BS EN 556-1:2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 medical devices. Requirements for medical devices to be designated \'STERILE\' Part 1. Requirements for terminally sterilized medical devices
Hardcopy , PDF
07-03-2024
English
11-30-2006
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CH/198
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| DevelopmentNote |
Supersedes 99/565209 DC and BS EN 556 (12/2001)
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| DocumentType |
Standard
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| Pages |
12
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| PublisherName |
British Standards Institution
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated \'STERILE\'. Part2 of 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), 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 EN550 , EN552 , EN554 , EN ISO14160 and EN ISO14937.
| Standards | Relationship |
| NBN EN 556-1 : 2001 COR 2006 | Identical |
| SN EN 556-1 : 2001 CORR 2006 | Identical |
| NF EN 556-1 : 2002 | Identical |
| NEN EN 556-1 : 2001 C1 2006 | Identical |
| DIN EN 556-1:2002-03 | Identical |
| NS EN 556-1 : 2002 AC 2006 | Identical |
| UNE-EN 556-1:2002 | Identical |
| I.S. EN 556-1:2002 | Identical |
| UNI EN 556-1 : 2002 | Identical |
| EN 556-1:2001 | Identical |
| ONORM EN 556-1 : 2006 | Identical |
| EN 556-1:2001/AC:2006 | Identical |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| 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 |
| ISO 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| EN ISO 13488 : 2000 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| 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 |
| EN ISO 9002:1994/AC:1997 | QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| 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) |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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