Committee
|
CTN 111 |
Development Note
|
Supersedes UNE EN 46001. (08/2003) Supersedes UNE EN ISO 13488 (03/2004) Supersedes UNE EN 46003. (08/2009) |
Document Type
|
Standard |
ISBN
|
|
Pages
|
|
Published
|
|
Publisher
|
Asociacion Espanola de Normalizacion
|
Status
|
Superseded |
Superseded By
|
|
Supersedes
|
|
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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