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AAMI QSR : 1996

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

QUALITY SYSTEM REGULATION (21 CFR PARTS 808, 812 AND 820) - OCTOBER 1996

Available format(s)

Hardcopy , PDF

Withdrawn date

17-01-1996

Language(s)

English

Published date

01-01-1996

€34.10
Excluding VAT

Provides the framework for device manufacturers to follow and gives them greater flexibility in achieving quality requirements.

DocumentType
Standard
Pages
62
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Withdrawn

EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO 9001:2015 Quality management systems — Requirements

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