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About This Item
Full Description
Cross References: ISO 8402:1994*EN ISO 8402:1995*ISO 9002:1994 *EN ISO 9002:1994*ISO 8402:1994*ISO 9002:1994 *ISO 11137:1995*
Replaces BS EN 46002:1997 which remains current.
Replaced by BS EN ISO 13485:2003 but remains current.
Document History
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BS EN ISO 13485:2016+A11:2021
Medical devices. Quality management systems. Requirements for regulatory purposes- Most Recent
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BS EN ISO 13485:2016
Medical devices. Quality management systems. Requirements for regulatory purposes- Historical Version
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BS EN ISO 13485:2012
Medical devices. Quality management systems. Requirements for regulatory purposes- Historical Version
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BS EN ISO 13485:2003
Medical devices. Quality management systems. Requirements for regulatory purposes- Historical Version
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BS EN ISO 13488:2001
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Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002- Historical Version
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BS EN ISO 13485:2001
Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001- Historical Version
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BS EN 46003:1999
Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003- Historical Version
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BS EN 46002:1997
Specification for application of EN ISO 9002 to the manufacture of medical devices- Historical Version
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BS EN 46001:1997
Specification for application of EN ISO 9001 to the manufacture of medical devices- Historical Version
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BS EN 46002:1994
Application of EN 29002 (BS 5750:Part 2) to the manufacture of medical devices- Historical Version
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BS EN 46001:1994
Application of EN 29001 (BS 5750:Part 1) to the manufacture of medical devices- Historical Version