Comment Closes On
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Committee
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CH/212 |
Document Type
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Draft |
ISBN
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Pages
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Published
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|
Publisher
|
British Standards Institution
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Status
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Superseded |
Superseded By
|
|
IEC 61025:2006
|
Fault tree analysis (FTA) |
ISO 19011:2011
|
Guidelines for auditing management systems |
ISO 14698-2:2003
|
Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data |
IEC 60812:2006
|
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
ISO 10012-2:1997
|
Quality assurance for measuring equipment Part 2: Guidelines for control of measurement processes |
ISO 14644-2:2015
|
Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
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 8402:1994
|
Quality management and quality assurance — Vocabulary |
ISO 14698-1:2003
|
Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
ISO/IEC Guide 51:2014
|
Safety aspects Guidelines for their inclusion in standards |
ISO 9004:2009
|
Managing for the sustained success of an organization A quality management approach |
ISO 14001:2015
|
Environmental management systems — Requirements with guidance for use |
ISO 10012:2003
|
Measurement management systems — Requirements for measurement processes and measuring equipment |
ISO 14644-1:2015
|
Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
ISO 9001:2015
|
Quality management systems — Requirements |
ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary |
ISO/IEC Guide 2:2004
|
Standardization and related activities General vocabulary |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
IEC 60601-1-4:1996+AMD1:1999 CSV
|
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
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