UNE-EN ISO 13485:2016
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Amended by
Available format(s)
Hardcopy , PDF
Superseded date
07-25-2018
Superseded by
Published date
05-25-2016
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 46001. (08/2003) Supersedes UNE EN ISO 13488 (03/2004) Supersedes UNE EN 46003. (08/2009)
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| DocumentType |
Standard
|
| Pages |
68
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 13485:2016 | Identical |
| BS EN ISO 13485:2016 | Identical |
| UNI EN ISO 13485 : 2004 | Identical |
| I.S. EN ISO 13485:2016 | Identical |
| NEN EN ISO 13485 : 2016 C11 2017 | Identical |
| NBN EN ISO 13485 : 2016 | Identical |
| NF EN ISO 13485 : 2016 | Identical |
| SN EN ISO 13485:2016 | Identical |
| ISO 13485:2016 | Identical |
| DIN EN ISO 13485:2016-08 | Identical |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| 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 |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
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