devices -- Application of risk management to medical devices
This product referenced by:BS 09/30176675 DC - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 980:2003 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 1733:2002 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 13060:2004 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN ISO 11137-1:2006 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN ISO 8836:2009 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 285:2006 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 1820:2005 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS 06/30122245 DC - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 980:2008 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 285:2006 A1:2008 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN ISO 15223-1:2012 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 13060:2004 A1:2009 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 13060:2004 A2:2010 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS 10/30232509 DC - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 1282-2:2005 A1:2009 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 1820:2005 A1:2009 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN 285:2006 A2:2009 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN ISO 5364:2011 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN ISO 15223-1:2012 (CD-ROM) - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS EN ISO 5361:2012 - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
BS 12/30261215 DC - Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for terminally sterilized medical devices
This product replaces:BS EN 556:1995 - Sterilization of Medical Devices - Requirements for Terminally-Sterilized Devices to be Labeled 'Sterile'
BS EN 556-1:2001
BS EN 556:1995
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BS EN 1041:2008- Information supplied by the manufacturer of medical devicesBS EN 980:2008- Symbols for use in the labelling of medical devicesBS EN 556-2:2003- Sterilization of medical devices. Requirements for medical devices to be designated STERILE. Requirements for aseptically processed medical devicesBS EN 1041:1998- Information supplied by the manufacturer with medical devicesBS EN 980:2003- Graphical symbols for use in the labelling of medical devicesBS EN ISO 11607-1:2006- Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systemsBS EN ISO 17665-1:2006- Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices ASTM F1980-07- Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical DevicesBS EN 1422:1998- Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methodsISTA 2A- ISTA Preshipment Testing Procedures - Combination Tests for packaged-products weighing 150 lbs. (68kg) or less
